M E D I C A L L A B O R A T O R Y E VVV AAA LLL UUU ......B-Type Natriuretic Peptide (BNP) 3 SD...

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MEDICAL LABORATORY E E V V A A L L U U A A T T I I O O N N PARTICIPANT SUMMARY 2 • 0 • 1 • 1 Chemistry MLE M1 Total Commitment to Education and Service Provided by ACP, Inc.

Transcript of M E D I C A L L A B O R A T O R Y E VVV AAA LLL UUU ......B-Type Natriuretic Peptide (BNP) 3 SD...

Page 1: M E D I C A L L A B O R A T O R Y E VVV AAA LLL UUU ......B-Type Natriuretic Peptide (BNP) 3 SD Parathyroid Hormone 3 SD Beta-2 Microglobulin 3 SD Phenobarbital 20% Bilirubin, Direct

M E D I C A L L A B O R A T O R Y

EEE VVV AAA LLL UUU AAA TTT III OOO NNN

PARTICIPANT SUMMARY

2 • 0 • 1 • 1

Chemistry

MLE – M1

Total Commitment to Education and Service

Provided by ACP, Inc.

Page 2: M E D I C A L L A B O R A T O R Y E VVV AAA LLL UUU ......B-Type Natriuretic Peptide (BNP) 3 SD Parathyroid Hormone 3 SD Beta-2 Microglobulin 3 SD Phenobarbital 20% Bilirubin, Direct

2/ 2011 MLE-M1 Participant Summary

Table of Contents 2011 Evaluation Criteria .................................................. 3 Glycohemoglobin (Specimens AFN-1 and AFN-2) ........ 97

Glycohemoglobin (Specimens GH-1 and GH-2) ........... 96

Acetaminophen ............................................................... 87 HCG, Serum—Qualitative ............................................. 74

Acetone ......................................................................... 108 HCG, Serum—Quantitative ........................................... 76

Albumin ............................................................................. 9 Hematocrit ...................................................................... 7

Alcohol, Serum .............................................................. 107 Hemoglobin ..................................................................... 7

Alkaline Phosphatase ...................................................... 54 HDL Cholesterol ............................................................ 81

Alpha-fetoprotein ........................................................... 102 Homocysteine ............................................................. 106

ALT (SGPT) ..................................................................... 51 Insulin ........................................................................... 99

Amikacin .......................................................................... 87 Iron ................................................................................ 25

Ammonia ....................................................................... 118 Lactate Dehydrogenase ................................................ 66

Amylase........................................................................... 64 LDL Cholesterol, Calculated ......................................... 80

Anti-Microsomal Antibody .............................................. 108 LDL Cholesterol, Direct ................................................. 80

Anti-Thyroglobulin Antibody ........................................... 108 LH ............................................................................... 106

Apolipoprotein A1 ............................................................ 92 Lipase ........................................................................... 67

Apolipoprotein B .............................................................. 92 Lithium .......................................................................... 89

AST (SGOT) .................................................................... 57 Magnesium ................................................................... 26

B-Type Natriuretic Peptide (BNP) .................................... 97 Myoglobin (Quantitative) ............................................. 100

B-Type Natriuretic Peptide (NT-proBNP)......................... 97 Myoglobin (Qualitative) ............................................... 101

Beta-2 Microglobulin ...................................................... 102 Parathyroid Hormone .................................................... 99

Bilirubin, Direct (Specimens CH-1 and CH-2) .................. 12 Phenobarbital ................................................................ 89

Bilirubin, Direct (Specimens NB-1 and NB-2) .................. 93 Phenytoin ...................................................................... 90

Bilirubin, Neonatal (Total) ................................................ 93 Phosphorus ................................................................... 28

Bilirubin, Total .................................................................. 13 Potassium (Specimens CH-1 through CH-5) ................ 42

Blood Gases .................................................................... 93 Potassium (Specimens IST-1 through IST-5) ................. 4

Blood Oximetry .............................................................. 120 Progesterone .............................................................. 106

C-Peptide ........................................................................ 99 Prolactin ...................................................................... 106

CA 125 .......................................................................... 102 Protein, Total................................................................. 29

CA 15-3 ......................................................................... 103 PSA (Specimens PS-1 and PS-2) ............................... 102

CA 19-9 ......................................................................... 103 PSA (Specimens TM-1 and TM-2) .............................. 104

CA 27/29 ....................................................................... 103 PSA, Free ................................................................... 104

Calcium ........................................................................... 16 Salicylate ...................................................................... 90

Calcium, Ionized (IST-1 through IST-5) ............................. 8 Sodium (Specimens CH-1 through CH-5) ..................... 45

Carbamazepine ............................................................... 87 Sodium (Specimens IST-1 through IST-5) ...................... 4

Cardiac Panel (Biosite Triage) ......................................... 97 T Uptake (Uptake Units) ............................................... 69

CEA (Specimens SC-1 and SC-2) ................................. 104 T3, Free ......................................................................... 70

CEA (Specimens TM-1 and TM-2) ................................ 103 T3 Uptake (% Uptake) ................................................... 68

Chloride (Specimens CH-1 through CH-5) ...................... 38 Testosterone ............................................................... 106

Chloride (Specimens IST-1 through IST-5) ....................... 5 Theophylline.................................................................. 91

Cholesterol, Total ............................................................ 77 Thyroglobulin .............................................................. 104

CK-MB (Qualitative) ...................................................... 100 Thyroxine, Free ............................................................. 71

CK-MB (Quantitative) .................................................... 100 Thyroxine, Total T4 ........................................................ 70

CO2 (Specimens CH-1 through CH-5) ............................. 41 TIBC, Calculated ........................................................... 48

CO2 (Specimens IST-1 through IST-5) .............................. 5 TIBC, Direct .................................................................. 49

Cortisol ............................................................................ 68 Transferrin .................................................................. 107

Creatine Kinase ............................................................... 60 Triglycerides.................................................................. 84

Creatinine (Specimens CH-1 through CH-5) ................... 19 Triiodothyronine, Total T3 .............................................. 69

Creatinine (Specimens IST-1 through IST-5) .................... 8 Troponin I (Qualitative) ............................................... 101

Digoxin ............................................................................ 88 Troponin I (Quantitative) ............................................. 101

Estradiol ........................................................................ 104 Troponin T .................................................................. 101

Ferritin ........................................................................... 105 TSH ............................................................................... 72

Folate ............................................................................ 105 UIBC ............................................................................. 50

Fructosamine ................................................................. 119 Urea Nitrogen (Specimens CH-1 through CH-5) ........... 32

FSH ............................................................................... 105 Urea Nitrogen (Specimens IST-1 through IST-5) ............ 6

Gentamicin ...................................................................... 88 Uric Acid ....................................................................... 35

GGT ................................................................................ 63 Urine Drug Screen ...................................................... 108

Glucose, Whole Blood (Specimens WBG-1 Valproic Acid ................................................................. 91

through WBG-5) ....................................................... 118 Vancomycin .................................................................. 92

Glucose, Serum (Specimens CH-1 through CH-5) .......... 22 Vitamin B12 .................................................................. 107

Glucose (Specimens IST-1 through IST-5)........................ 6 Vitamin D ...................................................................... 99

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2011 MLE-M1 Participant Summary/ 3

2011 EVALUATION CRITERIA For quantitative procedures, a mean and standard deviation (SD) are calculated for each peer group. Acceptable

performance is established on a target value mean the limits listed below. Acetaminophen 3 SD Homocysteine 3 SD Acetone 80% Consensus Insulin 3 SD Albumin 10% Iron 20% Alcohol 25% LDL Cholesterol 3 SD Alpha-fetoprotein 3 SD Lactate Dehydrogenase 20% Alkaline Phosphatase 30% LDL Cholesterol 3 SD ALT (SGPT) 20% Lipase 3 SD Amikacin 3 SD LH 3 SD Ammonia 3 SD Lithium 0.3 mmol/L or 20% * Amylase 30% Magnesium 25% Anti-Microsomal Antibody 3 SD Methemoglobin 3 SD Anti-Thyroglobulin Antibody 3 SD Myoglobin (Qualitative) 80% Consensus

Apoliprotein A1 3 SD Myoglobin (Quantitative) 3 SD Apoliprotein B 3 SD Oxyhemoglobin 3 SD AST (SGOT) 20% O2 Saturation 3 SD B-Type Natriuretic Peptide (BNP) 3 SD Parathyroid Hormone 3 SD Beta-2 Microglobulin 3 SD Phenobarbital 20% Bilirubin, Direct 3 SD Phenytoin 25% Bilirubin, Total 0.4 mg/dL or 20% * Phosphorus 3 SD Bilirubin, Neonatal (Total) 0.4 mg/dL or 20% * Potassium 0.5 mmol/L C-Peptide 3 SD Progesterone 3 SD

CA 125 3 SD Prolactin 3 SD CA 15-3 3 SD Protein, Total 10% CA 19-9 3 SD PSA 3 SD CA 27/29 3 SD PSA, Free 3 SD Calcium 1.0 mg/dL pCO2 5 mmHg or 8% * Calcium, Ionized 3 SD pH 0.04 Carbamazepine 25% pO2 3 SD Carboxyhemoglobin 3 SD Salicylate 3 SD CEA 3 SD Sodium 4.0 mmol/L Chloride 5% T Uptake (Uptake Units) 3 SD Cholesterol 10% T3 Uptake (% Uptake) 3 SD CK-MB (Qualitative) 80% Consensus T3, Free 3 SD CK-MB (Quantitative) 3 SD T4, Free 3 SD CO2 3 SD Testosterone 3 SD Cortisol 25% Theophylline 25% Creatine Kinase 30% Thyroglobulin 3 SD Creatinine 0.3 mg/dL or 15% * Thyroxine, Total T4 1.0 mcg/dL or 20% * D-Dimer 3 SD TIBC 3 SD Digoxin 0.2 mg/dL or 20% * Transferrin 3 SD Estradiol 3 SD Triglyceride 25% Ferritin 3 SD Triiodothyronine, Total T3 3 SD Folate 3 SD Troponin I (Qualitative) 80% Consensus

Fructosamine 3 SD Troponin I (Quantitative) 3 SD FSH 3 SD Troponin T (Qualitative) 80% Consensus

Gentamicin 25% TSH 3 SD GGT 3 SD UIBC 3 SD Glucose, Serum 6 mg/dL or 10% * Urea Nitrogen 2.0 mg/dL or 9% * Glucose, Whole Blood 3 SD Uric Acid 17% Glycohemoglobin 3 SD Urine Drug Screen 80% Consensus

HDL Cholesterol 30% Valproic Acid 25% HCG, Serum—Qualitative 80% Consensus Vancomycin 3 SD HCG, Serum—Quantitative 3 SD Vitamin B12 3 SD Hematocrit 6% Vitamin D 3 SD Hemoglobin 7% *Whichever is greater

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4/ 2011 MLE-M1 Participant Summary

Sodium (mmol/L)

Specimen IST-1 Specimen IST-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 72 138.9 1.0 0.7 139 134 - 143 71 110.2 0.6 0.6 110 106 - 115 All i-STAT Instruments 72 138.9 1.0 0.7 139 134 - 143 71 110.2 0.6 0.6 110 106 - 115 i-STAT - moderate 16 138.9 1.2 0.9 139 134 - 143 15 110.5 0.7 0.7 111 106 - 115 i-STAT - waived 54 139.0 0.8 0.6 139 135 - 144 55 110.1 0.5 0.5 110 106 - 115

Specimen IST-3 Specimen IST-4

All Method 56 121.9 0.8 0.6 122 117 - 126 55 148.9 1.1 0.8 149 144 - 153 All i-STAT Instruments 56 121.9 0.8 0.6 122 117 - 126 55 148.9 1.1 0.8 149 144 - 153 i-STAT - moderate 13 122.4 0.7 0.5 122 118 - 127 13 149.7 0.9 0.6 150 145 - 154 i-STAT - waived 42 121.7 0.6 0.5 122 117 - 126 43 148.6 1.2 0.8 148 144 - 153

Specimen IST-5 All Method 55 165.1 1.4 0.9 165 161 - 170 All i-STAT Instruments 55 165.1 1.4 0.9 165 161 - 170 i-STAT - moderate 12 165.8 1.3 0.8 166 161 - 170 i-STAT - waived 43 164.9 1.4 0.9 165 160 - 169

Potassium (mmol/L)

Specimen IST-1 Specimen IST-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 73 4.37 0.04 1.0 4.4 3.8 - 4.9 66 2.40 0.00 0.0 2.4 1.9 - 2.9 All i-STAT Instruments 73 4.37 0.04 1.0 4.4 3.8 - 4.9 66 2.40 0.00 0.0 2.4 1.9 - 2.9 i-STAT - moderate 15 4.35 0.05 1.2 4.3 3.8 - 4.9 14 2.40 0.00 0.0 2.4 1.9 - 2.9 i-STAT - waived 58 4.38 0.04 0.9 4.4 3.8 - 4.9 58 2.39 0.03 1.3 2.4 1.8 - 2.9

Specimen IST-3 Specimen IST-4

All Method 51 2.90 0.00 0.0 2.9 2.4 - 3.4 57 5.33 0.06 1.2 5.3 4.8 - 5.9 All i-STAT Instruments 51 2.90 0.00 0.0 2.9 2.4 - 3.4 57 5.33 0.06 1.2 5.3 4.8 - 5.9 i-STAT - moderate 13 2.90 0.00 0.0 2.9 2.4 - 3.4 13 5.32 0.06 1.1 5.3 4.8 - 5.9 i-STAT - waived 38 2.90 0.00 0.0 2.9 2.4 - 3.4 44 5.33 0.06 1.2 5.3 4.8 - 5.9

Specimen IST-5 All Method 55 6.91 0.07 1.1 6.9 6.4 - 7.5 All i-STAT Instruments 55 6.91 0.07 1.1 6.9 6.4 - 7.5 i-STAT - moderate 12 6.91 0.09 1.3 6.9 6.4 - 7.5 i-STAT - waived 43 6.92 0.07 1.0 6.9 6.4 - 7.5

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2011 MLE-M1 Participant Summary/ 5

Chloride (mmol/L)

Specimen IST-1 Specimen IST-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 68 107.7 1.5 1.4 108 102 - 114 66 81.2 0.8 1.0 81 77 - 86 All i-STAT Instruments 68 107.7 1.5 1.4 108 102 - 114 66 81.2 0.8 1.0 81 77 - 86 i-STAT - moderate 12 107.8 2.1 2.0 107 102 - 114 11 80.4 2.5 3.2 81 76 - 85 i-STAT - waived 56 107.7 1.3 1.3 108 102 - 114 56 81.2 0.8 1.0 81 77 - 86

Specimen IST-3 Specimen IST-4

All Method 50 88.2 0.7 0.8 88 83 - 93 52 116.6 1.6 1.4 117 110 - 123 All i-STAT Instruments 50 88.2 0.7 0.8 88 83 - 93 52 116.6 1.6 1.4 117 110 - 123 i-STAT - moderate 10 87.7 1.3 1.5 88 83 - 93 10 115.0 1.6 1.4 115 109 - 121 i-STAT - waived 41 88.3 0.6 0.7 88 83 - 93 42 116.9 1.4 1.2 117 111 - 123

Specimen IST-5

All Method 50 120.4 2.4 2.0 120 114 - 127 All i-STAT Instruments 50 120.4 2.4 2.0 120 114 - 127 i-STAT - moderate 9 - - - 119 114 - 127 i-STAT - waived 42 120.7 2.5 2.0 121 114 - 127

CO2 (mmol/L)

Specimen IST-1 Specimen IST-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 54 31.2 0.8 2.7 31 28 - 34 54 15.3 0.9 5.9 15 12 - 19 All i-STAT Instruments 54 31.2 0.8 2.7 31 28 - 34 54 15.3 0.9 5.9 15 12 - 19 i-STAT - waived 50 31.2 0.8 2.7 31 28 - 34 50 15.4 0.9 5.7 15 12 - 19

Specimen IST-3 Specimen IST-4 All Method 39 22.4 0.5 2.4 22 20 - 25 39 29.4 0.5 1.9 29 27 - 32 All i-STAT Instruments 39 22.4 0.5 2.4 22 20 - 25 39 29.4 0.5 1.9 29 27 - 32 i-STAT - waived 36 22.4 0.6 2.5 22 20 - 25 35 29.3 0.5 1.6 29 27 - 31

Specimen IST-5

All Method 39 48.1 1.3 2.7 48 44 - 52 All i-STAT Instruments 39 48.1 1.3 2.7 48 44 - 52 i-STAT - waived 37 48.1 1.3 2.7 48 44 - 53

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6/ 2011 MLE-M1 Participant Summary

Urea Nitrogen (BUN) (mg/dL)

Specimen IST-1 Specimen IST-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 69 10.9 0.6 5.4 11 8 - 13 67 93.8 2.2 2.3 94 85 - 103 All i-STAT Instruments 69 10.9 0.6 5.4 11 8 - 13 67 93.8 2.2 2.3 94 85 - 103 i-STAT - moderate 12 10.4 0.8 7.6 10 8 - 13 11 92.6 6.1 6.6 94 84 - 101 i-STAT - waived 58 11.0 0.5 5.0 11 9 - 14 57 93.7 2.2 2.4 94 85 - 103

Specimen IST-3 Specimen IST-4 All Method 53 46.3 1.3 2.8 46 42 - 51 53 10.4 0.5 5.2 10 8 - 13 All i-STAT Instruments 53 46.3 1.3 2.8 46 42 - 51 53 10.4 0.5 5.2 10 8 - 13 i-STAT - moderate 10 45.5 3.2 7.0 47 41 - 50 10 10.1 1.0 9.8 10 8 - 13 i-STAT - waived 44 46.3 1.3 2.9 46 42 - 51 44 10.5 0.5 4.8 10 8 - 13

Specimen IST-5

All Method 53 8.2 0.6 6.7 8 6 - 11 All i-STAT Instruments 53 8.2 0.6 6.7 8 6 - 11 i-STAT - moderate 9 - - - 8 6 - 11 i-STAT - waived 44 8.3 0.5 5.7 8 6 - 11

Glucose (mg/dL)

Specimen IST-1 Specimen IST-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 70 98.9 3.4 3.4 98 89 - 109 67 500.9 9.3 1.9 503 450 - 552 All i-STAT Instruments 70 98.9 3.4 3.4 98 89 - 109 67 500.9 9.3 1.9 503 450 - 552 i-STAT - moderate 13 101.7 4.5 4.4 101 91 - 112 11 491.9 13.5 2.7 493 442 - 542 i-STAT - waived 54 97.8 2.1 2.1 98 88 - 108 55 503.1 6.8 1.4 504 452 - 554

Specimen IST-3 Specimen IST-4

All Method 54 263.9 3.2 1.2 265 237 - 291 54 61.4 3.0 4.9 60 55 - 68 All i-STAT Instruments 54 263.9 3.2 1.2 265 237 - 291 54 61.4 3.0 4.9 60 55 - 68 i-STAT - moderate 11 262.6 5.1 2.0 262 236 - 289 11 63.6 3.7 5.9 65 57 - 71 i-STAT - waived 43 264.2 2.5 1.0 265 237 - 291 43 60.8 2.5 4.1 60 54 - 67

Specimen IST-5

All Method 52 26.5 2.0 7.5 26 20 - 33 All i-STAT Instruments 52 26.5 2.0 7.5 26 20 - 33 i-STAT - moderate 10 28.2 1.9 6.6 29 22 - 35 i-STAT - waived 42 26.1 1.8 6.9 26 20 - 33

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2011 MLE-M1 Participant Summary/ 7

Hematocrit (percent)

Specimen IST-1 Specimen IST-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 21 39.4 0.9 2.2 39 37 - 42 20 14.8 0.6 4.2 15 13 - 16 All i-STAT Instruments 21 39.4 0.9 2.2 39 37 - 42 20 14.8 0.6 4.2 15 13 - 16 i-STAT - waived 12 39.4 0.7 1.7 40 37 - 42 12 14.7 0.5 3.4 15 13 - 16

Specimen IST-3 Specimen IST-4

All Method 16 21.8 0.6 2.7 22 20 - 24 16 46.7 0.6 1.3 47 43 - 50 All i-STAT Instruments 16 21.8 0.6 2.7 22 20 - 24 16 46.7 0.6 1.3 47 43 - 50 i-STAT - waived 8 - - - 22 20 - 24 8 - - - 47 43 - 50

Specimen IST-5

All Method 16 59.4 0.5 0.9 59 55 - 64 All i-STAT Instruments 16 59.4 0.5 0.9 59 55 - 64 i-STAT - waived 8 - - - 60 55 - 64

Hemoglobin (g/dL)

Specimen IST-1 Specimen IST-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 19 13.38 0.22 1.7 13.3 12.4 - 14.4 18 5.00 0.15 2.9 5.1 4.6 - 5.4 All i-STAT Instruments 19 13.38 0.22 1.7 13.3 12.4 - 14.4 18 5.00 0.15 2.9 5.1 4.6 - 5.4 i-STAT - waived 12 13.42 0.22 1.6 13.6 12.4 - 14.4 12 5.00 0.15 3.0 5.1 4.6 - 5.4

Specimen IST-3 Specimen IST-4

All Method 15 7.39 0.22 3.0 7.5 6.8 - 8.0 15 15.86 0.23 1.5 16.0 14.7 - 17.0 All i-STAT Instruments 15 7.39 0.22 3.0 7.5 6.8 - 8.0 15 15.86 0.23 1.5 16.0 14.7 - 17.0 i-STAT - waived 8 - - - 7.5 6.8 - 8.0 8 - - - 16.0 14.7 - 17.0

Specimen IST-5 All Method 15 20.24 0.15 0.8 20.1 18.8 - 21.7 All i-STAT Instruments 15 20.24 0.15 0.8 20.1 18.8 - 21.7 i-STAT - waived 8 - - - 20.4 18.8 - 21.7

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8/ 2011 MLE-M1 Participant Summary

Creatinine (mg/dL)

Specimen IST-1 Specimen IST-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 83 1.53 0.07 4.3 1.5 1.2 - 1.9 84 8.50 0.40 4.7 8.5 7.2 - 9.8 All i-STAT Instruments 83 1.53 0.07 4.3 1.5 1.2 - 1.9 84 8.50 0.40 4.7 8.5 7.2 - 9.8 i-STAT - moderate 10 1.50 0.00 0.0 1.5 1.2 - 1.8 11 8.36 0.41 4.9 8.4 7.1 - 9.7 i-STAT - waived 72 1.53 0.07 4.4 1.5 1.2 - 1.9 71 8.55 0.35 4.1 8.5 7.2 - 9.9

Specimen IST-3 Specimen IST-4

All Method 53 3.44 0.15 4.3 3.4 2.9 - 4.0 54 0.84 0.06 7.5 0.8 0.5 - 1.2 All i-STAT Instruments 53 3.44 0.15 4.3 3.4 2.9 - 4.0 54 0.84 0.06 7.5 0.8 0.5 - 1.2 i-STAT - moderate 9 - - - 3.3 2.9 - 4.0 9 - - - 0.8 0.5 - 1.2 i-STAT - waived 44 3.45 0.15 4.3 3.5 2.9 - 4.0 45 0.84 0.07 7.8 0.8 0.5 - 1.2

Specimen IST-5 All Method 53 0.58 0.06 10.5 0.6 0.2 - 0.9 All i-STAT Instruments 53 0.58 0.06 10.5 0.6 0.2 - 0.9 i-STAT - moderate 8 - - - 0.6 0.2 - 0.9 i-STAT - waived 45 0.57 0.06 9.8 0.6 0.2 - 0.9

Ionized Calcium (mmol/L)

Specimen IST-1 Specimen IST-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 53 0.951 0.012 1.2 0.95 0.91 - 0.99 53 1.754 0.025 1.4 1.75 1.67 - 1.83 All i-STAT Instruments 53 0.951 0.012 1.2 0.95 0.91 - 0.99 53 1.754 0.025 1.4 1.75 1.67 - 1.83 i-STAT - waived 50 0.951 0.012 1.3 0.95 0.91 - 0.99 51 1.753 0.025 1.4 1.75 1.67 - 1.83

Specimen IST-3 Specimen IST-4

All Method 38 1.311 0.013 1.0 1.31 1.27 - 1.35 37 0.794 0.011 1.4 0.79 0.75 - 0.83 All i-STAT Instruments 38 1.311 0.013 1.0 1.31 1.27 - 1.35 37 0.794 0.011 1.4 0.79 0.75 - 0.83 i-STAT - waived 36 1.310 0.013 1.0 1.31 1.27 - 1.35 35 0.793 0.012 1.5 0.79 0.75 - 0.83

Specimen IST-5

All Method 38 0.510 0.020 3.9 0.51 0.45 - 0.58 All i-STAT Instruments 38 0.510 0.020 3.9 0.51 0.45 - 0.58 i-STAT - waived 37 0.511 0.020 3.9 0.51 0.45 - 0.58

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2011 MLE-M1 Participant Summary/ 9

Albumin (g/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 423 3.64 0.47 12.8 3.9 3.2 - 4.1 422 2.88 0.36 12.5 3.0 2.5 - 3.2 All Bromocresol Green Reagents 273 3.97 0.15 3.9 4.0 3.5 - 4.4 272 3.13 0.11 3.6 3.1 2.8 - 3.5 All Bromocresol Purple Reagents 139 3.03 0.08 2.7 3.0 2.7 - 3.4 135 2.40 0.07 3.1 2.4 2.1 - 2.7 Abaxis Piccolo Abaxis Piccolo - waived 21 3.00 0.09 3.1 3.0 2.7 - 3.4 21 2.46 0.12 4.7 2.5 2.2 - 2.8 Abaxis Piccolo 18 3.01 0.08 2.5 3.0 2.7 - 3.4 17 2.44 0.09 3.5 2.4 2.1 - 2.7 All Chemistry Instruments 40 3.01 0.08 2.8 3.0 2.7 - 3.4 39 2.45 0.10 4.2 2.5 2.2 - 2.7 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 72 3.97 0.11 2.8 4.0 3.5 - 4.4 73 3.19 0.09 2.7 3.2 2.8 - 3.6 Beckman - cartridge Beckman Synchron 11 3.04 0.08 2.7 3.1 2.7 - 3.4 11 2.40 0.06 2.6 2.4 2.1 - 2.7 Beckman Synchron LX/PRo/DxC 18 3.07 0.06 1.9 3.1 2.7 - 3.4 18 2.42 0.06 2.6 2.4 2.1 - 2.7 All Chemistry Instruments 29 3.06 0.07 2.2 3.1 2.7 - 3.4 28 2.40 0.05 2.1 2.4 2.1 - 2.7 Horiba ABX Pentra Horiba ABX Pentra 400 15 3.74 0.12 3.3 3.8 3.3 - 4.2 15 3.02 0.09 3.1 3.0 2.7 - 3.4 Olympus Olympus AU 20 3.96 0.09 2.2 4.0 3.5 - 4.4 20 3.11 0.06 1.8 3.1 2.7 - 3.5 Roche Integra Roche Integra 42 3.97 0.11 2.9 4.0 3.5 - 4.4 42 3.15 0.10 3.2 3.2 2.8 - 3.5 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 3.05 0.07 2.3 3.0 2.7 - 3.4 60 2.39 0.06 2.4 2.4 2.1 - 2.7 Vital Diagnostics Vital Diagnostics ATAC 8000 18 3.84 0.10 2.7 3.9 3.4 - 4.3 19 3.09 0.08 2.7 3.1 2.7 - 3.5 Vital Diagnostics Envoy 500 21 3.98 0.10 2.5 4.0 3.5 - 4.4 21 3.13 0.09 2.7 3.1 2.8 - 3.5 All Chemistry Instruments 39 3.92 0.12 3.1 3.9 3.5 - 4.4 40 3.12 0.09 2.8 3.1 2.8 - 3.5 VITROS VITROS 250,350,500,700,750,950 44 4.08 0.18 4.4 4.1 3.6 - 4.5 44 3.05 0.14 4.4 3.0 2.7 - 3.4 All Chemistry Instruments 49 4.09 0.17 4.2 4.1 3.6 - 4.5 49 3.05 0.13 4.2 3.0 2.7 - 3.4

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10/ 2011 MLE-M1 Participant Summary

Albumin (g/dL) Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 410 4.41 0.54 12.3 4.7 3.9 - 4.9 410 3.30 0.41 12.6 3.5 2.9 - 3.7 All Bromocresol Green Reagents 274 4.76 0.19 4.0 4.8 4.2 - 5.3 272 3.57 0.13 3.6 3.6 3.2 - 4.0 All Bromocresol Purple Reagents 126 3.66 0.10 2.7 3.7 3.2 - 4.1 125 2.73 0.06 2.4 2.7 2.4 - 3.1 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 3.6 3.2 - 4.0 8 - - - 2.7 2.4 - 3.1 Abaxis Piccolo 18 3.60 0.11 3.0 3.6 3.2 - 4.0 18 2.73 0.06 2.2 2.7 2.4 - 3.1 All Chemistry Instruments 27 3.60 0.11 3.2 3.6 3.2 - 4.0 27 2.73 0.06 2.3 2.7 2.4 - 3.1 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 73 4.76 0.12 2.6 4.8 4.2 - 5.3 71 3.59 0.08 2.3 3.6 3.2 - 4.0 Beckman - cartridge Beckman Synchron 11 3.68 0.06 1.6 3.7 3.3 - 4.1 11 2.73 0.06 2.4 2.7 2.4 - 3.1 Beckman Synchron LX/PRo/DxC 18 3.73 0.07 1.8 3.7 3.3 - 4.2 18 2.78 0.06 2.3 2.8 2.5 - 3.1 All Chemistry Instruments 29 3.71 0.07 1.8 3.7 3.3 - 4.1 29 2.76 0.07 2.5 2.7 2.4 - 3.1 Horiba ABX Pentra Horiba ABX Pentra 400 15 4.45 0.11 2.4 4.4 4.0 - 4.9 15 3.41 0.10 3.0 3.4 3.0 - 3.8 Olympus Olympus AU 20 4.75 0.10 2.1 4.8 4.2 - 5.3 20 3.57 0.07 1.9 3.6 3.2 - 4.0 Roche Integra Roche Integra 42 4.75 0.13 2.8 4.8 4.2 - 5.3 42 3.57 0.10 2.9 3.6 3.2 - 4.0 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 3.68 0.07 2.0 3.7 3.3 - 4.1 61 2.72 0.06 2.2 2.7 2.4 - 3.0 Vital Diagnostics Vital Diagnostics ATAC 8000 19 4.67 0.12 2.6 4.7 4.2 - 5.2 19 3.51 0.10 3.0 3.5 3.1 - 3.9 Vital Diagnostics Envoy 500 21 4.75 0.16 3.4 4.7 4.2 - 5.3 21 3.56 0.10 2.7 3.6 3.2 - 4.0 All Chemistry Instruments 39 4.70 0.13 2.7 4.7 4.2 - 5.2 40 3.54 0.10 2.9 3.6 3.1 - 3.9 VITROS VITROS 250,350,500,700,750,950 43 4.94 0.18 3.6 4.9 4.4 - 5.5 44 3.64 0.16 4.5 3.6 3.2 - 4.1 All Chemistry Instruments 48 4.94 0.17 3.5 4.9 4.4 - 5.5 49 3.64 0.16 4.3 3.6 3.2 - 4.1

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2011 MLE-M1 Participant Summary/ 11

Albumin (g/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range

All Method 409 1.44 0.21 14.3 1.5 1.2 - 1.6 All Bromocresol Green Reagents 279 1.56 0.12 7.8 1.6 1.4 - 1.8 All Bromocresol Purple Reagents 126 1.20 0.11 9.6 1.2 1.0 - 1.4 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 1.4 1.2 - 1.6 Abaxis Piccolo 18 1.37 0.08 5.6 1.4 1.2 - 1.6 All Chemistry Instruments 27 1.37 0.07 4.9 1.4 1.2 - 1.6 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 73 1.67 0.05 3.1 1.7 1.5 - 1.9 Beckman - cartridge Beckman Synchron 10 1.20 0.00 0.0 1.2 1.0 - 1.4 Beckman Synchron LX/PRo/DxC 18 1.23 0.06 4.7 1.2 1.1 - 1.4 All Chemistry Instruments 28 1.21 0.04 2.9 1.2 1.0 - 1.4 Horiba ABX Pentra Horiba ABX Pentra 400 15 1.59 0.07 4.7 1.6 1.4 - 1.8 Olympus Olympus AU 19 1.51 0.05 3.0 1.5 1.3 - 1.7 Roche Integra Roche Integra 43 1.57 0.07 4.5 1.6 1.4 - 1.8 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 1.11 0.05 4.5 1.1 1.0 - 1.3

Vital Diagnostics Vital Diagnostics ATAC 8000 19 1.51 0.06 4.1 1.5 1.3 - 1.7 Vital Diagnostics Envoy 500 21 1.53 0.06 3.8 1.5 1.3 - 1.7 All Chemistry Instruments 40 1.52 0.06 4.0 1.5 1.3 - 1.7 VITROS VITROS 250,350,500,700,750,950 42 1.42 0.08 5.4 1.4 1.2 - 1.6 All Chemistry Instruments 47 1.41 0.07 5.2 1.4 1.2 - 1.6

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12/ 2011 MLE-M1 Participant Summary

