Assay Information For COBAS INTEGRA Systems

Transcription

1 Information For COBAS INTEGRA Systems

2 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 or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics. Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing. However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development. is assay information document was created by the Roche Diagnostics Technical Publications department. Direct questions or concerns regarding the contents of this document to: Roche Diagnostics Technical Publications Department 9115 Hague Road P.O. Box Indianapolis, IN USA COBAS, COBAS INTEGRA, and MYLABONLINE are trademarks of Roche , Roche Diagnostics. All rights reserved Distribution in USA by: Roche Diagnostics, Indianapolis, IN is assay information document is only available on MyOnline. Additional copies of this document can be obtained by sending a message to Indianapolis.techpub@roche.com or leaving a message at the Technical Publication Hotline at , mailbox

3 Revision History Revisions to this document are provided by Roche Diagnostics when necessary. No part of this document may be reproduced in any form or by any means without prior written consent. Publication Date Revision purpose Reference Number February 2008 Document creation Version September 2009 Update for newly launched assays Version July 2011 Removed obsolete assays and added newly launched assays Version 2 2

4 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range -1-Antitrypsin AAT mg/dl Acid Glycoprotein 2 AAGP mg/dl Acetaminophen ACETA g/ml Albumin, Gen. 2 ALB g/dl Adults Albumin, Gen. 2 ALBU mg/dl Tina-Quant 24-hour urine Albumin, Gen. 2 (serum) ALBS g/dl Tina-Quant adults Alkaline Phosphatase, Gen. 2 ALP2L U/L M F Alkaline Phosphatase, Gen. 2 ALP2S U/L M F Alanine Aminotransferase ALTL U/L M 0-33 F Alanine Aminotransferase with ALTPL U/L M Pyridoxal Phosphate Activated F Amikacin AMIKMM g/ml P 5-10 T Ammonia NH3L mol/l M F Amphetamines II Semi-Quantitative 300 AM3S ng/ml

5 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range Amphetamines II Semi-Quantitative 500 Amphetamines II Semi-Quantitative 1000 Amphetamines II Amphetamines II Qualitative 500 Amphetamines II Qualitative 1000 Amphetamines II Qualitative 500 AM5S ng/ml Cutoff 500 AM1S ng/ml AM3Q n/a AM5Q n/a Cutoff 500 AM1Q n/a AM5QC n/a Cutoff 500 -Amylase EPS ver.2 AMYL U/L (serum/plasma) -Amylase EPS ver.2 AMYU U/L M F -Amylase EPS Pancreatic AMY-P U/L (serum/plasma) -Amylase EPS Pancreatic AMYUP U/L M F Apoliprotein A-1 ver.2 APOAT mg/dl M F Apoliprotein B ver.2 APOBT mg/dl M F Antistreotolysin O ASO IU/mL 0 1 Up to 200 Adult Up to 150 Children Aspartate Aminotransferase ASTL U/L M 0-32 F Aspartate Aminotransferase ASTPL U/L M w/ Pyridoxal Phospate F Barbiturates Qualitative 200 (using C.f.a.s. DAT Qualitative Plus BRBQC n/a Cutoff 200 Barbiturates Qualitative 200 BRBQL n/a Cutoff 200 4

6 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range Barbiturates BARBS ng/ml Cutoff 200 Semi-Quantitative 200 Barbiturates - urine UBARB g/ml See Method Sheet Barbiturates - serum SBARB g/ml See Method Sheet Benzodiazepines - serum SBENZ ng/ml See Method Sheet Benzodiazepines - urine UBENZ ng/ml See Method Sheet Benzodiazepines BENZS ng/ml Semi-quantitative 100 Benzodiazepines BZ1QC n/a Qualitative 100 Benzodiazepines BZ1QL n/a Qualitative 100 Benzodiazepines BZ2QL n/a Cutoff 200 Qualitative 200 Benzodiazepines BZ3QL n/a Bicarbonate CO2-L mmol/l Bilirubin Direct BIL-D mg/dl Bilirubin, Total Special BILTS mg/dl Up to 1.2 Adults Up to 1.0 > 1 month 5

7 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range Cannabinoids II Qualitative 50 THC5QC n/a Cutoff 50 Cannabinoids II THS ng/ml Cutoff 50 Semi-quantitative 50 Cannabinoids II TH5QP n/a Cutoff 50 Qualitative 50 Cannabinoids II THS ng/ml Semi-quantitative 100 Cannabinoids II TH1QP n/a Qualitative 100 Cannabinoids II THS ng/ml Cutoff 20 Semi-quantitative 20 Cannabinoids II TH2QP n/a Cutoff 20 Qualitative 20 Complement C3c ver.2 C3C mg/dl Complement C4 ver.2 C mg/dl Calcium (serum/plasma) CA mg/dl Calcium CAU mg/dl mg/24 h Carbamazepine CARBM g/ml Ceruloplasmin CERU mg/dl M (Application for C.f.a.s. PAC) F Cholinesterase Gen. 2 CHE U/L Cholesterol Gen.2 CHOL mg/dl

8 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range Chloride, Direct CL-D mmol/l Chloride, Indirect CL-I mmol/l Chloride, Urine CL-U mmol/l mmol/day Cocaine II Semi-quantitative 150 Cocaine II Semi-quantitative 300 Cocaine II Qualitative 150 Cocaine II Cocaine II CO1S ng/ml Cutoff 150 CO3S ng/ml CO1Q n/a Cutoff 150 CO3Q n/a CO3QC n/a Creatinine plus ver.2 CRE mg/dl M (serum/plasma) F Creatinine plus ver.2 CRE2U mg/dl mg/24 hrs F mg/24 hrs M Creatinine Jaffe Gen.2 CREJ mg/dl M (serum/plasma) F Creatinine Jaffe Gen.2 CRJ2U mg/dl mg/24 h M mg/24 h F Creatine Kinase CKL U/L M F Creatine Kinase-MB CKMBL U/L < 25 C-Reactive Protein CRPL mg/dl <0.5 (C.f.a.s. Protein) Adult C-Reactive Protein CRPHS mg/dl <0.5 High Sensitive Adult Cyclosporine II CSAII ng/ml user defined 7

