TRACEABILITY and UNCERTAINTY 7 cobas c 501 / c 502 / c 311 / c 701 / c Precinorm U
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1 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 ACP2 Acid phosphatase, non-postatic 1-naphthyl phosphate (Inhib.:tatate) Gen ACP2 Acid phosphatase, postatic 1-naphthyl phosphate (Inhib.:tatate) calculated ALB2 Albumin BCG Gen.2 ERM-DA470k/IFCC g/dl ALBP Albumin BCP CRM g/dl ALP2S Alkaline phosphatase IFCC Gen.2 Oiginal fomulation IFCC 5 (1983), manual ALP2L Alkaline phosphatase IFCC Gen.2 Oiginal fomulation IFCC 5 (1983), manual ALTLP Alanine aminotansfease IFCC with pyidoxal phosphate Oiginal fomulation IFCC cobas c systems_pecinom U_Ve 14 Page 1 of 13
2 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit ALTL Alanine aminotansfease IFCC without pyidoxal phosphate Oiginal fomulation IFCC 5 (2002) modified, manual AMYL2 Amylase alpha IFCC liquid ve. 2 Roche eagent accoding to IFCC 5 (1998), manual AMYL2 Amylase alpha IFCC liquid ve. 2 STAT Roche eagent accoding to IFCC 5 (1998), manual AMY-P Amylase panceatic alpha EPS ve ASTLP Aspatate aminotansfease IFCC with pyidoxal phosphate Oiginal fomulation IFCC ASTL Aspatate aminotansfease IFCC without pyidoxal phosphate Oiginal fomulation IFCC 5 (2002) modified, manual ASTL Aspatate aminotansfease IFCC without pyidoxal phosphate STAT Oiginal fomulation IFCC 5 (2002) modified, manual D-BIL Biliubin diect Jendassik-Gof c 501 only cobas c systems_pecinom U_Ve 14 Page 2 of 13
3 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit BILD2 Biliubin diect Gen.2 Jendassik-Gof BILD2 Biliubin diect Gen.2 Jendassik-Gof BILTS Biliubin total Diazo special acc. to Doumas BILTS Biliubin total Diazo special STAT acc. to Doumas BILTS Biliubin total Diazo special acc. to Doumas BILTS Biliubin total Diazo special STAT acc. to Doumas cobas c systems_pecinom U_Ve 14 Page 3 of 13
4 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit BILT2 Biliubin total DPD Gen. 2 acc. to Doumas BILT2 Biliubin total DPD Gen. 2 STAT acc. to Doumas BILT2 Biliubin total DPD Gen. 2 acc. to Doumas BILT3 Biliubin total Gen. 3 DPD acc. to Doumas BILT3 Biliubin total Gen. 3 DPD acc. to Doumas BUN Blood Uea nitogen Uease/GLDH SRM 909b 3 calculated BUN Blood Uea nitogen Uease/GLDH STAT SRM 909b 3 calculated cobas c systems_pecinom U_Ve 14 Page 4 of 13
5 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit CA o-cesolphthaleine complexone SRM 956c L CA o-cesolphthaleine complexone STAT SRM 956c L CA o-cesolphthaleine complexone SRM 956c L CA o-cesolphthaleine complexone STAT SRM 956c L CA2 nm-bapta SRM 956c L cobas c systems_pecinom U_Ve 14 Page 5 of 13
6 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit CA2 nm-bapta STAT SRM 956c L CA2 nm-bapta SRM 956c L CA2 nm-bapta STAT SRM 956c L CHE Cholinestease acethylthiocholine CHE2 Cholinestease butyylthiocholine Gen CHED2 Cholinestease butyylthiocholine Gen CHOL2 Cholesteol CHOD-PAP Gen. 2 stand. ID/MS ID-MS cobas c systems_pecinom U_Ve 14 Page 6 of 13
7 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit CHOL2 Cholesteol CHOD-PAP Gen. 2 stand. Abell-Kendall CKL Ceatine kinase IFCC liquid cobas c 501/ c 502 / c 311 CK Ceatine kinase IFCC liquid cobas c 701 / c 702 CREP2 Ceatinine plus ve. 2 Abell-Kendall 96.3 Oiginal fomulation IFCC 5 Oiginal fomulation IFCC 5 ID-MS CREJ2 Ceatinine Jaffé compensated Gen. 2 STAT seum, plasma ID-MS CREJ2 Ceatinine Jaffé ate-blanked and compensated Gen. 2 seum,plasma ID-MS GGT-2 Glutamyltansfease gamma liquid stand. Szasz Oiginal fomulation Pesijn/v.d. Slik (1976), manual cobas c systems_pecinom U_Ve 14 Page 7 of 13
