ACE Axcel™ Performance Characteristics 14 Henderson Drive, West Caldwell, NJ 07006 Phone:...
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4 Henderson Drive, West Caldwell, NJ 07006 Phone: 800-220-4488 Fax: 973-276-0383 Website: www.AlfaWassermannUS.com Email: [email protected] ACE Axcel™ Performance Characteristics 1 SA2001 SA2001 SA2002 SA2002 SA1046 SA1046 SA1004 SA1004 SA1047 SA1047 SA1007 SA1007 SA1008 SA1008 SA2024 SA2024 SA1009 SA1009 SA1010 SA1010 SA2011 SA2011 SA2039 SA2039 SA1012 SA1012 ACI-32 ACI-35 SA2013 SA2013 SA1014 SA1014 SA2038 SA2038 SA1044 SA2016 SA2016 SA1017 SA3018 SA1040 SA1040 SA1045 SA1045 SA1019 SA2019 SA3007 SA3007 SA1022 SA1023 SA1023 serum plasma serum plasma serum plasma serum plasma serum plasma serum plasma serum plasma serum plasma serum plasma serum plasma serum plasma serum plasma serum plasma serum serum serum plasma serum plasma serum plasma whole blood serum plasma serum serum serum plasma serum plasma serum plasma serum plasma serum plasma serum Albumin Albumin Alkaline Phosphatase Alkaline Phosphatase ALT ALT Amylase Amylase AST AST Bilirubin, Direct Bilirubin, Direct Bilirubin, Total Bilirubin, Total BUN BUN Calcium Calcium Cholesterol Cholesterol CK CK CO2-LC CO2-LC Creatinine Creatinine Direct TIBC Ferritin Gamma-GT Gamma-GT Glucose Glucose HDL-C HDL-C Hemoglobin A1c Inorganic Phosphorus Inorganic Phosphorus Total Iron LDH LDL-C LDL-C Lipase Lipase Magnesium Magnesium Total Thyroxine T4 Total Thyroxine T4 Total Protein Total Protein Triglycerides g/dL g/dL U/L U/L U/L U/L U/L U/L U/L U/L mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL U/L U/L mEq/L mEq/L mg/dL mg/dL μg/dL ng/mL U/L U/L mg/dL mg/dL mg/dL mg/dL % mg/dL mg/dL μg/dL U/L mg/dL mg/dL U/L U/L mg/dL mg/dL μg/dL μg/dL g/dL g/dL mg/dL Within-Run Precision%CV 2 ≤1.7 ≤1.6 ≤3.2 ≤1.5 ≤6.9 ≤2.9 ≤3.4 ≤2.5 ≤7.1 ≤3.5 ≤16.5 ≤2.4 ≤10.6 ≤0.5 ≤3.3 ≤6.3 ≤2.3 ≤1.2 ≤2.0 ≤1.8 ≤5.2 ≤2.8 ≤6.9 ≤1.3 ≤9.6 ≤6.6 ≤2.2 ≤4.3 ≤3.0 ≤2.0 ≤1.4 ≤1.5 ≤2.7 ≤2.6 ≤2.3 ≤1.9 ≤5.0 ≤5.2 ≤3.1 ≤4.6 ≤2.6 ≤6.5 ≤5.5 ≤6.7 ≤2.8 ≤4.8 ≤3.4 ≤2.4 ≤0.8 ≤2.9 Reportable Range 3 0.3-7.0 g/dL 0.3-7.0 g/dL 9-1400 U/L 9-1400 U/L 4 - 480 U/L 4 - 480 U/L 9-1900 U/L 9-1900 U/L 4-450 U/L 4-450 U/L 0.1-14.0 mg/dL 0.1-14.0 mg/dL 0.2-40.0 mg/dL 0.2-40.0 mg/dL 3-100 mg/dL 3-100 mg/dL 0.4-15.0 mg/dL 0.4-15.0 mg/dL 6-600 mg/dL 6-600 mg/dL 11-1350 U/L 11-1350 U/L 4.0-50.0 