TRACEABILITY and UNCERTAINTY 7 COBAS INTEGRA / c Precinorm U
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1 Roche Diagnostics GmbH Decembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit Acid phosphatase total 1-naphthyl phosphate Gen. 2 Intega Acid phosphatase total 1-naphthyl phosphate Gen. 2 Intega Acid phosphatase, non-postatic 1-naphthyl phosphate (Inhib.:tatate) Gen. 2 Intega Acid phosphatase, non-postatic 1-naphthyl phosphate (Inhib.:tatate) Gen. 2 Intega calculated Acid phosphatase, postatic 1-naphthyl phosphate (Inhib.:tatate) Gen. 2 Intega calculated Acid phosphatase, postatic 1-naphthyl phosphate (Inhib.:tatate) Gen. 2 Intega Intega_c 111_Pecinom U_Ve 20 Page 1 of 10
2 Roche Diagnostics GmbH Decembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit ALB2 Albumin BCG Gen. 2 ERM-DA470k/IFCC ALP2L Alkaline phosphatase IFCC Gen. 2 (1983), manual ALP2L Alkaline phosphatase IFCC Gen. 2 pimay tube (1983), manual ALP2S Alkaline phosphatase IFCC Gen. 2 (1983), manual ALP2S Alkaline phosphatase IFCC Gen. 2 pimay tube (1983), manual ALTL Alanine aminotansfease IFCC with pyidoxal phosphate (2002), manual ALTL Alanine aminotansfease IFCC without pyidoxal phosphate Oiginal fomulation IFC 5 (2002) modified, manual AMYL2 Amylase alpha IFCC EPS ve. 2 seum, plasma Roche eagent accoding to IFCC 5 (1998), manual Intega_c 111_Pecinom U_Ve 20 Page 2 of 10
3 Roche Diagnostics GmbH Decembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit AMYL2 Amylase alpha IFCC EPS ve. 2 uine Roche eagent accoding to IFCC 5 (1998), manual AMY-P Amylase panceatic alpha EPS liquid seum, plasma AMY-P Amylase panceatic alpha EPS liquid uine ASTL Aspatate aminotansfease IFCC with pyidoxal phosphate (2002), manual ASTL Aspatate aminotansfease IFCC without pyidoxal phosphate (2002) modified, manual BIL-D Biliubin diect Diazo Intega BILD2 Biliubin diect Diazo Gen BILT2 Biliubin total DPD Gen. 2 acc. to Doumas Intega_c 111_Pecinom U_Ve 20 Page 3 of 10
4 Roche Diagnostics GmbH Decembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit BILT3 Biliubin total Gen. 3 DPD acc. to Doumas BILTS Biliubin total Diazo special acc. to Doumas BUN Blood uea nitogen Uease/GLDH SRM 909b 3 calculated CA Calcium o-cesolphthaleine complexone SRM 956c L CA2 Calcium Gen. 2 nm-bapta SRM 956c L CHE2 Cholinestease butyylthiocholine Gen CHED2 Cholinestease/Dibucaine butyylthiocholine Gen CHOL2 Cholesteol CHOD-PAP Gen. 2 stand. ID/MS ID-MS Intega_c 111_Pecinom U_Ve 20 Page 4 of 10
5 Roche Diagnostics GmbH Decembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit CHOL2 Cholesteol CHOD-PAP Gen. 2 stand. Abell- Kendall Abell-Kendall CKL Ceatine kinase IFCC liquid (2002), manual CREP2 Ceatinine plus ve. 2 ID-MS CREJ2 Ceatinine Jaffé Gen. 2 compensated Intega 400 ID-MS CREJ2 Ceatinine Jaffé Gen. 2 compensated Intega 800 ID-MS GGT-2 Glutamyltansfease gamma liquid ve. 2 stand. IFCC (2002), manual GGT-2 Glutamyltansfease gamma liquid ve. 2 stand. Szasz Oiginal fomulation Pesijn/v.d. Slik (1976), manual GLDH3 Glutamate dehydogenase opt. (DGKC) Gen Intega_c 111_Pecinom U_Ve 20 Page 5 of 10
6 Roche Diagnostics GmbH Decembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit GLUC2 HK seum, plasma GLUC2 HK CSF GLUC2 HK uine GLUC2 HK hemolysate Gen. 2 HK Gen. 3 seum, plasma HK Gen. 3 seum, plasma STAT HK Gen. 3 CSF HK Gen. 3 CSF STAT Intega_c 111_Pecinom U_Ve 20 Page 6 of 10
7 Roche Diagnostics GmbH Decembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit HK Gen. 3 uine HK Gen. 3 uine STAT HBDH2 Hydoxybutyate dehydogenase alpha opt. (DGKC) Gen IGA Immunoglobulin A immunotubidimetic standad CRM IGGT Immunoglobulin G immunotubidimetic CRM IGM Immunoglobulin M immunotubidimetic standad CRM IRON2 Ion FeoZine Gen. 2 SRM μ LACT2 Lactate enzymatic coloimetic test Gen. 2 plasma Pimay efeence mateial (weighed in puified mateial) Intega_c 111_Pecinom U_Ve 20 Page 7 of 10