Bilirubin, Direct (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 278 0.87 0.26 29.9 0.8 0.0 - 1.7 277 0.46 0.20 43.3 0.4 0.0 - 1.1 All Roche Integra/c111/c501 Reagents 40 0.71 0.04 6.2 0.7 0.5 - 0.9 37 0.40 0.00 0.0 0.4 0.4 - 0.4 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 49 1.23 0.08 6.3 1.2 0.9 - 1.5 49 0.74 0.06 8.2 0.7 0.5 - 1.0 Beckman - cartridge Beckman Synchron LX/PRo/DxC 16 0.76 0.05 6.8 0.8 0.6 - 1.0 16 0.41 0.03 8.3 0.4 0.3 - 0.6 All Chemistry Instruments 23 0.74 0.06 7.9 0.7 0.5 - 1.0 23 0.40 0.04 10.7 0.4 0.2 - 0.6 Horiba ABX Pentra Horiba ABX Pentra 400 12 1.09 0.07 6.1 1.1 0.8 - 1.3 12 0.59 0.05 8.7 0.6 0.4 - 0.8 Olympus Olympus AU 16 1.08 0.10 9.3 1.1 0.7 - 1.4 16 0.57 0.07 12.4 0.6 0.3 - 0.8 Roche Integra Roche Integra 34 0.71 0.05 6.4 0.7 0.5 - 0.9 31 0.40 0.00 0.0 0.4 0.4 - 0.4 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 48 0.63 0.10 16.1 0.6 0.3 - 1.0 47 0.32 0.08 23.4 0.3 0.0 - 0.6 Vital Diagnostics Vital Diagnostics ATAC 8000 13 1.12 0.08 7.4 1.1 0.8 - 1.4 13 0.57 0.10 18.1 0.6 0.2 - 0.9 All Chemistry Instruments 22 1.16 0.09 7.8 1.2 0.8 - 1.5 22 0.61 0.10 16.9 0.6 0.3 - 1.0 VITROS-BuBc and Bc VITROS 250,350,500,700,750,950 30 0.64 0.12 19.1 0.6 0.2 - 1.1 29 0.17 0.10 61.0 0.1 0.0 - 0.5 All Chemistry Instruments 35 0.67 0.13 20.3 0.7 0.2 - 1.1 34 0.19 0.13 67.9 0.2 0.0 - 0.6

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2011 MLE-M1 Participant Summary/ 13

Bilirubin, Total (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 422 2.08 0.25 12.0 2.0 1.6 - 2.5 420 1.31 0.19 14.6 1.3 0.9 - 1.8 All Roche T. bili Special Reagents 43 1.76 0.10 5.5 1.8 1.3 - 2.2 43 1.09 0.07 6.7 1.1 0.6 - 1.5 Abaxis Piccolo Abaxis Piccolo - waived 21 1.98 0.10 5.0 2.0 1.5 - 2.4 21 1.31 0.08 6.0 1.3 0.9 - 1.8 Abaxis Piccolo 18 2.01 0.08 4.0 2.0 1.6 - 2.5 18 1.32 0.07 5.5 1.3 0.9 - 1.8 All Chemistry Instruments 40 1.99 0.09 4.5 2.0 1.5 - 2.4 40 1.32 0.07 5.7 1.3 0.9 - 1.8 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 70 2.33 0.13 5.4 2.4 1.8 - 2.8 69 1.49 0.09 5.9 1.5 1.0 - 1.9 Beckman - cartridge Beckman Synchron 11 2.45 0.25 10.4 2.5 1.9 - 3.0 11 1.67 0.18 11.1 1.7 1.2 - 2.1 Beckman Synchron LX/PRo/DxC 19 2.50 0.17 6.7 2.5 2.0 - 3.0 19 1.64 0.16 9.8 1.7 1.2 - 2.1 All Chemistry Instruments 30 2.48 0.20 8.1 2.5 1.9 - 3.0 30 1.65 0.17 10.1 1.7 1.2 - 2.1 Carolina Liquid Chemistries Beckman Synchron 10 2.21 0.14 6.2 2.2 1.7 - 2.7 10 1.41 0.14 10.3 1.5 1.0 - 1.9 All Chemistry Instruments 11 2.17 0.18 8.3 2.2 1.7 - 2.7 11 1.38 0.17 12.0 1.4 0.9 - 1.8 Horiba ABX Pentra Horiba ABX Pentra 400 15 2.00 0.09 4.6 2.0 1.6 - 2.4 15 1.27 0.07 5.7 1.3 0.8 - 1.7 Olympus Olympus AU 20 2.23 0.12 5.4 2.2 1.7 - 2.7 20 1.47 0.08 5.5 1.5 1.0 - 1.9 Roche Integra Roche Integra 10 1.75 0.07 4.0 1.8 1.3 - 2.2 10 1.08 0.10 9.6 1.1 0.6 - 1.5 Roche Integra-T. bili Special Roche Integra 34 1.74 0.09 5.1 1.7 1.3 - 2.2 34 1.08 0.08 7.1 1.1 0.6 - 1.5 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 2.00 0.11 5.4 2.0 1.5 - 2.4 61 1.23 0.08 6.5 1.2 0.8 - 1.7 Vital Diagnostics Vital Diagnostics ATAC 8000 20 2.21 0.15 6.9 2.2 1.7 - 2.7 20 1.34 0.11 8.2 1.3 0.9 - 1.8 Vital Diagnostics Envoy 500 20 1.80 0.09 5.1 1.8 1.4 - 2.2 21 1.08 0.11 10.0 1.1 0.6 - 1.5 All Chemistry Instruments 41 1.99 0.26 12.9 1.9 1.5 - 2.4 41 1.21 0.17 14.0 1.2 0.8 - 1.7 VITROS - TBIL VITROS 250,350,500,700,750,950 37 1.98 0.11 5.8 2.0 1.5 - 2.4 38 1.17 0.09 7.4 1.2 0.7 - 1.6 All Chemistry Instruments 42 1.99 0.11 5.7 2.0 1.5 - 2.4 43 1.17 0.09 7.5 1.2 0.7 - 1.6

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14/ 2011 MLE-M1 Participant Summary

Bilirubin, Total (mg/dL)

Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 410 2.98 0.34 11.5 2.9 2.3 - 3.6 408 1.67 0.23 13.7 1.6 1.2 - 2.1 All Roche T. bili Special Reagents 43 2.51 0.13 5.3 2.5 2.0 - 3.1 42 1.39 0.09 6.2 1.4 0.9 - 1.8 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 2.9 2.2 - 3.5 8 - - - 1.6 1.2 - 2.1 Abaxis Piccolo 18 2.86 0.10 3.6 2.9 2.2 - 3.5 18 1.64 0.11 7.0 1.7 1.2 - 2.1 All Chemistry Instruments 27 2.86 0.12 4.2 2.9 2.2 - 3.5 27 1.62 0.12 7.1 1.6 1.2 - 2.1 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 69 3.33 0.17 5.1 3.3 2.6 - 4.0 69 1.90 0.09 4.8 1.9 1.5 - 2.4 Beckman - cartridge Beckman Synchron 11 3.42 0.23 6.8 3.4 2.7 - 4.2 11 2.08 0.22 10.5 2.1 1.6 - 2.5 Beckman Synchron LX/PRo/DxC 19 3.45 0.16 4.6 3.4 2.7 - 4.2 19 2.04 0.16 7.7 2.0 1.6 - 2.5 All Chemistry Instruments 30 3.44 0.18 5.4 3.4 2.7 - 4.2 30 2.06 0.18 8.7 2.1 1.6 - 2.5 Carolina Liquid Chemistries Beckman Synchron 10 3.07 0.16 5.1 3.1 2.4 - 3.7 10 1.78 0.09 5.2 1.8 1.3 - 2.2 All Chemistry Instruments 11 3.05 0.17 5.6 3.1 2.4 - 3.7 11 1.75 0.14 8.2 1.8 1.3 - 2.2 Horiba ABX Pentra Horiba ABX Pentra 400 15 2.82 0.17 5.9 2.8 2.2 - 3.4 15 1.61 0.09 5.7 1.6 1.2 - 2.1 Olympus Olympus AU 19 3.01 0.13 4.4 3.0 2.4 - 3.7 19 1.84 0.09 4.9 1.9 1.4 - 2.3 Roche Integra Roche Integra 10 2.55 0.18 7.0 2.5 2.0 - 3.1 10 1.40 0.09 6.7 1.4 1.0 - 1.8 Roche Integra-T. bili Special Roche Integra 33 2.48 0.11 4.3 2.5 1.9 - 3.0 33 1.38 0.09 6.2 1.4 0.9 - 1.8 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 2.88 0.14 4.8 2.9 2.3 - 3.5 61 1.58 0.10 6.2 1.6 1.1 - 2.0 Vital Diagnostics Vital Diagnostics ATAC 8000 20 3.23 0.18 5.6 3.2 2.5 - 3.9 20 1.75 0.15 8.6 1.8 1.3 - 2.2 Vital Diagnostics Envoy 500 21 2.53 0.13 5.3 2.6 2.0 - 3.1 21 1.40 0.14 9.7 1.4 0.9 - 1.8 All Chemistry Instruments 41 2.87 0.39 13.4 2.8 2.2 - 3.5 41 1.57 0.23 14.5 1.5 1.1 - 2.0 VITROS - TBIL VITROS 250,350,500,700,750,950 38 2.92 0.17 5.8 2.9 2.3 - 3.6 38 1.53 0.11 7.0 1.5 1.1 - 2.0 All Chemistry Instruments 43 2.92 0.16 5.6 2.9 2.3 - 3.6 43 1.54 0.10 6.7 1.5 1.1 - 2.0

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2011 MLE-M1 Participant Summary/ 15

Bilirubin, Total (mg/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range

All Method 403 5.92 0.53 8.9 5.8 4.7 - 7.2 All Roche T. bili Special Reagents 41 5.49 0.26 4.7 5.4 4.3 - 6.6 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 5.4 4.3 - 6.5 Abaxis Piccolo 18 5.42 0.14 2.7 5.4 4.3 - 6.6 All Chemistry Instruments 27 5.40 0.15 2.8 5.4 4.3 - 6.5 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 70 6.70 0.27 4.0 6.7 5.3 - 8.1 Beckman - cartridge Beckman Synchron 11 6.03 0.30 5.0 5.9 4.8 - 7.3 Beckman Synchron LX/PRo/DxC 19 6.02 0.30 5.0 6.0 4.8 - 7.3 All Chemistry Instruments 30 6.02 0.30 4.9 6.0 4.8 - 7.3 Carolina Liquid Chemistries Beckman Synchron 10 5.70 0.23 4.1 5.7 4.5 - 6.9 All Chemistry Instruments 11 5.66 0.25 4.4 5.7 4.5 - 6.8 Horiba ABX Pentra Horiba ABX Pentra 400 15 6.09 0.28 4.6 6.0 4.8 - 7.4 Olympus Olympus AU 18 6.08 0.26 4.3 6.1 4.8 - 7.3 Roche Integra Roche Integra 10 5.48 0.33 6.0 5.4 4.3 - 6.6 Roche Integra-T. bili Special Roche Integra 33 5.45 0.23 4.3 5.4 4.3 - 6.6 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 59 5.75 0.20 3.4 5.8 4.6 - 7.0

Vital Diagnostics Vital Diagnostics ATAC 8000 20 5.98 0.32 5.4 6.0 4.7 - 7.2 Vital Diagnostics Envoy 500 21 5.47 0.25 4.5 5.4 4.3 - 6.6 All Chemistry Instruments 41 5.72 0.38 6.7 5.7 4.5 - 6.9 VITROS - TBIL VITROS 250,350,500,700,750,950 38 5.63 0.31 5.5 5.6 4.5 - 6.8 All Chemistry Instruments 43 5.68 0.34 5.9 5.7 4.5 - 6.9

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16/ 2011 MLE-M1 Participant Summary

Calcium (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 432 9.95 0.36 3.6 10.0 8.9 - 11.0 434 13.45 0.57 4.2 13.4 12.4 - 14.5 All Arsenazo Methods 205 9.99 0.43 4.3 10.0 8.9 - 11.0 206 13.41 0.66 4.9 13.4 12.4 - 14.5 All CPC Methods 195 9.91 0.29 2.9 9.9 8.9 - 11.0 190 13.52 0.41 3.1 13.5 12.5 - 14.6 Abaxis Piccolo Abaxis Piccolo - waived 21 10.50 0.27 2.6 10.5 9.5 - 11.6 21 14.35 0.40 2.8 14.4 13.3 - 15.4 Abaxis Piccolo 18 10.37 0.17 1.6 10.4 9.3 - 11.4 18 14.31 0.31 2.2 14.3 13.3 - 15.4 All Chemistry Instruments 40 10.44 0.24 2.3 10.4 9.4 - 11.5 40 14.32 0.36 2.5 14.3 13.3 - 15.4 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 70 9.59 0.26 2.7 9.6 8.5 - 10.6 70 12.86 0.33 2.6 12.8 11.8 - 13.9 Beckman - electrode Beckman Synchron LX/PRo/DxC 17 9.92 0.21 2.1 10.0 8.9 - 11.0 16 13.22 0.17 1.3 13.3 12.2 - 14.3 All Chemistry Instruments 25 9.90 0.22 2.2 10.0 8.8 - 10.9 24 13.16 0.27 2.1 13.2 12.1 - 14.2 Horiba ABX Pentra Horiba ABX Pentra 400 12 10.29 0.31 3.0 10.3 9.2 - 11.3 12 14.24 0.71 5.0 14.4 13.2 - 15.3 Olympus Olympus AU 20 9.95 0.29 2.9 10.0 8.9 - 11.0 18 13.41 0.19 1.4 13.4 12.4 - 14.5 Roche Integra Roche Integra 43 9.90 0.24 2.5 9.9 8.8 - 10.9 43 13.85 0.33 2.4 13.9 12.8 - 14.9 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 9.80 0.24 2.4 9.8 8.8 - 10.8 60 13.38 0.30 2.3 13.4 12.3 - 14.4 Vital Diagnostics Vital Diagnostics ATAC 8000 19 9.71 0.20 2.1 9.7 8.7 - 10.8 19 13.31 0.27 2.0 13.2 12.3 - 14.4 Vital Diagnostics Envoy 500 24 10.08 0.24 2.4 10.1 9.0 - 11.1 24 13.22 0.36 2.8 13.2 12.2 - 14.3 All Chemistry Instruments 43 9.91 0.29 2.9 9.9 8.9 - 11.0 43 13.26 0.33 2.5 13.2 12.2 - 14.3 VITROS VITROS 250,350,500,700,750,950 43 10.11 0.24 2.4 10.1 9.1 - 11.2 44 13.56 0.27 2.0 13.5 12.5 - 14.6 All Chemistry Instruments 50 10.10 0.23 2.3 10.1 9.1 - 11.2 51 13.55 0.27 2.0 13.5 12.5 - 14.6

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2011 MLE-M1 Participant Summary/ 17

Calcium (mg/dL)

Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 419 6.56 0.32 4.9 6.6 5.5 - 7.6 417 11.73 0.40 3.4 11.7 10.7 - 12.8 All Arsenazo Methods 193 6.67 0.32 4.9 6.6 5.6 - 7.7 192 11.73 0.49 4.1 11.8 10.7 - 12.8 All CPC Methods 195 6.44 0.30 4.7 6.4 5.4 - 7.5 189 11.76 0.29 2.5 11.8 10.7 - 12.8 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 7.0 5.8 - 7.9 8 - - - 12.5 11.3 - 13.4 Abaxis Piccolo 18 6.84 0.33 4.9 6.8 5.8 - 7.9 17 12.30 0.25 2.0 12.4 11.3 - 13.3 All Chemistry Instruments 27 6.85 0.34 5.0 6.8 5.8 - 7.9 26 12.34 0.30 2.4 12.4 11.3 - 13.4 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 70 6.66 0.18 2.7 6.7 5.6 - 7.7 69 11.37 0.23 2.0 11.3 10.3 - 12.4 Beckman - electrode Beckman Synchron LX/PRo/DxC 17 6.60 0.17 2.6 6.6 5.6 - 7.6 17 11.59 0.23 2.0 11.7 10.5 - 12.6 All Chemistry Instruments 24 6.61 0.22 3.3 6.6 5.6 - 7.7 25 11.55 0.30 2.6 11.7 10.5 - 12.6 Horiba ABX Pentra Horiba ABX Pentra 400 12 6.43 0.27 4.2 6.4 5.4 - 7.5 12 12.36 0.51 4.1 12.4 11.3 - 13.4 Olympus Olympus AU 20 6.67 0.18 2.7 6.7 5.6 - 7.7 18 11.72 0.13 1.1 11.7 10.7 - 12.8 Roche Integra Roche Integra 43 6.20 0.19 3.0 6.2 5.1 - 7.2 44 11.86 0.27 2.3 11.8 10.8 - 12.9 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 60 6.53 0.20 3.0 6.5 5.5 - 7.6 60 11.64 0.29 2.5 11.7 10.6 - 12.7 Vital Diagnostics Vital Diagnostics ATAC 8000 19 6.14 0.20 3.2 6.1 5.1 - 7.2 19 11.66 0.27 2.3 11.7 10.6 - 12.7 Vital Diagnostics Envoy 500 24 6.77 0.29 4.3 6.8 5.7 - 7.8 24 11.68 0.32 2.8 11.7 10.6 - 12.7 All Chemistry Instruments 43 6.49 0.40 6.2 6.4 5.4 - 7.5 43 11.67 0.30 2.5 11.7 10.6 - 12.7 VITROS VITROS 250,350,500,700,750,950 44 6.40 0.19 2.9 6.3 5.4 - 7.5 44 11.94 0.25 2.1 11.9 10.9 - 13.0 All Chemistry Instruments 51 6.39 0.18 2.8 6.3 5.3 - 7.4 51 11.92 0.26 2.2 11.9 10.9 - 13.0

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18/ 2011 MLE-M1 Participant Summary

Calcium (mg/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range All Method 413 9.55 0.31 3.2 9.5 8.5 - 10.6 All Arsenazo Methods 191 9.56 0.40 4.2 9.5 8.5 - 10.6 All CPC Methods 194 9.57 0.28 2.9 9.6 8.5 - 10.6 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 10.3 9.2 - 11.3 Abaxis Piccolo 18 10.22 0.29 2.8 10.3 9.2 - 11.3 All Chemistry Instruments 27 10.25 0.29 2.8 10.2 9.2 - 11.3 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 69 9.38 0.22 2.3 9.4 8.3 - 10.4 Beckman - electrode Beckman Synchron LX/PRo/DxC 17 9.50 0.19 2.0 9.6 8.5 - 10.5 All Chemistry Instruments 25 9.49 0.20 2.1 9.5 8.4 - 10.5 Horiba ABX Pentra Horiba ABX Pentra 400 12 9.80 0.35 3.5 9.8 8.8 - 10.8 Olympus Olympus AU 20 9.40 0.26 2.8 9.5 8.3 - 10.4 Roche Integra Roche Integra 44 9.68 0.24 2.5 9.7 8.6 - 10.7 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 9.53 0.26 2.8 9.5 8.5 - 10.6

Vital Diagnostics Vital Diagnostics ATAC 8000 18 9.61 0.23 2.4 9.6 8.6 - 10.7 Vital Diagnostics Envoy 500 24 9.40 0.29 3.1 9.4 8.4 - 10.4 All Chemistry Instruments 42 9.49 0.28 3.0 9.5 8.4 - 10.5 VITROS VITROS 250,350,500,700,750,950 44 9.46 0.21 2.3 9.4 8.4 - 10.5 All Chemistry Instruments 51 9.44 0.22 2.4 9.4 8.4 - 10.5

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2011 MLE-M1 Participant Summary/ 19

Creatinine (mg/dL) Technical note: The National Kidney Disease Education Program (NKDEP) has launched the Creatinine Standardization Program to address inter-laboratory variation in creatinine assay calibration and provide more accurate estimates of glomerular filtration rate (GFR). Both efforts are part of a larger NKDEP initiative to help health care providers better identify and treat chronic kidney disease in order to prevent or delay kidney failure and improve patient outcomes. The Creatinine Standardization Program encourages in-vitro diagnostics manufacturers to adjust the calibrations of routine serum creatinine methods to be traceable to the internationally accepted reference method—isotope dilution mass spectrometry (IDMS)—and to work with clinical laboratories to coordinate this calibration adjustment with the introduction of a revised GFR estimating equation appropriate for use with IDMS-traceable creatinine methods. In order to provide appropriate PT grading during this transition, MLE has added ovals to the proficiency test result form to allow participating laboratories to indicate which creatinine calibration method is currently in use. Participants will need to select either ―IDMS‖ for IDMS-traceable calibration method, or ―OLD‖ for traditional calibration method. If you have any question about the traceability of the calibration for the creatinine method in use by your laboratory, contact the reagent and/or calibrator manufacturer for assistance. For more information, and recommendations for clinical laboratories, see http://www.nkdep.nih.gov/labprofessionals/index.htm

Specimen CH-1 Specimen CH-2 Standardization/Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 437 0.80 0.09 11.6 0.8 0.4 - 1.1 442 0.46 0.09 19.7 0.5 0.1 - 0.8 IDMS Standardization 170 0.77 0.09 11.7 0.8 0.4 - 1.1 172 0.45 0.09 19.3 0.5 0.1 - 0.8 Abaxis Piccolo Abaxis Piccolo - waived 14 0.89 0.11 12.0 0.9 0.5 - 1.2 14 0.49 0.10 20.2 0.5 0.1 - 0.8 All Chemistry Instruments 20 0.85 0.15 17.8 0.9 0.5 - 1.2 20 0.49 0.09 18.6 0.5 0.1 - 0.8 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 18 0.76 0.09 12.0 0.8 0.4 - 1.1 18 0.49 0.08 17.0 0.5 0.1 - 0.8 Beckman - cartridge Beckman Synchron LX/PRo/DxC 14 0.73 0.07 10.0 0.7 0.4 - 1.1 14 0.36 0.05 14.4 0.4 0.0 - 0.7 All Chemistry Instruments 22 0.72 0.07 9.5 0.7 0.4 - 1.1 22 0.35 0.05 14.4 0.4 0.0 - 0.7 CREA (blnk corrected -NH3) All Chemistry Instruments 10 0.74 0.05 7.0 0.7 0.4 - 1.1 10 0.50 0.00 0.0 0.5 0.2 - 0.8 CRSC (single slide) VITROS 250,350,500,700,750,950 19 0.73 0.05 6.2 0.7 0.4 - 1.1 19 0.50 0.05 9.4 0.5 0.2 - 0.8 All Chemistry Instruments 26 0.74 0.06 7.7 0.7 0.4 - 1.1 26 0.50 0.04 8.8 0.5 0.2 - 0.9 Olympus Olympus AU 10 0.82 0.06 7.7 0.8 0.5 - 1.2 10 0.43 0.07 15.7 0.4 0.1 - 0.8 Roche Integra Roche Integra 19 0.71 0.06 8.0 0.7 0.4 - 1.1 19 0.38 0.04 9.7 0.4 0.0 - 0.7 Non-IDMS Method 211 0.82 0.09 10.8 0.8 0.5 - 1.2 211 0.47 0.10 20.2 0.5 0.1 - 0.8 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 43 0.81 0.07 8.7 0.8 0.5 - 1.2 43 0.52 0.09 17.0 0.5 0.2 - 0.9 Roche Integra Roche Integra 20 0.74 0.08 11.1 0.7 0.4 - 1.1 20 0.40 0.07 17.4 0.4 0.0 - 0.7 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 50 0.82 0.07 8.1 0.8 0.5 - 1.2 50 0.46 0.08 16.7 0.5 0.1 - 0.8 Vital Diagnostics Vital Diagnostics ATAC 8000 13 0.91 0.05 5.4 0.9 0.6 - 1.3 13 0.52 0.08 15.5 0.5 0.2 - 0.9 Vital Diagnostics Envoy 500 17 0.86 0.08 9.3 0.9 0.5 - 1.2 17 0.45 0.06 13.8 0.4 0.1 - 0.8 All Chemistry Instruments 30 0.88 0.07 8.1 0.9 0.5 - 1.2 30 0.48 0.08 15.9 0.5 0.1 - 0.8

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20/ 2011 MLE-M1 Participant Summary

Creatinine (mg/dL)

Specimen CH-3 Specimen CH-4 Standardization/Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 431 1.11 0.17 15.5 1.1 0.8 - 1.5 431 0.64 0.09 13.8 0.6 0.3 - 1.0 IDMS Standardization 164 1.04 0.19 17.9 1.0 0.7 - 1.4 163 0.62 0.09 14.0 0.6 0.3 - 1.0 Abaxis Piccolo All Chemistry Instruments 11 1.36 0.10 7.5 1.3 1.0 - 1.7 11 0.68 0.11 15.8 0.7 0.3 - 1.0 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 18 1.03 0.14 13.3 1.1 0.7 - 1.4 18 0.62 0.07 11.8 0.6 0.3 - 1.0 Beckman - cartridge Beckman Synchron LX/PRo/DxC 14 1.08 0.06 5.4 1.1 0.7 - 1.4 14 0.55 0.05 9.4 0.6 0.2 - 0.9 All Chemistry Instruments 22 1.07 0.06 5.1 1.1 0.7 - 1.4 22 0.56 0.06 10.6 0.6 0.2 - 0.9 CREA (blnk corrected -NH3) All Chemistry Instruments 10 0.82 0.04 5.1 0.8 0.5 - 1.2 10 0.67 0.05 7.2 0.7 0.3 - 1.0 CRSC (single slide) VITROS 250,350,500,700,750,950 19 0.82 0.04 4.6 0.8 0.5 - 1.2 19 0.64 0.05 7.9 0.6 0.3 - 1.0 All Chemistry Instruments 26 0.82 0.04 5.2 0.8 0.5 - 1.2 26 0.66 0.06 8.6 0.7 0.3 - 1.0 Olympus Olympus AU 10 1.21 0.06 4.7 1.2 0.9 - 1.6 10 0.63 0.07 10.7 0.6 0.3 - 1.0 Roche Integra Roche Integra 19 1.04 0.10 9.8 1.0 0.7 - 1.4 19 0.54 0.05 9.2 0.5 0.2 - 0.9 Non-IDMS Method 209 1.17 0.14 11.7 1.2 0.8 - 1.5 211 0.65 0.09 13.9 0.7 0.3 - 1.0 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 43 1.08 0.08 7.8 1.1 0.7 - 1.4 43 0.68 0.06 9.0 0.7 0.3 - 1.0 Roche Integra Roche Integra 20 1.07 0.13 12.3 1.1 0.7 - 1.4 20 0.57 0.05 8.7 0.6 0.2 - 0.9 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 49 1.22 0.06 5.1 1.2 0.9 - 1.6 49 0.63 0.07 10.4 0.6 0.3 - 1.0 Vital Diagnostics Vital Diagnostics ATAC 8000 13 1.25 0.08 6.2 1.3 0.9 - 1.6 13 0.73 0.05 6.6 0.7 0.4 - 1.1 Vital Diagnostics Envoy 500 17 1.28 0.12 9.2 1.3 0.9 - 1.6 17 0.65 0.06 9.6 0.6 0.3 - 1.0 All Chemistry Instruments 30 1.27 0.10 8.0 1.3 0.9 - 1.6 30 0.69 0.07 9.9 0.7 0.3 - 1.0

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2011 MLE-M1 Participant Summary/ 21

Creatinine (mg/dL)

Specimen CH-5 Standardization/Reagent/Instrument Labs Mean SD CV Median Range

All Method 423 7.01 0.37 5.2 7.0 5.9 - 8.1 IDMS Standardization 162 6.96 0.34 4.9 7.0 5.9 - 8.0 Abaxis Piccolo All Chemistry Instruments 11 7.22 0.14 1.9 7.2 6.1 - 8.4 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 18 6.78 0.38 5.7 6.9 5.7 - 7.8 Beckman - cartridge Beckman Synchron LX/PRo/DxC 14 7.26 0.21 2.8 7.2 6.1 - 8.4 All Chemistry Instruments 22 7.26 0.18 2.5 7.2 6.1 - 8.4 CREA (blnk corrected -NH3) All Chemistry Instruments 10 6.07 1.86 30.6 6.7 5.1 - 7.0 CRSC (single slide) VITROS 250,350,500,700,750,950 19 6.76 0.21 3.2 6.7 5.7 - 7.8 All Chemistry Instruments 26 6.78 0.19 2.8 6.8 5.7 - 7.8 Olympus Olympus AU 10 7.06 0.12 1.7 7.1 6.0 - 8.2 Roche Integra Roche Integra 19 6.88 0.34 5.0 6.9 5.8 - 8.0 Non-IDMS Method 206 7.05 0.38 5.4 7.1 5.9 - 8.2 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 42 6.81 0.30 4.4 6.8 5.7 - 7.9 Roche Integra Roche Integra 20 6.87 0.37 5.4 6.8 5.8 - 8.0 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 50 7.37 0.20 2.8 7.4 6.2 - 8.5

Vital Diagnostics Vital Diagnostics ATAC 8000 13 7.17 0.25 3.5 7.1 6.0 - 8.3 Vital Diagnostics Envoy 500 17 6.95 0.35 5.0 6.8 5.9 - 8.0 All Chemistry Instruments 30 7.04 0.32 4.6 7.1 5.9 - 8.1

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22/ 2011 MLE-M1 Participant Summary

Glucose (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 459 147.5 4.3 2.9 148 132 - 163 458 244.1 6.4 2.6 244 219 - 269 All Roche Integra/c111/c501 Reagents 55 145.3 4.1 2.8 145 130 - 160 55 243.1 5.5 2.2 243 218 - 268 Abaxis Piccolo Abaxis Piccolo - waived 21 148.3 1.5 1.0 149 133 - 164 21 243.7 2.3 1.0 244 219 - 269 Abaxis Piccolo 18 148.4 1.3 0.9 148 133 - 164 18 243.2 1.9 0.8 244 218 - 268 All Chemistry Instruments 39 148.5 1.2 0.8 148 133 - 164 39 243.3 1.8 0.8 244 218 - 268 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 70 147.9 3.4 2.3 148 133 - 163 70 246.5 5.2 2.1 247 221 - 272 Beckman - cartridge Beckman Synchron 10 147.9 6.0 4.1 150 133 - 163 10 245.3 9.2 3.7 249 220 - 270 Beckman Synchron LX/PRo/DxC 15 149.5 2.6 1.7 149 134 - 165 15 247.9 5.5 2.2 246 223 - 273 All Chemistry Instruments 25 148.9 4.3 2.9 149 133 - 164 25 246.9 7.1 2.9 246 222 - 272 Carolina Liquid Chemistries Beckman Synchron 10 145.9 5.1 3.5 148 131 - 161 10 245.1 4.5 1.8 244 220 - 270 All Chemistry Instruments 11 146.2 4.9 3.3 148 131 - 161 11 245.4 4.4 1.8 244 220 - 270 Cholestech LDX Cholestech LDX - waived 13 149.8 10.9 7.3 149 134 - 165 12 234.7 12.7 5.4 232 211 - 259 All Chemistry Instruments 15 149.1 10.3 6.9 148 134 - 165 14 235.9 12.3 5.2 235 212 - 260 Horiba ABX Pentra Horiba ABX Pentra 400 15 148.1 7.6 5.1 150 133 - 163 15 246.3 11.3 4.6 247 221 - 271 Olympus Olympus AU 20 144.2 3.4 2.4 144 129 - 159 20 242.6 4.6 1.9 243 218 - 267 Roche Integra Roche Integra 45 145.4 4.4 3.0 145 130 - 160 45 243.2 5.8 2.4 242 218 - 268 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 59 148.3 4.3 2.9 149 133 - 164 59 243.3 5.8 2.4 244 218 - 268 Vital Diagnostics Vital Diagnostics ATAC 8000 20 149.4 4.8 3.2 148 134 - 165 20 250.3 7.8 3.1 250 225 - 276 Vital Diagnostics Envoy 500 23 150.3 3.9 2.6 150 135 - 166 24 246.4 6.0 2.4 246 221 - 272 All Chemistry Instruments 42 149.5 3.8 2.6 149 134 - 165 44 248.2 7.1 2.8 248 223 - 273 VITROS VITROS 250,350,500,700,750,950 45 145.9 4.1 2.8 147 131 - 161 45 239.0 5.6 2.3 239 215 - 263 VITROS DT/DTII/DT60 14 148.9 4.1 2.8 149 133 - 164 14 240.2 6.0 2.5 241 216 - 265 All Chemistry Instruments 64 146.5 4.2 2.8 147 131 - 162 64 239.2 5.6 2.3 240 215 - 264

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2011 MLE-M1 Participant Summary/ 23

Glucose (mg/dL)

Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 440 50.9 2.6 5.1 51 44 - 57 438 196.5 5.4 2.8 196 176 - 217 All Roche Integra/c111/c501 Reagents 53 48.1 1.3 2.7 48 42 - 55 55 194.0 5.2 2.7 194 174 - 214 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 53 47 - 60 8 - - - 197 176 - 216 Abaxis Piccolo 18 53.7 1.3 2.4 53 47 - 60 18 195.3 1.7 0.9 195 175 - 215 All Chemistry Instruments 27 53.7 1.3 2.4 53 47 - 60 27 195.8 2.1 1.1 196 176 - 216 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 70 51.8 1.4 2.6 52 45 - 58 70 197.5 4.9 2.5 197 177 - 218 Beckman - cartridge Beckman Synchron 10 50.8 2.2 4.3 51 44 - 57 10 197.8 8.6 4.3 199 178 - 218 Beckman Synchron LX/PRo/DxC 15 53.0 2.2 4.1 53 47 - 59 15 200.2 5.0 2.5 199 180 - 221 All Chemistry Instruments 25 52.1 2.4 4.6 52 46 - 59 25 199.2 6.6 3.3 199 179 - 220 Carolina Liquid Chemistries Beckman Synchron 10 49.9 2.9 5.9 51 43 - 56 10 197.4 4.5 2.3 198 177 - 218 All Chemistry Instruments 11 50.1 2.8 5.7 51 44 - 57 11 197.8 4.4 2.2 198 178 - 218 Cholestech LDX Cholestech LDX - waived 4 - - - 50 44 - 57 4 - - - 199 176 - 217 All Chemistry Instruments 5 - - - 50 44 - 57 5 - - - 198 160 - 196 Horiba ABX Pentra Horiba ABX Pentra 400 15 50.6 2.2 4.3 51 44 - 57 15 198.7 8.2 4.1 200 178 - 219 Olympus Olympus AU 19 47.3 0.9 1.9 47 41 - 54 20 193.2 2.7 1.4 193 173 - 213 Roche Integra Roche Integra 43 48.1 1.4 2.9 48 42 - 55 45 194.2 5.3 2.7 194 174 - 214 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 60 52.3 2.0 3.9 52 46 - 59 59 196.6 5.1 2.6 197 176 - 217 Vital Diagnostics Vital Diagnostics ATAC 8000 20 51.5 2.1 4.2 52 45 - 58 20 201.1 6.3 3.1 202 180 - 222 Vital Diagnostics Envoy 500 24 52.9 2.4 4.5 53 46 - 59 24 199.3 5.5 2.8 200 179 - 220 All Chemistry Instruments 44 52.2 2.4 4.5 52 46 - 59 44 200.1 5.9 2.9 200 180 - 221 VITROS VITROS 250,350,500,700,750,950 45 49.7 1.8 3.7 50 43 - 56 45 194.0 4.8 2.5 195 174 - 214 VITROS DT/DTII/DT60 14 49.6 3.2 6.4 49 43 - 56 14 196.4 4.9 2.5 198 176 - 216 All Chemistry Instruments 63 49.5 1.9 3.9 49 43 - 56 64 194.5 4.8 2.5 195 175 - 214

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24/ 2011 MLE-M1 Participant Summary

Glucose (mg/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range All Method 439 97.7 4.1 4.2 98 87 - 108 All Roche Integra/c111/c501 Reagents 55 98.6 2.5 2.5 99 88 - 109

Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 102 91 - 112 Abaxis Piccolo 18 101.4 1.1 1.1 101 91 - 112 All Chemistry Instruments 27 101.6 1.4 1.3 101 91 - 112 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 71 98.6 2.6 2.6 99 88 - 109 Beckman - cartridge Beckman Synchron 10 97.4 4.6 4.7 97 87 - 108 Beckman Synchron LX/PRo/DxC 15 100.3 2.6 2.6 100 90 - 111 All Chemistry Instruments 25 99.2 3.7 3.7 99 89 - 110 Carolina Liquid Chemistries Beckman Synchron 10 97.8 2.6 2.7 98 88 - 108 All Chemistry Instruments 11 97.9 2.5 2.6 98 88 - 108 Cholestech LDX Cholestech LDX - waived 4 - - - 100 87 - 108 All Chemistry Instruments 5 - - - 89 99 - 121 Horiba ABX Pentra Horiba ABX Pentra 400 15 100.7 4.7 4.7 101 90 - 111 Olympus Olympus AU 20 98.6 1.7 1.7 99 88 - 109 Roche Integra Roche Integra 45 98.8 2.5 2.5 99 88 - 109 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 60 98.4 3.4 3.5 99 88 - 109

Vital Diagnostics Vital Diagnostics ATAC 8000 20 98.2 2.0 2.1 99 88 - 109 Vital Diagnostics Envoy 500 24 98.0 3.5 3.5 98 88 - 108 All Chemistry Instruments 44 98.1 2.9 2.9 99 88 - 108 VITROS VITROS 250,350,500,700,750,950 45 91.2 2.8 3.1 91 82 - 101 VITROS DT/DTII/DT60 14 89.0 4.0 4.5 89 80 - 98 All Chemistry Instruments 63 90.9 2.8 3.1 91 81 - 100

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2011 MLE-M1 Participant Summary/ 25

Iron (mcg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 146 231.1 15.8 6.9 231 184 - 278 145 193.9 11.1 5.7 194 155 - 233 All Roche Integra/c111/c501 Reagents 19 232.6 4.3 1.9 232 186 - 280 19 197.2 6.1 3.1 197 157 - 237 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 14 215.8 3.6 1.6 215 172 - 259 14 183.0 4.0 2.2 183 146 - 220 Beckman - cartridge Beckman Synchron LX/PRo/DxC 14 237.4 6.2 2.6 238 189 - 285 14 199.1 6.0 3.0 201 159 - 239 All Chemistry Instruments 16 238.1 6.6 2.8 238 190 - 286 16 199.7 6.0 3.0 201 159 - 240 Olympus Olympus AU 10 254.5 5.9 2.3 255 203 - 306 10 207.7 9.9 4.8 210 166 - 250 Roche Integra Roche Integra 17 232.2 4.3 1.9 232 185 - 279 17 196.9 6.4 3.2 195 157 - 237 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 31 228.7 4.9 2.1 230 182 - 275 31 192.5 4.1 2.1 193 154 - 232 VITROS VITROS 250,350,500,700,750,950 15 250.1 10.5 4.2 251 200 - 301 15 203.7 8.1 4.0 204 162 - 245 All Chemistry Instruments 19 251.7 11.8 4.7 254 201 - 303 19 205.5 8.6 4.2 207 164 - 247

Specimen CH-3 Specimen CH-4

All Method 145 269.5 21.0 7.8 268 215 - 324 146 212.8 14.1 6.6 212 170 - 256 All Roche Integra/c111/c501 Reagents 19 272.2 5.5 2.0 272 217 - 327 19 215.3 6.9 3.2 214 172 - 259 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 14 249.4 5.5 2.2 250 199 - 300 14 200.3 5.4 2.7 201 160 - 241 Beckman - cartridge Beckman Synchron LX/PRo/DxC 14 277.3 10.5 3.8 279 221 - 333 14 219.4 7.0 3.2 221 175 - 264 All Chemistry Instruments 16 278.3 10.5 3.8 279 222 - 334 16 220.3 7.0 3.2 221 176 - 265 Olympus Olympus AU 10 300.6 13.3 4.4 299 240 - 361 10 229.7 6.0 2.6 232 183 - 276 Roche Integra Roche Integra 17 271.5 5.4 2.0 271 217 - 326 17 214.9 7.1 3.3 213 171 - 258 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 31 264.9 5.0 1.9 265 211 - 318 31 211.1 4.2 2.0 212 168 - 254 VITROS VITROS 250,350,500,700,750,950 15 300.0 12.7 4.2 303 240 - 360 15 227.7 11.0 4.8 227 182 - 274 All Chemistry Instruments 19 302.2 13.0 4.3 303 241 - 363 19 229.8 11.1 4.8 229 183 - 276

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26/ 2011 MLE-M1 Participant Summary

Iron (mcg/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range

All Method 144 49.0 4.9 10.1 49 39 - 59 All Roche Integra/c111/c501 Reagents 18 50.7 4.8 9.5 50 40 - 61

Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 14 47.8 2.4 4.9 48 38 - 58 Beckman - cartridge Beckman Synchron LX/PRo/DxC 14 53.4 3.0 5.5 54 42 - 65 All Chemistry Instruments 16 53.9 3.2 6.0 55 43 - 65 Olympus Olympus AU 10 55.3 4.7 8.5 56 44 - 67 Roche Integra Roche Integra 16 50.4 5.0 10.0 49 40 - 61 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 31 49.3 2.4 4.9 49 39 - 60

VITROS VITROS 250,350,500,700,750,950 15 43.6 4.6 10.5 45 34 - 53 All Chemistry Instruments 19 44.2 4.3 9.8 45 35 - 54

Magnesium (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 186 2.17 0.18 8.2 2.2 1.6 - 2.8 184 1.31 0.14 10.6 1.3 0.9 - 1.7 All Roche Integra/c111/c501 Reagents 25 2.14 0.08 3.6 2.1 1.6 - 2.7 25 1.36 0.06 4.3 1.4 1.0 - 1.7 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 20 2.08 0.18 8.8 2.0 1.5 - 2.6 20 1.26 0.11 9.1 1.3 0.9 - 1.6 Beckman - cartridge Beckman Synchron LX/PRo/DxC 12 2.23 0.09 4.0 2.2 1.6 - 2.8 12 1.38 0.09 6.3 1.4 1.0 - 1.8 All Chemistry Instruments 18 2.24 0.09 4.1 2.2 1.6 - 2.8 17 1.36 0.05 3.7 1.4 1.0 - 1.7 Horiba ABX Pentra Horiba ABX Pentra 400 10 2.26 0.20 8.7 2.3 1.6 - 2.9 10 1.44 0.20 13.6 1.5 1.0 - 1.8 Olympus Olympus AU 13 2.12 0.09 4.2 2.1 1.5 - 2.7 13 1.27 0.08 5.9 1.3 0.9 - 1.6 Roche Integra Roche Integra 19 2.15 0.08 3.6 2.2 1.6 - 2.7 19 1.35 0.06 4.5 1.3 1.0 - 1.7 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 28 2.04 0.11 5.5 2.1 1.5 - 2.6 28 1.15 0.07 6.0 1.2 0.8 - 1.5 Vital Diagnostics All Chemistry Instruments 15 2.16 0.24 11.3 2.2 1.6 - 2.7 15 1.30 0.09 7.1 1.3 0.9 - 1.7 VITROS VITROS 250,350,500,700,750,950 19 2.27 0.14 6.2 2.3 1.7 - 2.9 19 1.38 0.13 9.5 1.4 1.0 - 1.8 All Chemistry Instruments 24 2.31 0.15 6.4 2.3 1.7 - 2.9 24 1.40 0.12 8.8 1.4 1.0 - 1.8

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2011 MLE-M1 Participant Summary/ 27

Magnesium (mg/dL)

Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 183 2.99 0.22 7.2 3.0 2.2 - 3.8 183 1.74 0.14 8.1 1.7 1.3 - 2.2 All Roche Integra/c111/c501 Reagents 25 2.87 0.08 2.8 2.9 2.1 - 3.6 25 1.76 0.06 3.2 1.8 1.3 - 2.3 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 20 2.85 0.21 7.5 2.8 2.1 - 3.6 20 1.66 0.12 7.4 1.6 1.2 - 2.1 Beckman - cartridge Beckman Synchron LX/PRo/DxC 12 3.14 0.14 4.4 3.1 2.3 - 4.0 12 1.82 0.08 4.6 1.8 1.3 - 2.3 All Chemistry Instruments 18 3.14 0.12 4.0 3.1 2.3 - 4.0 18 1.80 0.09 5.0 1.8 1.3 - 2.3 Horiba ABX Pentra Horiba ABX Pentra 400 10 3.09 0.22 7.2 3.0 2.3 - 3.9 10 1.84 0.18 10.0 1.8 1.3 - 2.3 Olympus Olympus AU 13 2.93 0.14 4.9 3.0 2.1 - 3.7 13 1.68 0.08 5.0 1.7 1.2 - 2.1 Roche Integra Roche Integra 19 2.87 0.08 2.8 2.9 2.1 - 3.6 19 1.77 0.06 3.3 1.8 1.3 - 2.3 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 28 2.96 0.10 3.5 3.0 2.2 - 3.8 28 1.61 0.08 5.0 1.6 1.2 - 2.1 Vital Diagnostics All Chemistry Instruments 15 2.81 0.30 10.8 2.9 2.1 - 3.6 15 1.73 0.16 9.1 1.8 1.2 - 2.2 VITROS VITROS 250,350,500,700,750,950 19 3.19 0.14 4.2 3.2 2.3 - 4.0 19 1.84 0.13 6.8 1.9 1.3 - 2.3 All Chemistry Instruments 24 3.23 0.15 4.5 3.3 2.4 - 4.1 24 1.86 0.12 6.5 1.9 1.3 - 2.4

Specimen CH-5

All Method 185 4.40 0.35 7.9 4.4 3.3 - 5.6 All Roche Integra/c111/c501 Reagents 25 4.26 0.10 2.4 4.3 3.1 - 5.4

Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 19 4.21 0.18 4.4 4.2 3.1 - 5.3 Beckman - cartridge Beckman Synchron LX/PRo/DxC 12 4.44 0.18 4.0 4.4 3.3 - 5.6 All Chemistry Instruments 18 4.46 0.18 4.0 4.4 3.3 - 5.6 Horiba ABX Pentra Horiba ABX Pentra 400 10 4.30 0.33 7.7 4.2 3.2 - 5.4 Olympus Olympus AU 13 4.36 0.20 4.5 4.4 3.2 - 5.5 Roche Integra Roche Integra 19 4.27 0.11 2.6 4.3 3.2 - 5.4 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 28 4.53 0.13 2.9 4.5 3.3 - 5.7

Vital Diagnostics All Chemistry Instruments 15 4.00 0.41 10.3 4.1 3.0 - 5.0 VITROS VITROS 250,350,500,700,750,950 19 4.91 0.14 3.0 4.9 3.6 - 6.2 All Chemistry Instruments 24 4.93 0.15 3.0 4.9 3.6 - 6.2

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28/ 2011 MLE-M1 Participant Summary

Phosphorus (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 167 2.83 0.27 9.5 2.8 2.0 - 3.7 164 2.16 0.19 8.8 2.1 1.5 - 2.8 All Roche Integra/c111/c501 Reagents 22 2.84 0.06 2.1 2.8 2.6 - 3.1 22 2.16 0.07 3.4 2.2 1.9 - 2.4 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 22 2.53 0.10 3.9 2.5 2.2 - 2.9 24 1.99 0.09 4.4 2.0 1.7 - 2.3 Beckman - cartridge Beckman Synchron LX/PRo/DxC 13 2.86 0.13 4.6 2.9 2.4 - 3.3 13 2.13 0.09 4.4 2.1 1.8 - 2.5 All Chemistry Instruments 18 2.92 0.15 5.3 2.9 2.4 - 3.4 18 2.17 0.11 5.2 2.2 1.8 - 2.6 Roche Integra Roche Integra 17 2.84 0.06 2.2 2.8 2.6 - 3.1 17 2.16 0.08 3.6 2.2 1.9 - 2.5 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 27 2.87 0.10 3.6 2.9 2.5 - 3.2 26 2.13 0.10 4.6 2.1 1.8 - 2.5 Vital Diagnostics All Chemistry Instruments 12 2.38 0.14 6.0 2.4 1.9 - 2.9 12 1.86 0.09 4.8 1.9 1.5 - 2.2 VITROS VITROS 250,350,500,700,750,950 16 2.96 0.15 5.1 3.0 2.5 - 3.5 16 2.35 0.13 5.6 2.4 1.9 - 2.8 All Chemistry Instruments 19 2.95 0.14 4.7 3.0 2.5 - 3.4 19 2.35 0.13 5.6 2.4 1.9 - 2.8

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2011 MLE-M1 Participant Summary/ 29

Protein, Total (g/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 417 7.17 0.28 3.9 7.2 6.4 - 7.9 419 5.53 0.21 3.7 5.5 4.9 - 6.1 All Roche Integra/c111/c501 Reagents 51 7.07 0.18 2.6 7.1 6.3 - 7.8 52 5.49 0.15 2.8 5.5 4.9 - 6.1 Abaxis Piccolo Abaxis Piccolo - waived 21 7.34 0.10 1.4 7.4 6.6 - 8.1 21 5.70 0.09 1.6 5.7 5.1 - 6.3 Abaxis Piccolo 18 7.41 0.11 1.5 7.4 6.6 - 8.2 18 5.72 0.10 1.8 5.7 5.1 - 6.3 All Chemistry Instruments 40 7.38 0.11 1.5 7.4 6.6 - 8.2 40 5.71 0.10 1.7 5.7 5.1 - 6.3 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 68 7.13 0.17 2.4 7.1 6.4 - 7.9 69 5.50 0.15 2.7 5.5 4.9 - 6.1 Beckman - cartridge Beckman Synchron 10 7.00 0.08 1.2 7.0 6.3 - 7.7 10 5.30 0.12 2.2 5.3 4.7 - 5.9 Beckman Synchron LX/PRo/DxC 18 6.94 0.33 4.7 7.0 6.2 - 7.7 18 5.30 0.23 4.3 5.3 4.7 - 5.9 All Chemistry Instruments 26 6.97 0.16 2.3 7.0 6.2 - 7.7 26 5.30 0.13 2.4 5.3 4.7 - 5.9 Carolina Liquid Chemistries Beckman Synchron 10 6.81 0.33 4.9 6.7 6.1 - 7.5 10 5.13 0.17 3.3 5.1 4.6 - 5.7 All Chemistry Instruments 11 6.85 0.35 5.1 6.7 6.1 - 7.6 11 5.18 0.24 4.6 5.1 4.6 - 5.7 Horiba ABX Pentra Horiba ABX Pentra 400 15 7.38 0.23 3.1 7.4 6.6 - 8.2 15 5.68 0.20 3.5 5.6 5.1 - 6.3 Olympus Olympus AU 20 7.04 0.19 2.7 7.1 6.3 - 7.8 20 5.40 0.16 2.9 5.4 4.8 - 6.0 Roche Integra Roche Integra 44 7.06 0.18 2.6 7.1 6.3 - 7.8 43 5.47 0.13 2.3 5.5 4.9 - 6.1 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 58 7.47 0.09 1.2 7.5 6.7 - 8.3 61 5.72 0.11 1.9 5.7 5.1 - 6.3 Vital Diagnostics Vital Diagnostics ATAC 8000 19 7.29 0.27 3.7 7.3 6.5 - 8.1 19 5.64 0.17 3.0 5.6 5.0 - 6.3 Vital Diagnostics Envoy 500 20 7.25 0.14 2.0 7.3 6.5 - 8.0 20 5.55 0.11 1.9 5.5 4.9 - 6.2 All Chemistry Instruments 39 7.27 0.21 2.9 7.3 6.5 - 8.0 39 5.59 0.15 2.6 5.6 5.0 - 6.2 VITROS VITROS 250,350,500,700,750,950 43 6.78 0.17 2.6 6.8 6.1 - 7.5 42 5.35 0.13 2.4 5.4 4.8 - 5.9 All Chemistry Instruments 48 6.77 0.17 2.5 6.8 6.0 - 7.5 47 5.35 0.13 2.4 5.4 4.8 - 5.9

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30/ 2011 MLE-M1 Participant Summary

Protein, Total (g/dL)

Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 408 8.77 0.43 4.9 8.8 7.8 - 9.7 406 6.38 0.25 3.9 6.4 5.7 - 7.1 All Roche Integra/c111/c501 Reagents 52 8.63 0.25 3.0 8.6 7.7 - 9.5 52 6.30 0.18 2.8 6.3 5.6 - 7.0 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 9.2 8.2 - 10.1 8 - - - 6.6 5.9 - 7.3 Abaxis Piccolo 18 9.13 0.17 1.9 9.1 8.2 - 10.1 18 6.61 0.15 2.2 6.6 5.9 - 7.3 All Chemistry Instruments 26 9.14 0.16 1.8 9.2 8.2 - 10.1 27 6.61 0.14 2.1 6.6 5.9 - 7.3 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 67 8.80 0.23 2.6 8.8 7.9 - 9.7 68 6.36 0.15 2.4 6.4 5.7 - 7.0 Beckman - cartridge Beckman Synchron 10 8.69 0.14 1.7 8.7 7.8 - 9.6 10 6.18 0.19 3.0 6.2 5.5 - 6.8 Beckman Synchron LX/PRo/DxC 18 8.64 0.41 4.8 8.7 7.7 - 9.6 18 6.14 0.30 4.8 6.2 5.5 - 6.8 All Chemistry Instruments 27 8.70 0.28 3.2 8.7 7.8 - 9.6 28 6.15 0.26 4.2 6.2 5.5 - 6.8 Carolina Liquid Chemistries Beckman Synchron 10 8.40 0.46 5.5 8.3 7.5 - 9.3 10 6.00 0.28 4.7 6.0 5.4 - 6.6 All Chemistry Instruments 11 8.45 0.48 5.6 8.3 7.6 - 9.3 11 6.05 0.31 5.1 6.0 5.4 - 6.7 Horiba ABX Pentra Horiba ABX Pentra 400 15 8.99 0.29 3.2 9.0 8.0 - 9.9 15 6.53 0.20 3.1 6.5 5.8 - 7.2 Olympus Olympus AU 20 8.63 0.24 2.8 8.6 7.7 - 9.5 20 6.23 0.17 2.7 6.2 5.6 - 6.9 Roche Integra Roche Integra 44 8.61 0.26 3.0 8.6 7.7 - 9.5 44 6.29 0.18 2.9 6.3 5.6 - 7.0 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 59 9.23 0.15 1.7 9.2 8.3 - 10.2 59 6.64 0.10 1.5 6.6 5.9 - 7.3 Vital Diagnostics Vital Diagnostics ATAC 8000 18 9.02 0.21 2.4 9.0 8.1 - 10.0 19 6.48 0.19 2.9 6.5 5.8 - 7.2 Vital Diagnostics Envoy 500 20 8.86 0.18 2.1 8.9 7.9 - 9.8 20 6.38 0.12 1.9 6.4 5.7 - 7.1 All Chemistry Instruments 38 8.93 0.21 2.4 9.0 8.0 - 9.9 39 6.43 0.17 2.6 6.4 5.7 - 7.1 VITROS VITROS 250,350,500,700,750,950 44 8.12 0.26 3.2 8.1 7.3 - 9.0 43 6.12 0.16 2.7 6.1 5.5 - 6.8 All Chemistry Instruments 49 8.09 0.27 3.3 8.1 7.2 - 8.9 48 6.11 0.17 2.7 6.1 5.4 - 6.8

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2011 MLE-M1 Participant Summary/ 31

Protein, Total (g/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range All Method 402 2.77 0.13 4.5 2.8 2.4 - 3.1 All Roche Integra/c111/c501 Reagents 52 2.68 0.13 4.8 2.7 2.4 - 3.0

Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 2.8 2.5 - 3.1 Abaxis Piccolo 18 2.78 0.08 2.8 2.8 2.5 - 3.1 All Chemistry Instruments 27 2.79 0.07 2.6 2.8 2.5 - 3.1 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 69 2.80 0.11 3.9 2.8 2.5 - 3.1 Beckman - cartridge Beckman Synchron 10 2.65 0.08 3.2 2.7 2.3 - 3.0 Beckman Synchron LX/PRo/DxC 17 2.69 0.14 5.2 2.7 2.4 - 3.0 All Chemistry Instruments 27 2.68 0.12 4.6 2.7 2.4 - 3.0 Carolina Liquid Chemistries Beckman Synchron 8 - - - 2.5 2.4 - 3.1 All Chemistry Instruments 9 - - - 2.5 2.3 - 2.9 Horiba ABX Pentra Horiba ABX Pentra 400 15 2.87 0.12 4.0 2.8 2.5 - 3.2 Olympus Olympus AU 19 2.68 0.12 4.4 2.7 2.4 - 3.0 Roche Integra Roche Integra 44 2.66 0.13 4.8 2.6 2.3 - 3.0 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 2.76 0.09 3.2 2.8 2.4 - 3.1

Vital Diagnostics Vital Diagnostics ATAC 8000 19 2.82 0.13 4.5 2.8 2.5 - 3.2 Vital Diagnostics Envoy 500 20 2.75 0.07 2.5 2.8 2.4 - 3.1 All Chemistry Instruments 39 2.78 0.11 3.9 2.8 2.5 - 3.1 VITROS VITROS 250,350,500,700,750,950 42 2.85 0.08 2.8 2.9 2.5 - 3.2 All Chemistry Instruments 46 2.84 0.07 2.4 2.9 2.5 - 3.2

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Urea Nitrogen (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 436 31.6 2.1 6.8 32 28 - 35 436 43.4 3.1 7.2 44 39 - 48 All Roche Integra/c111/c501 Reagents 54 31.4 1.3 4.0 31 28 - 35 53 43.4 1.5 3.5 44 39 - 48 Abaxis Piccolo Abaxis Piccolo - waived 21 30.9 1.0 3.4 31 28 - 34 21 42.4 1.6 3.7 43 38 - 47 Abaxis Piccolo 18 30.9 0.6 2.1 31 28 - 34 18 42.5 1.1 2.6 43 38 - 47 All Chemistry Instruments 40 30.9 0.9 2.8 31 28 - 34 40 42.4 1.3 3.2 43 38 - 47 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 69 32.3 1.3 4.1 32 29 - 36 69 45.3 1.8 4.0 45 41 - 50 Beckman - cartridge Beckman Synchron 10 32.6 0.7 2.1 33 29 - 36 10 44.6 1.3 2.8 45 40 - 49 Beckman Synchron LX/PRo/DxC 17 33.1 0.8 2.5 33 30 - 37 18 44.9 1.2 2.7 45 40 - 49 All Chemistry Instruments 27 32.9 0.8 2.4 33 29 - 36 28 44.8 1.2 2.7 45 40 - 49 Carolina Liquid Chemistries Beckman Synchron 10 32.1 1.1 3.4 32 29 - 35 10 43.8 1.5 3.5 44 39 - 48 All Chemistry Instruments 11 32.1 1.0 3.3 32 29 - 35 11 44.0 1.6 3.7 44 40 - 48 Horiba ABX Pentra Horiba ABX Pentra 400 15 33.4 1.3 3.9 33 30 - 37 15 45.1 1.5 3.2 46 41 - 50 Olympus Olympus AU 20 32.2 0.6 1.8 32 29 - 36 20 44.6 1.2 2.8 44 40 - 49 Roche Integra Roche Integra 43 31.5 1.3 4.0 31 28 - 35 42 43.5 1.5 3.3 44 39 - 48 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 32.8 1.5 4.4 33 29 - 36 61 45.0 1.8 4.1 45 40 - 50 Vital Diagnostics Vital Diagnostics ATAC 8000 20 32.7 1.0 3.0 33 29 - 36 20 45.6 1.2 2.7 46 41 - 50 Vital Diagnostics Envoy 500 24 33.2 1.5 4.6 33 30 - 37 24 44.8 2.1 4.7 45 40 - 49 All Chemistry Instruments 44 33.0 1.3 4.0 33 30 - 36 44 45.1 1.8 3.9 45 41 - 50 VITROS VITROS 250,350,500,700,750,950 45 27.3 0.8 2.8 27 24 - 30 45 36.8 0.9 2.5 37 33 - 41 All Chemistry Instruments 54 27.2 0.8 2.9 27 24 - 30 54 36.8 1.0 2.6 37 33 - 41

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2011 MLE-M1 Participant Summary/ 33

Urea Nitrogen (mg/dL)

Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 419 19.8 1.2 6.2 20 17 - 22 424 37.7 2.7 7.2 38 34 - 42 All Roche Integra/c111/c501 Reagents 54 19.4 0.8 4.0 19 17 - 22 54 37.5 1.5 4.0 38 34 - 41 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 20 17 - 22 8 - - - 37 33 - 40 Abaxis Piccolo 18 19.7 0.9 4.6 20 17 - 22 18 36.8 0.9 2.6 37 33 - 41 All Chemistry Instruments 27 19.8 0.8 4.2 20 17 - 22 27 36.7 1.0 2.6 37 33 - 40 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 67 20.1 0.9 4.2 20 18 - 23 68 39.3 1.5 3.8 39 35 - 43 Beckman - cartridge Beckman Synchron 10 20.5 0.5 2.6 21 18 - 23 10 38.5 1.4 3.5 39 35 - 42 Beckman Synchron LX/PRo/DxC 18 20.8 0.4 2.1 21 18 - 23 18 39.3 1.0 2.6 39 35 - 43 All Chemistry Instruments 28 20.7 0.5 2.3 21 18 - 23 28 39.0 1.2 3.1 39 35 - 43 Carolina Liquid Chemistries Beckman Synchron 10 19.6 2.0 10.0 20 17 - 22 10 38.0 0.8 2.1 38 34 - 42 All Chemistry Instruments 11 19.7 1.9 9.6 20 17 - 22 11 38.1 0.8 2.2 38 34 - 42 Horiba ABX Pentra Horiba ABX Pentra 400 15 20.9 0.9 4.4 21 18 - 23 15 39.5 1.2 3.2 39 35 - 44 Olympus Olympus AU 20 19.9 0.5 2.5 20 17 - 22 20 38.3 1.0 2.5 38 34 - 42 Roche Integra Roche Integra 43 19.5 0.8 4.1 19 17 - 22 43 37.7 1.5 3.9 38 34 - 42 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 20.2 1.1 5.4 20 18 - 23 60 39.0 1.4 3.6 39 35 - 43 Vital Diagnostics Vital Diagnostics ATAC 8000 20 20.6 0.8 3.7 21 18 - 23 20 39.0 1.2 3.1 39 35 - 43 Vital Diagnostics Envoy 500 24 21.3 1.2 5.4 21 19 - 24 24 38.9 1.4 3.7 39 35 - 43 All Chemistry Instruments 44 21.0 1.1 5.0 21 18 - 23 44 38.9 1.3 3.4 39 35 - 43 VITROS VITROS 250,350,500,700,750,950 45 17.9 0.5 2.8 18 15 - 20 45 32.2 0.8 2.5 32 29 - 36 All Chemistry Instruments 53 17.9 0.5 2.9 18 15 - 20 54 32.0 0.9 2.7 32 29 - 35

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34/ 2011 MLE-M1 Participant Summary

Urea Nitrogen (mg/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range All Method 421 11.2 1.0 8.6 11 9 - 14 All Roche Integra/c111/c501 Reagents 54 10.9 0.5 4.2 11 8 - 13

Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 12 9 - 14 Abaxis Piccolo 18 11.6 0.6 5.3 12 9 - 14 All Chemistry Instruments 27 11.7 0.7 5.8 12 9 - 14 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 67 11.6 0.7 6.2 12 9 - 14 Beckman - cartridge Beckman Synchron 10 11.8 0.4 3.6 12 9 - 14 Beckman Synchron LX/PRo/DxC 18 11.8 0.4 3.6 12 9 - 14 All Chemistry Instruments 28 11.8 0.4 3.5 12 9 - 14 Carolina Liquid Chemistries Beckman Synchron 10 11.5 1.3 11.0 12 9 - 14 All Chemistry Instruments 11 11.5 1.2 10.5 12 9 - 14 Horiba ABX Pentra Horiba ABX Pentra 400 15 12.3 1.0 8.4 12 10 - 15 Olympus Olympus AU 20 11.2 0.7 6.0 11 9 - 14 Roche Integra Roche Integra 43 10.9 0.5 4.4 11 8 - 13 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 11.1 0.8 7.3 11 9 - 14

Vital Diagnostics Vital Diagnostics ATAC 8000 20 11.4 0.9 7.7 12 9 - 14 Vital Diagnostics Envoy 500 24 12.6 0.8 6.2 13 10 - 15 All Chemistry Instruments 43 12.1 0.9 7.5 12 10 - 15 VITROS VITROS 250,350,500,700,750,950 44 9.9 0.5 5.0 10 7 - 12 All Chemistry Instruments 53 9.9 0.5 5.5 10 7 - 12

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2011 MLE-M1 Participant Summary/ 35

Uric Acid (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 270 7.36 0.33 4.5 7.3 6.1 - 8.7 268 13.00 0.56 4.3 13.0 10.7 - 15.3 All Roche Integra/c111/c501 Reagents 33 7.26 0.22 3.1 7.3 6.0 - 8.5 33 12.82 0.41 3.2 12.8 10.6 - 15.0 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 43 7.51 0.29 3.8 7.5 6.2 - 8.8 44 13.22 0.42 3.2 13.2 10.9 - 15.5 Beckman - cartridge Beckman Synchron LX/PRo/DxC 18 7.27 0.19 2.6 7.3 6.0 - 8.6 18 13.16 0.63 4.8 13.3 10.9 - 15.4 All Chemistry Instruments 26 7.27 0.18 2.4 7.3 6.0 - 8.6 25 13.07 0.69 5.2 13.3 10.8 - 15.3 Horiba ABX Pentra Horiba ABX Pentra 400 11 7.20 0.13 1.9 7.2 5.9 - 8.5 11 12.77 0.22 1.8 12.8 10.6 - 15.0 Olympus Olympus AU 15 7.94 0.14 1.7 7.9 6.5 - 9.3 15 14.07 0.23 1.6 14.0 11.6 - 16.5 Roche Integra Roche Integra 30 7.25 0.23 3.1 7.3 6.0 - 8.5 30 12.83 0.40 3.1 12.8 10.6 - 15.1 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 42 7.21 0.19 2.6 7.2 5.9 - 8.5 42 12.74 0.30 2.3 12.8 10.5 - 15.0 Vital Diagnostics Vital Diagnostics ATAC 8000 11 6.97 0.26 3.8 7.0 5.7 - 8.2 11 12.24 0.39 3.1 12.2 10.1 - 14.4 Vital Diagnostics Envoy 500 16 7.67 0.20 2.6 7.7 6.3 - 9.0 16 13.47 0.32 2.4 13.5 11.1 - 15.8 All Chemistry Instruments 27 7.39 0.41 5.6 7.4 6.1 - 8.7 27 12.97 0.70 5.4 13.1 10.7 - 15.2 VITROS VITROS 250,350,500,700,750,950 31 7.26 0.17 2.4 7.2 6.0 - 8.5 31 12.71 0.31 2.5 12.6 10.5 - 14.9 All Chemistry Instruments 36 7.26 0.17 2.4 7.2 6.0 - 8.5 36 12.70 0.30 2.4 12.6 10.5 - 14.9