mEq/L 4.0-50.0 mEq/L 0.33-25.00 mg/dL 0.33-25.00 mg/dL 52-700 μg/dL 11-860 ng/mL 7-950 U/L 7-950 U/L 4-750 mg/dL 4-750 mg/dL 8-125 mg/dL 8-125 mg/dL 4.2-13.0% 0.4-20.0 mg/dL 0.4-20.0 mg/dL 12-600 μg/dL 18-850 U/L 4-430 mg/dL 4-430 mg/dL 15-700 U/L 15-700 U/L 0.4-6.0 mg/dL 0.4-6.1 mg/dL 1.3-19.6 μg/dL 1.3-19.6 μg/dL 0.4-14.0 g/dL 0.4-14.0 g/dL 16-1000 mg/dL Reportable Range Tolerance Limits 4 ± 5% or 0.5 g/dL ± 5% or 0.5 g/dL ± 10% or 10 U/L ± 10% or 10 U/L ± 7% or 10 U/L ± 7% or 10 U/L ± 10% or 10 U/L ± 10% or 10 U/L ± 7% or 10 U/L ± 7% or 10 U/L ± 10% or 0.2 mg/dL ± 10% or 0.2 mg/dL ± 9% or 0.3 mg/dL ± 9% or 0.3 mg/dL ± 5% or 3 mg/dL ± 5% or 3 mg/dL ± 5% or 0.4 mg/dL ± 5% or 0.4 mg/dL ± 4% or 6 mg/dL ± 4% or 6 mg/dL ± 10% or 10 U/L ± 10% or 10 U/L ± 10% or 4 mEq/L ± 10% or 4 mEq/L ± 5% or 0.1 mg/dL ± 5% or 0.1 mg/dL ± 8% or 11 μg/dL ± 12% or 15 ng/mL ± 7% or 5 U/L ± 7% or 5 U/L ± 5% or 6 mg/dL ± 5% or 6 mg/dL ± 10% or 3 mg/dL ±10% or 3 mg/dL ± 5% or 1% HbA1c ± 10% or 0.4 mg/dL ± 10% or 0.4 mg/dL ± 7% or 30 μg/dL ± 10% or 10 U/L ± 10% or 3 mg/dL ± 10% or 3 mg/dL ± 10% or 15 U/L ± 10% or 15 U/L ± 8% or 0.5 mg/dL ± 8% or 0.5 mg/dL ± 20% or 1.0 μg/dL ± 20% or 1.0 μg/dL ± 7% or 0.2 g/dL ± 7% or 0.2 g/dL ± 8% or 7 mg/dL Accuracy 5 : y = mx + b 0.996x + 0.03 0.956x + 0.20 0.983x + 0.6 1.017x - 6.5 1.041x + 0.3 0.985x - 3.4 0.958x + 0.7 0.994x - 1.8 1.007x + 2.3 1.001x + 0.2 0.972x + 0.00 1.004x + 0.00 0.966x + 0.01 1.008x + 0.00 1.012x + 0.2 1.007x + 0.3 1.020x - 0.29 0.978x + 0.33 1.012x - 3.3 0.987x - 1.9 1.016x - 0.1 1.006x - 0.5 0.984x - 0.18 0.988x - 0.35 0.979x - 0.006 1.003x + 0.009 0.979x - 2.5 1.015x - 1.1 0.984x + 0.1 0.987x + 4.0 1.005x - 0.7 1.003x - 6.6 0.972x + 0.5 1.011x - 1.1 1.012x + 0.10 1.005x - 0.01 0.999x + 0.04 1.006x - 1.8 1.046x + 4.9 0.982x - 1.0 1.006x - 1.6 0.982x + 3.97 0.980x - 2.0 1.046x - 0.18 0.986x + 0.025 1.014x - 0.01 1.007x + 0.01 0.990x - 0.03 0.994x + 0.34 1.014x - 0.01 Total Precision%CV 2 ≤ 2.0 ≤ 1.6 ≤4.4 ≤5.1 ≤6.9 ≤4.1 ≤3.6 ≤6.0 ≤8.5 ≤4.0 ≤16.6 ≤2.4 ≤10.6 ≤0.5 ≤4.6 ≤6.3 ≤2.3 ≤1.4 ≤2.2 ≤2.1 ≤5.5 ≤5.5 ≤7.4 ≤5.0 ≤9.8 ≤9.3 ≤3.3 ≤6.8 ≤6.1 ≤2.4 ≤1.9 ≤0.6 ≤4.8 ≤3.1 ≤3.0 ≤2.5 ≤6.1 ≤5.4 ≤4.6 ≤4.9 ≤2.6 ≤10.7 ≤6.4 ≤7.5 ≤6.8 ≤4.8 ≤5.4 ≤2.9 ≤1.4 ≤3.2 Catalog # Assay Sample Type Units
Transcript of ACE Axcel™ Performance Characteristics 14 Henderson Drive, West Caldwell, NJ 07006 Phone:...