8 Roche Diagnostics GmbH Decembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit LACT2 Lactate enzymatic coloimetic test Gen. 2 CSF Pimay efeence mateial (weighed in puified mateial) LDHI2 Lactate dehydogenase IFCC liquid ve. 2 (2002), manual LDHI2 Lactate dehydogenase IFCC liquid ve. 2 pimay tube (2002), manual LDHL Lactate dehydogenase opt. (DGKC) LDHL Lactate dehydogenase opt. (DGKC) pimay tube LIPC Lipase enzymatic coloimetic test MG Magnesium Chloophosphonazo III Atomic absoption PHOS2 Phosphate (inoganic) molybdate UV ve. 2 Pimay efeence mateial (NERL) (weighed in puified mateial) Intega_c 111_Pecinom U_Ve 20 Page 8 of 10
9 Roche Diagnostics GmbH Decembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit TP2 Total potein Biuet Gen. 2 SRM 927d TP2 Total potein Biuet Gen. 2 monochomatic SRM 927d TRIGL Tiglyceides GPO-PAP ID-MS TRSF2 Tansfein immunotubidimetic ve. 2 CRM UA2 Uic acid enzymatic coloimetic test ve. 2 ID-MS UIBC Unsatuated ion-binding capacity FeoZine Pimay efeence mateial (ion) (weighed in puified mateial) μ Intega 400 UIBC Unsatuated ion-binding capacity FeoZine Pimay efeence mateial (ion) (weighed in puified mateial) μ Intega 800 UREAL Uea/BUN Uease/GLDH SRM 909b Intega_c 111_Pecinom U_Ve 20 Page 9 of 10
10 Roche Diagnostics GmbH Decembe This uncetainty (expanded uncetainty; k = 2) was calculated in accodance with the Guide to the expession of uncetainty in (GUM:1993). Fo the estimation of the single standad uncetainties nomal distibution of the esults is assumed; the level of confidence of the expanded uncetainty is about 95% with the coveage facto k=2 (analogue to the 2sd of the standad uncetainty). 2 CRM = Cetified Refeence Mateial, Euopean 3 SRM = Standad Refeence Mateial 4 ID-MS = Isotope Dilution - Mass Spectomety 5 IFCC = Intenational Fedeationof clinical chemisty and laboatoy medicine 6 ERM = Euopean Refeence Mateials 7 Unless othewise noted, the assigned values and uncetainties ae valid fo Intega and c 111 povided that the method is available on that analyze. Intega_c 111_Pecinom U_Ve 20 Page 10 of 10
TRACEABILITY and UNCERTAINTY 7 COBAS INTEGRA / cobas c Precipath U
Refeence Method Refeence Mateial Selected Measuement Acid phosphatase total 1-naphthyl phosphate Gen. 2 Intega 400 47.2 0.788 0.605 0.0101 Acid phosphatase total 1-naphthyl phosphate Gen. 2 Intega 800
TRACEABILITY and UNCERTAINTY 7 cobas c 501 / c 502 / c 311 / c 701 / c Precinorm U
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit ACP2 Acid phosphatase total 1-naphthyl phosphate Gen.2 24.0 0.401 0.279
TRACEABILITY and UNCERTAINTY 7 cobas c 501 / c 502 / c 311 / c 701 / c C.f.a.s.
Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Calibato Value Uncetainty 1 Unit ACP2 Acid phosphatase total 1-naphthyl phosphate Gen. 2 Roche eagent, manual
COBAS INTEGRA / cobas c C.f.a.s.
COBAS INTEGRA / cobas c - C.f.a.s. Cat. No. 0 79 30 90 Roche Diagnostics GmbH May 20 Acid phosphatase total -naphthyl phosphate Gen. 2 Integra 00 plus Acid phosphatase total -naphthyl phosphate Gen. 2
TRACEABILITY and UNCERTAINTY 7
Routine Method COBAS INTEGRA systems Acid phosphatase total 1-naphthyl phosphate Integra 00 plus Acid phosphatase total 1-naphthyl phosphate Acid phosphatase, non-prostatic Integra 00 plus Acid phosphatase,
TRACEABILITY and UNCERTAINTY 9
AAT Antitrypsin alpha 1 AAGP Acid glycoprotein alpha 1 immunoturbidimetric Gen. Acid phosphatase total 1-naphthyl phosphate Gen. Acid phosphatase total 1-naphthyl phosphate Gen. Integra 00 plus Acid phosphatase,
TRACEABILITY and UNCERTAINTY
Cat. No. 0 79 0 90 ACP Acid phosphatase total -naphthyl phosphate NPP Acid phosphatase, non-prostatic -naphthyl phosphate (Inhib.:tartrate) ALB Albumin BCG plus ALB Albumin BCP ALP Alkaline phosphatase
TRACEABILITY and UNCERTAINTY
ACP Acid phosphatase total 1-naphthyl phosphate NPP Acid phosphatase, non-prostatic 1-naphthyl phosphate (Inhib.:tartrate) ACP-P Acid phosphatase, prostatic 1-naphthyl phosphate (Inhib.:tartrate) ALB Albumin
Roche/Hitachi - PreciControl ClinChem Multi 2
ATRYP Antitrypsin alpha 1 ERM-DA470k/IFCC 9 136 1.36 1.84 0.0184 GPROT Acid glycoprotein alpha 1 CRM 470 2 90.1 0.901 0.890 0.00890 ACP Acid phosphatase total 1-naphthyl phosphate 0.720 43.1 0.00703 0.421
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