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Uric Acid (mg/dL)

Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 271 2.12 0.56 26.3 1.9 1.7 - 2.5 264 10.15 0.43 4.2 10.1 8.4 - 11.9 All Roche Integra/c111/c501 Reagents 33 1.69 0.07 3.9 1.7 1.4 - 2.0 33 10.04 0.33 3.2 10.0 8.3 - 11.8 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 44 3.23 0.18 5.7 3.2 2.6 - 3.8 43 10.28 0.38 3.7 10.3 8.5 - 12.1 Beckman - cartridge Beckman Synchron LX/PRo/DxC 18 2.04 0.07 3.4 2.0 1.6 - 2.4 18 10.01 0.31 3.1 10.0 8.3 - 11.8 All Chemistry Instruments 26 2.07 0.09 4.4 2.1 1.7 - 2.5 26 10.00 0.28 2.8 10.0 8.3 - 11.7 Horiba ABX Pentra Horiba ABX Pentra 400 11 1.76 0.10 5.8 1.8 1.4 - 2.1 11 10.03 0.19 1.9 10.0 8.3 - 11.8 Olympus Olympus AU 15 1.93 0.05 2.5 1.9 1.6 - 2.3 14 10.94 0.14 1.3 11.0 9.0 - 12.8 Roche Integra Roche Integra 30 1.69 0.06 3.7 1.7 1.3 - 2.0 30 10.03 0.33 3.3 10.0 8.3 - 11.8 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 42 1.95 0.12 5.9 2.0 1.6 - 2.3 42 9.99 0.24 2.4 10.0 8.2 - 11.7 Vital Diagnostics Vital Diagnostics ATAC 8000 11 1.85 0.19 10.1 1.9 1.5 - 2.2 11 10.02 0.85 8.5 9.7 8.3 - 11.8 Vital Diagnostics Envoy 500 16 1.92 0.19 9.9 1.9 1.5 - 2.3 15 10.58 0.28 2.6 10.6 8.7 - 12.4 All Chemistry Instruments 26 1.91 0.15 7.9 1.9 1.5 - 2.3 27 10.41 0.73 7.0 10.4 8.6 - 12.2 VITROS VITROS 250,350,500,700,750,950 31 1.74 0.08 4.6 1.7 1.4 - 2.1 31 10.00 0.27 2.7 10.0 8.2 - 11.7 All Chemistry Instruments 36 1.74 0.08 4.8 1.7 1.4 - 2.1 36 9.99 0.25 2.5 10.0 8.2 - 11.7

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2011 MLE-M1 Participant Summary/ 37

Uric Acid (mg/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range All Method 268 7.53 0.40 5.3 7.5 6.2 - 8.9 All Roche Integra/c111/c501 Reagents 32 7.49 0.19 2.5 7.5 6.2 - 8.8

Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 43 7.34 0.23 3.2 7.4 6.0 - 8.6 Beckman - cartridge Beckman Synchron LX/PRo/DxC 18 7.00 0.19 2.7 7.0 5.8 - 8.2 All Chemistry Instruments 26 7.02 0.18 2.6 7.0 5.8 - 8.3 Horiba ABX Pentra Horiba ABX Pentra 400 11 7.64 0.16 2.1 7.6 6.3 - 9.0 Olympus Olympus AU 15 8.44 0.08 1.0 8.4 7.0 - 9.9 Roche Integra Roche Integra 29 7.49 0.19 2.6 7.5 6.2 - 8.8 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 42 7.72 0.16 2.0 7.7 6.4 - 9.1

Vital Diagnostics Vital Diagnostics ATAC 8000 11 7.21 0.73 10.1 7.4 5.9 - 8.5 Vital Diagnostics Envoy 500 15 7.95 0.24 3.1 7.9 6.6 - 9.4 All Chemistry Instruments 25 7.74 0.35 4.5 7.8 6.4 - 9.1 VITROS VITROS 250,350,500,700,750,950 31 7.51 0.19 2.5 7.5 6.2 - 8.8 All Chemistry Instruments 36 7.51 0.18 2.4 7.5 6.2 - 8.8

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Chloride (mmol/L)

Specimen CH-1 Specimen CH-2 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 418 102.3 2.7 2.6 102 97 - 108 420 84.7 2.5 3.0 84 80 - 89 Abaxis Piccolo Abaxis Piccolo - waived 21 102.9 2.5 2.4 102 97 - 109 21 87.9 2.2 2.5 88 83 - 93 Abaxis Piccolo 18 101.8 2.9 2.9 102 96 - 107 18 87.2 2.4 2.7 87 82 - 92 All Chemistry Instruments 40 102.4 2.7 2.6 102 97 - 108 40 87.6 2.3 2.6 87 83 - 92 ISE Diluted Beckman Synchron 17 101.7 2.0 2.0 102 96 - 107 17 87.1 1.9 2.1 87 82 - 92 Beckman Synchron LX/PRo/DxC 17 100.5 2.2 2.2 100 95 - 106 17 86.1 2.1 2.4 85 81 - 91 Olympus AU 17 99.9 0.9 0.9 100 94 - 105 17 84.2 1.4 1.7 84 79 - 89 Roche Integra 38 101.2 1.2 1.2 101 96 - 107 39 83.4 1.3 1.6 83 79 - 88 Siemens Dimension QuickLyte - RxL 15 104.9 2.5 2.4 105 99 - 111 15 81.6 1.0 1.2 82 77 - 86 Siemens Dimension QuickLyte - Xpand/EXL 29 104.0 1.5 1.5 104 98 - 110 30 83.0 0.9 1.1 83 78 - 88 Vital Diagnostics ATAC 8000 15 103.6 3.4 3.2 103 98 - 109 15 86.9 3.7 4.2 86 82 - 92 Vital Diagnostics Envoy 500 19 106.1 2.8 2.6 106 100 - 112 19 87.9 2.2 2.5 88 83 - 93 All Chemistry Instruments 201 102.5 2.9 2.8 102 97 - 108 202 84.4 2.6 3.1 84 80 - 89 ISE Undiluted Alfa Wassermann ACE/NexCT/Alera 67 103.5 1.6 1.6 103 98 - 109 67 83.9 2.0 2.3 84 79 - 89 All Chemistry Instruments 118 103.1 2.2 2.1 103 97 - 109 119 84.5 2.2 2.6 84 80 - 89 VITROS VITROS 250,350,500,700,750,950 42 100.0 1.4 1.4 100 95 - 105 42 84.7 1.3 1.5 85 80 - 89 All Chemistry Instruments 48 100.1 1.4 1.4 100 95 - 106 48 84.8 1.3 1.5 85 80 - 89

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2011 MLE-M1 Participant Summary/ 39

Chloride (mmol/L)

Specimen CH-3 Specimen CH-4 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 408 119.8 4.4 3.7 120 113 - 126 408 93.6 2.2 2.3 93 88 - 99 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 114 109 - 122 8 - - - 95 90 - 101 Abaxis Piccolo 18 115.8 2.8 2.4 116 109 - 122 18 95.7 2.0 2.1 96 90 - 101 All Chemistry Instruments 27 115.4 3.2 2.7 115 109 - 122 26 95.3 2.2 2.3 95 90 - 101 ISE Diluted Beckman Synchron 17 115.6 1.9 1.6 115 109 - 122 17 94.5 1.8 1.9 94 89 - 100 Beckman Synchron LX/PRo/DxC 17 115.9 2.8 2.4 116 110 - 122 17 93.6 2.2 2.4 93 88 - 99 Olympus AU 18 115.6 1.1 0.9 116 109 - 122 18 92.4 1.0 1.1 92 87 - 98 Roche Integra 37 119.2 1.5 1.2 119 113 - 126 39 92.5 1.3 1.4 92 87 - 98 Siemens Dimension QuickLyte - RxL 15 125.6 3.4 2.7 126 119 - 132 15 92.7 1.5 1.6 93 88 - 98 Siemens Dimension QuickLyte - Xpand/EXL 30 124.6 2.0 1.6 125 118 - 131 30 93.2 1.1 1.2 93 88 - 98 Vital Diagnostics ATAC 8000 14 119.7 3.5 2.9 119 113 - 126 15 95.1 3.4 3.5 94 90 - 100 Vital Diagnostics Envoy 500 19 125.2 3.2 2.6 126 118 - 132 18 97.8 1.4 1.4 98 92 - 103 All Chemistry Instruments 203 120.4 4.7 3.9 120 114 - 127 203 93.5 2.3 2.4 93 88 - 99 ISE Undiluted Alfa Wassermann ACE/NexCT/Alera 68 121.6 2.4 2.0 122 115 - 128 69 93.9 1.7 1.9 94 89 - 99 All Chemistry Instruments 118 121.2 3.5 2.9 122 115 - 128 120 93.8 2.0 2.2 94 89 - 99 VITROS VITROS 250,350,500,700,750,950 41 116.3 1.6 1.4 116 110 - 123 41 92.8 1.3 1.4 93 88 - 98 All Chemistry Instruments 47 116.3 1.5 1.3 116 110 - 123 47 92.8 1.3 1.4 93 88 - 98

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Chloride (mmol/L)

Specimen CH-5 Method/Instrument Labs Mean SD CV Median Range

All Method 410 106.2 2.3 2.2 106 100 - 112 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 107 101 - 113 Abaxis Piccolo 18 106.7 2.7 2.6 106 101 - 113 All Chemistry Instruments 27 107.0 3.0 2.8 106 101 - 113 ISE Diluted Beckman Synchron 17 105.8 2.0 1.9 106 100 - 112 Beckman Synchron LX/PRo/DxC 17 106.3 2.2 2.1 106 100 - 112 Olympus AU 18 106.5 1.0 0.9 107 101 - 112 Roche Integra 40 106.1 1.2 1.1 106 100 - 112 Siemens Dimension QuickLyte - RxL 15 108.7 1.6 1.5 108 103 - 115 Siemens Dimension QuickLyte - Xpand/EXL 30 108.5 1.3 1.2 109 103 - 114

Vital Diagnostics ATAC 8000 15 105.6 2.6 2.4 105 100 - 111 Vital Diagnostics Envoy 500 19 106.6 2.6 2.4 106 101 - 112 All Chemistry Instruments 202 106.8 2.1 1.9 107 101 - 113 ISE Undiluted Alfa Wassermann ACE/NexCT/Alera 67 104.9 1.4 1.3 105 99 - 111 All Chemistry Instruments 120 105.3 2.2 2.1 105 100 - 111 VITROS VITROS 250,350,500,700,750,950 41 105.4 1.6 1.5 105 100 - 111 All Chemistry Instruments 47 105.3 1.6 1.5 105 100 - 111

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2011 MLE-M1 Participant Summary/ 41

CO2 (mmol/L)

Specimen CH-1 Specimen CH-2 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 413 25.7 2.3 9.1 26 18 - 33 411 15.6 1.8 11.3 16 10 - 21 Enzymatic Reagent Abaxis Piccolo - waived 14 27.4 0.8 3.1 28 24 - 30 14 16.6 0.6 3.9 17 14 - 19 Abaxis Piccolo 11 26.7 1.1 4.1 27 23 - 31 11 15.9 0.9 5.9 16 13 - 19 Alfa Wassermann ACE/NexCT/Alera 48 23.7 2.4 9.9 24 16 - 31 48 14.2 1.8 12.4 14 8 - 20 Horiba ABX Pentra 400 10 27.1 1.4 5.3 27 22 - 32 10 16.6 0.8 5.1 17 14 - 20 Olympus AU 19 24.7 1.7 6.8 25 19 - 30 19 14.7 1.6 10.9 15 9 - 20 Roche Integra 37 25.1 2.0 8.1 25 18 - 32 37 15.1 1.5 10.1 15 10 - 20 Siemens Dimension/AR/ES/RxL/Xpand/EXL 39 27.8 1.2 4.3 28 24 - 32 41 16.9 1.3 7.9 17 12 - 21 All Chemistry Instruments 214 25.7 2.5 9.8 26 18 - 34 214 15.5 1.9 12.1 16 9 - 22 ISE Diluted Beckman Synchron 17 26.9 2.0 7.5 27 20 - 33 17 16.9 1.3 7.9 17 12 - 21 Beckman Synchron LX/PRo/DxC 16 26.2 1.2 4.7 26 22 - 30 16 16.1 0.9 5.5 16 13 - 19 Vital Diagnostics ATAC 8000 15 25.9 2.5 9.7 27 18 - 34 15 17.3 1.8 10.1 17 12 - 23 Vital Diagnostics Envoy 500 17 24.3 4.4 17.9 24 11 - 38 17 14.5 2.7 18.9 15 6 - 23 All Chemistry Instruments 81 26.0 2.3 8.8 26 19 - 33 80 16.1 1.8 11.0 16 10 - 22 ISE Undiluted Alfa Wassermann ACE/NexCT/Alera 19 24.2 1.9 7.7 24 18 - 30 19 14.4 1.4 9.9 15 10 - 19 All Chemistry Instruments 49 24.8 2.4 9.8 25 17 - 33 49 15.0 1.8 11.8 15 9 - 21 VITROS VITROS 250,350,500,700,750,950 40 25.6 1.6 6.1 26 20 - 31 40 16.2 1.2 7.4 16 12 - 20 All Chemistry Instruments 46 25.6 1.5 6.0 26 21 - 31 46 16.2 1.2 7.4 16 12 - 20

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Potassium (mmol/L)

Specimen CH-1 Specimen CH-2 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 433 3.58 0.11 3.1 3.6 3.0 - 4.1 432 2.22 0.09 4.2 2.2 1.7 - 2.8 Abaxis Piccolo Abaxis Piccolo - waived 21 3.60 0.20 5.7 3.6 3.0 - 4.1 20 2.16 0.18 8.2 2.1 1.6 - 2.7 Abaxis Piccolo 18 3.64 0.15 4.0 3.7 3.1 - 4.2 18 2.22 0.20 8.9 2.2 1.7 - 2.8 All Chemistry Instruments 39 3.63 0.15 4.1 3.6 3.1 - 4.2 39 2.18 0.18 8.4 2.2 1.6 - 2.7 ISE Diluted Beckman Synchron 14 3.53 0.08 2.3 3.5 3.0 - 4.1 15 2.18 0.08 3.6 2.2 1.6 - 2.7 Beckman Synchron LX/PRo/DxC 16 3.50 0.07 2.1 3.5 3.0 - 4.0 16 2.12 0.07 3.1 2.1 1.6 - 2.7 Olympus AU 18 3.53 0.08 2.4 3.6 3.0 - 4.1 17 2.31 0.07 3.2 2.3 1.8 - 2.9 Roche Integra 37 3.52 0.04 1.2 3.5 3.0 - 4.1 38 2.21 0.03 1.4 2.2 1.7 - 2.8 Siemens Dimension QuickLyte - RxL 15 3.52 0.06 1.6 3.5 3.0 - 4.1 15 2.19 0.04 1.6 2.2 1.6 - 2.7 Siemens Dimension QuickLyte - Xpand/EXL 28 3.51 0.04 1.3 3.5 3.0 - 4.1 28 2.19 0.04 1.7 2.2 1.6 - 2.7 Vital Diagnostics ATAC 8000 14 3.53 0.09 2.6 3.5 3.0 - 4.1 14 2.18 0.08 3.7 2.2 1.6 - 2.7 Vital Diagnostics Envoy 500 19 3.41 0.11 3.4 3.4 2.9 - 4.0 19 2.14 0.07 3.2 2.1 1.6 - 2.7 All Chemistry Instruments 195 3.52 0.08 2.3 3.5 3.0 - 4.1 196 2.20 0.07 3.4 2.2 1.6 - 2.7 ISE Undiluted Alfa Wassermann ACE/NexCT/Alera 68 3.66 0.09 2.4 3.6 3.1 - 4.2 68 2.23 0.10 4.5 2.2 1.7 - 2.8 All Chemistry Instruments 131 3.61 0.10 2.8 3.6 3.1 - 4.2 131 2.23 0.10 4.4 2.2 1.7 - 2.8 VITROS VITROS 250,350,500,700,750,950 43 3.70 0.04 1.2 3.7 3.1 - 4.2 44 2.31 0.04 1.8 2.3 1.8 - 2.9 All Chemistry Instruments 58 3.67 0.10 2.6 3.7 3.1 - 4.2 57 2.29 0.07 3.3 2.3 1.7 - 2.8

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2011 MLE-M1 Participant Summary/ 43

Potassium (mmol/L)

Specimen CH-3 Specimen CH-4 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 426 4.92 0.14 2.9 4.9 4.4 - 5.5 423 2.90 0.10 3.5 2.9 2.3 - 3.4 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 5.1 4.4 - 5.5 8 - - - 3.0 2.4 - 3.5 Abaxis Piccolo 18 4.96 0.24 4.8 5.0 4.4 - 5.5 18 2.97 0.18 6.2 3.0 2.4 - 3.5 All Chemistry Instruments 27 5.00 0.24 4.8 5.0 4.4 - 5.5 27 2.94 0.19 6.6 3.0 2.4 - 3.5 ISE Diluted Beckman Synchron 15 4.87 0.11 2.3 4.8 4.3 - 5.4 15 2.84 0.09 3.2 2.8 2.3 - 3.4 Beckman Synchron LX/PRo/DxC 16 4.88 0.10 2.0 4.9 4.3 - 5.4 16 2.82 0.07 2.3 2.8 2.3 - 3.4 Olympus AU 18 4.85 0.06 1.3 4.9 4.3 - 5.4 16 2.91 0.03 1.2 2.9 2.4 - 3.5 Roche Integra 38 4.83 0.05 1.1 4.8 4.3 - 5.4 36 2.90 0.00 0.0 2.9 2.4 - 3.4 Siemens Dimension QuickLyte - RxL 15 4.82 0.08 1.6 4.8 4.3 - 5.4 15 2.83 0.05 1.6 2.8 2.3 - 3.4 Siemens Dimension QuickLyte - Xpand/EXL 29 4.86 0.06 1.3 4.9 4.3 - 5.4 29 2.84 0.06 2.0 2.8 2.3 - 3.4 Vital Diagnostics ATAC 8000 14 4.85 0.08 1.6 4.9 4.3 - 5.4 14 2.87 0.09 3.2 2.9 2.3 - 3.4 Vital Diagnostics Envoy 500 19 4.75 0.12 2.6 4.7 4.2 - 5.3 19 2.79 0.10 3.5 2.8 2.2 - 3.3 All Chemistry Instruments 197 4.84 0.09 1.9 4.8 4.3 - 5.4 192 2.86 0.07 2.3 2.9 2.3 - 3.4 ISE Undiluted Alfa Wassermann ACE/NexCT/Alera 71 5.04 0.10 2.0 5.0 4.5 - 5.6 69 2.94 0.10 3.4 2.9 2.4 - 3.5 All Chemistry Instruments 134 4.96 0.14 2.7 5.0 4.4 - 5.5 130 2.91 0.09 3.0 2.9 2.4 - 3.5 VITROS VITROS 250,350,500,700,750,950 43 5.09 0.08 1.5 5.1 4.5 - 5.6 44 3.02 0.06 1.9 3.0 2.5 - 3.6 All Chemistry Instruments 58 5.07 0.12 2.3 5.1 4.5 - 5.6 57 3.00 0.08 2.8 3.0 2.4 - 3.5

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Potassium (mmol/L)

Specimen CH-5 Method/Instrument Labs Mean SD CV Median Range

All Method 414 6.68 0.15 2.3 6.7 6.1 - 7.2 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 6.7 6.1 - 7.2 Abaxis Piccolo 18 6.59 0.22 3.4 6.6 6.0 - 7.1 All Chemistry Instruments 27 6.61 0.22 3.4 6.6 6.1 - 7.2 ISE Diluted Beckman Synchron 15 6.68 0.09 1.3 6.7 6.1 - 7.2 Beckman Synchron LX/PRo/DxC 16 6.73 0.11 1.6 6.7 6.2 - 7.3 Olympus AU 16 6.66 0.09 1.3 6.6 6.1 - 7.2 Roche Integra 38 6.70 0.05 0.7 6.7 6.2 - 7.3 Siemens Dimension QuickLyte - RxL 15 6.69 0.11 1.6 6.7 6.1 - 7.2 Siemens Dimension QuickLyte - Xpand/EXL 28 6.80 0.05 0.7 6.8 6.3 - 7.4

Vital Diagnostics ATAC 8000 15 6.79 0.23 3.3 6.8 6.2 - 7.3 Vital Diagnostics Envoy 500 18 6.49 0.11 1.7 6.5 5.9 - 7.0 All Chemistry Instruments 192 6.70 0.12 1.8 6.7 6.1 - 7.2 ISE Undiluted Alfa Wassermann ACE/NexCT/Alera 70 6.73 0.16 2.4 6.7 6.2 - 7.3 All Chemistry Instruments 130 6.67 0.19 2.8 6.7 6.1 - 7.2 VITROS VITROS 250,350,500,700,750,950 45 6.62 0.13 1.9 6.6 6.1 - 7.2 All Chemistry Instruments 58 6.61 0.14 2.2 6.6 6.1 - 7.2

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2011 MLE-M1 Participant Summary/ 45

Sodium (mmol/L) Technical tip: Incomplete or incorrect method reporting is a common cause of proficiency test failure, especially when it comes to the electrolytes. If your test method is ―ISE Direct‖, it should be reported as ISE Undiluted on your MLE test result form (TRF). If your test method is ―ISE Indirect‖, it should be reported as ISE Diluted on your MLE TRF. Be sure to check your package insert for the correct test method, or contact the manufacturer of the instrument or reagent.

Specimen CH-1 Specimen CH-2 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 432 138.5 2.9 2.1 138 134 - 143 426 119.0 2.1 1.8 119 114 - 123 Abaxis Piccolo Abaxis Piccolo - waived 21 141.2 2.3 1.6 141 137 - 146 18 120.1 3.2 2.6 121 116 - 125 Abaxis Piccolo 17 139.9 3.0 2.2 139 135 - 144 16 118.5 3.6 3.1 118 114 - 123 All Chemistry Instruments 40 140.6 2.6 1.9 141 136 - 145 36 119.2 3.4 2.8 119 115 - 124 ISE Diluted Beckman Synchron 16 137.8 1.6 1.2 138 133 - 142 16 118.9 1.7 1.4 119 114 - 123 Beckman Synchron LX/PRo/DxC 16 136.6 1.2 0.9 137 132 - 141 16 118.8 1.8 1.5 118 114 - 123 Olympus AU 17 135.8 1.2 0.9 136 131 - 140 17 118.4 2.3 1.9 118 114 - 123 Roche Integra 36 135.4 0.9 0.7 136 131 - 140 38 117.6 1.0 0.8 118 113 - 122 Siemens Dimension QuickLyte - RxL 15 136.7 1.6 1.2 136 132 - 141 15 119.0 1.1 0.9 119 115 - 123 Siemens Dimension QuickLyte - Xpand/EXL 29 137.6 1.3 1.0 138 133 - 142 29 119.9 0.8 0.7 120 115 - 124 Vital Diagnostics ATAC 8000 14 138.3 1.9 1.4 139 134 - 143 14 118.6 2.2 1.9 119 114 - 123 Vital Diagnostics Envoy 500 18 136.3 3.4 2.5 135 132 - 141 18 117.7 3.4 2.9 118 113 - 122 All Chemistry Instruments 195 136.6 1.8 1.3 136 132 - 141 193 118.5 1.7 1.4 118 114 - 123 ISE Undiluted Alfa Wassermann ACE/NexCT/Alera 67 140.8 1.6 1.1 141 136 - 145 69 118.3 1.6 1.3 118 114 - 123 All Chemistry Instruments 133 139.4 2.8 2.0 140 135 - 144 133 118.7 1.9 1.6 119 114 - 123 VITROS VITROS 250,350,500,700,750,950 44 141.1 2.3 1.6 141 137 - 146 44 121.0 2.1 1.7 121 117 - 125 All Chemistry Instruments 51 141.2 2.4 1.7 141 137 - 146 51 121.1 2.2 1.8 121 117 - 126

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Sodium (mmol/L)

Specimen CH-3 Specimen CH-4 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 422 157.9 4.6 2.9 157 153 - 162 416 128.6 2.4 1.8 128 124 - 133 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 163 158 - 167 8 - - - 128 124 - 133 Abaxis Piccolo 17 162.2 2.4 1.5 162 158 - 167 16 128.8 3.1 2.4 129 124 - 133 All Chemistry Instruments 27 162.6 2.5 1.6 162 158 - 167 26 128.7 2.8 2.2 129 124 - 133 ISE Diluted Beckman Synchron 16 154.8 2.8 1.8 155 150 - 159 16 127.7 1.8 1.4 128 123 - 132 Beckman Synchron LX/PRo/DxC 15 155.1 1.6 1.0 155 151 - 160 15 127.7 1.3 1.0 128 123 - 132 Olympus AU 18 153.9 1.7 1.1 154 149 - 158 17 127.2 1.1 0.9 127 123 - 132 Roche Integra 38 153.3 1.1 0.7 153 149 - 158 38 126.4 1.0 0.8 126 122 - 131 Siemens Dimension QuickLyte - RxL 15 153.5 2.5 1.6 153 149 - 158 15 127.5 1.6 1.3 127 123 - 132 Siemens Dimension QuickLyte - Xpand/EXL 29 154.7 1.6 1.1 155 150 - 159 29 128.4 1.1 0.8 128 124 - 133 Vital Diagnostics ATAC 8000 14 157.6 2.3 1.4 159 153 - 162 14 129.1 1.6 1.3 130 125 - 134 Vital Diagnostics Envoy 500 18 156.4 4.2 2.7 157 152 - 161 18 128.0 3.4 2.7 128 124 - 132 All Chemistry Instruments 193 154.6 2.2 1.4 154 150 - 159 194 127.6 1.6 1.3 127 123 - 132 ISE Undiluted Alfa Wassermann ACE/NexCT/Alera 69 162.1 2.0 1.2 162 158 - 167 69 129.6 1.6 1.3 130 125 - 134 All Chemistry Instruments 135 159.7 3.9 2.4 161 155 - 164 132 129.0 2.1 1.6 129 124 - 133 VITROS VITROS 250,350,500,700,750,950 43 163.2 2.1 1.3 163 159 - 168 43 131.9 1.8 1.3 132 127 - 136 All Chemistry Instruments 49 163.2 2.1 1.3 163 159 - 168 50 131.9 2.0 1.5 132 127 - 136

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2011 MLE-M1 Participant Summary/ 47

Sodium (mmol/L)

Specimen CH-5 Method/Instrument Labs Mean SD CV Median Range

All Method 416 137.4 2.6 1.9 137 133 - 142 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 142 136 - 145 Abaxis Piccolo 15 140.1 3.6 2.6 141 136 - 145 All Chemistry Instruments 25 140.6 3.0 2.2 141 136 - 145 ISE Diluted Beckman Synchron 16 137.8 1.6 1.1 138 133 - 142 Beckman Synchron LX/PRo/DxC 16 138.6 1.4 1.0 139 134 - 143 Olympus AU 18 137.2 1.3 1.0 137 133 - 142 Roche Integra 38 136.4 0.9 0.6 136 132 - 141 Siemens Dimension QuickLyte - RxL 15 137.5 1.5 1.1 137 133 - 142 Siemens Dimension QuickLyte - Xpand/EXL 29 138.6 1.3 1.0 138 134 - 143

Vital Diagnostics ATAC 8000 14 141.1 1.8 1.3 142 137 - 146 Vital Diagnostics Envoy 500 17 137.8 2.1 1.5 138 133 - 142 All Chemistry Instruments 195 137.6 1.8 1.3 138 133 - 142 ISE Undiluted Alfa Wassermann ACE/NexCT/Alera 68 134.5 1.5 1.1 135 130 - 139 All Chemistry Instruments 133 135.9 2.7 2.0 135 131 - 140 VITROS VITROS 250,350,500,700,750,950 44 138.3 2.2 1.6 139 134 - 143 All Chemistry Instruments 51 138.4 2.4 1.7 139 134 - 143

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48/ 2011 MLE-M1 Participant Summary

TIBC – Calculated (µg/dL)

Specimen CH-1 Specimen CH-2 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 33 283.3 60.6 21.4 305 101 - 466 33 220.8 54.2 24.6 244 58 - 384 Calculated TIBC (TRF x CF) All Chemistry Instruments 33 283.3 60.6 21.4 305 101 - 466 33 220.8 54.2 24.6 244 58 - 384

Specimen CH-3 Specimen CH-4

All Method 32 338.1 67.4 19.9 361 135 - 541 32 252.0 53.8 21.3 278 90 - 414 Calculated TIBC (TRF x CF) All Chemistry Instruments 32 338.1 67.4 19.9 361 135 - 541 32 252.0 53.8 21.3 278 90 - 414

Specimen CH-5

All Method 26 119.1 18.1 15.2 122 64 - 174 Calculated TIBC (TRF x CF) All Chemistry Instruments 26 119.1 18.1 15.2 122 64 - 174

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2011 MLE-M1 Participant Summary/ 49

TIBC – Direct (µg/dL)

Specimen CH-1 Specimen CH-2 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 59 277.0 69.2 25.0 255 69 - 485 59 220.8 43.4 19.7 204 90 - 352 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 25 250.8 13.8 5.5 250 209 - 293 25 197.8 12.5 6.3 199 160 - 236 VITROS VITROS 250,350,500,700,750,950 11 378.9 26.3 6.9 392 300 - 458 11 283.4 28.5 10.1 285 197 - 369 All Chemistry Instruments 14 331.4 97.1 29.3 389 39 - 623 14 256.9 58.2 22.6 284 82 - 432

Specimen CH-3 Specimen CH-4

All Method 59 328.0 95.0 29.0 309 43 - 613 59 246.2 50.7 20.6 229 94 - 399 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 25 307.9 15.3 5.0 308 261 - 354 25 224.9 11.6 5.2 224 189 - 260 VITROS VITROS 250,350,500,700,750,950 11 480.0 35.1 7.3 485 374 - 586 11 320.2 24.8 7.8 323 245 - 395 All Chemistry Instruments 14 410.6 141.2 34.4 484 0 - 835 14 285.9 71.5 25.0 316 71 - 501

Specimen CH-5

All Method 59 108.9 24.3 22.3 102 35 - 182 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 25 89.7 11.4 12.7 89 55 - 124

VITROS VITROS 250,350,500,700,750,950 11 122.1 21.5 17.6 119 57 - 187 All Chemistry Instruments 14 116.9 21.6 18.5 118 52 - 182

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50/ 2011 MLE-M1 Participant Summary

UIBC – Direct (µg/dL)

Specimen CH-1 Specimen CH-2 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 34 75.2 12.4 16.5 77 38 - 113 34 52.6 9.2 17.5 54 25 - 81 All Roche Integra/c 501 reagents 14 75.4 9.3 12.4 75 47 - 104 14 50.9 8.8 17.3 52 24 - 78 Roche Integra Roche Integra 13 74.8 9.5 12.6 73 46 - 104 13 50.5 9.1 18.0 51 23 - 78

Specimen CH-3 Specimen CH-4 All Method 34 95.7 12.5 13.0 96 58 - 134 34 63.1 9.8 15.6 63 33 - 93 All Roche Integra/c 501 reagents 14 95.5 10.2 10.6 94 65 - 126 14 65.0 8.9 13.7 68 38 - 92 Roche Integra Roche Integra 13 95.7 10.5 11.0 94 64 - 128 13 64.9 9.3 14.3 68 37 - 93

Specimen CH-5

All Method 33 68.4 8.1 11.9 69 43 - 93 All Roche Integra/c 501 reagents 14 68.6 7.3 10.7 71 46 - 91 Roche Integra Roche Integra 13 68.4 7.6 11.1 71 45 - 92

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2011 MLE-M1 Participant Summary/ 51

ALT (SGPT) (IU/L)