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4 Henderson Drive, West Caldwell, NJ 07006 Phone: 800-220-4488 Fax: 973-276-0383 Website: www.AlfaWassermannUS.com Email: [email protected]
ACE Axcel™ Performance Characteristics1
SA2001SA2001SA2002SA2002SA1046SA1046SA1004SA1004SA1047SA1047SA1007SA1007SA1008SA1008SA2024SA2024 SA1009SA1009SA1010SA1010SA2011SA2011SA2039SA2039SA1012SA1012ACI-32ACI-35SA2013SA2013SA1014SA1014SA2038SA2038SA1044SA2016SA2016SA1017SA3018SA1040SA1040SA1045SA1045SA1019SA2019SA3007SA3007SA1022SA1023SA1023
serumplasmaserum
plasmaserum
plasmaserum
plasmaserum
plasmaserum
plasmaserum
plasmaserum
plasmaserum
plasmaserum
plasmaserum
plasmaserum
plasmaserum
plasmaserumserumserum
plasmaserum
plasmaserum
plasmawhole blood
serumplasmaserumserumserum
plasmaserum
plasmaserum
plasmaserum
plasmaserum
plasmaserum
AlbuminAlbumin
Alkaline PhosphataseAlkaline Phosphatase
ALTALT
AmylaseAmylase
ASTAST
Bilirubin, DirectBilirubin, Direct Bilirubin, TotalBilirubin, Total
BUNBUN
CalciumCalcium
CholesterolCholesterol
CKCK
CO2-LCCO2-LC
CreatinineCreatinine Direct TIBC
FerritinGamma-GTGamma-GT
GlucoseGlucose
HDL-CHDL-C
Hemoglobin A1cInorganic PhosphorusInorganic Phosphorus
Total IronLDH
LDL-CLDL-CLipaseLipase
MagnesiumMagnesium
Total Thyroxine T4Total Thyroxine T4
Total ProteinTotal Protein Triglycerides
g/dLg/dLU/LU/LU/LU/LU/LU/LU/LU/L
mg/dLmg/dLmg/dLmg/dLmg/dLmg/dLmg/dLmg/dLmg/dLmg/dL
U/LU/L
mEq/LmEq/Lmg/dLmg/dLμg/dLng/mL
U/LU/L
mg/dLmg/dLmg/dLmg/dL
%mg/dLmg/dLμg/dL
U/Lmg/dLmg/dL
U/LU/L
mg/dLmg/dLμg/dLμg/dLg/dLg/dL
mg/dL
Within-RunPrecision%CV2
≤1.7≤1.6≤3.2≤1.5≤6.9≤2.9≤3.4≤2.5≤7.1≤3.5≤16.5≤2.4≤10.6≤0.5≤3.3≤6.3≤2.3≤1.2≤2.0≤1.8≤5.2≤2.8≤6.9≤1.3≤9.6≤6.6≤2.2≤4.3≤3.0≤2.0≤1.4≤1.5≤2.7≤2.6≤2.3≤1.9≤5.0≤5.2≤3.1≤4.6≤2.6≤6.5≤5.5≤6.7≤2.8≤4.8≤3.4≤2.4≤0.8≤2.9
ReportableRange3
0.3-7.0 g/dL0.3-7.0 g/dL9-1400 U/L9-1400 U/L4 - 480 U/L4 - 480 U/L9-1900 U/L9-1900 U/L4-450 U/L4-450 U/L
0.1-14.0 mg/dL0.1-14.0 mg/dL0.2-40.0 mg/dL0.2-40.0 mg/dL
3-100 mg/dL3-100 mg/dL
0.4-15.0 mg/dL0.4-15.0 mg/dL
6-600 mg/dL6-600 mg/dL11-1350 U/L11-1350 U/L
4.0-50.0 mEq/L4.0-50.0 mEq/L
