TRACEABILITY and UNCERTAINTY 9
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1 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, non-prostatic 1-naphthyl phosphate (Inhib.:tartrate) Gen. Acid phosphatase, non-prostatic 1-naphthyl phosphate (Inhib.:tartrate) Gen. Integra 00 plus Acid phosphatise, prostatic 1-naphthyl phosphate (Inhib.:tartrate) Gen. Acid phosphatise, prostatic 1-naphthyl phosphate (Inhib.:tartrate) Gen. Integra 00 plus calculated calculated
2 ALB Albumin BCG Gen. ALBT Albumin immunoturbidimetric Gen. ALPL IFCC Gen. ALPL IFCC Gen. ALPL IFCC Gen. primary tube ALPL IFCC Gen. primary tube ALPS IFCC Gen. ALPS IFCC Gen. ALPS IFCC Gen. primary tube ALPS IFCC Gen. primary tube ALTL Alanine aminotransferase IFCC with pyridoxal phosphate 0-9 c 111: 13 I00: 0-17 I00: g/dl g/dl c 111: c 111: c 111: 6 (Tietz, 193), manual (Schumann, 011), manual (Tietz, 193), manual (Schumann, 011), manual (Tietz, 193), manual (Schumann, 011), manual (Tietz, 193), manual (Schumann, 011), manual (00), manual
3 ALTL Alanine aminotransferase IFCC without pyridoxal phosphate AMYL Amylase alpha IFCC EPS ver. serum, plasma AMYL Amylase alpha IFCC EPS ver. urine AMY-P Amylase pancreatic alpha EPS liquid serum, plasma AMY-P Amylase pancreatic alpha EPS liquid urine APOAT Apolipoprotein A-1 APOBT Apoliprotein B APOBT Apoliprotein B Integra 00 plus ASO Antistreptolysin 0 immunoturbidimetric ASTL Aspartate aminotransferase IFCC with pyridoxal phosphate ASTL Aspartate aminotransferase IFCC without pyridoxal phosphate 0-9 c 111: 6 (00) modified, manual Roche reagent according to IFCC (199), manual Roche reagent according to IFCC (199), manual c 111: c 111: WHO international reference material SP WHO international reference material SP WHO international reference material SP Internal standard material 1 1. IU/mL c 111: 66 (00), manual 0-9 c 111: 67 (00) modified, manual
4 BILD Bilirubin direct Diazo Gen. BILD Bilirubin direct Diazo Gen. BILT3 Bilirubin total DPD Gen. 3 BUN Blood urea nitrogen Urease/GLDH C3C- Complement C3c immunturbidimetric ver. C- Complement C CA Calcium Gen. -Nitro--Methly-BAPTA CERU Ceruloplasmin immunoturbidimetric CHE Cholinesterase butyrylthiocholine Gen. CHED Cholinesterase/ Dibucaine butyrylthiocholine Gen. CHOL Cholesterol CHOD-PAP Gen. stand. ID/MS (Jendrassik-Grof) (Doumas) 0-73 c 111: c 111: c 111: 71 acc. to Doumas c 111: c 111: 69 SRM 96c L c 111: 79 11
5 CHOL Cholesterol CHOD-PAP Gen. stand. AbellKendall CKL Creatine kinase IFCC liquid CK Creatine kinase IFCC liquid Integra 00 plus, cobas c 111 CKMBL Creatine Kinase-MB liquid CKMB Creatine Kinase-MB liquid Integra 00 plus, cobas c 111 CREJ Creatinine Jaffé Gen. compensated CREP Creatinine plus ver. CRPLX C-Reactive protein particle enhanced turbidimetric Latex Integra 00 plus, cobas c 111 CRPLX C-Reactive protein particle enhanced turbidimetric Latex 0-6 c 111: 33 Abell-Kendall 0-33 c 111: 7 (00), manual 0-0 c 111: 0 (00), manual (00) modified, manual 0-3 c 111: 60 (00) modified, manual 0-07 c 111: 6 I00: 0- I00: 0- c 111: c 111: m m 0-93 c 111: c 111:
6 CRPHS C-Reactive protein particle enhanced turbidimetric Latex high sensitive FERR Ferritin Particle enhanced turbidimetric Gen. GGT- Glutamyltransferase gamma liquid ver. stand. Szasz GGT- Glutamyltransferase gamma liquid ver. stand. IFCC GLDH3 Glutamate dehydrogenase opt. (DGKC) Gen. 3 GLUC HK Gen. serum, plasma GLUC HK Gen. CSF GLUC HK Gen. urine GLUC HK Gen. hemolysate HK Gen. 3 serum, plasma HK Gen. 3 serum, plasma STAT m µ pmol/l c 111: c 111: c 111: 0 Elecsys Ferritin assay (immunological method) which 9 6 is traceable to NIBSC (WHO ) Original formulation Persijn/v.d. Slik (1976), manual (00), manual c 111: c 111:
7 HK Gen. 3 CSF HK Gen. 3 CSF STAT HK Gen. 3 urine HK Gen. 3 urine STAT HBDH Hydroxybutyrate dehydrogenase alpha opt. (DGKC) Gen. HDLC3 HDL-Cholesterol plus 3rd generation HDLC3 HDL-Cholesterol plus 3rd generation Integra 00 plus, cobas c 111 HDLC HDL-Cholesterol, enzymatic colorimetric rd generation Integra 00 plus, cobas c 111 HAPT Haptoglobin IGA Immunoglobulin A immunoturbidimetric standard c 111: 3 7 According to the CDC reference method [Precipitation by dextran sulphate and Abell-Kendall] c 111: According to the CDC reference method [Precipitation by dextran sulphate and Abell-Kendall]