Specimen CH-1 Specimen CH-2 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 425 180.8 12.1 6.7 181 144 - 217 429 259.0 18.6 7.2 257 207 - 311 All Roche Integra/c111/c501 Reagents 52 189.3 3.9 2.0 189 151 - 228 52 273.9 5.7 2.1 274 219 - 329 Abaxis Piccolo Abaxis Piccolo - waived 21 169.4 4.4 2.6 169 135 - 204 20 237.9 5.4 2.3 238 190 - 286 Abaxis Piccolo 18 168.4 3.2 1.9 169 134 - 203 18 238.0 5.0 2.1 239 190 - 286 All Chemistry Instruments 40 168.9 3.9 2.3 169 135 - 203 39 238.0 5.1 2.1 238 190 - 286 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 76 168.8 7.1 4.2 170 135 - 203 75 243.0 9.3 3.8 244 194 - 292 Beckman - cartridge Beckman Synchron 12 176.3 6.0 3.4 178 141 - 212 12 251.2 8.4 3.3 254 200 - 302 Beckman Synchron LX/PRo/DxC 19 182.6 4.5 2.5 183 146 - 220 19 261.6 6.0 2.3 261 209 - 314 All Chemistry Instruments 31 180.2 5.9 3.3 180 144 - 217 31 257.5 8.6 3.3 258 206 - 310 Carolina Liquid Chemistries All Chemistry Instruments 10 185.1 6.8 3.7 184 148 - 223 10 265.2 11.4 4.3 262 212 - 319 Cholestech LDX All Chemistry Instruments 10 272.7 35.9 13.2 277 218 - 328 10 319.5 45.9 14.4 309 255 - 384 Horiba ABX Pentra Horiba ABX Pentra 400 15 199.9 7.9 4.0 197 159 - 240 15 291.2 12.2 4.2 292 232 - 350 Olympus Olympus AU 19 166.8 4.6 2.7 168 133 - 201 19 239.5 6.8 2.8 240 191 - 288 Roche Integra Roche Integra 43 189.5 4.1 2.2 189 151 - 228 43 274.4 5.9 2.1 274 219 - 330 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 62 182.4 4.7 2.6 183 145 - 219 61 254.9 6.3 2.5 255 203 - 306 Vital Diagnostics Vital Diagnostics ATAC 8000 19 177.7 8.6 4.9 179 142 - 214 19 257.4 17.9 6.9 258 205 - 309 Vital Diagnostics Envoy 500 20 195.8 6.4 3.3 196 156 - 235 20 278.4 9.2 3.3 275 222 - 335 All Chemistry Instruments 40 187.2 11.7 6.3 189 149 - 225 40 268.4 17.3 6.5 272 214 - 323 VITROS VITROS 250,350,500,700,750,950 42 192.0 5.8 3.0 192 153 - 231 43 276.3 7.2 2.6 276 221 - 332 All Chemistry Instruments 47 192.4 5.6 2.9 192 153 - 231 48 276.5 7.0 2.5 277 221 - 332

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ALT (SGPT) (IU/L)

Specimen CH-3 Specimen CH-4 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 410 104.4 7.0 6.7 105 83 - 126 411 220.5 14.7 6.7 221 176 - 265 All Roche Integra/c111/c501 Reagents 52 105.6 2.3 2.2 105 84 - 127 52 231.1 4.9 2.1 231 184 - 278 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 98 77 - 117 8 - - - 202 162 - 244 Abaxis Piccolo 18 96.7 2.4 2.5 97 77 - 117 18 203.4 4.4 2.1 205 162 - 245 All Chemistry Instruments 27 96.9 2.8 2.9 97 77 - 117 27 203.1 4.2 2.1 205 162 - 244 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 76 98.8 4.6 4.6 99 79 - 119 76 206.9 7.4 3.6 207 165 - 249 Beckman - cartridge Beckman Synchron 12 100.4 3.6 3.5 101 80 - 121 12 214.3 7.2 3.4 215 171 - 258 Beckman Synchron LX/PRo/DxC 19 105.2 3.3 3.2 105 84 - 127 19 223.7 5.7 2.6 223 178 - 269 All Chemistry Instruments 31 103.4 4.1 4.0 103 82 - 125 31 220.1 7.7 3.5 220 176 - 265 Carolina Liquid Chemistries All Chemistry Instruments 10 104.9 4.1 3.9 106 83 - 126 10 228.0 11.0 4.8 225 182 - 274 Cholestech LDX All Chemistry Instruments 2 - - - 146 114 - 173 2 - - - 378 301 - 453 Horiba ABX Pentra Horiba ABX Pentra 400 15 114.3 5.1 4.5 113 91 - 138 15 246.9 11.5 4.7 247 197 - 297 Olympus Olympus AU 20 94.0 2.5 2.7 95 75 - 113 19 202.2 5.1 2.5 203 161 - 243 Roche Integra Roche Integra 43 105.6 2.4 2.3 105 84 - 127 43 231.4 5.1 2.2 232 185 - 278 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 109.8 3.2 2.9 110 87 - 132 62 219.6 5.8 2.6 220 175 - 264 Vital Diagnostics Vital Diagnostics ATAC 8000 17 102.0 3.2 3.2 102 81 - 123 19 216.9 12.0 5.5 216 173 - 261 Vital Diagnostics Envoy 500 20 111.3 4.3 3.8 111 89 - 134 20 237.2 8.3 3.5 235 189 - 285 All Chemistry Instruments 38 107.1 6.0 5.6 107 85 - 129 40 227.5 14.2 6.3 232 181 - 273 VITROS VITROS 250,350,500,700,750,950 43 110.3 4.7 4.2 110 88 - 133 43 235.5 6.7 2.8 236 188 - 283 All Chemistry Instruments 48 110.5 4.6 4.2 110 88 - 133 48 235.8 6.5 2.8 237 188 - 283

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2011 MLE-M1 Participant Summary/ 53

ALT (SGPT) (IU/L)

Specimen CH-5 Instrument/Reagent Labs Mean SD CV Median Range

All Method 410 30.9 6.4 20.7 29 24 - 38 All Roche Integra/c111/c501 Reagents 53 27.0 1.1 4.2 27 21 - 33

Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 30 23 - 36 Abaxis Piccolo 17 28.8 3.0 10.5 29 23 - 35 All Chemistry Instruments 26 29.4 3.7 12.6 29 23 - 36 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 76 30.7 2.8 9.2 31 24 - 37 Beckman - cartridge Beckman Synchron 12 26.9 1.2 4.6 27 21 - 33 Beckman Synchron LX/PRo/DxC 19 28.9 1.4 4.8 29 23 - 35 All Chemistry Instruments 31 28.2 1.7 5.9 29 22 - 34 Carolina Liquid Chemistries All Chemistry Instruments 10 26.9 1.8 6.7 27 21 - 33 Cholestech LDX All Chemistry Instruments 2 - - - 35 26 - 41 Horiba ABX Pentra Horiba ABX Pentra 400 15 29.0 2.2 7.7 28 23 - 35 Olympus Olympus AU 20 23.4 1.2 5.2 23 18 - 29 Roche Integra Roche Integra 44 26.8 1.2 4.4 27 21 - 33 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 58 35.0 1.5 4.4 35 28 - 43

Vital Diagnostics Vital Diagnostics ATAC 8000 18 26.5 1.9 7.0 27 21 - 32 Vital Diagnostics Envoy 500 20 27.4 1.6 5.8 27 21 - 33 All Chemistry Instruments 39 27.0 1.7 6.4 27 21 - 33 VITROS VITROS 250,350,500,700,750,950 43 45.0 4.4 9.8 45 36 - 55 All Chemistry Instruments 48 45.3 4.3 9.5 45 36 - 55

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54/ 2011 MLE-M1 Participant Summary

Alkaline Phosphatase (IU/L)

Specimen CH-1 Specimen CH-2 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 422 255.6 37.4 14.6 263 178 - 333 421 394.3 62.2 15.8 410 276 - 513 All Roche Integra/c111/c501 Reagents 53 260.3 10.7 4.1 259 182 - 339 53 407.0 17.3 4.2 406 284 - 530 Abaxis Piccolo Abaxis Piccolo - waived 21 202.1 9.8 4.8 201 141 - 263 21 311.3 13.4 4.3 310 217 - 405 Abaxis Piccolo 18 199.0 8.7 4.4 199 139 - 259 18 309.6 18.3 5.9 312 216 - 403 All Chemistry Instruments 40 201.2 9.8 4.9 199 140 - 262 40 311.2 16.0 5.2 312 217 - 405 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 74 274.8 15.3 5.6 277 192 - 358 74 428.0 23.1 5.4 433 299 - 557 Beckman - cartridge Beckman Synchron 11 237.9 20.7 8.7 246 166 - 310 11 363.4 30.9 8.5 380 254 - 473 Beckman Synchron LX/PRo/DxC 19 253.4 11.1 4.4 252 177 - 330 19 390.1 19.5 5.0 387 273 - 508 All Chemistry Instruments 30 247.7 16.8 6.8 251 173 - 323 30 380.3 27.1 7.1 386 266 - 495 Carolina Liquid Chemistries Beckman Synchron 10 230.7 23.7 10.3 238 161 - 300 10 355.4 36.2 10.2 370 248 - 463 All Chemistry Instruments 11 234.6 26.0 11.1 238 164 - 306 11 361.7 40.3 11.1 370 253 - 471 Horiba ABX Pentra Horiba ABX Pentra 400 15 296.2 14.8 5.0 299 207 - 386 15 457.9 23.8 5.2 460 320 - 596 Olympus Olympus AU 18 252.3 15.5 6.1 252 176 - 328 18 391.0 24.7 6.3 391 273 - 509 Roche Integra Roche Integra 44 261.1 11.1 4.3 260 182 - 340 44 408.5 17.7 4.3 407 285 - 532 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 297.6 17.8 6.0 294 208 - 387 60 461.8 25.9 5.6 457 323 - 601 Vital Diagnostics Vital Diagnostics ATAC 8000 19 268.9 11.2 4.2 268 188 - 350 19 416.2 17.1 4.1 417 291 - 542 Vital Diagnostics Envoy 500 20 264.5 15.9 6.0 268 185 - 344 20 413.1 22.4 5.4 414 289 - 537 All Chemistry Instruments 40 265.9 14.4 5.4 268 186 - 346 40 413.2 21.4 5.2 415 289 - 538 VITROS VITROS 250,350,500,700,750,950 43 194.8 11.4 5.9 195 136 - 254 43 281.8 16.0 5.7 283 197 - 367 All Chemistry Instruments 48 196.3 11.7 6.0 198 137 - 256 48 284.2 17.0 6.0 283 198 - 370

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2011 MLE-M1 Participant Summary/ 55

Alkaline Phosphatase (IU/L)

Specimen CH-3 Specimen CH-4 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 406 121.0 14.8 12.2 122 84 - 158 409 329.8 47.9 14.5 339 230 - 429 All Roche Integra/c111/c501 Reagents 53 118.8 4.9 4.2 118 83 - 155 53 336.2 12.9 3.8 334 235 - 438 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 96 66 - 123 8 - - - 273 183 - 341 Abaxis Piccolo 18 92.9 4.9 5.3 93 65 - 121 18 258.2 13.9 5.4 256 180 - 336 All Chemistry Instruments 27 94.3 5.5 5.8 94 66 - 123 27 261.7 13.5 5.2 261 183 - 341 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 74 126.1 7.2 5.7 127 88 - 164 74 351.1 20.5 5.8 355 245 - 457 Beckman - cartridge Beckman Synchron 11 111.5 9.6 8.6 116 78 - 146 11 303.1 24.9 8.2 312 212 - 395 Beckman Synchron LX/PRo/DxC 19 120.3 6.2 5.2 119 84 - 157 19 326.0 16.3 5.0 323 228 - 424 All Chemistry Instruments 30 117.1 8.6 7.4 118 81 - 153 30 317.6 22.5 7.1 321 222 - 413 Carolina Liquid Chemistries Beckman Synchron 10 109.1 11.3 10.3 112 76 - 142 10 300.4 32.6 10.8 310 210 - 391 All Chemistry Instruments 11 110.8 12.1 10.9 112 77 - 145 11 305.1 34.6 11.3 310 213 - 397 Horiba ABX Pentra Horiba ABX Pentra 400 15 138.8 7.9 5.7 140 97 - 181 15 379.5 18.4 4.9 380 265 - 494 Olympus Olympus AU 19 116.9 6.6 5.7 117 81 - 152 18 322.3 19.9 6.2 324 225 - 420 Roche Integra Roche Integra 44 119.0 5.2 4.3 118 83 - 155 44 337.0 13.1 3.9 334 235 - 439 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 140.3 10.0 7.1 139 98 - 183 61 381.7 19.3 5.1 382 267 - 497 Vital Diagnostics Vital Diagnostics ATAC 8000 18 127.3 6.1 4.8 128 89 - 166 19 345.2 17.5 5.1 345 241 - 449 Vital Diagnostics Envoy 500 20 126.2 7.4 5.9 128 88 - 165 20 342.8 15.9 4.7 347 239 - 446 All Chemistry Instruments 39 126.3 7.1 5.7 128 88 - 165 40 343.1 17.2 5.0 345 240 - 446 VITROS VITROS 250,350,500,700,750,950 43 102.7 5.9 5.8 103 71 - 134 43 243.0 14.1 5.8 245 170 - 316 All Chemistry Instruments 48 103.3 6.0 5.8 103 72 - 135 48 244.4 14.1 5.8 246 171 - 318

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56/ 2011 MLE-M1 Participant Summary

Alkaline Phosphatase (IU/L)

Specimen CH-5 Instrument/Reagent Labs Mean SD CV Median Range

All Method 406 42.2 6.5 15.3 42 29 - 55 All Roche Integra/c111/c501 Reagents 52 40.2 1.9 4.8 40 28 - 53

Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 38 24 - 46 Abaxis Piccolo 17 33.0 3.5 10.5 33 23 - 43 All Chemistry Instruments 26 34.8 4.7 13.6 35 24 - 46 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 74 44.6 3.4 7.7 45 31 - 59 Beckman - cartridge Beckman Synchron 11 37.8 3.7 9.7 39 26 - 50 Beckman Synchron LX/PRo/DxC 19 39.3 1.6 4.0 40 27 - 52 All Chemistry Instruments 29 39.0 2.0 5.2 40 27 - 51 Carolina Liquid Chemistries Beckman Synchron 10 38.8 3.2 8.1 39 27 - 51 All Chemistry Instruments 11 39.6 4.1 10.3 39 27 - 52 Horiba ABX Pentra Horiba ABX Pentra 400 15 48.4 3.0 6.2 48 33 - 63 Olympus Olympus AU 19 41.2 2.5 6.1 41 28 - 54 Roche Integra Roche Integra 43 40.3 2.1 5.2 40 28 - 53 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 62 51.4 5.8 11.2 52 35 - 67

Vital Diagnostics Vital Diagnostics ATAC 8000 19 43.3 6.8 15.7 45 30 - 57 Vital Diagnostics Envoy 500 20 43.9 3.8 8.7 45 30 - 58 All Chemistry Instruments 38 44.3 3.7 8.3 45 31 - 58 VITROS VITROS 250,350,500,700,750,950 43 34.3 3.1 9.1 34 24 - 45 All Chemistry Instruments 48 34.5 3.0 8.8 34 24 - 45

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2011 MLE-M1 Participant Summary/ 57

AST (SGOT) (IU/L)

Specimen CH-1 Specimen CH-2 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 425 170.2 23.9 14.0 162 136 - 205 425 256.0 29.0 11.3 248 204 - 308 All Roche Integra/c111/c501 Reagents 52 160.1 7.2 4.5 160 128 - 193 51 247.0 7.8 3.2 248 197 - 297 Abaxis Piccolo Abaxis Piccolo - waived 21 161.2 7.1 4.4 162 128 - 194 21 241.9 7.9 3.3 241 193 - 291 Abaxis Piccolo 18 161.3 7.6 4.7 162 129 - 194 18 241.8 9.1 3.8 244 193 - 291 All Chemistry Instruments 40 161.3 7.2 4.4 162 129 - 194 40 241.9 8.3 3.4 242 193 - 291 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 76 155.8 8.8 5.7 156 124 - 187 76 242.8 9.9 4.1 243 194 - 292 Beckman - cartridge Beckman Synchron 12 153.3 10.5 6.9 158 122 - 184 12 232.3 10.5 4.5 238 185 - 279 Beckman Synchron LX/PRo/DxC 19 158.2 5.2 3.3 159 126 - 190 19 241.1 6.4 2.7 242 192 - 290 All Chemistry Instruments 31 156.3 7.9 5.1 158 125 - 188 31 237.7 9.2 3.9 239 190 - 286 Carolina Liquid Chemistries All Chemistry Instruments 10 163.7 8.7 5.3 165 130 - 197 10 252.9 9.3 3.7 259 202 - 304 Cholestech LDX Cholestech LDX - waived 10 321.0 47.2 14.7 333 256 - 386 10 392.7 20.4 5.2 400 314 - 472 All Chemistry Instruments 11 324.4 46.2 14.2 333 259 - 390 11 393.4 19.5 5.0 400 314 - 473 Horiba ABX Pentra Horiba ABX Pentra 400 15 156.9 6.9 4.4 154 125 - 189 15 239.2 8.3 3.5 240 191 - 288 Olympus Olympus AU 19 143.7 9.3 6.5 145 114 - 173 19 217.9 9.7 4.5 220 174 - 262 Roche Integra Roche Integra 44 159.2 8.2 5.1 160 127 - 192 42 247.1 7.4 3.0 248 197 - 297 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 205.8 5.4 2.6 207 164 - 247 61 292.0 8.6 3.0 293 233 - 351 Vital Diagnostics Vital Diagnostics ATAC 8000 19 148.4 9.0 6.0 151 118 - 179 19 226.3 13.4 5.9 222 181 - 272 Vital Diagnostics Envoy 500 20 165.1 7.1 4.3 166 132 - 199 20 249.2 12.2 4.9 251 199 - 299 All Chemistry Instruments 40 157.4 11.7 7.4 159 125 - 189 40 238.3 17.0 7.1 240 190 - 286 VITROS VITROS 250,350,500,700,750,950 43 206.5 9.3 4.5 206 165 - 248 43 305.8 14.2 4.6 304 244 - 367 All Chemistry Instruments 48 205.9 9.0 4.4 205 164 - 248 49 305.0 15.1 4.9 302 244 - 367

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58/ 2011 MLE-M1 Participant Summary

AST (SGOT) (IU/L)

Specimen CH-3 Specimen CH-4 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 409 92.8 16.9 18.2 87 74 - 112 411 212.2 26.9 12.7 204 169 - 255 All Roche Integra/c111/c501 Reagents 53 83.1 4.8 5.7 83 66 - 100 51 201.3 7.3 3.6 202 161 - 242 Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 86 69 - 105 8 - - - 195 158 - 239 Abaxis Piccolo 18 87.7 6.1 7.0 88 70 - 106 18 200.1 9.0 4.5 201 160 - 241 All Chemistry Instruments 27 87.1 6.0 6.9 88 69 - 105 27 198.4 8.9 4.5 198 158 - 239 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 76 82.7 6.5 7.9 83 66 - 100 75 197.6 8.9 4.5 198 158 - 238 Beckman - cartridge Beckman Synchron 12 80.9 6.4 7.9 81 64 - 98 12 191.3 11.4 6.0 193 153 - 230 Beckman Synchron LX/PRo/DxC 19 84.8 4.2 4.9 84 67 - 102 19 198.9 6.7 3.3 199 159 - 239 All Chemistry Instruments 31 83.3 5.4 6.5 83 66 - 100 31 196.0 9.4 4.8 197 156 - 236 Carolina Liquid Chemistries All Chemistry Instruments 10 86.4 6.6 7.6 89 69 - 104 10 206.7 7.4 3.6 207 165 - 249 Cholestech LDX Cholestech LDX - waived 1 - - - 183 146 - 220 1 - - - 400 320 - 480 All Chemistry Instruments 2 - - - 183 138 - 208 2 - - - 400 320 - 480 Horiba ABX Pentra Horiba ABX Pentra 400 15 83.4 5.3 6.3 82 66 - 101 15 196.7 9.6 4.9 193 157 - 237 Olympus Olympus AU 19 76.5 6.2 8.1 78 61 - 92 19 179.4 9.7 5.4 181 143 - 216 Roche Integra Roche Integra 44 82.5 4.7 5.7 83 66 - 100 42 200.8 7.2 3.6 202 160 - 241 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 60 120.9 4.0 3.3 121 96 - 146 62 249.5 7.0 2.8 250 199 - 300 Vital Diagnostics Vital Diagnostics ATAC 8000 18 78.8 6.9 8.8 79 63 - 95 19 187.2 11.4 6.1 186 149 - 225 Vital Diagnostics Envoy 500 20 87.8 6.2 7.1 90 70 - 106 20 204.7 9.6 4.7 204 163 - 246 All Chemistry Instruments 39 83.7 7.9 9.4 85 66 - 101 40 196.5 13.6 6.9 198 157 - 236 VITROS VITROS 250,350,500,700,750,950 43 115.8 6.0 5.2 115 92 - 139 43 256.7 11.1 4.3 256 205 - 308 All Chemistry Instruments 48 115.7 5.8 5.0 115 92 - 139 48 255.9 11.1 4.4 256 204 - 308

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2011 MLE-M1 Participant Summary/ 59

AST (SGOT) (IU/L)

Specimen CH-5 Instrument/Reagent Labs Mean SD CV Median Range

All Method 412 29.0 5.3 18.4 27 23 - 35 All Roche Integra/c111/c501 Reagents 53 24.8 1.8 7.2 25 19 - 30

Abaxis Piccolo Abaxis Piccolo - waived 8 - - - 29 22 - 34 Abaxis Piccolo 16 27.8 2.8 10.2 28 22 - 34 All Chemistry Instruments 24 28.1 2.0 7.0 29 22 - 34 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 76 28.8 3.0 10.4 28 23 - 35 Beckman - cartridge Beckman Synchron 12 23.8 2.1 8.6 25 19 - 29 Beckman Synchron LX/PRo/DxC 18 24.9 0.9 3.6 25 19 - 30 All Chemistry Instruments 31 24.6 1.8 7.4 25 19 - 30 Carolina Liquid Chemistries All Chemistry Instruments 10 26.4 1.3 5.1 26 21 - 32 Cholestech LDX Cholestech LDX - waived 1 - - - 38 30 - 46 All Chemistry Instruments 2 - - - 38 29 - 45 Horiba ABX Pentra Horiba ABX Pentra 400 15 26.7 1.8 6.6 27 21 - 33 Olympus Olympus AU 20 22.5 2.0 8.7 23 18 - 27 Roche Integra Roche Integra 44 24.6 1.9 7.7 25 19 - 30 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 61 36.8 2.0 5.4 37 29 - 45

Vital Diagnostics Vital Diagnostics ATAC 8000 19 25.6 2.3 8.9 26 20 - 31 Vital Diagnostics Envoy 500 20 26.4 2.0 7.4 27 21 - 32 All Chemistry Instruments 40 26.0 2.1 8.2 26 20 - 32 VITROS VITROS 250,350,500,700,750,950 43 35.9 2.1 5.8 36 28 - 44 All Chemistry Instruments 48 35.8 2.0 5.7 36 28 - 43

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Creatine Kinase (IU/L)

Specimen CH-1 Specimen CH-2 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 199 359.5 31.1 8.6 365 251 - 468 197 164.4 12.5 7.6 165 115 - 214 All Roche Integra/c111/c501 Reagents 24 368.8 10.1 2.7 368 258 - 480 24 168.4 5.4 3.2 169 117 - 219 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 34 350.7 21.8 6.2 349 245 - 456 33 164.0 10.1 6.2 162 114 - 214 Beckman - cartridge Beckman Synchron LX/PRo/DxC 13 405.5 18.6 4.6 411 283 - 528 13 182.0 10.2 5.6 184 127 - 237 All Chemistry Instruments 19 401.7 17.8 4.4 407 281 - 523 19 180.1 9.7 5.4 181 126 - 235 Horiba ABX Pentra Horiba ABX Pentra 400 10 380.5 13.9 3.6 383 266 - 495 10 169.5 4.5 2.7 170 118 - 221 Olympus Olympus AU 11 361.6 14.3 4.0 362 253 - 471 11 162.0 7.3 4.5 164 113 - 211 Roche Integra Roche Integra 23 367.9 9.2 2.5 367 257 - 479 23 168.0 5.0 3.0 169 117 - 219 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 33 376.6 10.6 2.8 376 263 - 490 33 167.8 7.4 4.4 169 117 - 219 Vital Diagnostics Vital Diagnostics ATAC 8000 10 341.6 26.8 7.8 349 239 - 445 10 155.2 17.7 11.4 158 108 - 202 All Chemistry Instruments 18 346.9 23.2 6.7 349 242 - 451 17 151.5 9.4 6.2 153 106 - 197 VITROS VITROS 250,350,500,700,750,950 21 313.6 16.4 5.2 309 219 - 408 21 154.4 8.0 5.2 153 108 - 201 All Chemistry Instruments 24 312.5 17.1 5.5 309 218 - 407 24 154.1 8.2 5.3 153 107 - 201

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Creatine Kinase (IU/L)

Specimen CH-3 Specimen CH-4 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 198 552.7 61.7 11.2 568 386 - 719 198 260.6 21.2 8.1 263 182 - 339 All Roche Integra/c111/c501 Reagents 24 572.4 16.5 2.9 572 400 - 745 24 267.8 7.9 3.0 267 187 - 349 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 33 536.3 28.3 5.3 531 375 - 698 32 257.8 11.5 4.5 257 180 - 336 Beckman - cartridge Beckman Synchron LX/PRo/DxC 13 637.6 31.4 4.9 645 446 - 829 13 294.1 14.5 4.9 299 205 - 383 All Chemistry Instruments 19 632.5 32.6 5.2 635 442 - 823 19 291.1 14.6 5.0 295 203 - 379 Horiba ABX Pentra Horiba ABX Pentra 400 10 592.6 15.8 2.7 592 414 - 771 10 274.0 9.3 3.4 275 191 - 357 Olympus Olympus AU 11 566.1 23.2 4.1 568 396 - 736 11 260.2 10.8 4.1 263 182 - 339 Roche Integra Roche Integra 23 570.7 14.8 2.6 572 399 - 742 23 267.0 7.1 2.7 266 186 - 348 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 33 585.0 13.0 2.2 584 409 - 761 33 269.9 9.4 3.5 269 188 - 351 Vital Diagnostics Vital Diagnostics ATAC 8000 10 542.6 44.3 8.2 562 379 - 706 10 245.8 18.7 7.6 254 172 - 320 All Chemistry Instruments 18 551.9 37.5 6.8 562 386 - 718 18 247.2 15.1 6.1 251 173 - 322 VITROS VITROS 250,350,500,700,750,950 21 429.1 26.9 6.3 430 300 - 558 21 234.1 13.4 5.7 230 163 - 305 All Chemistry Instruments 24 429.5 27.3 6.4 431 300 - 559 24 233.6 14.3 6.1 230 163 - 304

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Creatine Kinase (IU/L)

Specimen CH-5 Instrument/Reagent Labs Mean SD CV Median Range

All Method 197 45.9 6.4 14.0 47 32 - 60 All Roche Integra/c111/c501 Reagents 23 47.8 2.4 5.1 49 33 - 63

Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 33 49.9 3.9 7.9 49 34 - 65 Beckman - cartridge Beckman Synchron LX/PRo/DxC 13 54.2 3.7 6.8 55 37 - 71 All Chemistry Instruments 19 53.6 3.3 6.2 54 37 - 70 Horiba ABX Pentra Horiba ABX Pentra 400 10 49.6 3.9 8.0 51 34 - 65 Olympus Olympus AU 11 45.5 1.8 4.0 45 31 - 60 Roche Integra Roche Integra 22 47.8 2.5 5.2 49 33 - 63 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 33 44.2 4.6 10.5 45 30 - 58

Vital Diagnostics Vital Diagnostics ATAC 8000 10 42.8 4.3 10.0 43 29 - 56 All Chemistry Instruments 18 43.7 3.4 7.9 45 30 - 57 VITROS VITROS 250,350,500,700,750,950 21 36.2 3.9 10.7 36 25 - 48 All Chemistry Instruments 24 35.9 4.0 11.2 36 25 - 47

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GGT (IU/L)

Specimen CH-1 Specimen CH-2 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 115 162.5 35.5 21.9 156 55 - 270 115 233.9 49.7 21.2 228 84 - 383 All Roche Integra/c111/c501 Reagents 10 146.7 4.1 2.8 148 134 - 159 10 212.8 6.3 3.0 214 193 - 232 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 18 122.3 4.7 3.9 121 108 - 137 19 178.3 6.5 3.6 178 158 - 198 Beckman - cartridge All Chemistry Instruments 14 176.9 6.0 3.4 179 158 - 196 14 257.1 9.9 3.9 261 227 - 287 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 18 195.8 3.1 1.6 196 186 - 206 18 278.4 5.0 1.8 280 263 - 294 VITROS All Chemistry Instruments 12 230.4 9.9 4.3 234 200 - 261 12 330.4 14.5 4.4 327 287 - 374

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Amylase (IU/L)

Specimen CH-1 Specimen CH-2 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 125 345.7 107.2 31.0 361 241 - 450 124 509.7 159.1 31.2 539 356 - 663 All Roche Integra/c111/c501 Reagents 18 348.9 8.8 2.5 351 244 - 454 17 510.5 9.4 1.8 511 357 - 664 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 14 417.2 23.8 5.7 414 292 - 543 13 621.5 32.2 5.2 625 435 - 808 Olympus Olympus AU 11 342.0 12.7 3.7 346 239 - 445 11 514.3 22.1 4.3 522 359 - 669 Roche Integra Roche Integra 17 348.5 8.9 2.6 350 243 - 454 17 507.5 14.6 2.9 510 355 - 660 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 20 445.4 8.0 1.8 446 311 - 580 20 685.9 17.8 2.6 685 480 - 892 VITROS VITROS 250,350,500,700,750,950 16 143.3 8.4 5.8 145 100 - 187 16 224.5 14.0 6.2 223 157 - 292 All Chemistry Instruments 19 143.5 10.4 7.2 144 100 - 187 19 224.6 15.3 6.8 223 157 - 293

Specimen CH-3 Specimen CH-4 All Method 118 181.2 51.3 28.3 194 126 - 236 119 428.3 130.5 30.5 451 299 - 557 All Roche Integra/c111/c501 Reagents 17 188.2 3.9 2.1 188 131 - 245 18 428.9 12.3 2.9 431 300 - 558 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 13 217.3 14.4 6.6 213 152 - 283 13 522.8 33.5 6.4 530 365 - 680 Olympus Olympus AU 11 175.3 7.2 4.1 177 122 - 228 11 431.6 16.8 3.9 433 302 - 562 Roche Integra Roche Integra 16 187.8 3.6 1.9 188 131 - 245 17 428.5 12.5 2.9 430 299 - 558 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 20 224.8 3.9 1.7 226 157 - 293 20 559.9 10.3 1.8 559 391 - 728 VITROS VITROS 250,350,500,700,750,950 15 78.5 6.1 7.8 77 54 - 103 15 184.1 10.8 5.9 186 128 - 240 All Chemistry Instruments 18 78.9 8.4 10.6 78 55 - 103 18 183.8 11.3 6.1 189 128 - 239

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Amylase (IU/L)

Specimen CH-5 Instrument/Reagent Labs Mean SD CV Median Range

All Method 119 71.0 19.5 27.4 74 49 - 93 All Roche Integra/c111/c501 Reagents 17 73.2 1.3 1.8 74 51 - 96

Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 14 79.4 8.7 10.9 82 55 - 104 Olympus Olympus AU 11 70.3 2.6 3.7 71 49 - 92 Roche Integra Roche Integra 16 73.2 1.3 1.8 74 51 - 96 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 20 90.7 2.1 2.3 91 63 - 118

VITROS VITROS 250,350,500,700,750,950 15 31.3 2.0 6.3 30 21 - 41 All Chemistry Instruments 18 32.0 3.0 9.3 30 22 - 42

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Lactate Dehydrogenase (IU/L)

Specimen CH-1 Specimen CH-2 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 113 433.7 55.6 12.8 444 346 - 521 113 650.0 85.6 13.2 685 520 - 781 All Roche Integra/c111/c501 Reagents 22 486.6 11.5 2.4 486 389 - 584 21 726.4 18.3 2.5 724 581 - 872 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 17 344.2 19.5 5.7 349 275 - 414 17 514.8 24.0 4.7 520 411 - 618 Beckman - cartridge Beckman Synchron LX/PRo/DxC 12 412.8 16.0 3.9 416 330 - 496 12 606.4 21.5 3.5 615 485 - 728 All Chemistry Instruments 18 411.7 15.9 3.9 415 329 - 495 18 605.2 21.6 3.6 612 484 - 727 Roche Integra Roche Integra 16 486.9 10.0 2.1 486 389 - 585 15 726.6 14.5 2.0 725 581 - 872 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 20 464.3 37.7 8.1 482 371 - 558 20 713.7 48.6 6.8 727 570 - 857 VITROS VITROS 250,350,500,700,750,950 10 1628.8 61.9 3.8 1640 1303 - 1955 10 2424.1 251.8 10.4 2560 1939 - 2909 All Chemistry Instruments 12 1632.8 57.4 3.5 1640 1306 - 1960 12 2469.1 251.3 10.2 2600 1975 - 2963

Specimen CH-3 Specimen CH-4

All Method 113 215.6 26.3 12.2 224 172 - 259 113 542.6 69.7 12.8 556 434 - 652 All Roche Integra/c111/c501 Reagents 22 238.8 6.0 2.5 239 191 - 287 22 610.2 17.6 2.9 608 488 - 733 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 17 172.5 7.9 4.6 173 137 - 207 17 432.2 20.6 4.8 438 345 - 519 Beckman - cartridge Beckman Synchron LX/PRo/DxC 12 208.6 10.7 5.1 206 166 - 251 12 518.3 19.4 3.7 519 414 - 622 All Chemistry Instruments 18 206.0 10.3 5.0 206 164 - 248 18 517.1 21.4 4.1 519 413 - 621 Roche Integra Roche Integra 16 238.1 5.3 2.2 238 190 - 286 16 609.6 17.2 2.8 606 487 - 732 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 20 230.2 16.4 7.1 234 184 - 277 20 581.2 47.4 8.1 604 464 - 698 VITROS VITROS 250,350,500,700,750,950 10 789.1 24.9 3.2 791 631 - 947 9 - - - 2179 1735 - 2604 All Chemistry Instruments 12 790.0 22.6 2.9 793 632 - 948 11 2169.7 72.6 3.3 2179 1735 - 2604

