New TRACEABILITY and UNCERTAINTY · 2018. 5. 14. · 0.0970 mg/dL mmol/L BUN Blood urea nitrogen...

TRACEABILITY and UNCERTAINTY Hitachi - Precinorm® U plus

Cat. No. 12 149 435 122

Roche Diagnostics GmbH October 2017

Routine Method

Roche/Hitachi SystemsACN Reference Method Reference Material

Selected Measurement

ProcedureAssigned Value Uncertainty 1 Unit

ACPAcid phosphatase total1-naphthyl phosphate

021Roche reagent, manual measurement

20.10.336

0.4910.00820

U/Lµkat/L

NPPAcid phosphatase, non-prostatic1-naphthyl phosphate(Inhib.:tartrate)


10.90.182

0.3200.00534

U/Lµkat/L

ACP-PAcid phosphatise, prostatic1-naphthyl phosphate(Inhib.:tartrate)

028 calculated9.200.154

0.5860.00979

U/Lµkat/L

ALBAlbumin BCG plus

413 ERM-DA470k/IFCC6 5.04

50.40.04740.474

g/dLg/L

ALBAlbumin BCP

760 ERM-DA470k/IFCC6 3.74

37.40.05060.506

g/dLg/L

ALPAlkaline phosphataseIFCC liquid

158Original formulation IFCC

5

(Tietz, 1983), manual measurement

74.8 0.455 U/L

ALPAlkaline phosphataseIFCC liquid


5

(Schumann, 2011), manual measurement

93.9 0.926 U/L

ALPAlkaline phosphataseopt. (DGKC)


151 1.56 U/L

ALTAlanine aminotransferaseIFCC with pyridoxal phosphate


5

(2002), manual measurement37.80.631

0.8090.0135

U/Lµkat/L

ALTAlanine aminotransferaseIFCC without pyridoxal phosphate


5

(2002) modified, manual measurement

37.80.631

0.8090.0135

U/Lµkat/L

ALTAlanine aminotransferaseIFCC without pyridoxal phosphate HiCo


5


37.80.631

0.8090.0135

U/Lµkat/L


Cat. No. 12 149 435 122


Routine Method




AMY-LAmylase alphaIFCC liquid

570Roche reagent according to IFCC

5 (1998), manual

measurement

76.31.27

0.7880.0132

U/Lµkat/L

AMY-LAmylase alphaIFCC liquid STAT

566Roche reagent according to IFCC

5 (1998), manual

measurement

76.31.27

0.7880.0132

U/Lµkat/L

P-AMYAmylase alpha pancreaticEPS liquid


36.10.603

0.3720.00621

U/Lµkat/L

ASTAspartate aminotransferaseIFCC with pyridoxal phosphate


5


0.5680.00949

U/Lµkat/L

ASTAspartate aminotransferaseIFCC without pyridoxal phosphate


5


38.50.643

0.5680.00949

U/Lµkat/L

BILD2Bilirubin direkt Diazo Gen. 2Jendrassik-Grof


0.79013.5

0.005060.0865

mg/dLµmol/L

BILD2Bilirubin direkt Diazo Gen. 2Doumas


0.67211.5

0.004300.0735

mg/dLµmol/L

BILT3 Bilirubin total Gen. 3

712 acc. to Doumas1.0217.4

0.01660.284

mg/dLµmol/L

BUN Blood urea nitrogenkinetic UV

421 ID-MS4 18.36.53

0.2720.0970

mg/dLmmol/L

BUN Blood urea nitrogenkinetic UV STAT

427 ID-MS4 18.36.53

0.2720.0970

mg/dLmmol/L

CaCalcium o-cresolphthaleine complexone

726 / 298

SRM 956c L33 2.088.34

0.02700.108

mmol/Lmg/dL


Cat. No. 12 149 435 122


Routine Method




CaCalcium o-cresolphthaleine complexone STAT

706 / 749

SRM 956c L33 2.088.34

0.02700.108

mmol/Lmg/dL

Ca2Calcium 5-Nitro-5’-methyl-BAPTA Gen. 2

698 SRM 956c L23 2.128.50

0.02580.103

mmol/Lmg/dL

Ca2Calcium 5-Nitro-5’-methyl-BAPTA Gen. 2 STAT

699 SRM 956c L23 2.128.50

0.02580.103

mmol/Lmg/dL

CHECholinesterase acethylthiocholine


272045.4

25.70.429

U/Lµkat/L

CHECholinesterase butyrylthiocholine Gen.2


499083.3

46.00.768

U/Lµkat/L

CHOLCholesterolCHOD-PAP stand. ID/MS

433 ID-MS4 2.00 0.01767

mmol/L

CHOLCholesterolCHOD-PAP stand. Abell-Kendall

433 Abell-Kendall 2.03 0.01797

mmol/L

CKCreatine kinase IFCC liquid


5

(2002), manual measurement1522.54

1.370.0229

U/Lµkat/L

CO2-LBicarbonate kinetic liquid

452 /156

Primary reference material (aqueous volumetric standards prepared with pure Sodium Carbonate (ACS))