8 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit GGT-2 Glutamyltansfease gamma liquid stand. IFCC Oiginal fomulation IFCC GLDH3 Glutamate dehydogenase opt. (DGKC) Gen GLUC2 Glucose HK ID-MS GLUC2 Glucose HK STAT ID-MS GLUC2 Glucose HK hemolysate Gen. 2 ID-MS GLUC2 Glucose HK hemolysate Gen. 2 STAT ID-MS GLUC3 Glucose HK ID-MS GLUC3 Glucose HK STAT ID-MS cobas c systems_pecinom U_Ve 14 Page 8 of 13
9 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit HBDH2 Hydoxybutyate dehydogenase alpha opt. (DGKC) Gen IGA-2 Immunoglobulin A immunotubidimetic Gen. 2 standad CRM IGG-2 Immunoglobulin G immunotubidimetic Gen. 2 standad seum, plasma ERM-DA470k/IFCC IGM-2 Immunoglobulin M immunotubidimetic Gen. 2 standad CRM IRON2 Ion FeoZine Gen. 2 SRM μg/dl LACT2 Lactate enzymatic coloimetic test Gen. 2 Pimay efeence mateial (weighed in puified mateial) LACT2 Lactate enzymatic coloimetic test Gen. 2 STAT Pimay efeence mateial (weighed in puified mateial) cobas c systems_pecinom U_Ve 14 Page 9 of 13
10 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit LDHI2 Lactate dehydogenase IFCC liquid ve. 2 Oiginal fomulation IFCC LDHI2 Lactate dehydogenase IFCC liquid ve. 2 sample pe-dilution Oiginal fomulation IFCC LDHL Lactate dehydogenase opt. (DGKC) LIPC Lipase enzymatic coloimetic test LIPC Lipase enzymatic coloimetic test STAT LI Lithium coloimetic test Flame photomety MG Magnesium Chloophosphonazo III seum,plasma Atomic absoption cobas c systems_pecinom U_Ve 14 Page 10 of 13
11 Roche Diagnostics GmbH Novembe 2012 MG Magnesium Chloophosphonazo III seum,plasma STAT MG2 Magnesium Gen. 2 MG2 Magnesium xylidyl blue method MG2 Magnesium xylidyl blue method STAT PHOS2 Phospahte (inoganic) molybdate UV ve. 2 Refeence Method Refeence Mateial Selected Measuement Pocedue Atomic absoption Atomic absoption Atomic absoption Atomic absoption Pimay efeence mateial (NERL) (weighed in puified mateial) Assigned Value Uncetainty 1 Unit PHOS2 Phospahte (inoganic) molybdate UV ve. 2 STAT Pimay efeence mateial (NERL) (weighed in puified mateial) cobas c systems_pecinom U_Ve 14 Page 11 of 13
12 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit TRIGL Tiglyceides GPO-PAP ID-MS TRIGB Tiglyceides/Glyceol Blanked glyceol blanked SRM 909b TP2 Total potein Biuet Gen. 2 SRM 927d g/dl TP2 Total potein Biuet Gen. 2 STAT SRM 927d g/dl TRSF2 Tansfein immunotubidimetic ve. 2 CRM UA2 Uic acid enzymatic coloimetc test ve. 2 ID-MS cobas c systems_pecinom U_Ve 14 Page 12 of 13
13 Roche Diagnostics GmbH Novembe 2012 Refeence Method Refeence Mateial Selected Measuement Pocedue Assigned Value Uncetainty 1 Unit UIBC Unsatuated ion-binding capacity FeoZine Pimay efeence mateial (ion) (weighed in puified mateial) μg/dl UIBC Unsatuated ion-binding capacity FeoZine Pimay efeence mateial (ion) (weighed in puified mateial) μg/dl UREAL Uea Uease/GLDH SRM 909b UREAL Uea Uease/GLDH STAT SRM 909b 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 cobas c 501, cobas c 502, cobas c 311 cobas c 701 and cobas c 702 povided that the method is available on that analyze. cobas c systems_pecinom U_Ve 14 Page 13 of 13
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
TRACEABILITY and UNCERTAINTY 7 COBAS INTEGRA / c Precinorm U
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 400 20.4 0.341
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
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
Reagents on COBAS INTEGRA Systems
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