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Lactate Dehydrogenase (IU/L)

Specimen CH-5 Instrument/Reagent Labs Mean SD CV Median Range

All Method 112 108.9 13.5 12.4 114 87 - 131 All Roche Integra/c111/c501 Reagents 22 122.0 2.9 2.4 123 97 - 147 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 17 91.8 11.2 12.2 90 73 - 111 Beckman - cartridge Beckman Synchron LX/PRo/DxC 12 99.5 5.5 5.5 100 79 - 120 All Chemistry Instruments 18 99.4 4.9 5.0 100 79 - 120 Roche Integra Roche Integra 16 122.0 3.1 2.5 123 97 - 147 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 20 114.8 8.7 7.6 116 91 - 138 VITROS VITROS 250,350,500,700,750,950 10 400.5 17.3 4.3 401 320 - 481 All Chemistry Instruments 12 401.9 16.6 4.1 401 321 - 483

Lipase (IU/L)

Specimen CH-1 Specimen CH-2 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 41 76.1 10.8 14.2 83 43 - 109 41 37.1 5.5 14.9 40 20 - 54 All Roche Integra/c111/c501 Reagents 14 75.8 5.8 7.6 77 58 - 94 14 37.2 3.0 8.0 38 28 - 47 Roche Integra Roche Integra 13 76.2 5.7 7.5 77 59 - 94 13 37.5 2.8 7.5 38 29 - 46 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 11 346.2 81.2 23.5 313 102 - 590 11 174.9 54.1 31.0 153 12 - 338 VITROS All Chemistry Instruments 10 1131.5 210.2 18.6 1203 500 - 1763 10 611.1 483.3 79.1 519 0 - 2062

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Cortisol (mcg/dL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 19 18.63 1.87 10.1 18.8 13.9 - 23.3 19 13.79 1.27 9.2 14.0 10.3 - 17.3

Specimen CH-3 Specimen CH-4

All Method 19 24.05 2.37 9.8 24.8 18.0 - 30.1 19 16.66 1.41 8.5 16.4 12.4 - 20.9

Specimen CH-5

All Method 19 5.19 0.52 10.0 5.3 3.8 - 6.5

T3 Uptake (percent)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 41 44.43 2.40 5.4 44.3 37.2 - 51.7 42 43.86 3.13 7.1 43.4 34.4 - 53.3 Beckman ACCESS / 2 / DxI 10 44.45 4.18 9.4 45.4 31.9 - 57.0 10 45.36 4.34 9.6 46.5 32.3 - 58.4 Siemens Dimension/AR/ES/RxL/Xpand/EXL 11 45.34 2.08 4.6 45.0 39.0 - 51.6 11 43.31 1.95 4.5 43.4 37.4 - 49.2 TOSOH ST AIA 13 43.48 1.51 3.5 43.9 38.9 - 48.1 13 42.66 1.55 3.6 42.7 38.0 - 47.4

Specimen CH-3 Specimen CH-4

All Method 42 44.50 3.30 7.4 44.2 34.6 - 54.4 42 44.41 2.86 6.4 44.2 35.8 - 53.0 Beckman ACCESS / 2 / DxI 10 45.23 4.56 10.1 46.1 31.5 - 59.0 10 45.56 4.13 9.1 48.2 33.1 - 58.0 Siemens Dimension/AR/ES/RxL/Xpand/EXL 11 45.73 2.15 4.7 46.0 39.2 - 52.2 11 43.95 2.05 4.7 44.0 37.8 - 50.1 TOSOH ST AIA 13 43.83 1.26 2.9 44.0 40.0 - 47.6 13 43.55 1.44 3.3 44.1 39.2 - 47.9

Specimen CH-5

All Method 41 47.54 4.65 9.8 47.0 33.5 - 61.6 Beckman ACCESS / 2 / DxI 10 49.77 5.14 10.3 52.1 34.3 - 65.2 Siemens Dimension/AR/ES/RxL/Xpand/EXL 11 44.54 2.46 5.5 44.9 37.1 - 52.0 TOSOH ST AIA 13 47.15 1.85 3.9 47.4 41.5 - 52.8

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T Uptake (uptake units)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 9 0.489 0.029 6.0 0.50 0.40 - 0.58 9 0.524 0.154 29.3 0.42 0.06 - 0.99 All Abbott Instruments 5 0.508 0.013 2.6 0.51 0.46 - 0.55 5 0.396 0.023 5.8 0.40 0.32 - 0.47 Abbott AxSYM 5 0.508 0.013 2.6 0.51 0.46 - 0.55 5 0.396 0.023 5.8 0.40 0.32 - 0.47

Specimen CH-3 Specimen CH-4 All Method 9 0.459 0.184 40.1 0.59 0.00 - 1.02 9 0.521 0.055 10.5 0.49 0.35 - 0.69 All Abbott Instruments 5 0.612 0.033 5.5 0.60 0.51 - 0.72 5 0.478 0.011 2.3 0.48 0.44 - 0.52 Abbott AxSYM 5 0.612 0.033 5.5 0.60 0.51 - 0.72 5 0.478 0.011 2.3 0.48 0.44 - 0.52

Specimen CH-5 All Method 9 0.456 0.296 65.1 0.23 0.00 - 1.35 All Abbott Instruments 5 0.206 0.021 10.1 0.21 0.14 - 0.27 Abbott AxSYM 5 0.206 0.021 10.1 0.21 0.14 - 0.27

Triiodothyronine (ng/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 71 2.26 1.20 53.1 1.9 0.0 - 5.9 71 1.48 0.93 62.9 1.2 0.0 - 4.3 All TOSOH Instruments 10 6.02 2.36 39.3 5.3 0.0 - 13.2 11 4.37 1.25 28.6 3.9 0.6 - 8.2 Beckman ACCESS / 2 / DxI 16 1.97 0.09 4.4 2.0 1.7 - 2.3 16 1.24 0.07 5.8 1.2 1.0 - 1.5

Specimen CH-3 Specimen CH-4

All Method 71 2.94 1.47 50.0 2.5 0.0 - 7.4 71 1.87 1.05 56.2 1.6 0.0 - 5.1 All TOSOH Instruments 10 7.82 3.96 50.6 6.7 0.0 - 19.7 11 5.49 2.33 42.5 4.7 0.0 - 12.5 Beckman ACCESS / 2 / DxI 17 2.74 0.25 8.9 2.7 2.0 - 3.5 16 1.62 0.08 4.6 1.6 1.3 - 1.9

Specimen CH-5 All Method 71 0.93 0.73 78.7 0.7 0.0 - 3.2 All TOSOH Instruments 11 3.15 0.86 27.3 2.8 0.5 - 5.8 Beckman ACCESS / 2 / DxI 17 0.76 0.10 13.2 0.8 0.4 - 1.1

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Free T3 (pg/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 38 6.49 3.14 48.4 5.2 0.0 - 15.9 38 4.00 1.59 39.8 3.6 0.0 - 8.8 All DPC Immulite Instruments 10 3.86 0.31 8.0 3.9 2.9 - 4.8 10 2.35 0.17 7.3 2.3 1.8 - 2.9 All TOSOH Instruments 10 11.40 1.15 10.1 11.5 7.9 - 14.9 10 6.40 0.54 8.5 6.3 4.7 - 8.1 Beckman ACCESS / 2 / DxI 10 4.66 0.42 9.1 4.6 3.3 - 6.0 10 3.38 0.28 8.3 3.3 2.5 - 4.3

Thyroxine (mcg/dL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 88 12.44 1.14 9.2 12.4 9.9 - 15.0 89 7.90 0.70 8.8 7.9 6.3 - 9.5 All Abbott Instruments 11 11.75 0.58 5.0 11.7 9.3 - 14.1 11 7.41 0.42 5.7 7.4 5.9 - 8.9 All TOSOH Instruments 23 13.44 1.03 7.6 13.6 10.7 - 16.2 22 8.38 0.58 7.0 8.4 6.7 - 10.1 Abbott AxSYM 11 11.75 0.58 5.0 11.7 9.3 - 14.1 11 7.41 0.42 5.7 7.4 5.9 - 8.9 Beckman ACCESS / 2 / DxI 16 12.34 0.80 6.5 12.3 9.8 - 14.9 16 8.17 0.67 8.2 8.5 6.5 - 9.9 Siemens Dimension/AR/ES/RxL/Xpand/EXL 17 13.05 0.55 4.2 13.1 10.4 - 15.7 17 7.93 0.66 8.3 7.9 6.3 - 9.6 TOSOH ST AIA 19 13.36 0.88 6.6 13.6 10.6 - 16.1 19 8.37 0.61 7.3 8.4 6.6 - 10.1

Specimen CH-3 Specimen CH-4

All Method 87 16.77 1.71 10.2 16.9 13.4 - 20.2 90 10.32 0.85 8.2 10.3 8.2 - 12.4 All Abbott Instruments 11 15.29 1.04 6.8 15.5 12.2 - 18.4 11 9.74 0.57 5.8 9.8 7.7 - 11.7 All TOSOH Instruments 23 18.12 1.22 6.7 18.3 14.4 - 21.8 23 10.99 0.62 5.7 10.9 8.7 - 13.2 Abbott AxSYM 11 15.29 1.04 6.8 15.5 12.2 - 18.4 11 9.74 0.57 5.8 9.8 7.7 - 11.7 Beckman ACCESS / 2 / DxI 16 16.09 1.10 6.9 16.2 12.8 - 19.4 16 10.54 0.83 7.8 10.6 8.4 - 12.7 Siemens Dimension/AR/ES/RxL/Xpand/EXL 17 17.97 0.85 4.7 17.8 14.3 - 21.6 17 10.48 0.52 4.9 10.5 8.3 - 12.6 TOSOH ST AIA 19 18.04 1.27 7.1 18.3 14.4 - 21.7 19 11.04 0.56 5.1 11.2 8.8 - 13.3

Specimen CH-5

All Method 87 3.31 0.53 16.1 3.3 2.3 - 4.4 All Abbott Instruments 11 3.51 0.45 12.8 3.5 2.5 - 4.6 All TOSOH Instruments 23 3.17 0.35 11.0 3.2 2.1 - 4.2 Abbott AxSYM 11 3.51 0.45 12.8 3.5 2.5 - 4.6 Beckman ACCESS / 2 / DxI 16 3.33 0.49 14.6 3.5 2.3 - 4.4 Siemens Dimension/AR/ES/RxL/Xpand/EXL 17 3.34 0.49 14.6 3.2 2.3 - 4.4

TOSOH ST AIA 19 3.14 0.30 9.5 3.2 2.1 - 4.2

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Free Thyroxine (ng/dL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 256 3.50 1.04 29.7 3.4 0.3 - 6.7 256 2.35 0.74 31.6 2.4 0.1 - 4.6 All Abbott Instruments 26 2.17 0.17 8.0 2.2 1.6 - 2.7 26 1.32 0.10 7.7 1.3 1.0 - 1.7 All DPC Immulite Instruments 21 3.68 0.21 5.8 3.7 3.0 - 4.4 21 2.71 0.18 6.6 2.7 2.1 - 3.3 All Roche Elecsys/cobas e 601 Instruments 16 3.95 0.30 7.6 4.0 3.0 - 4.9 16 2.58 0.16 6.2 2.6 2.1 - 3.1 All TOSOH Instruments 51 4.84 0.31 6.5 4.9 3.9 - 5.8 51 3.19 0.22 7.0 3.2 2.5 - 3.9 Abbott AxSYM 26 2.17 0.17 8.0 2.2 1.6 - 2.7 26 1.32 0.10 7.7 1.3 1.0 - 1.7 Beckman ACCESS / 2 / DxI 39 2.85 0.17 6.1 2.8 2.3 - 3.4 39 2.03 0.14 7.0 2.0 1.6 - 2.5 bioMerieux Vidas, Mini Vidas 47 2.55 0.17 6.5 2.6 2.0 - 3.1 48 1.64 0.12 7.4 1.6 1.2 - 2.1 DPC Immulite/1000 16 3.71 0.21 5.8 3.8 3.0 - 4.4 16 2.75 0.18 6.6 2.8 2.2 - 3.3 Roche Elecsys 1010/2010 15 3.96 0.31 7.7 4.0 3.0 - 4.9 15 2.59 0.16 6.3 2.6 2.0 - 3.1 Siemens Dimension/AR/ES/RxL/Xpand/EXL 30 4.21 0.46 11.0 4.2 2.8 - 5.6 31 2.99 0.42 14.1 3.0 1.7 - 4.3 TOSOH AIA 13 4.82 0.27 5.7 4.8 3.9 - 5.7 13 3.08 0.26 8.4 3.1 2.3 - 3.9 TOSOH ST AIA 38 4.85 0.33 6.8 4.9 3.8 - 5.9 38 3.22 0.20 6.2 3.3 2.6 - 3.9

Specimen CH-3 Specimen CH-4 All Method 259 4.52 1.29 28.7 4.2 0.6 - 8.4 255 2.96 0.90 30.3 3.0 0.2 - 5.7 All Abbott Instruments 26 3.10 0.22 7.1 3.1 2.4 - 3.8 26 1.75 0.13 7.6 1.8 1.3 - 2.2 All DPC Immulite Instruments 21 4.48 0.30 6.6 4.5 3.5 - 5.4 21 3.27 0.17 5.2 3.2 2.7 - 3.8 All Roche Elecsys/cobas e 601 Instruments 16 5.42 0.41 7.6 5.4 4.1 - 6.7 16 3.28 0.20 6.1 3.3 2.6 - 3.9 All TOSOH Instruments 49 6.37 0.38 5.9 6.3 5.2 - 7.6 49 4.05 0.24 6.0 4.1 3.3 - 4.8 Abbott AxSYM 26 3.10 0.22 7.1 3.1 2.4 - 3.8 26 1.75 0.13 7.6 1.8 1.3 - 2.2 Beckman ACCESS / 2 / DxI 37 3.36 0.18 5.4 3.4 2.8 - 4.0 39 2.52 0.17 6.9 2.5 1.9 - 3.1 bioMerieux Vidas, Mini Vidas 48 3.50 0.27 7.8 3.5 2.6 - 4.4 47 2.13 0.20 9.3 2.1 1.5 - 2.8 DPC Immulite/1000 16 4.55 0.30 6.6 4.6 3.6 - 5.5 16 3.30 0.16 4.9 3.3 2.8 - 3.8 Roche Elecsys 1010/2010 15 5.43 0.43 7.9 5.4 4.1 - 6.8 15 3.28 0.20 6.2 3.3 2.6 - 3.9 Siemens Dimension/AR/ES/RxL/Xpand/EXL 31 5.12 0.48 9.3 5.1 3.6 - 6.6 31 3.72 0.48 13.0 3.7 2.2 - 5.2 TOSOH AIA 13 6.48 0.44 6.8 6.5 5.1 - 7.9 13 3.96 0.29 7.4 4.0 3.0 - 4.9 TOSOH ST AIA 36 6.33 0.35 5.5 6.3 5.2 - 7.4 36 4.08 0.22 5.3 4.1 3.4 - 4.8

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Free Thyroxine (ng/dL)

Specimen CH-5

Method Labs Mean SD CV Median Range

All Method 256 1.09 0.35 32.0 1.1 0.0 - 2.2

All Abbott Instruments 26 0.87 0.09 10.0 0.9 0.6 - 1.2 All DPC Immulite Instruments 21 1.52 0.10 6.5 1.5 1.2 - 1.9 All Roche Elecsys/cobas e 601 Instruments 16 1.23 0.08 6.3 1.2 0.9 - 1.5

All TOSOH Instruments 51 1.47 0.12 8.1 1.5 1.1 - 1.9 Abbott AxSYM 26 0.87 0.09 10.0 0.9 0.6 - 1.2 Beckman ACCESS / 2 / DxI 39 1.03 0.09 8.9 1.0 0.7 - 1.3 bioMerieux Vidas, Mini Vidas 47 0.75 0.06 8.3 0.7 0.5 - 1.0 DPC Immulite/1000 16 1.55 0.10 6.2 1.5 1.2 - 1.9 Roche Elecsys 1010/2010 15 1.23 0.08 6.5 1.2 0.9 - 1.5 Siemens Dimension/AR/ES/RxL/Xpand/EXL 30 1.17 0.19 16.6 1.2 0.5 - 1.8

TOSOH AIA 13 1.42 0.14 10.0 1.5 0.9 - 1.9 TOSOH ST AIA 38 1.48 0.11 7.3 1.5 1.1 - 1.9

TSH (U/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 370 7.45 0.95 12.8 7.5 4.5 - 10.4 369 3.09 0.40 13.0 3.1 1.8 - 4.3 All Abbott Instruments 47 6.47 0.71 11.0 6.4 4.3 - 8.6 46 2.62 0.25 9.4 2.6 1.8 - 3.4 All DPC Immulite Instruments 24 7.38 0.64 8.7 7.3 5.4 - 9.3 24 3.06 0.27 8.8 3.0 2.2 - 3.9 All Roche Elecsys/cobas e 601 Instruments 19 7.01 0.49 7.1 7.0 5.5 - 8.5 19 3.06 0.19 6.1 3.1 2.5 - 3.7 All TOSOH Instruments 74 8.42 0.39 4.6 8.3 7.2 - 9.6 76 3.52 0.22 6.4 3.5 2.8 - 4.2 Abbott AxSYM 41 6.48 0.76 11.7 6.5 4.2 - 8.8 41 2.64 0.29 11.0 2.6 1.7 - 3.6 Beckman ACCESS / 2 / DxI 51 6.55 0.40 6.1 6.5 5.3 - 7.8 49 2.76 0.18 6.5 2.8 2.2 - 3.3 bioMerieux Vidas, Mini Vidas 79 8.15 0.38 4.7 8.2 6.9 - 9.4 77 3.31 0.15 4.6 3.3 2.8 - 3.8 DPC Immulite/1000 18 7.35 0.63 8.6 7.4 5.4 - 9.3 18 2.99 0.24 7.9 3.0 2.2 - 3.8 Roche Elecsys 1010/2010 18 6.98 0.49 7.1 7.0 5.5 - 8.5 18 3.05 0.18 6.0 3.1 2.5 - 3.6 Siemens Dimension/AR/ES/RxL/Xpand/EXL 48 6.70 0.58 8.6 6.7 4.9 - 8.5 48 2.73 0.23 8.3 2.7 2.0 - 3.5 TOSOH AIA 27 8.36 0.41 5.0 8.3 7.1 - 9.6 27 3.52 0.18 5.2 3.5 2.9 - 4.1 TOSOH ST AIA 47 8.45 0.37 4.4 8.4 7.3 - 9.6 49 3.51 0.24 7.0 3.5 2.7 - 4.3

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TSH (U/mL)

Specimen CH-3 Specimen CH-4 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 369 11.43 1.55 13.6 11.7 6.7 - 16.1 370 5.31 0.69 13.0 5.4 3.2 - 7.4 All Abbott Instruments 47 10.27 1.05 10.2 10.1 7.1 - 13.5 47 4.59 0.51 11.2 4.5 3.0 - 6.2 All DPC Immulite Instruments 24 11.23 1.13 10.0 10.8 7.8 - 14.7 23 5.29 0.42 8.0 5.3 4.0 - 6.6 All Roche Elecsys/cobas e 601 Instruments 19 10.47 0.75 7.1 10.5 8.2 - 12.8 19 5.11 0.35 6.9 5.1 4.0 - 6.2 All TOSOH Instruments 76 12.83 0.66 5.2 12.7 10.8 - 14.9 76 6.02 0.34 5.7 6.0 4.9 - 7.1 Abbott AxSYM 41 10.34 1.11 10.8 10.2 6.9 - 13.7 41 4.61 0.54 11.8 4.5 2.9 - 6.3 Beckman ACCESS / 2 / DxI 51 9.38 0.75 8.0 9.3 7.1 - 11.7 50 4.70 0.30 6.4 4.7 3.8 - 5.6 bioMerieux Vidas, Mini Vidas 77 12.71 0.59 4.6 12.6 10.9 - 14.5 80 5.76 0.33 5.8 5.8 4.7 - 6.8 DPC Immulite/1000 18 11.07 0.95 8.6 10.8 8.2 - 14.0 18 5.31 0.47 8.8 5.3 3.9 - 6.8 Roche Elecsys 1010/2010 18 10.42 0.73 7.0 10.5 8.2 - 12.7 18 5.09 0.36 7.0 5.1 4.0 - 6.2 Siemens Dimension/AR/ES/RxL/Xpand/EXL 48 10.63 1.01 9.5 10.7 7.5 - 13.7 48 4.68 0.42 8.9 4.6 3.4 - 6.0 TOSOH AIA 27 12.88 0.57 4.4 12.7 11.1 - 14.6 27 5.99 0.36 6.0 5.9 4.9 - 7.1 TOSOH ST AIA 49 12.80 0.71 5.6 12.7 10.6 - 15.0 49 6.03 0.33 5.5 6.0 5.0 - 7.1

Specimen CH-5 All Method 364 0.34 0.07 19.5 0.3 0.1 - 0.6 All Abbott Instruments 47 0.30 0.05 15.3 0.3 0.1 - 0.5 All DPC Immulite Instruments 24 0.31 0.03 10.8 0.3 0.2 - 0.5 All Roche Elecsys/cobas e 601 Instruments 19 0.40 0.00 0.0 0.4 0.4 - 0.4

All TOSOH Instruments 68 0.40 0.00 0.0 0.4 0.4 - 0.4 Abbott AxSYM 41 0.30 0.05 16.3 0.3 0.1 - 0.5 Beckman ACCESS / 2 / DxI 48 0.30 0.00 0.0 0.3 0.3 - 0.3 bioMerieux Vidas, Mini Vidas 80 0.35 0.05 15.1 0.3 0.1 - 0.6 DPC Immulite/1000 17 0.30 0.00 0.0 0.3 0.3 - 0.3 Roche Elecsys 1010/2010 18 0.40 0.00 0.0 0.4 0.4 - 0.4 Siemens Dimension/AR/ES/RxL/Xpand/EXL 45 0.25 0.05 21.8 0.2 0.0 - 0.5

TOSOH AIA 24 0.40 0.00 0.0 0.4 0.4 - 0.4 TOSOH ST AIA 49 0.39 0.03 7.8 0.4 0.2 - 0.5

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Serum hCG Qualitative

Specimen HCG-1 Specimen HCG-2

Method

Positive

Negative

Positive

Negative

ALL METHODS 1 155 156 - Abbott AxSYM - 1 1 - Beckman Coulter ICON 25 hCG - 13 13 - Cardinal Health SP Brand combo - 5 5 - CONSULT diagnostics hCG Combo - 16 16 - Genzyme OSOM hCG Combo Test - 3 3 - Henry Schein One Step + Combo - 7 7 - Immunostics Detector Combi - 2 2 - Inverness Acceava hCG Combo II - 1 1 - Inverness Clearview hCG Combo II - 6 6 - Inverness Signify hCG combo - 1 1 - LifeSign Status hCG - 2 2 - McKesson hCG Combo Cassette - 10 10 - PEP (Lab Supply) HCG Combo Test - 1 1 - Polymedco Poly stat hCG - 3 3 - PSS Select hCG Combo - 6 6 - Quidel QuickVue + One-Step - 13 13 - Quidel QuickVue One-Step Combo 1 54 55 - Stanbio QUPID Plus - 3 3 - Sure-Vue hCG - 25mIU - 1 1 - Sure-Vue hCG-STAT (10mIU) - 2 2 -

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2011 MLE-M1 Participant Summary/ 75

Serum hCG Qualitative

Specimen HCG-3 Specimen HCG-4

ALL METHODS 155 1 2 154 Abbott AxSYM 1 - - 1 Beckman Coulter ICON 25 hCG 13 - - 13 Cardinal Health SP Brand combo 5 - - 5 CONSULT diagnostics hCG Combo 16 - - 16 Genzyme OSOM hCG Combo Test 3 - - 3 Henry Schein One Step + Combo 7 - - 7 Immunostics Detector Combi 2 - - 2 Inverness Acceava hCG Combo II 1 - - 1 Inverness Clearview hCG Combo II 6 - - 6 Inverness Signify hCG combo 1 - - 1 LifeSign Status hCG 2 - - 2 McKesson hCG Combo Cassette 10 - - 10 PEP (Lab Supply) HCG Combo Test 1 - - 1 Polymedco Poly stat hCG 3 - - 3 PSS Select hCG Combo 6 - - 6 Quidel QuickVue + One-Step 13 - 1 12 Quidel QuickVue One-Step Combo 54 1 1 54 Stanbio QUPID Plus 3 - - 3 Sure-Vue hCG - 25mIU 1 - - 1 Sure-Vue hCG-STAT (10mIU) 2 - - 2

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Serum hCG Qualitative

Specimen HCG-5

Method

Positive

Negative

ALL METHODS 153 3 Abbott AxSYM 1 -

Beckman Coulter ICON 25 hCG 13 - Cardinal Health SP Brand combo 5 - CONSULT diagnostics hCG Combo 16 -

Genzyme OSOM hCG Combo Test 3 - Henry Schein One Step + Combo 7 - Immunostics Detector Combi 2 -

Inverness Acceava hCG Combo II 1 - Inverness Clearview hCG Combo II 6 - Inverness Signify hCG combo 1 -

LifeSign Status hCG 2 - McKesson hCG Combo Cassette 9 1 PEP (Lab Supply) HCG Combo Test 1 -

Polymedco Poly stat hCG 3 - PSS Select hCG Combo 6 - Quidel QuickVue + One-Step 12 1

Quidel QuickVue One-Step Combo 54 1 Stanbio QUPID Plus 3 - Sure-Vue hCG - 25mIU 1 -

Sure-Vue hCG-STAT (10mIU) 2 -

Serum hCG Quantitative

Specimen HCG-1 Specimen HCG-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 33 1.1 0.8 70.1 1 0 - 4 33 1028.6 116.6 11.3 1043 678 - 1379

Specimen HCG-3 Specimen HCG-4

All Method 34 214.6 24.2 11.3 212 142 - 288 33 1.1 0.8 69.7 1 0 - 4

Specimen HCG-5 All Method 34 413.6 53.9 13.0 410 251 - 576

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2011 MLE-M1 Participant Summary/ 77

Cholesterol, Total (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 439 223.4 8.2 3.7 223 201 - 246 435 198.0 6.8 3.4 198 178 - 218 All Roche Integra/c111/c501 Reagents 44 219.5 5.9 2.7 220 197 - 242 44 196.6 5.1 2.6 197 176 - 217 Abaxis Piccolo Abaxis Piccolo - waived 10 217.9 3.2 1.5 217 196 - 240 10 191.9 4.1 2.2 192 172 - 212 All Chemistry Instruments 17 218.1 2.8 1.3 217 196 - 240 17 191.4 3.4 1.8 191 172 - 211 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 60 218.8 4.0 1.8 219 196 - 241 60 194.6 5.1 2.6 195 175 - 215 Beckman - cartridge Beckman Synchron 11 223.9 4.4 2.0 226 201 - 247 11 197.9 3.7 1.9 198 178 - 218 Beckman Synchron LX/PRo/DxC 18 225.1 4.0 1.8 226 202 - 248 18 199.1 5.5 2.8 199 179 - 220 All Chemistry Instruments 29 224.6 4.1 1.8 226 202 - 248 29 198.7 4.8 2.4 199 178 - 219 Cholestech LDX Cholestech LDX - waived 50 234.0 9.7 4.2 233 210 - 258 52 205.2 9.8 4.8 204 184 - 226 All Chemistry Instruments 56 233.7 9.6 4.1 233 210 - 258 58 204.5 9.6 4.7 203 184 - 225 Horiba ABX Pentra Horiba ABX Pentra 400 13 225.2 4.6 2.1 225 202 - 248 13 202.5 4.5 2.2 202 182 - 223 Olympus Olympus AU 19 216.9 4.8 2.2 216 195 - 239 19 193.8 4.4 2.3 192 174 - 214 Pointe Scientific Spectrophotometer 11 222.1 8.3 3.7 225 199 - 245 11 197.0 6.5 3.3 199 177 - 217 All Chemistry Instruments 15 224.8 9.0 4.0 226 202 - 248 15 199.7 8.1 4.0 200 179 - 220 Roche Integra Roche Integra 38 219.3 6.3 2.9 220 197 - 242 38 196.2 5.3 2.7 197 176 - 216 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 56 221.1 5.0 2.3 222 198 - 244 56 197.6 5.3 2.7 199 177 - 218 Vital Diagnostics Vital Diagnostics ATAC 8000 19 218.7 8.1 3.7 218 196 - 241 19 197.5 8.3 4.2 197 177 - 218 Vital Diagnostics Envoy 500 17 220.5 10.4 4.7 222 198 - 243 17 192.4 8.6 4.5 194 173 - 212 All Chemistry Instruments 37 219.5 9.0 4.1 220 197 - 242 37 194.9 8.7 4.5 195 175 - 215 VITROS VITROS 250,350,500,700,750,950 37 229.8 5.2 2.3 229 206 - 253 38 200.8 5.2 2.6 200 180 - 221 VITROS DT/DTII/DT60 11 230.8 8.8 3.8 229 207 - 254 11 206.2 8.2 4.0 204 185 - 227 All Chemistry Instruments 54 229.6 6.8 3.0 229 206 - 253 53 201.1 5.8 2.9 201 181 - 222

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Cholesterol, Total (mg/dL)

Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 395 246.9 9.5 3.9 246 222 - 272 392 210.6 7.3 3.4 210 189 - 232 All Roche Integra/c111/c501 Reagents 44 242.0 6.7 2.8 241 217 - 267 44 208.3 6.1 3.0 208 187 - 230 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 248 222 - 273 5 - - - 203 182 - 223 All Chemistry Instruments 12 247.7 2.8 1.1 247 222 - 273 12 202.6 3.2 1.6 203 182 - 223 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 59 240.4 4.7 2.0 241 216 - 265 60 207.1 5.0 2.4 207 186 - 228 Beckman - cartridge Beckman Synchron 11 249.5 4.4 1.8 250 224 - 275 11 211.1 4.3 2.0 211 189 - 233 Beckman Synchron LX/PRo/DxC 17 250.6 5.1 2.0 250 225 - 276 18 213.3 6.2 2.9 213 191 - 235 All Chemistry Instruments 28 250.2 4.8 1.9 250 225 - 276 29 212.5 5.6 2.6 213 191 - 234 Cholestech LDX Cholestech LDX - waived 17 262.5 8.8 3.4 262 236 - 289 16 217.3 8.8 4.0 217 195 - 240 All Chemistry Instruments 22 262.3 9.4 3.6 262 236 - 289 21 216.8 8.8 4.1 215 195 - 239 Horiba ABX Pentra Horiba ABX Pentra 400 13 249.5 5.3 2.1 251 224 - 275 13 215.8 3.8 1.8 218 194 - 238 Olympus Olympus AU 19 238.8 5.4 2.3 239 214 - 263 19 205.2 4.1 2.0 204 184 - 226 Pointe Scientific Spectrophotometer 11 243.9 5.1 2.1 245 219 - 269 11 210.5 5.3 2.5 212 189 - 232 All Chemistry Instruments 15 248.6 10.0 4.0 246 223 - 274 15 213.3 8.1 3.8 212 191 - 235 Roche Integra Roche Integra 38 241.5 6.7 2.8 241 217 - 266 38 208.1 6.5 3.1 208 187 - 229 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 56 243.9 6.2 2.6 244 219 - 269 56 209.7 5.2 2.5 210 188 - 231 Vital Diagnostics Vital Diagnostics ATAC 8000 19 246.7 11.0 4.5 248 222 - 272 18 211.3 6.4 3.0 210 190 - 233 Vital Diagnostics Envoy 500 17 245.8 10.2 4.1 247 221 - 271 17 207.0 8.5 4.1 209 186 - 228 All Chemistry Instruments 37 246.2 10.3 4.2 247 221 - 271 35 209.7 6.4 3.1 210 188 - 231 VITROS VITROS 250,350,500,700,750,950 38 256.5 6.3 2.5 257 230 - 283 38 216.4 5.9 2.7 216 194 - 239 VITROS DT/DTII/DT60 10 254.4 9.0 3.5 255 228 - 280 11 213.9 8.3 3.9 214 192 - 236 All Chemistry Instruments 53 256.4 7.4 2.9 257 230 - 282 55 215.3 7.1 3.3 215 193 - 237

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2011 MLE-M1 Participant Summary/ 79

Cholesterol, Total (mg/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range

All Method 395 108.9 5.7 5.3 108 98 - 120 All Roche Integra/c111/c501 Reagents 44 106.9 3.1 2.9 107 96 - 118

Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 118 106 - 130 All Chemistry Instruments 12 118.1 3.6 3.0 118 106 - 130 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 60 108.0 2.7 2.5 108 97 - 119 Beckman - cartridge Beckman Synchron 11 114.1 2.3 2.0 114 102 - 126 Beckman Synchron LX/PRo/DxC 18 115.2 4.0 3.5 115 103 - 127 All Chemistry Instruments 29 114.8 3.5 3.0 114 103 - 127 Cholestech LDX Cholestech LDX - waived 16 106.6 4.3 4.0 107 95 - 118 All Chemistry Instruments 21 105.9 4.6 4.4 106 95 - 117 Horiba ABX Pentra Horiba ABX Pentra 400 13 111.0 3.0 2.7 112 99 - 123 Olympus Olympus AU 19 103.6 2.4 2.3 104 93 - 114 Pointe Scientific Spectrophotometer 11 106.6 1.2 1.1 107 95 - 118 All Chemistry Instruments 15 108.8 4.3 3.9 107 97 - 120 Roche Integra Roche Integra 38 106.6 3.2 3.0 107 95 - 118 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 56 103.9 4.0 3.9 104 93 - 115