15.7 0.319 mmol/L

CREACreatinineplus

652 ID-MS4 0.98387.0

0.02462.18

mg/dLµmol/L

CREACreatinine Jaffé compensated STAT

773 ID-MS4 0.93582.7

0.02462.18

mg/dLµmol/L


Cat. No. 12 149 435 122


Routine Method




CREACreatinine Jaffé rate-blanked and compensated

690 ID-MS4 1.1097.5

0.02011.78

mg/dLµmol/L

FeIron Ferro Zine

661 SRM 9373 19.4108

0.2731.53

µmol/Lµg/dL

GGTGlutamyltransferase gammaliquid stand. IFCC HiCo


5


0.6680.0112

U/Lµkat/L

GGTGlutamyltransferase gammaliquid stand. IFCC


5


0.6680.0112

U/Lµkat/L

GGTGlutamyltransferase gammaliquid stand. Szasz HiCo

480Original formulation Persijn/v.d. Slik (1976), manual measurement

35.70.596

0.5350.00893

U/Lµkat/L

GGTGlutamyltransferase gammaliquid stand. Szasz

479Original formulation Persijn/v.d. Slik (1976), manual measurement

35.70.596

0.5350.00893

U/Lµkat/L

GLDHGlutamate dehydrogenaseopt. (DGKC)


22.60.377

0.3740.00625

U/Lµkat/L

GLUGlucose HK

668 ID-MS4 82.24.56

0.6540.0363

mg/dLmmol/L

GLUH2Glucose HK hemolysate Gen. 2

409 ID-MS4 82.24.56

0.6540.0363

mg/dLmmol/L

GLUGlucoseHK STAT

767 ID-MS4 82.24.56

0.6540.0363

mg/dLmmol/L

GLUGlucose GOD-PAP

525 ID-MS4 82.24.56

0.6540.0363

mg/dLmmol/L


Cat. No. 12 149 435 122


Routine Method




HBDHHydroxybutyrate dehydrogenase alphaopt. (DGKC)


1402.34

1.320.0220

U/Lµkat/L

LACLactateenzymatic colorimetric test

040Primary reference material (weighed in purified material)

14.91.65

0.1310.0145

mg/dLmmol/L

LDH Lactate dehydrogenase IFCC liquid


5

(2002), manual measurement1572.62

2.250.0376

U/Lµkat/L

LDH Lactate dehydrogenaseIFCC liquid with automatic sample pre-dilution


1572.62

2.250.0376

U/Lµkat/L

LDH Lactate dehydrogenaseopt. (DGKC)


3005.01

3.240.0541

U/Lµkat/L

LIPLipase enzymatic colorimetric test


51.60.862

0.5550.00927

U/Lµkat/L

LIPLipase enzymatic colorimetric test STAT


51.60.862

0.5550.00927

U/Lµkat/L

MGMagnesium xylidyl blue method

693 Atomic absorption0.8001.94

0.006120.0149

mmol/Lmg/dL

MGMagnesium xylidyl blue method STAT

770 Atomic absorption0.8001.94

0.006120.0149

mmol/Lmg/dL

PHOSPhosphate (inorganic) molybdate UV

714Primary reference material (NERL) (weighed in purified material)

1.063.29

0.01050.0326

mmol/Lmg/dL

PHOSPhosphate (inorganic) molybdate UV STAT

675Primary reference material (NERL) (weighed in purified material)

1.063.29

0.01050.0326

mmol/Lmg/dL


Cat. No. 12 149 435 122


Routine Method




TGTriglyceridesGPO-PAP

781 ID-MS4 1.30 0.0143 mmol/L

TGTriglycerides GPO-PAP GB

783 SRM 909b 338.30.433

0.6810.00770

mg/dLmmol/L

TPTotal proteinBiuret

678 SRM 927d 35.6956.9

0.02950.295

g/dLg/L

TPTotal proteinBiuret STAT

679 SRM 927d 35.6956.9

0.02950.295

g/dLg/L

UAUric acidplus

700 ID-MS4 4.72281

0.02281.36

mg/dLµmol/L

UIBCUnsaturated iron-binding capacityFerroZine

785Primary reference material (iron) (weighed in purified material)

21.3119

0.6013.36

µmol/Lµg/dL

UREAUrea kinetiv UV

418 ID-MS4 39.26.53

0.5830.0970

mg/dLmmol/L

UREAUrea kinetiv UV STAT

419 ID-MS4 39.26.53

0.5830.0970

mg/dLmmol/L

1 This uncertainty (expanded uncertainty; k = 2) was calculated in accordance with the “Guide to the expression of uncertainty in measurement” (GUM: 1993). For the estimation of the single standard uncertainties normal distribution of the measurement results is assumed; the level of confidence of the expanded uncertainty is about 95% with the coverage factor k=2 (analogue to the 2sd of the standard uncertainty).

2 CRM = Certified Reference Material, European3 SRM = Standard Reference Material4 ID-MS =Isotope Dilution - Mass Spectrometry5 IFCC = International Federationof clinical chemistry and laboratory medicine6 ERM = European Reference Materials


Cat. No. 12 149 435 122


7 The value describes the uncertainty within a system class. By transferring the setpoint from one system class to another an additional systematic deviation can arise. This deviation is limited by the instrument to instrument specification. The relative maximum deviation is 5%, resp. Chol IDMS/AK 0.1 mmol/L.

New TRACEABILITY and UNCERTAINTY · 2018. 5. 14. · 0.0970 mg/dL mmol/L BUN Blood urea nitrogen...

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