0.33-25.00 mg/dL0.33-25.00 mg/dL
52-700 μg/dL11-860 ng/mL
7-950 U/L7-950 U/L
4-750 mg/dL4-750 mg/dL8-125 mg/dL8-125 mg/dL
4.2-13.0%0.4-20.0 mg/dL0.4-20.0 mg/dL12-600 μg/dL
18-850 U/L4-430 mg/dL4-430 mg/dL15-700 U/L15-700 U/L
0.4-6.0 mg/dL0.4-6.1 mg/dL1.3-19.6 μg/dL1.3-19.6 μg/dL0.4-14.0 g/dL0.4-14.0 g/dL
16-1000 mg/dL
Reportable RangeTolerance Limits4
± 5% or 0.5 g/dL± 5% or 0.5 g/dL± 10% or 10 U/L± 10% or 10 U/L± 7% or 10 U/L± 7% or 10 U/L± 10% or 10 U/L± 10% or 10 U/L± 7% or 10 U/L± 7% or 10 U/L
± 10% or 0.2 mg/dL± 10% or 0.2 mg/dL± 9% or 0.3 mg/dL± 9% or 0.3 mg/dL± 5% or 3 mg/dL± 5% or 3 mg/dL
± 5% or 0.4 mg/dL± 5% or 0.4 mg/dL± 4% or 6 mg/dL± 4% or 6 mg/dL± 10% or 10 U/L± 10% or 10 U/L
± 10% or 4 mEq/L± 10% or 4 mEq/L± 5% or 0.1 mg/dL± 5% or 0.1 mg/dL± 8% or 11 μg/dL
± 12% or 15 ng/mL± 7% or 5 U/L± 7% or 5 U/L
± 5% or 6 mg/dL± 5% or 6 mg/dL± 10% or 3 mg/dL±10% or 3 mg/dL
± 5% or 1% HbA1c± 10% or 0.4 mg/dL± 10% or 0.4 mg/dL
± 7% or 30 μg/dL± 10% or 10 U/L
± 10% or 3 mg/dL± 10% or 3 mg/dL± 10% or 15 U/L± 10% or 15 U/L
± 8% or 0.5 mg/dL± 8% or 0.5 mg/dL± 20% or 1.0 μg/dL± 20% or 1.0 μg/dL
± 7% or 0.2 g/dL± 7% or 0.2 g/dL± 8% or 7 mg/dL
Accuracy5:y = mx + b0.996x + 0.030.956x + 0.200.983x + 0.61.017x - 6.51.041x + 0.30.985x - 3.40.958x + 0.70.994x - 1.81.007x + 2.31.001x + 0.2
0.972x + 0.001.004x + 0.000.966x + 0.011.008x + 0.001.012x + 0.21.007x + 0.31.020x - 0.290.978x + 0.331.012x - 3.30.987x - 1.91.016x - 0.11.006x - 0.5
0.984x - 0.180.988x - 0.35
0.979x - 0.0061.003x + 0.009
0.979x - 2.51.015x - 1.10.984x + 0.10.987x + 4.01.005x - 0.71.003x - 6.60.972x + 0.51.011x - 1.1
1.012x + 0.101.005x - 0.010.999x + 0.041.006x - 1.81.046x + 4.90.982x - 1.01.006x - 1.6
0.982x + 3.970.980x - 2.0
1.046x - 0.180.986x + 0.0251.014x - 0.011.007x + 0.010.990x - 0.030.994x + 0.341.014x - 0.01
TotalPrecision%CV2
≤ 2.0≤ 1.6≤4.4≤5.1≤6.9≤4.1≤3.6≤6.0≤8.5≤4.0≤16.6≤2.4≤10.6≤0.5≤4.6≤6.3≤2.3≤1.4≤2.2≤2.1≤5.5≤5.5≤7.4≤5.0≤9.8≤9.3≤3.3≤6.8≤6.1≤2.4≤1.9≤0.6≤4.8≤3.1≤3.0≤2.5≤6.1≤5.4≤4.6≤4.9≤2.6≤10.7≤6.4≤7.5≤6.8≤4.8≤5.4≤2.9≤1.4≤3.2