Vital Diagnostics Vital Diagnostics ATAC 8000 19 113.9 8.4 7.4 116 102 - 126 Vital Diagnostics Envoy 500 17 114.8 5.8 5.0 116 103 - 127 All Chemistry Instruments 37 114.2 7.1 6.3 116 102 - 126 VITROS VITROS 250,350,500,700,750,950 38 111.3 3.5 3.2 111 100 - 123 VITROS DT/DTII/DT60 11 107.6 4.6 4.3 107 96 - 119 All Chemistry Instruments 54 110.3 4.2 3.8 111 99 - 122

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LDL Cholesterol - Calculated (mg/dL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 233 84.8 16.3 19.2 88 35 - 134 273 75.0 18.0 24.0 76 20 - 130 Calculated-Trig/5 Alfa Wassermann ACE/NexCT/Alera 36 98.6 7.8 7.9 98 75 - 122 36 88.6 7.1 8.0 89 67 - 110 Beckman Synchron 10 64.7 16.1 24.8 59 16 - 113 10 42.8 13.6 31.7 43 2 - 84 Cholestech LDX - waived 11 98.7 6.1 6.2 98 80 - 118 38 88.7 10.9 12.3 91 56 - 122 Olympus AU 12 77.5 13.5 17.4 77 36 - 119 12 71.8 13.0 18.2 68 32 - 111 Roche Integra 21 83.1 7.6 9.1 83 60 - 106 21 66.6 5.8 8.8 67 49 - 85 Siemens Dimension/AR/ES/RxL/Xpand/EXL 23 86.9 8.3 9.6 87 61 - 112 23 72.4 9.7 13.4 72 43 - 102 Vital Diagnostics ATAC 8000 11 88.5 16.1 18.2 89 40 - 137 11 82.0 13.6 16.6 84 41 - 123 Vital Diagnostics Envoy 500 11 72.5 13.1 18.1 70 33 - 112 11 64.5 14.7 22.9 62 20 - 109 VITROS 250,350,500,700,750,950 34 73.7 13.5 18.3 74 33 - 115 34 60.4 11.1 18.4 61 27 - 94 All Chemistry Instruments 223 84.3 16.4 19.5 87 35 - 134 261 74.7 18.2 24.4 75 20 - 130

LDL Cholesterol - Direct (mg/dL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 129 58.6 11.8 20.1 57 23 - 95 129 47.3 10.9 23.1 46 14 - 81 Alfa Wass. ACE HDL-C / LDL-C Alfa Wassermann ACE/NexCT/Alera 14 60.1 13.2 22.0 56 20 - 100 13 45.1 5.5 12.2 44 28 - 62 Roche LDL Direct Roche Integra 13 77.0 4.4 5.7 77 63 - 91 13 64.0 4.0 6.2 64 52 - 76 All Chemistry Instruments 14 76.4 4.7 6.2 77 62 - 91 14 63.4 4.4 6.9 64 50 - 77 Siemens Automated LDL Siemens Dimension/AR/ES/RxL/Xpand/EXL 23 60.4 4.1 6.7 59 48 - 73 23 49.2 4.1 8.4 49 36 - 62

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Cholesterol, HDL (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 399 103.7 14.0 13.5 100 72 - 135 418 97.7 15.9 16.3 97 68 - 127 All Dex-Sulfate 50,000 MW Methods 82 106.9 14.6 13.6 100 74 - 139 89 98.5 19.3 19.5 94 68 - 129 All Direct Methods 215 99.7 12.4 12.5 100 69 - 130 230 95.7 15.6 16.3 97 66 - 125 All Phosphotungstic Acid Methods 36 103.4 10.9 10.6 102 72 - 135 36 99.0 10.7 10.8 100 69 - 129 Abaxis Piccolo All Chemistry Instruments 7 - - - 107 73 - 137 12 101.2 3.2 3.1 100 70 - 132 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 49 89.2 6.6 7.4 89 62 - 116 49 80.9 5.3 6.6 81 56 - 106 Beckman HDLD All Chemistry Instruments 11 138.1 8.1 5.8 142 96 - 180 14 131.1 8.3 6.4 132 91 - 171 Cholestech LDX Cholestech LDX - waived 40 99.8 0.9 0.9 100 69 - 130 46 89.0 9.4 10.6 91 62 - 116 All Chemistry Instruments 46 99.8 0.8 0.8 100 69 - 130 51 89.7 8.2 9.1 91 62 - 117 Horiba ABX Pentra Horiba ABX Pentra 400 11 91.2 13.6 15.0 97 63 - 119 11 82.5 12.3 14.9 86 57 - 108 Roche HDL Direct Roche Integra 17 107.6 9.0 8.4 104 75 - 140 17 106.4 5.2 4.9 106 74 - 139 All Chemistry Instruments 21 105.2 6.4 6.1 104 73 - 137 22 105.2 5.5 5.2 104 73 - 137 Siemens Automated HDL Siemens Dimension/AR/ES/RxL/Xpand/EXL 34 98.7 3.3 3.3 99 69 - 129 34 97.6 5.7 5.8 99 68 - 127 Vital Diagnostics Direct Vital Diagnostics ATAC 8000 12 98.8 14.6 14.8 103 69 - 129 12 88.5 12.2 13.8 91 61 - 116 All Chemistry Instruments 19 104.0 15.2 14.6 106 72 - 136 19 94.8 13.8 14.6 94 66 - 124 VITROS All Chemistry Instruments 14 115.1 14.1 12.3 117 80 - 150 14 102.2 16.5 16.1 104 71 - 133 VITROS dHDL Slide VITROS 250,350,500,700,750,950 32 117.4 13.8 11.7 114 82 - 153 32 111.8 9.8 8.7 110 78 - 146

All Chemistry Instruments 36 117.6 13.9 11.8 114 82 - 153 36 112.1 10.2 9.1 110 78 - 146

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Cholesterol, HDL (mg/dL)

Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 366 109.9 16.3 14.8 106 76 - 143 374 102.0 15.7 15.4 100 71 - 133 All Dex-Sulfate 50,000 MW Methods 56 117.1 22.3 19.1 109 81 - 153 57 109.3 19.8 18.1 100 76 - 143 All Direct Methods 212 105.4 12.9 12.3 102 73 - 137 224 98.6 15.5 15.7 99 69 - 129 All Phosphotungstic Acid Methods 37 108.0 16.1 14.9 104 75 - 141 36 100.5 10.8 10.8 99 70 - 131 Abaxis Piccolo All Chemistry Instruments 1 - - - 100 70 - 130 7 - - - 103 72 - 136 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 49 95.7 6.7 7.0 97 66 - 125 49 84.1 6.2 7.4 85 58 - 110 Beckman HDLD All Chemistry Instruments 13 139.1 21.8 15.7 140 97 - 181 14 134.5 7.3 5.4 135 94 - 175 Cholestech LDX Cholestech LDX - waived 16 100.0 0.0 0.0 100 70 - 130 15 98.7 3.6 3.6 100 69 - 129 All Chemistry Instruments 20 100.0 0.0 0.0 100 70 - 130 20 98.2 4.7 4.8 100 68 - 128 Horiba ABX Pentra Horiba ABX Pentra 400 11 100.8 15.6 15.5 105 70 - 132 11 91.6 24.1 26.3 88 64 - 120 Roche HDL Direct Roche Integra 17 107.4 6.8 6.3 106 75 - 140 17 106.8 6.6 6.1 105 74 - 139 All Chemistry Instruments 22 106.7 6.8 6.4 106 74 - 139 22 105.8 6.5 6.1 104 74 - 138 Siemens Automated HDL Siemens Dimension/AR/ES/RxL/Xpand/EXL 34 100.9 5.8 5.7 99 70 - 132 33 98.8 3.0 3.0 99 69 - 129 Vital Diagnostics Direct Vital Diagnostics ATAC 8000 12 108.3 14.1 13.0 112 75 - 141 12 94.6 13.5 14.2 96 66 - 123 All Chemistry Instruments 19 115.2 15.1 13.1 118 80 - 150 19 100.1 14.4 14.4 101 70 - 131 VITROS All Chemistry Instruments 14 129.7 16.1 12.4 130 90 - 169 14 111.4 14.8 13.3 106 77 - 145 VITROS dHDL Slide VITROS 250,350,500,700,750,950 32 124.0 15.0 12.1 121 86 - 162 32 114.5 11.0 9.6 112 80 - 149 All Chemistry Instruments 36 124.0 15.1 12.2 121 86 - 162 36 114.9 11.6 10.1 112 80 - 150

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Cholesterol, HDL (mg/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range All Method 382 58.9 10.3 17.5 61 41 - 77 All Dex-Sulfate 50,000 MW Methods 57 63.8 10.4 16.3 64 44 - 83 All Direct Methods 230 56.9 11.0 19.4 56 39 - 74 All Phosphotungstic Acid Methods 36 60.1 7.8 12.9 62 42 - 79 Abaxis Piccolo All Chemistry Instruments 12 51.6 3.9 7.6 53 36 - 68 Alfa Wassermann - New Alfa Wassermann ACE/NexCT/Alera 49 46.6 3.5 7.6 47 32 - 61 Beckman HDLD All Chemistry Instruments 14 77.9 6.4 8.2 79 54 - 102 Cholestech LDX Cholestech LDX - waived 16 58.4 6.9 11.8 59 40 - 76 All Chemistry Instruments 21 58.3 6.9 11.9 59 40 - 76 Horiba ABX Pentra Horiba ABX Pentra 400 11 48.5 5.9 12.2 51 33 - 64 Roche HDL Direct Roche Integra 17 68.2 4.0 5.8 67 47 - 89 All Chemistry Instruments 22 67.4 3.9 5.9 67 47 - 88 Siemens Automated HDL Siemens Dimension/AR/ES/RxL/Xpand/EXL 34 60.7 5.8 9.6 63 42 - 79

Vital Diagnostics Direct Vital Diagnostics ATAC 8000 12 54.1 8.7 16.0 57 37 - 71 All Chemistry Instruments 19 56.4 7.6 13.5 58 39 - 74 VITROS All Chemistry Instruments 14 64.7 3.8 5.9 65 45 - 85 VITROS dHDL Slide VITROS 250,350,500,700,750,950 32 63.8 3.4 5.3 64 44 - 83 All Chemistry Instruments 36 63.8 3.2 5.1 64 44 - 83

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Triglycerides (mg/dL)

Specimen CH-1 Specimen CH-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 423 166.6 9.6 5.7 164 124 - 209 421 131.7 7.2 5.5 131 98 - 165 All Roche Integra/c111/c501 Reagents 44 158.7 5.1 3.2 158 119 - 199 44 127.0 4.2 3.3 128 95 - 159 Abaxis Piccolo Abaxis Piccolo - waived 10 173.0 5.0 2.9 173 129 - 217 10 134.4 3.1 2.3 135 100 - 168 All Chemistry Instruments 17 173.3 4.1 2.4 173 129 - 217 17 135.1 2.8 2.1 136 101 - 169 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 59 162.2 3.7 2.3 162 121 - 203 59 133.2 4.0 3.0 132 99 - 167 Beckman - cartridge Beckman Synchron 11 163.5 5.5 3.3 163 122 - 205 10 133.4 15.5 11.6 130 100 - 167 Beckman Synchron LX/PRo/DxC 17 163.6 6.9 4.2 165 122 - 205 17 126.9 6.3 4.9 127 95 - 159 All Chemistry Instruments 28 163.5 6.2 3.8 164 122 - 205 26 127.6 6.3 4.9 128 95 - 160 Cholestech LDX Cholestech LDX - waived 45 172.4 9.6 5.6 174 129 - 216 47 133.5 9.6 7.2 134 100 - 167 All Chemistry Instruments 51 171.9 9.3 5.4 173 128 - 215 53 133.4 9.2 6.9 134 100 - 167 Horiba ABX Pentra Horiba ABX Pentra 400 13 163.5 6.5 4.0 163 122 - 205 13 130.3 5.5 4.2 132 97 - 163 Olympus Olympus AU 19 162.5 3.8 2.3 163 121 - 204 19 128.4 4.4 3.4 129 96 - 161 Pointe Scientific All Chemistry Instruments 13 158.0 5.6 3.5 159 118 - 198 12 126.4 6.1 4.8 127 94 - 159 Roche Integra Roche Integra 38 158.3 4.6 2.9 158 118 - 198 38 126.5 3.7 2.9 127 94 - 159 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 55 164.2 3.9 2.4 164 123 - 206 54 128.3 3.0 2.3 128 96 - 161 Vital Diagnostics Vital Diagnostics ATAC 8000 19 165.5 6.7 4.0 168 124 - 207 18 133.1 5.7 4.3 133 99 - 167 Vital Diagnostics Envoy 500 17 167.2 6.3 3.8 167 125 - 209 17 130.3 6.0 4.6 129 97 - 163 All Chemistry Instruments 37 166.3 6.4 3.8 167 124 - 208 36 131.6 5.9 4.4 132 98 - 165 VITROS VITROS 250,350,500,700,750,950 39 185.5 9.2 5.0 187 139 - 232 39 142.0 8.0 5.6 142 106 - 178 All Chemistry Instruments 49 183.2 10.0 5.5 185 137 - 230 49 140.5 8.3 5.9 142 105 - 176

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Triglycerides (mg/dL)

Specimen CH-3 Specimen CH-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 386 201.0 14.7 7.3 198 150 - 252 380 149.9 8.4 5.6 148 112 - 188 All Roche Integra/c111/c501 Reagents 44 189.2 6.8 3.6 190 141 - 237 43 143.2 4.6 3.2 144 107 - 180 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 210 158 - 265 5 - - - 153 115 - 193 All Chemistry Instruments 12 211.4 5.6 2.7 212 158 - 265 12 153.8 3.4 2.2 154 115 - 193 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 60 190.8 5.7 3.0 190 143 - 239 59 149.0 4.8 3.2 149 111 - 187 Beckman - cartridge Beckman Synchron 11 202.0 9.9 4.9 202 151 - 253 10 147.9 9.0 6.1 146 110 - 185 Beckman Synchron LX/PRo/DxC 17 199.1 9.8 4.9 199 149 - 249 17 146.6 7.1 4.9 148 109 - 184 All Chemistry Instruments 28 200.3 9.8 4.9 201 150 - 251 27 147.1 7.7 5.2 147 110 - 184 Cholestech LDX Cholestech LDX - waived 17 211.5 14.1 6.7 215 158 - 265 16 152.8 8.4 5.5 154 114 - 191 All Chemistry Instruments 22 215.9 18.5 8.6 216 161 - 270 21 152.6 8.8 5.8 154 114 - 191 Horiba ABX Pentra Horiba ABX Pentra 400 13 197.2 6.5 3.3 198 147 - 247 12 150.0 4.6 3.0 151 112 - 188 Olympus Olympus AU 19 196.8 4.0 2.1 197 147 - 246 18 145.9 4.2 2.9 148 109 - 183 Pointe Scientific All Chemistry Instruments 13 189.5 6.6 3.5 189 142 - 237 13 142.9 5.3 3.7 144 107 - 179 Roche Integra Roche Integra 38 188.5 6.0 3.2 190 141 - 236 37 142.9 4.4 3.1 143 107 - 179 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 54 200.1 3.6 1.8 200 150 - 251 55 147.0 3.7 2.5 147 110 - 184 Vital Diagnostics Vital Diagnostics ATAC 8000 19 201.5 9.3 4.6 203 151 - 252 19 148.6 9.4 6.3 150 111 - 186 Vital Diagnostics Envoy 500 16 205.2 8.0 3.9 205 153 - 257 17 150.3 7.3 4.9 146 112 - 188 All Chemistry Instruments 35 204.0 7.2 3.5 204 152 - 255 36 150.2 7.1 4.7 150 112 - 188 VITROS VITROS 250,350,500,700,750,950 39 230.9 10.1 4.4 232 173 - 289 39 165.2 8.6 5.2 166 123 - 207 All Chemistry Instruments 48 229.3 10.1 4.4 231 171 - 287 49 163.4 8.8 5.4 165 122 - 205

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Triglycerides (mg/dL)

Specimen CH-5 Reagent/Instrument Labs Mean SD CV Median Range All Method 382 93.6 7.8 8.3 93 70 - 118 All Roche Integra/c111/c501 Reagents 44 90.3 3.1 3.4 91 67 - 113

Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 99 73 - 124 All Chemistry Instruments 12 98.5 2.3 2.3 99 73 - 124 Alfa Wassermann Alfa Wassermann ACE/NexCT/Alera 59 90.6 2.9 3.2 91 67 - 114 Beckman - cartridge Beckman Synchron 11 89.0 9.5 10.7 87 66 - 112 Beckman Synchron LX/PRo/DxC 16 88.4 5.1 5.8 90 66 - 111 All Chemistry Instruments 28 89.6 8.5 9.5 88 67 - 112 Cholestech LDX Cholestech LDX - waived 16 82.7 3.9 4.8 85 62 - 104 All Chemistry Instruments 21 81.3 5.6 6.9 82 60 - 102 Horiba ABX Pentra Horiba ABX Pentra 400 13 94.6 4.0 4.2 94 70 - 119 Olympus Olympus AU 18 94.2 3.9 4.1 96 70 - 118 Pointe Scientific All Chemistry Instruments 11 88.0 7.7 8.7 92 66 - 110 Roche Integra Roche Integra 38 90.0 2.7 3.0 91 67 - 113 Siemens (Dade) Healthcare Siemens Dimension/AR/ES/RxL/Xpand/EXL 55 95.3 2.8 3.0 96 71 - 120

Vital Diagnostics Vital Diagnostics ATAC 8000 19 105.2 8.0 7.6 106 78 - 132 Vital Diagnostics Envoy 500 17 102.8 6.1 6.0 102 77 - 129 All Chemistry Instruments 37 104.0 7.1 6.8 104 77 - 130 VITROS VITROS 250,350,500,700,750,950 39 102.5 5.6 5.5 103 76 - 129 All Chemistry Instruments 49 101.6 5.7 5.6 102 76 - 127

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Amikacin (mcg/mL) One participant reported results for Amikacin. The vendor assay values for specimens CH-1 through CH-5 are: 29.9 mcg/mL, 19.6 mcg/mL, 38.9 mcg/mL, 24.3 mcg/mL, and 7.1 mcg/mL, respectively.

Acetaminophen (mcg/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 8 69.84 4.60 6.6 69.8 56.0 - 83.7 8 17.30 2.24 12.9 18.3 10.5 - 24.1

Specimen CH-3 Specimen CH-4

All Method 8 117.81 14.87 12.6 121.5 73.1 - 162.5 8 43.81 3.11 7.1 44.5 34.4 - 53.2

Specimen CH-5 All Method 8 9.85 3.25 33.0 11.0 0.1 - 19.6

Carbamazepine (mcg/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 10 11.60 0.55 4.7 11.6 8.7 - 14.5 10 15.70 0.69 4.4 15.5 11.7 - 19.7

Specimen CH-3 Specimen CH-4 All Method 10 7.73 0.29 3.7 7.8 5.7 - 9.7 10 13.61 0.78 5.7 13.6 10.2 - 17.1

Specimen CH-5 All Method 10 3.67 0.18 4.8 3.7 2.7 - 4.6

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Digoxin (ng/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 43 2.33 0.21 9.0 2.3 1.8 - 2.8 43 1.67 0.18 10.9 1.7 1.3 - 2.1 Siemens Dimension/AR/ES/RxL/Xpand/EXL 10 2.45 0.11 4.4 2.4 1.9 - 3.0 10 1.78 0.10 5.8 1.8 1.4 - 2.2

Specimen CH-3 Specimen CH-4 All Method 44 3.05 0.32 10.4 3.0 2.4 - 3.7 43 2.02 0.19 9.3 2.0 1.6 - 2.5 Siemens Dimension/AR/ES/RxL/Xpand/EXL 10 3.18 0.09 2.9 3.2 2.5 - 3.9 10 2.15 0.10 4.5 2.2 1.7 - 2.6

Specimen CH-5 All Method 45 0.77 0.16 20.7 0.7 0.5 - 1.0 Siemens Dimension/AR/ES/RxL/Xpand/EXL 10 0.77 0.09 12.3 0.8 0.5 - 1.0

Gentamicin (mcg/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Media

n Range

All Method 3 - - - 2.3 Not graded 3 - - - 1.4 Not graded

Specimen CH-3 Specimen CH-4

All Method 3 - - - 3.0 Not graded 3 - - - 1.9 Not graded

Specimen CH-5

All Method 3 - - - 11.9 Not graded

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Lithium (mmol/L)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Media

n Range

All Method 2 - - - 0.7 Not graded 2 - - - 1.1 Not graded

Specimen CH-3 Specimen CH-4

All Method 2 - - - 0.2 Not graded 2 - - - 0.9 Not graded

Specimen CH-5

All Method 2 - - - 2.8 Not graded

Phenobarbital (mcg/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Media

n Range

All Method 8 38.94 3.34 8.6 37.1 31.1 - 46.8 8 30.38 3.14 10.3 30.0 24.3 - 36.5

Specimen CH-3 Specimen CH-4

All Method 8 48.11 4.99 10.4 48.3 38.4 - 57.8 8 34.49 2.53 7.3 33.4 27.5 - 41.4

Specimen CH-5

All Method 8 15.80 1.15 7.3 16.0 12.6 - 19.0

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Phenytoin (mcg/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 20 23.52 2.08 8.8 24.1 17.6 - 29.4 20 32.19 3.16 9.8 33.1 24.1 - 40.3

Specimen CH-3 Specimen CH-4

All Method 20 15.06 1.50 9.9 15.4 11.2 - 18.9 20 27.78 2.51 9.0 28.0 20.8 - 34.8

Specimen CH-5

All Method 18 6.66 0.28 4.2 6.7 4.9 - 8.4

Salicylate (mg/dL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 25.26 3.05 12.1 25.0 16.1 - 34.5 5 12.56 0.99 7.9 12.8 9.5 - 15.6

Specimen CH-3 Specimen CH-4

All Method 5 37.70 1.75 4.6 37.8 32.4 - 43.0 5 18.26 1.48 8.1 18.8 13.8 - 22.8

Specimen CH-5

All Method 5 2.96 3.00 101.4 2.8 0.0 - 12.0

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Theophylline (mcg/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 8 25.96 1.43 5.5 25.9 19.4 - 32.5 7 39.61 0.99 2.5 39.4 29.7 - 49.6

Specimen CH-3 Specimen CH-4

All Method 8 10.43 0.56 5.3 10.5 7.8 - 13.1 8 34.38 2.86 8.3 32.9 25.7 - 43.0

Specimen CH-5

All Method 8 22.26 1.27 5.7 22.1 16.6 - 27.9

Valproic Acid (mcg/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 12 90.48 3.16 3.5 90.7 67.8 - 113.1 13 44.65 3.80 8.5 44.0 33.4 - 55.9

Specimen CH-3 Specimen CH-4

All Method 13 138.87 7.98 5.7 137.6 104.1 - 173.6 13 70.38 7.67 10.9 68.4 52.7 - 88.0

Specimen CH-5

All Method 13 95.32 5.69 6.0 93.7 71.4 - 119.2

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Vancomycin (mcg/mL)

Specimen CH-1 Specimen CH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 7 40.87 1.98 4.9 41.5 34.9 - 46.9 7 29.99 2.08 6.9 31.2 23.7 - 36.3

Specimen CH-3 Specimen CH-4

All Method 7 51.94 3.27 6.3 52.4 42.1 - 61.8 7 35.51 3.00 8.5 34.7 26.5 - 44.6

Specimen CH-5

All Method 7 5.10 1.38 27.1 4.6 0.9 - 9.3

Apolipoproteins A1 (mg/dL)

Specimen LP-1 Specimen LP-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 7 107.4 32.0 29.8 108 11 - 204 7 69.3 12.1 17.5 65 32 - 106

Apolipoproteins B (mg/dL)

Specimen LP-1 Specimen LP-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 7 102.6 10.7 10.5 105 70 - 135 7 42.7 3.4 7.8 41 32 - 53

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Neonatal Bilirubin, Total (mg/dL)

Specimen NB-1 Specimen NB-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 27 0.85 0.41 48.2 0.8 0.4 - 1.3 27 15.15 1.80 11.9 15.8 12.1 - 18.2 No Reagent Required All Chemistry Instruments 13 0.90 0.53 58.6 0.6 0.5 - 1.3 13 16.35 0.55 3.3 16.2 13.0 - 19.7

Specimen NB-3 Specimen NB-4

All Method 27 7.30 1.07 14.6 7.2 5.8 - 8.8 27 4.37 0.70 15.9 4.2 3.4 - 5.3 No Reagent Required All Chemistry Instruments 13 7.73 0.87 11.2 7.2 6.1 - 9.3 13 4.52 0.72 16.0 4.2 3.6 - 5.5

Specimen NB-5 All Method 27 22.94 4.44 19.4 23.3 18.3 - 27.6 No Reagent Required All Chemistry Instruments 13 23.88 2.03 8.5 23.3 19.1 - 28.7

Bilirubin, Direct (mg/dL)

Specimen NB-1 Specimen NB-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 12 0.48 0.20 41.3 0.4 0.0 - 1.1 12 4.67 1.06 22.7 4.9 1.4 - 7.9

Blood Gases – pH

Specimen BG-1 Specimen BG-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 18 7.155 0.029 0.4 7.17 7.11 - 7.20 18 7.276 0.025 0.3 7.29 7.23 - 7.32 i-STAT 10 7.174 0.008 0.1 7.18 7.13 - 7.22 10 7.294 0.007 0.1 7.30 7.25 - 7.34

Specimen BG-3 Specimen BG-4

All Method 18 7.451 0.024 0.3 7.45 7.41 - 7.50 18 7.549 0.027 0.4 7.56 7.50 - 7.59 i-STAT 10 7.464 0.021 0.3 7.46 7.42 - 7.51 10 7.568 0.013 0.2 7.57 7.52 - 7.61

Specimen BG-5 All Method 18 7.659 0.032 0.4 7.68 7.61 - 7.70 i-STAT 10 7.681 0.011 0.1 7.68 7.64 - 7.73

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Blood Gases - pCO2 (mmHg)

Specimen BG-1 Specimen BG-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 16 69.56 5.53 7.9 66.0 63.9 - 75.2 16 49.17 3.66 7.4 46.8 44.1 - 54.2 i-STAT 9 - - - 65.0 63.9 - 75.2 8 - - - 46.2 44.1 - 54.2

Specimen BG-3 Specimen BG-4

All Method 18 34.72 2.91 8.4 33.7 29.7 - 39.8 18 29.55 1.05 3.6 29.4 24.5 - 34.6 i-STAT 10 32.69 1.53 4.7 32.8 27.6 - 37.7 10 28.86 0.64 2.2 28.6 23.8 - 33.9

Specimen BG-5

All Method 18 21.72 1.34 6.2 21.2 16.7 - 26.8 i-STAT 10 20.96 0.85 4.0 20.8 15.9 - 26.0

Blood Gases - pO2 (mmHg)

Specimen BG-1 Specimen BG-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 17 163.31 12.84 7.9 165.0 124.7 - 201.9 17 146.06 9.97 6.8 144.0 116.1 - 176.0

i-STAT

Specimen BG-3 Specimen BG-4

All Method 16 96.16 8.10 8.4 97.0 71.8 - 120.5 17 209.74 24.94 11.9 205.0 134.9 - 284.6

Specimen BG-5

All Method 17 128.39 9.47 7.4 127.0 99.9 - 156.9

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Blood Gases - Ionized Calcium (mmol/L)

One participant reported results for Blood Gases – Ionized Calcium. The vendor assay mean values for specimens BG-1 and BG-2 are: 1.62 mmol/L and 1.15 mmol/L, respectively.

Blood Gases – Chloride (mmol/L)

One participant reported results for Blood Gases-Chloride. The vendor mean assay values for specimens BG-1 through BG-5 are: 76.0 mmol/L, 85.4 mmol/L, 99.9 mmol/L, 71.2 mmol/L, and 118.8 mmol/L, respectively.

Blood Gases - Potassium (mmol/L)

Specimen BG-1 Specimen BG-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 3 - - - 7.3 Not graded 3 - - - 2.5 Not graded

Specimen BG-3 Specimen BG-4

All Method 3 - - - 4.2 Not graded 3 - - - 3.3 Not graded

Specimen BG-5

All Method 3 - - - 6.6 Not graded

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Blood Gases - Sodium (mmol/L)

Specimen BG-1 Specimen BG-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 3 - - - 110 Not graded 3 - - - 122 Not graded

Specimen BG-3 Specimen BG-4

All Method 3 - - - 136 Not graded 3 - - - 122 Not graded

Specimen BG-5

All Method 3 - - - 154 Not graded

Glycohemoglobin (percent)

Specimen GH-1 Specimen GH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 337 9.48 0.50 5.3 9.6 7.9 - 11.0 335 6.10 0.27 4.4 6.1 5.2 - 7.0 All Hemoglobin A1c Methods 334 9.49 0.48 5.1 9.6 8.0 - 11.0 333 6.10 0.27 4.3 6.1 5.3 - 6.9 Bayer (Metrika) A1C Now 12 8.55 0.53 6.2 8.5 6.9 - 10.2 12 5.48 0.32 5.8 5.5 4.5 - 6.5 Bayer DCA 2000/+ 48 9.79 0.30 3.0 9.8 8.8 - 10.7 48 6.24 0.21 3.4 6.3 5.5 - 6.9 Beckman Synchron HbA1C 13 9.30 0.34 3.7 9.2 8.2 - 10.4 13 5.91 0.27 4.6 5.9 5.0 - 6.8 Bio-Rad D-10 HbA1C 14 9.54 0.18 1.9 9.5 9.0 - 10.1 14 6.21 0.11 1.7 6.2 5.8 - 6.6 Roche Integra A1C 22 9.17 0.30 3.2 9.2 8.2 - 10.1 22 5.95 0.32 5.4 6.0 4.9 - 7.0 Siemens DCA Vantage 115 9.69 0.23 2.4 9.7 8.9 - 10.4 116 6.17 0.15 2.5 6.2 5.7 - 6.7 Siemens Dimension HA1C 48 8.96 0.43 4.8 9.0 7.6 - 10.3 46 6.06 0.18 2.9 6.0 5.5 - 6.6 TOSOH G7 10 9.86 1.57 15.9 9.6 5.1 - 14.6 10 6.49 1.00 15.3 6.2 3.5 - 9.5

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B-Type Natriuretic Peptide (BNP)

Specimen BNP-1 Specimen BNP-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 42 803.4 128.7 16.0 799 417 - 1190 43 605.0 68.7 11.4 602 398 - 812 Biosite Triage 41 813.8 111.0 13.6 809 480 - 1147 43 605.0 68.7 11.4 614 398 - 812

NT-proBNP

Specimen BNP-1 Specimen BNP-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 3 - - - 2289 Not graded 3 - - - 1481 Not graded

Afinion Glycohemoglobin (percent)

Specimen AFN-1 Specimen AFN-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 44 6.20 0.14 2.3 6.2 5.7 - 6.7 44 8.16 0.17 2.1 8.2 7.6 - 8.7 Axis-Shield Afinion AS100 44 6.20 0.14 2.3 6.2 5.7 - 6.7 44 8.16 0.17 2.1 8.2 7.6 - 8.7

BNP (pg/mL) – Biosite Triage Cardiac Panel

Specimen TCK-1 Specimen TCK-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 38 790.3 123.1 15.6 775 420 - 1160 39 600.9 80.3 13.4 592 360 - 842

Specimen TCK-3 Specimen TCK-4

All Method 38 231.3 34.1 14.7 232 128 - 334 39 429.3 49.0 11.4 423 282 - 577

Specimen TCK-5

All Method 39 95.3 10.9 11.4 95 62 - 128

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CK-MB (ng/mL) – Biosite Triage Cardiac Panel

Specimen TCK-1 Specimen TCK-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 40 31.3 7.1 22.6 32 10 - 53 39 22.4 4.3 19.2 22 9 - 36

Specimen TCK-3 Specimen TCK-4 All Method 39 7.1 1.8 24.8 7 1 - 13 38 13.9 2.5 18.2 14 6 - 22

Specimen TCK-5 All Method 40 2.5 0.7 27.2 3 0 - 5

D-Dimer (ng/mL) – Biosite Triage Cardiac Panel

Specimen TCK-1 Specimen TCK-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 35 932.0 144.7 15.5 907 498 - 1367 36 735.1 117.4 16.0 747 382 - 1088

Specimen TCK-3 Specimen TCK-4

All Method 35 430.2 87.5 20.3 418 167 - 693 35 562.8 91.2 16.2 552 289 - 837

Specimen TCK-5

All Method 34 191.9 59.1 30.8 177 14 - 370

Myoglobin (ng/mL) – Biosite Triage Cardiac Panel

Specimen TCK-1 Specimen TCK-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 36 408.8 78.8 19.3 436 172 - 646 36 328.4 67.1 20.4 329 127 - 530

Specimen TCK-3 Specimen TCK-4 All Method 35 130.5 21.8 16.7 133 65 - 196 36 237.1 40.4 17.0 234 115 - 359

Specimen TCK-5 All Method 35 60.5 7.3 12.1 61 38 - 83

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Troponin I (ng/mL) – Biosite Triage Cardiac Panel

Specimen TCK-1 Specimen TCK-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 37 1.458 0.494 33.8 1.49 0.00 - 2.94 37 0.862 0.367 42.6 0.85 0.00 - 1.97

Specimen TCK-3 Specimen TCK-4

All Method 38 0.191 0.085 44.6 0.19 0.00 - 0.45 39 0.479 0.195 40.6 0.46 0.00 - 1.07

Specimen TCK-5

All Method 38 0.059 0.017 29.4 0.05 0.00 - 0.12

C-Peptide (ng/mL)

Specimen CIP-1 Specimen CIP-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 13 0.702 0.244 34.8 0.70 0.00 - 1.44 12 8.223 0.498 6.1 8.30 6.72 - 9.72

Insulin (U/mL)

Specimen CIP-1 Specimen CIP-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 17 12.96 3.43 26.5 15.0 2.6 - 23.3 17 89.06 39.15 44.0 111.9 0.0 - 206.6

Parathyroid hormone (pg/mL)

Specimen CIP-1 Specimen CIP- Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 19.7 3.0 15.3 20 10 - 29 30 143.1 16.2 11.4 143 94 - 192

Vitamin D

Specimen CIP-1 Specimen CIP-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 10 13.19 2.20 16.7 14.3 6.5 - 19.8 10 57.32 7.52 13.1 56.9 34.7 - 79.9

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CK-MB (ng/mL) Quantitative

Specimen CK-1 Specimen CK-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 27 82.30 28.97 35.2 90.1 0.0 - 169.3 27 54.77 19.02 34.7 60.5 0.0 - 111.9

Specimen CK-3 Specimen CK-4 All Method 27 17.14 5.90 34.4 18.7 0.0 - 34.9 27 34.49 12.70 36.8 38.5 0.0 - 72.7

Specimen CK-5 All Method 26 6.18 2.34 37.8 7.0 0.0 - 13.2

CK-MB (Qualitative)

Specimen CK-1 Specimen CK-2 Specimen CK-3

Method Positive Negative Positive Negative Positive Negative

ALL METHODS 2 - 2 - 1 1

LifeSign MI 2 - 2 - 1 1

Specimen CK-4 Specimen CK-5

ALL METHODS 2 - 1 1

LifeSign MI 2 - 1 1

Specimens CK-3 and CK-5 are ungraded challenges due to less than 80% participant consensus.

