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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
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.