Catalog # Assay Sample Type Units
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4 Henderson Drive, West Caldwell, NJ 07006 Phone: 800-220-4488 Fax: 973-276-0383 Website: www.AlfaWassermannUS.com Email: [email protected]
SA1023SA1025SA1025
ISEISEISEISEISEISE
plasmaserum
plasmaserum
plasmaserum
plasmaserum
plasma
Triglycerides Uric AcidUric AcidSodiumSodium
PotassiumPotassium ChlorideChloride
mg/dLmg/dLmg/dLmmol/Lmmol/Lmmol/Lmmol/Lmmol/Lmmol/L
Within-RunPrecision%CV2
≤1.2≤4.9≤2.8≤1.0≤0.5≤3.5≤1.1≤1.0≤0.5
ReportableRange3
16-1000 mg/dL1.5-16.0 mg/dL1.5-16.0 mg/dL40-205 mmol/L40-205 mmol/L1.5-15.0 mmol/L1.5-15.0 mmol/L50-200 mmol/L50-200 mmol/L
Reportable RangeTolerance Limits4
± 8% or 7 mg/dL± 8% or 0.9 mg/dL± 8% or 0.9 mg/dL± 3% or 4 mmol/L± 3% or 4 mmol/L
± 0.5 mmol/L± 0.5 mmol/L
± 4% or 4 mmol/L± 4% or 4 mmol/L
Accuracy5:y = mx + b1.007x + 0.011.042x - 0.061.025x - 0.091.008x - 1.341.005x - 2.13
1.002x + 0.0221.024x -0.0960.970x + 2.281.000x - 0.69
TotalPrecision%CV2
≤3.2≤5.4≤4.5≤1.4≤1.2≤3.5≤1.8≤1.5≤1.4
ACE Axcel™ Performance Characteristics1
1 Representative expected performance. See method specific package insert for details.2 Reference: CLSI, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition CLSI document EP5-A2. CLSI, 940 West Valley Road, Suite 100, Wayne, PA 19087-1898, USA, 2004. (Precision study conducted over 20 days)3 Represents the undiluted sample reportable range. NOTE: For expected values, refer to method specific package insert. IT IS RECOMMENDED THAT EACH LABORATORY DETERMINE THE EXPECTED VALUES FOR ITS PARTICULAR POPULATION.4 Reportable range tolerance limits represent the value expected ± the greater of the two criteria (% or units). These limits may be used when verifying the reportable range.5 Expressed as correlation with ACE® Clinical Chemistry System; plasma correlation vs. serum
* Typical range; actual range is the value of the low and high calibrators.
SM466 Rev 5 1014
Catalog # Assay Sample Type Units
SM466 ACE Axcel Performance Characteristics Rev 5_pg1SM466 ACE Axcel Performance Characteristics Rev 5_pg2