Myoglobin (Quantitative)

Specimen CK-1 Specimen CK-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 17 480.51 101.67 21.2 479.0 175.4 - 785.6 17 341.34 70.96 20.8 340.0 128.4 - 554.3

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Troponin I (Qualitative)

Specimen CK-1 Specimen CK-2

Method Positive Negative Positive Negative

ALL METHODS 2 - 2 -

LifeSign MI 2 - 2 -

Myoglobin (Qualitative)

Specimen CK-1 Specimen CK-2

Method Positive Negative Positive Negative

ALL METHODS 2 - 2 -

LifeSign MI 2 - 2 - Troponin I (ng/mL) Quantitative

Specimen CK-1 Specimen CK-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 29 7.84 12.21 155.7 3.3 0.0 - 44.5 29 5.17 8.40 162.5 2.1 0.0 - 30.4 Siemens Dimension/AR/ES/RxL/Xpand/EXL 10 3.31 0.41 12.4 3.3 2.0 - 4.6 10 2.12 0.30 14.2 2.1 1.2 - 3.1

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PSA (ng/mL)

Specimen PS-1 Specimen PS-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 255 28.31 4.45 15.7 28.6 14.9 - 41.7 262 0.35 0.08 22.7 0.3 0.1 - 0.6 All Roche Elecsys/cobas e 601 Instruments 14 31.13 1.19 3.8 30.9 27.5 - 34.7 14 0.40 0.00 0.0 0.4 0.4 - 0.4 All TOSOH Instruments 61 23.19 0.94 4.0 23.3 20.3 - 26.0 57 0.30 0.00 0.0 0.3 0.3 - 0.3 Abbott AxSYM 15 25.79 2.10 8.1 25.1 19.4 - 32.1 15 0.30 0.04 12.6 0.3 0.1 - 0.5 Abbott AxSYM Total PSA 17 24.38 1.92 7.9 24.6 18.6 - 30.2 17 0.28 0.04 15.8 0.3 0.1 - 0.5 Beckman ACCESS / 2 / DxI 10 33.24 5.62 16.9 32.9 16.3 - 50.1 10 0.42 0.06 15.1 0.4 0.2 - 0.7 Beckman ACCESS Hybritech PSA 29 32.70 1.59 4.9 32.9 27.9 - 37.5 27 0.40 0.00 0.0 0.4 0.4 - 0.4 bioMerieux Vidas, Mini Vidas 48 32.65 2.47 7.6 32.6 25.2 - 40.1 47 0.41 0.04 10.4 0.4 0.2 - 0.6 Roche Elecsys 1010/2010 14 31.13 1.19 3.8 30.9 27.5 - 34.7 14 0.40 0.00 0.0 0.4 0.4 - 0.4 Siemens Dimension TPSA 30 28.37 1.33 4.7 28.7 24.3 - 32.4 30 0.30 0.05 15.2 0.3 0.1 - 0.5 TOSOH AIA 14 23.22 1.01 4.4 23.5 20.1 - 26.3 13 0.30 0.00 0.0 0.3 0.3 - 0.3 TOSOH ST AIA 47 23.18 0.92 4.0 23.3 20.4 - 26.0 44 0.30 0.00 0.0 0.3 0.3 - 0.3

Alpha-fetoprotein (ng/mL)

Specimen TM-1 Specimen TM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 5 1.0 0.0 0.0 1 1 - 1 5 334.2 9.1 2.7 336 306 - 362

Beta-2 microglobulin

Specimen TM-1 Specimen TM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 8 0.194 0.058 30.1 0.19 0.01 - 0.37 8 3.419 0.439 12.8 3.42 2.10 - 4.74 TOSOH ST AIA 6 0.192 0.027 14.2 0.19 0.11 - 0.28 6 3.442 0.508 14.8 3.42 1.91 - 4.97

CA 125 (U/mL)

Specimen TM-1 Specimen TM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 21 9.9 2.0 20.4 10 3 - 16 21 168.1 39.8 23.7 192 48 - 288 TOSOH ST AIA 11 11.3 1.0 9.0 11 8 - 15 11 203.1 11.5 5.7 202 168 - 238

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CA 15-3 (U/mL)

Specimen TM-1 Specimen TM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 16 14.7 3.6 24.8 16 3 - 26 16 127.1 34.8 27.4 142 22 - 232

CA 19-9 (U/mL)

Specimen TM-1 Specimen TM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 6 8.8 2.4 27.2 9 1 - 17 6 57.5 19.4 33.7 56 0 - 116

CA 27/29 (U/mL)

Specimen TM-1 Specimen TM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 19 16.4 1.9 11.4 16 10 - 22 18 139.4 8.8 6.3 141 112 - 166 All TOSOH Instruments 19 16.4 1.9 11.4 16 10 - 22 18 139.4 8.8 6.3 141 112 - 166 TOSOH ST AIA 16 16.3 1.8 10.9 16 10 - 22 15 139.7 7.6 5.4 141 116 - 163

CEA (ng/mL)

Specimen TM-1 Specimen TM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 32 1.58 0.51 32.2 1.4 0.0 - 3.1 32 47.50 9.53 20.1 51.3 18.9 - 76.1 All TOSOH Instruments 15 2.08 0.13 6.3 2.1 1.6 - 2.5 15 56.69 1.45 2.6 56.8 52.3 - 61.1 TOSOH ST AIA 13 2.08 0.14 6.7 2.1 1.6 - 2.6 13 56.82 1.47 2.6 56.8 52.3 - 61.3

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Free PSA (ng/mL)

Specimen TM-1 Specimen TM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 23 0.018 0.021 119.5 0.01 0.00 - 0.09 25 18.070 3.601 19.9 18.88 7.26 - 28.88

PSA (ng/mL)

Specimen TM-1 Specimen TM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 56 0.05 0.05 115.9 0.0 0.0 - 0.3 61 21.15 3.33 15.8 21.4 11.1 - 31.2 All TOSOH Instruments 15 0.09 0.04 40.6 0.1 0.0 - 0.2 15 17.82 0.90 5.0 17.8 15.1 - 20.6 Beckman ACCESS Hybritech PSA 14 0.04 0.09 260.1 0.0 0.0 - 0.4 15 24.85 1.02 4.1 24.8 21.7 - 28.0 TOSOH ST AIA 14 0.09 0.04 42.4 0.1 0.0 - 0.2 15 18.17 1.59 8.7 18.1 13.4 - 23.0

Thyroglobulin (ng/mL)

Specimen TM-1 Specimen TM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 7 0.86 0.63 73.7 0.7 0.0 - 2.8 7 49.69 11.50 23.1 45.8 15.1 - 84.2

CEA (ng/mL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 25 41.78 7.16 17.1 40.3 20.2 - 63.3 25 0.72 0.21 29.6 0.8 0.0 - 1.4 All TOSOH Instruments 11 49.19 1.53 3.1 49.6 44.5 - 53.8 11 0.91 0.08 9.1 0.9 0.6 - 1.2

Estradiol (pg/mL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 38 286.2 146.3 51.1 323 0 - 726 36 31.0 8.0 25.9 31 6 - 56 TOSOH ST AIA 10 426.8 44.0 10.3 423 294 - 559 10 33.3 4.7 14.0 32 19 - 48

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2011 MLE-M1 Participant Summary/ 105

Ferritin (ng/mL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 145 291.9 40.2 13.8 283 171 - 413 146 9.1 1.4 15.9 9 4 - 14 All Abbott Instruments 17 354.3 40.7 11.5 339 232 - 477 17 9.6 1.1 11.6 10 6 - 13 All Immulite Instruments 13 308.4 19.7 6.4 312 249 - 368 13 10.5 0.8 7.4 10 8 - 13 All Roche Elecsys/cobas e 601 Instruments 10 338.1 26.9 8.0 343 257 - 419 10 10.6 0.8 8.0 11 8 - 14 All TOSOH Instruments 32 265.7 11.6 4.4 266 230 - 301 32 7.6 0.6 8.1 8 5 - 10 Abbott AxSYM 14 346.4 39.2 11.3 336 228 - 465 14 9.6 1.2 12.8 10 5 - 14 Beckman ACCESS / 2 / DxI 34 254.7 15.5 6.1 254 208 - 302 34 8.1 0.9 10.8 8 5 - 11 Siemens Dimension/AR/ES/RxL/Xpand/EXL 17 313.8 12.8 4.1 312 275 - 353 17 10.5 0.6 6.0 11 8 - 13 TOSOH ST AIA 24 265.3 12.0 4.5 266 229 - 302 24 7.6 0.6 8.5 8 5 - 10

Folate (ng/mL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 79 13.11 2.58 19.7 12.9 5.3 - 20.9 78 0.86 0.47 55.4 0.8 0.0 - 2.3

Abbott AxSYM 13 15.96 1.27 8.0 16.3 12.1 - 19.8 13 1.29 0.32 24.6 1.3 0.3 - 2.3

Beckman ACCESS / 2 / DxI 29 12.30 0.89 7.3 12.5 9.6 - 15.0 30 0.46 0.18 38.1 0.5 0.0 - 1.0 TOSOH AIA 11 11.12 1.63 14.7 10.6 6.2 - 16.1 11 1.25 0.43 34.4 1.1 0.0 - 2.6

FSH (mIU/mL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 55 60.21 5.95 9.9 60.2 42.3 - 78.1 53 6.35 1.04 16.4 6.3 3.2 - 9.5 All Immulite Instruments 12 61.27 4.22 6.9 61.7 48.5 - 74.0 12 5.34 0.29 5.4 5.3 4.4 - 6.3 All TOSOH Instruments 15 57.87 5.14 8.9 56.1 42.4 - 73.4 15 7.61 0.62 8.1 7.5 5.7 - 9.5 Beckman ACCESS / 2 / DxI 11 60.73 3.23 5.3 60.6 51.0 - 70.5 11 6.65 0.33 4.9 6.8 5.6 - 7.7 TOSOH ST AIA 12 56.87 4.04 7.1 56.1 44.7 - 69.0 12 7.50 0.51 6.8 7.5 5.9 - 9.1

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Homocysteine (mol/L)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 19 57.3 10.0 17.4 57 27 - 88 19 6.6 1.1 17.0 7 3 - 10

LH (mIU/mL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 45 49.34 8.63 17.5 46.5 23.4 - 75.3 44 2.79 0.43 15.6 2.7 1.4 - 4.1 All Immulite Instruments 11 61.21 5.74 9.4 63.5 43.9 - 78.5 11 3.15 0.31 10.0 3.2 2.2 - 4.1 TOSOH ST AIA 10 48.56 5.58 11.5 46.5 31.8 - 65.4 10 2.95 0.91 30.7 2.6 0.2 - 5.7

Progesterone (ng/mL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 22 36.41 6.61 18.1 38.9 16.5 - 56.3 22 2.75 0.49 17.8 2.7 1.2 - 4.3

Prolactin (ng/mL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 39 17.28 2.21 12.8 17.1 10.6 - 24.0 38 2.66 0.35 13.2 2.7 1.6 - 3.8 All Immulite Instruments 12 16.99 1.41 8.3 16.9 12.7 - 21.3 12 2.48 0.22 9.1 2.5 1.8 - 3.2

Testosterone (ng/dL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 79 1167.9 170.2 14.6 1137 657 - 1679 77 139.6 35.0 25.1 133 34 - 245 Beckman ACCESS / 2 / DxI 19 1011.5 115.3 11.4 1061 665 - 1358 19 105.4 11.0 10.5 105 72 - 139 DPC Immulite/1000 11 1183.4 108.1 9.1 1147 859 - 1508 11 166.7 20.2 12.1 168 106 - 228 TOSOH ST AIA 14 1380.3 125.7 9.1 1375 1003 - 1758 14 134.7 18.4 13.6 136 79 - 190

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Transferrin (mg/dL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 12 277.3 9.6 3.5 277 248 - 307 12 76.7 3.4 4.5 76 66 - 87

Vitamin B12 (pg/mL)

Specimen SC-1 Specimen SC-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 95 1272.5 185.2 14.6 1273 716 - 1828 93 445.2 64.4 14.5 439 252 - 639 Abbott AxSYM 16 1172.9 72.2 6.2 1190 956 - 1390 17 439.4 31.9 7.3 437 343 - 536 Beckman ACCESS / 2 / DxI 35 1212.6 212.5 17.5 1243 575 - 1850 34 414.7 45.1 10.9 420 279 - 550 TOSOH AIA 14 1420.1 157.7 11.1 1460 947 - 1894 14 567.0 64.0 11.3 559 375 - 759

Serum Alcohol (mg/dL)

Specimen ETH-1 Specimen ETH-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 9 72.7 4.1 5.6 73 54 - 91 9 98.0 33.7 34.4 108 73 - 123

Specimen ETH-3 Specimen ETH-4 All Method 9 329.2 30.0 9.1 333 246 - 412 9 1.14 1.35 118.4 1 0 - 3

Specimen ETH-5 All Method 9 138.0 8.9 6.4 139 103 - 173

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Acetone

Specimen ETH-1 Specimen ETH-2

Method Labs Negative Small Moderate Large Labs Negative Small Moderate Large

Bayer Acetest 2 - 2 - - 2 2 - - -

Specimen ETH-3 Specimen ETH-4

Bayer Acetest 2 2 - - - 2 2 - - -

Specimen ETH-5

Bayer Acetest 2 - - 1 1

Urine Drug Screen Alcohol Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 7 7 - 7 7 - Dade Behring EMIT II Plus 2 2 - 2 2 - Microgenics DRI 2 2 - 2 2 - Roche Integra 1 1 - 1 1 - Siemens (Dade) Dimension 1 1 - 1 1 -

Anti-Thyroglobulin Antibody (IU/mL)

Specimen THY-1 Specimen THY-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 14 12.4 9.5 76.6 20 0 - 41 12 2704.5 866.1 32.0 3000 106 - 5303

Anti-Microsomal Antibody (IU/mL)

Specimen THY-1 Specimen THY-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 18 4.9 4.8 98.9 5 0 - 20 18 205.2 71.7 34.9 231 0 - 421

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Acetaminophen

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 7 7 - 7 - 7 BioSite Diagnostics Triage 7 7 - 7 - 7 Amphetamines

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 82 - 82 82 81 1 ACON Laboratories 4 - 4 4 4 - Beckman Synchron 1 - 1 1 1 - BioSite Diagnostics Triage 10 - 10 10 10 - BMC QuickTox Drug Screen 1 - 1 1 1 - Dade Behring EMIT II Plus 4 - 4 4 4 - Innovacon Multi-CLIN Drug Screen 3 - 3 3 3 - Innovacon Multi-Drug One Step 1 - 1 1 1 - Instant Technologies i Cassette 6 - 6 6 6 - Instant Technologies i Screen 4 - 4 4 4 - Instant Technologies iCup 3 - 3 3 2 1 Integrated E-Z Split Key Cup / II 3 - 3 3 3 - MEDTOX Diagnostics 9 - 9 9 9 - Microgenics DRI 5 - 5 5 5 - Noble Medical Inc. 3 - 3 3 3 - Phamatech QuickScreen Pro 12 - 12 12 12 - Roche Integra 1 - 1 1 1 -

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Barbiturates

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 62 - 62 62 - 62 Abbott AxSYM 3 - 3 3 - 3 ACON Laboratories 1 - 1 1 - 1 Beckman Synchron 1 - 1 1 - 1 BioSite Diagnostics Triage 10 - 10 10 - 10 BMC QuickTox Drug Screen 1 - 1 1 - 1 Dade Behring EMIT II Plus 3 - 3 3 - 3 Innovacon Multi-CLIN Drug Screen 2 - 2 2 - 2 Innovacon Multi-Drug One Step 2 - 2 2 - 2 Instant Technologies i Cassette 6 - 6 6 - 6 Instant Technologies i Screen 4 - 4 4 - 4 Instant Technologies iCup 3 - 3 3 - 3 Integrated E-Z Split Key Cup / II 1 - 1 1 - 1 MEDTOX Diagnostics 7 - 7 7 - 7 Microgenics DRI 5 - 5 5 - 5 Noble Medical Inc. 2 - 2 2 - 2 Phamatech QuickScreen Pro 1 - 1 1 - 1 Roche Integra 1 - 1 1 - 1

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Benzodiazepines

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 64 64 - 63 - 63 Abbott AxSYM 3 3 - 3 - 3 ACON Laboratories 1 1 - 1 - 1 Beckman Synchron 1 1 - 1 - 1 BioSite Diagnostics Triage 10 10 - 10 - 10 BMC QuickTox Drug Screen 1 1 - 1 - 1 Dade Behring EMIT II Plus 4 4 - 4 - 4 Innovacon Multi-CLIN Drug Screen 3 3 - 3 - 3 Innovacon Multi-Drug One Step 1 1 - 1 - 1 Instant Technologies i Cassette 6 6 - 6 - 6 Instant Technologies i Screen 4 4 - 4 - 4 Instant Technologies iCup 3 3 - 3 - 3 Integrated E-Z Split Key Cup / II 1 1 - 1 - 1 MEDTOX Diagnostics 7 7 - 7 - 7 Microgenics DRI 5 5 - 5 - 5 Noble Medical Inc. 2 2 - 2 - 2 Phamatech QuickScreen Pro 2 2 - 2 - 2 Roche Integra 1 1 - 1 - 1

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Burprenophrine Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 9 9 - 9 - 9 Dade Behring EMIT II Plus 1 1 - 1 - 1 Integrated E-Z Split Key Cup / II 1 1 - 1 - 1 Microgenics CEDIA 4 4 - 4 - 4 Noble Medical Inc. 1 1 - 1 - 1 Cannabinoids (THC)

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 88 1 87 88 - 88 Abbott AxSYM 3 - 3 3 - 3 ACON Laboratories 4 - 4 4 - 4 Beckman Synchron 1 - 1 1 - 1 BioSite Diagnostics Triage 10 - 10 10 - 10 BMC QuickTox Drug Screen 1 - 1 1 - 1 Dade Behring EMIT II Plus 4 - 4 4 - 4 Innovacon Multi-CLIN Drug Screen 3 - 3 3 - 3 Innovacon Multi-Drug One Step 2 - 2 2 - 2 InstaCheck Drug Screen 1 - 1 1 - 1 Instant Technologies i Cassette 6 - 6 6 - 6 Instant Technologies i Screen 4 - 4 4 - 4 Instant Technologies iCup 3 - 3 3 - 3 Integrated E-Z Split Key Cup / II 4 - 4 4 - 4 MEDTOX Diagnostics 9 1 8 9 - 9 Microgenics DRI 5 - 5 5 - 5 Noble Medical Inc. 3 - 3 3 - 3 Phamatech QuickScreen Pro 12 - 12 12 - 12 Roche Integra 1 - 1 1 - 1

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Cocaine Metabolites

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 90 - 90 90 - 90 Abbott AxSYM 3 - 3 3 - 3 ACON Laboratories 4 - 4 4 - 4 Beckman Synchron 1 - 1 1 - 1 BioSite Diagnostics Triage 10 - 10 10 - 10 BMC QuickTox Drug Screen 1 - 1 1 - 1 Dade Behring EMIT II Plus 4 - 4 4 - 4 Innovacon Multi-CLIN Drug Screen 3 - 3 3 - 3 Innovacon Multi-Drug One Step 2 - 2 2 - 2 InstaCheck Drug Screen 1 - 1 1 - 1 Instant Technologies i Cassette 6 - 6 6 - 6 Instant Technologies i Screen 4 - 4 4 - 4 Instant Technologies iCup 3 - 3 3 - 3 Integrated E-Z Split Key Cup / II 4 - 4 4 - 4 MEDTOX Diagnostics 9 - 9 9 - 9 Microgenics DRI 5 - 5 5 - 5 Noble Medical Inc. 3 - 3 3 - 3 Phamatech QuickScreen Pro 13 - 13 13 - 13 Roche Integra 1 - 1 1 - 1

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MDMA

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 18 - 18 18 18 - Innovacon Multi-CLIN Drug Screen 3 - 3 3 3 - Instant Technologies i Cassette 3 - 3 3 3 - Integrated E-Z Split Key Cup / II 1 - 1 1 1 - MEDTOX Diagnostics 1 - 1 1 1 - Microgenics DRI 4 - 4 4 4 - Noble Medical Inc. 1 - 1 1 1 - Phamatech QuickScreen Pro 1 - 1 1 1 -

Methadone

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 42 1 41 42 - 42 Abbott AxSYM 3 - 3 3 - 3 Beckman Synchron 1 - 1 1 - 1 BioSite Diagnostics Triage 7 - 7 7 - 7 BMC QuickTox Drug Screen 1 - 1 1 - 1 Dade Behring EMIT II Plus 4 1 3 4 - 4 Innovacon Multi-Drug One Step 1 - 1 1 - 1 Instant Technologies i Cassette 1 - 1 1 - 1 Instant Technologies i Screen 4 - 4 4 - 4 Instant Technologies iCup 2 - 2 2 - 2 Integrated E-Z Split Key Cup / II 1 - 1 1 - 1 MEDTOX Diagnostics 5 - 5 5 - 5 Microgenics DRI 5 - 5 5 - 5 Noble Medical Inc. 2 - 2 2 - 2 Roche Integra 1 - 1 1 - 1

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Methamphetamines

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 59 - 59 59 57 2 Abbott AxSYM 3 - 3 3 3 - ACON Laboratories 1 - 1 1 1 - BioSite Diagnostics Triage 10 - 10 10 10 - BMC QuickTox Drug Screen 1 - 1 1 1 - Innovacon Multi-Drug One Step 2 - 2 2 2 - InstaCheck Drug Screen 1 - 1 1 1 - Instant Technologies i Cassette 2 - 2 2 2 - Instant Technologies i Screen 4 - 4 4 4 - Instant Technologies iCup 3 - 3 3 3 - Integrated E-Z Split Key Cup / II 2 - 2 2 2 - MEDTOX Diagnostics 6 - 6 6 6 - Noble Medical Inc. 2 - 2 2 2 - Phamatech QuickScreen Pro 13 - 13 13 12 1

Methaqualone

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 4 3 1 4 - 4 Dade Behring EMIT II Plus 2 2 - 2 - 2 Microgenics DRI 1 1 - 1 - 1

Morphine Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 1 - 1 1 1 - Integrated E-Z Split Key Cup / II 1 - 1 1 1 -

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Opiates Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 89 - 89 89 83 6 Abbott AxSYM 3 - 3 3 3 - ACON Laboratories 4 - 4 4 3 1 Beckman Synchron 1 - 1 1 1 - BioSite Diagnostics Triage 10 - 10 10 10 - BMC QuickTox Drug Screen 1 - 1 1 1 - Dade Behring EMIT II Plus 4 - 4 4 4 - Innovacon Multi-CLIN Drug Screen 3 - 3 3 3 - Innovacon Multi-Drug One Step 2 - 2 2 2 - InstaCheck Drug Screen 1 - 1 1 1 - Instant Technologies i Cassette 6 - 6 6 6 - Instant Technologies i Screen 4 - 4 4 4 - Instant Technologies iCup 2 - 2 2 1 1 Integrated E-Z Split Key Cup / II 3 - 3 3 2 1 MEDTOX Diagnostics 9 - 9 9 9 - Microgenics DRI 5 - 5 5 5 - Noble Medical Inc. 3 - 3 3 3 - Phamatech QuickScreen Pro 13 - 13 13 13 - Roche Integra 1 - 1 1 1 -

Oxycodone

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 33 - 33 33 1 32 Beckman Synchron 1 - 1 1 - 1 BMC QuickTox Drug Screen 1 - 1 1 - 1 Innovacon Multi-CLIN Drug Screen 3 - 3 3 - 3 Innovacon Multi-Drug One Step 1 - 1 1 - 1 Instant Technologies i Cassette 3 - 3 3 - 3 Instant Technologies i Screen 2 - 2 2 - 2 Instant Technologies iCup 1 - 1 1 - 1 Integrated E-Z Split Key Cup / II 1 - 1 1 - 1 MEDTOX Diagnostics 4 - 4 4 1 3 Microgenics DRI 6 - 6 6 - 6 Noble Medical Inc. 2 - 2 2 - 2 Phamatech QuickScreen Pro 1 - 1 1 - 1

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Phencyclidine (PCP)

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 65 64 1 65 - 65 Abbott AxSYM 1 1 - 1 - 1 ACON Laboratories 4 4 - 4 - 4 Beckman Synchron 1 1 - 1 - 1 BioSite Diagnostics Triage 10 10 - 10 - 10 Dade Behring EMIT II Plus 3 2 1 3 - 3 Innovacon Multi-CLIN Drug Screen 3 3 - 3 - 3 Innovacon Multi-Drug One Step 2 2 - 2 - 2 InstaCheck Drug Screen 1 1 - 1 - 1 Instant Technologies i Cassette 6 6 - 6 - 6 Instant Technologies i Screen 4 4 - 4 - 4 Instant Technologies iCup 1 1 - 1 - 1 Integrated E-Z Split Key Cup / II 3 3 - 3 - 3 MEDTOX Diagnostics 7 7 - 7 - 7 Microgenics DRI 4 4 - 4 - 4 Noble Medical Inc. 3 3 - 3 - 3 Phamatech QuickScreen Pro 1 1 - 1 - 1 Roche Integra 1 1 - 1 - 1

Propoxyphene

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 29 - 29 29 29 - Beckman Synchron 1 - 1 1 1 - Dade Behring EMIT II Plus 3 - 3 3 3 - Innovacon Multi-CLIN Drug Screen 3 - 3 3 3 - Instant Technologies i Cassette 4 - 4 4 4 - Instant Technologies iCup 1 - 1 1 1 - Integrated E-Z Split Key Cup / II 1 - 1 1 1 - MEDTOX Diagnostics 3 - 3 3 3 - Microgenics DRI 4 - 4 4 4 - Noble Medical Inc. 3 - 3 3 3 - Roche Integra 1 - 1 1 1 -

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Tricyclic Antidepressants

Specimen UDS-1 Specimen UDS-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 24 24 - 24 - 24 BioSite Diagnostics Triage 7 7 - 7 - 7 Innovacon Multi-CLIN Drug Screen 3 3 - 3 - 3 Instant Technologies i Cassette 3 3 - 3 - 3 Instant Technologies i Screen 4 4 - 4 - 4 MEDTOX Diagnostics 4 4 - 4 - 4

Ammonia (µmol/L)

Specimen AMM-1 Specimen AMM-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 3 - - - 169 Not graded 3 - - - 207 Not graded

Whole Blood Glucose (mg/dL)

Specimen WBG-1 Specimen WBG-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 447 181.0 30.9 17.0 172 88 - 274 450 85.5 14.6 17.1 84 41 - 130 Abbott FreeStyle Lite 14 191.2 16.8 8.8 196 140 - 242 14 92.6 3.7 3.9 93 81 - 104 Bayer Contour 80 163.2 29.3 18.0 150 75 - 252 80 74.8 7.7 10.4 71 51 - 99 HemoCue 201 24 190.7 5.6 2.9 191 173 - 208 24 113.8 5.4 4.7 115 97 - 130 Lifescan One Touch Ultra/2/Mini 61 203.9 9.9 4.9 204 174 - 234 60 92.8 5.8 6.2 93 75 - 111 Lifescan Surestep 14 233.0 31.8 13.7 229 137 - 329 14 105.9 6.3 5.9 106 87 - 125 LifeScan SureStep Flex 17 240.6 24.9 10.4 232 165 - 316 18 104.2 4.9 4.7 106 89 - 119 Medisense Precis. Xtra/Optium 12 207.7 18.7 9.0 202 151 - 264 12 101.9 7.2 7.1 102 80 - 124 Other Waived Method 11 266.0 18.3 6.9 272 210 - 322 11 102.0 7.6 7.5 101 79 - 125 Roche Accu-Chek Advantage/Comp/GTS 84 162.1 7.8 4.8 162 138 - 186 85 74.4 4.6 6.2 75 60 - 89 Roche Accu-Chek Aviva 33 169.8 4.7 2.8 170 155 - 185 33 82.3 4.0 4.9 83 70 - 95 Roche Accu-Chek Inform 50 159.4 8.5 5.3 160 134 - 185 50 71.9 3.7 5.1 72 60 - 83

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Whole Blood Glucose (mg/dL)

Specimen WBG-3 Specimen WBG-4 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 39 49.1 5.5 11.1 50 32 - 66 40 246.1 34.1 13.9 252 143 - 349 Bayer Contour 6 - - - 43 32 - 66 6 - - - 195 143 - 349 Lifescan One Touch Ultra/2/Mini 20 50.5 3.7 7.4 51 39 - 62 20 266.1 14.5 5.4 264 222 - 310 Medisense Precis. Xtra/Optium 1 - - - 63 32 - 66 1 - - - 278 143 - 349 Roche Accu-Chek Advantage/Comp/GTS 6 - - - 44 32 - 66 6 - - - 215 143 - 349 Roche Accu-Chek Aviva 4 - - - 55 32 - 66 4 - - - 230 143 - 349

Specimen WBG-5

All Method 40 151.2 20.9 13.8 161 88 - 214 Bayer Contour 6 - - - 123 88 - 214 Lifescan One Touch Ultra/2/Mini 20 166.1 6.7 4.0 165 145 - 187 Medisense Precis. Xtra/Optium 1 - - - 174 88 - 214 Roche Accu-Chek Advantage/Comp/GTS 6 - - - 129 88 - 214

Roche Accu-Chek Aviva 4 - - - 146 88 - 214

Fructosamine (mmol/L)

Specimen FR-1 Specimen FR-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 6 2.480 0.349 14.1 2.60 1.43 - 3.53 6 1.062 0.159 15.0 1.10 0.58 - 1.54

Fructosamine (mol/L)

Specimen FR-1 Specimen FR-2 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 10 1048.7 540.6 51.5 957 0 - 2671 10 512.5 234.6 45.8 416 0 - 1217

Roche Integra 5 816.8 237.6 29.1 888 104 - 1530 5 512.0 236.2 46.1 415 0 - 1221

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Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700

Washington, DC 20001-7401

800-338-2746 202-261-4500 Fax: 202-835-0440

www.acponline.org/mle

Blood Oximetry - Carboxyhemoglobin (percent) One participant reported results for Carboxyhemoglobin. The vendor mean assay values for specimens CX-1 through CX-5 are: 35.7 percent, 4.8 percent, 8.3 percent, 6.5 percent, and 29.2 percent, respectively.

Blood Oximetry – Hemoglobin, Total (g/dL)

One participant reported results for Hemoglobin, Total. The vendor mean assay values for specimens CX-1 through CX-5 are: 12.8 g/dL , 12.0

g/dL , 12.1 g/dL , 12.7 g/dL , and 12.4 g/dL , respectively.

Blood Oximetry - Oxyhemoglobin (percent) One participant reported results for Oxyhemoglobin. The vendor mean assay values for specimens CX-1 through CX-5 are: 56.1 percent, 91.3 percent, 87.9 percent, 81.8 percent, and 61.7 percent, respectively.

Blood Oximetry - Methemoglobin (percent) One participant reported results for Methemoglobin. The vendor mean assay values for specimens CX-1 through CX-5 are: 8.0 percent, 3.6 percent, 3.6 percent, 11.5 percent, and 8.8 percent, respectively.