8 IGA Immunoglobulin A immunoturbidimetric sensitive IGGT Immunoglobulin G immunoturbidimetric IGM Immunoglobulin M immunoturbidimetric standard IGM Immunoglobulin M immunoturbidimetric sensitive IRON Iron FerroZine Gen. LACT Lactate enzymatic colorimetric test Gen. serum/plasma LACT Lactate enzymatic colorimetric test Gen. CSF LDHI Lactate dehydrogenase IFCC liquid ver. LDHI Lactate dehydrogenase IFCC liquid ver. primary tube LDHL Lactate dehydrogenase opt. (DGKC) LDHL Lactate dehydrogenase opt. (DGKC) primary tube µg/dl c 111: 661 SRM c 111: 0 Primary reference material (weighed in purified material) Primary reference material (weighed in purified material) c 111: 0 (00), manual 0-07 (00), manual
9 LDL_C LDL-Cholesterol plus nd generation LDL_C LDL-Cholesterol plus nd generation Integra 00 plus, cobas c 111 LDLC3 LDL-Cholesterol Gen. 3 Integra 00 plus, cobas c 111 LIPC Lipase enzymatic colorimetric test MG Magnesium Chlorophosphonazo III PREA Prealbumin immunoturbidimetric PHOS Phosphate (inorganic) molybdate UV ver. TRSF Transferrin TRIGL Triglycerides GPO-PAP m c 111: 9 According to CDC beta quantification method [Precipitation by heparinmanganese (ultracentrifugation) and Abell-Kendall] 7 0- c 111: According to CDC beta quantification method [Precipitation by heparinmanganese (ultracentrifugation) and Abell-Kendall] c 111: c 111: 693 Atomic absorption 0-66 Primary reference material (NERL) (weighed in purified material) 0-61 c 111: c 111: 71
10 TP Total protein Biuret Gen. TP Total protein Biuret Gen. monochromatic UA Uric acid enzymatic colorimetric test ver. UIBC Unsaturated iron-binding capacity FerroZine UIBC Unsaturated iron-binding capacity FerroZine Integra 00 plus UREAL Urea/BUN Urease/GLDH SRM 97d c 111: 7 SRM 97d c 111: g/dl g/dl Primary reference material (iron) (weighed in purified material) Primary reference material (iron) (weighed in purified material) c 111: m m This uncertainty (expanded uncertainty; k = ) was calculated in accordance with the Guide to the expression of uncertainty in (GUM: 1993). For the estimation of the single standard uncertainties normal distribution of the results is assumed; the level of confidence of the expanded uncertainty is about 9% with the coverage factor k= (analogue to the sd of the standard uncertainty). CRM = Certified, European 3 SRM = Standard =Isotope Dilution - Mass Spectrometry IFCC = International Federation of clinical chemistry and laboratory medicine 6 WHO = World Health Organisation 7 CDC = Centre for Disease Control = European s 9 Unless otherwise noted, the assigned values and uncertainties are valid for Integra and cobas c 111, provided that the method is available on that analyzer. 10 NIBSC = National Institute for Biological Standards and Control 11 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 %, resp. CHOL 0.1.
11 1 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 3 %, resp. CK 10 or CKMB. 13 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 %, resp. HDLC 0.0.
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,
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
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
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
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
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
Reagents on COBAS INTEGRA Systems
within specification within specification Lipemia AAGP α1-acid Glycoprotein X X no no no no no no no AAGP2 α1-acid Glycoprotein Gen.2 X X X 60 60 1000 1026 1026 621 700 AAT2 α1-antitrypsin ver.2 X X X
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Information For COBAS INTEGRA Systems General Information e contents of this document, including all graphics and photographs, are the property of Roche Diagnostics. No part of this document may be reproduced
short catalogue clinical chemistry immunoturbidimetric tests calibrators standards controls supplementary reagents instruments Probedruck ::018 ::016
DiaSys_Kurzkatalog_2015_141209 10.12.2014 12:07 Uhr Seite 1 C ::010 ::011 ::012 ::013 ::014 M Y CM MY ::015 CY CMY K ::016 ::017 15 short catalogue ::026 ::027 ::028 ::029 ::036 ::030 ::037 ::018 ::031
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