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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)
022Roche reagent, manual measurement
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
158Original formulation IFCC
5
(Schumann, 2011), manual measurement
93.9 0.926 U/L
ALPAlkaline phosphataseopt. (DGKC)
683Roche reagent, manual measurement
151 1.56 U/L
ALTAlanine aminotransferaseIFCC with pyridoxal phosphate
684Original formulation IFCC
5
(2002), manual measurement37.80.631
0.8090.0135
U/Lµkat/L
ALTAlanine aminotransferaseIFCC without pyridoxal phosphate
685Original formulation IFCC
5
(2002) modified, manual measurement
37.80.631
0.8090.0135
U/Lµkat/L
ALTAlanine aminotransferaseIFCC without pyridoxal phosphate HiCo
176Original formulation IFCC
5
(2002) modified, manual measurement
37.80.631
0.8090.0135
U/Lµkat/L
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
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
571Roche reagent, manual measurement
36.10.603
0.3720.00621
U/Lµkat/L
ASTAspartate aminotransferaseIFCC with pyridoxal phosphate
686Original formulation IFCC
5
(2002), manual measurement38.50.643
0.5680.00949
U/Lµkat/L
ASTAspartate aminotransferaseIFCC without pyridoxal phosphate
687Original formulation IFCC
5
(2002) modified, manual measurement
38.50.643
0.5680.00949
U/Lµkat/L
BILD2Bilirubin direkt Diazo Gen. 2Jendrassik-Grof
734Roche reagent, manual measurement
0.79013.5
0.005060.0865
mg/dLµmol/L
BILD2Bilirubin direkt Diazo Gen. 2Doumas
727Roche reagent, manual measurement
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
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
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
725Roche reagent, manual measurement
272045.4
25.70.429
U/Lµkat/L
CHECholinesterase butyrylthiocholine Gen.2
510Roche reagent, manual measurement
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
057Original formulation IFCC
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
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
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
220Original formulation IFCC
5
(2002), manual measurement39.90.666
0.6680.0112
U/Lµkat/L
GGTGlutamyltransferase gammaliquid stand. IFCC
219Original formulation IFCC
5
(2002), manual measurement39.90.666
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)
588Roche reagent, manual measurement
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
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
HBDHHydroxybutyrate dehydrogenase alphaopt. (DGKC)
567Roche reagent, manual measurement
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
080Original formulation IFCC
5
(2002), manual measurement1572.62
2.250.0376
U/Lµkat/L
LDH Lactate dehydrogenaseIFCC liquid with automatic sample pre-dilution
147Roche reagent, manual measurement
1572.62
2.250.0376
U/Lµkat/L
LDH Lactate dehydrogenaseopt. (DGKC)
672Roche reagent, manual measurement
3005.01
3.240.0541
U/Lµkat/L
LIPLipase enzymatic colorimetric test
731Roche reagent, manual measurement
51.60.862
0.5550.00927
U/Lµkat/L
LIPLipase enzymatic colorimetric test STAT
733Roche reagent, manual measurement
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
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
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
TRACEABILITY and UNCERTAINTY Hitachi - Precinorm® U plus
Cat. No. 12 149 435 122
Roche Diagnostics GmbH October 2017
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.