9 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range Cystatin C CYSC mg/l (20-70 years) D-Dimer D-DIMER g < 0.5 FEU/mL Digoxin DIGM ng/ml Ethanol Gen.2 ETOH mg/dl user defined (serum/plasma) Ethanol Gen.2 ETOU mg/dl user defined Free Phenytoin FPHNY g/ml Free Valproic Acid FVALP g/ml See Method Sheet Fructosamine FRA mol/l Gentamicin GENTM g/ml Peak Trough -Glutamytransferase Ver. 2 GGTS U/L M 5-36 F Glucose HK Gen.3 GLUC mg/dl (serum, plasma) Glucose HK Gen.3 GLU3U mg/dl Glucose HK Gen.3 GLU3C mg/dl (CSF) Glucose HK Gen. 3 STAT SGLU mg/dl (serum, plasma) (Adults) Glucose HK Gen. 3 STAT SGL3U mg/dl (Random uine) Glucose HK Gen. 3 STAT SGL3C mg/dl (CSF) (Adults) Haptoglobin HAPT mg/dl

10 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range HDL, Gen. 3 HDLC mg/dl > 55 M > 65 F HBA1c Gen. 2 Tina-Quant Whole HB-W g/dl n/a Blood HBA1c Gen. 2 Tina-Quant Whole A1-W g/dl n/a Blood % HBA1c Gen. 2 Tina-Quant Whole RWD % % Blood (DCCT) HBA1c Gen. 2 Tina-Quant HB-H g/dl n/a Hemolysate HBA1c Gen. 2 Tina-Quant A1-H g/dl n/a Hemolysate HBA1c Gen. 2 Tina-Quant RHD % % Hemolysate (DCCT) IGA IGA mg/dl * (age dependent) IGAP (Sensitive) IGAP mg/dl age dependent IGG (serum, plasma) IGGT mg/dl IGG (CSF) IGGTC mg/dl IGM IGM mg/dl IGM (Sensitive) IGMP mg/dl age dependent Iron, Gen 2 IRON g/dl M F ISE Direct Multi n/a n/a n/a n/a ISE Indirect Multi n/a n/a n/a n/a ISE Urine Multi n/a n/a n/a n/a 9

11 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range Potassium, direct K-D mmol/l Potassium, indirect K-I mmol/l Potassium, urine K-U mmol/l /24 hours Lactate, Gen. 2 LACT mg/dl Plasma Lactate, Gen. 2 LACC mg/dl CSF Adult LD version 2 LDHI U/L M F LDL, Gen. 2 LDL_C mg/dl < 100 Lithium LI-D mmol/l Lidocaine LIDOM g/ml Lipase LIPC U/L LSD LSD n/a Cutoff 0.5 Magnesium MG mg/dl See Method Sheet Magnesium, urine MGU mg/dl per 24 hours Methadone II Methadone II Semi-quantitative 300 Methadone II Methadone Metabolite Semi-quantitative 100 MD3Q n/a MD3S ng/ml MD3QC n/a MM1S ng/ml

12 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range Methadone Metabolite Semi-quantitative 300 Methadone Metabolite Qualitative 100 Methadone Metabolite Methaqualone Semi-quantitative 300 Methaqualone Methaqualone MM3S ng/ml MM1Q n/a MM3Q n/a MTQLS ng/ml MTQQL n/a MTQQC n/a Myoglobin Gen. 2 MYO g/l M F Na (Sodium), Direct NA-D mmol/l Na (Sodium), Indirect NA-I mmol/l Na (Sodium), Urine NA-U mmol/l per 24 hours N-Acetyl-Procainamide NAPAM g/ml Opiates Qualitative 2000 Opiates Semi-quantitative 2000 Opiates Opiates OP2QL n/a Cutoff 2000 OPI2S ng/ml Cutoff 2000 OPI3Q n/a OP3QC n/a

13 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range Oxycodone OXY3S ng/ml Semi-quantiative 300 Oxycodone OXY1Q n/a Qualitative 100 Oxycodone OXY3Q n/a Phencyclidine PCPQL n/a Cutoff 25 Qualitative 25 Phencyclidine PCPS ng/ml Cutoff 25 Semi-quantitative 25 Phencyclidine PCPQC n/a Cutoff 25 Qualitative 25 Phenobarbital PHNOM g/ml Phenytoin PHNYM g/ml Phosphate (Inorganic) ver.2 PHOS mg/dl adults (serum, plasma) Phosphate (Inorganic) ver.2 PHOU mg/dl g/d per 24h Propoxyphene PPXQL n/a Propoxyphene PPXS ng/ml Semi-quantitative 300 Propoxyphene PPXQC n/a Prealbumin PREA mg/dl Application for C.f.a.s. PAC Primidone PRIMM g/ml Procainamide PROCM g/ml

14 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range Rheumatoid factors II RF-II IU/mL Salicylate SALI mg/dl Soluble Transferrin Receptor STFR mg/l M F Total T4 (Thyroxine) T g/dl Theophylline THEOM g/ml Tobramycin TOBRM g/ml Peak Trough Total Mycophenolic Acid TMPA g/ml Varies - See Method Sheet Total Protein Gen.2 TP g/dl Total Protein, Gen. 3 - Urine TPUUS mg/dl per 24 hours Total Protein, Gen. 3 - CSF TPCUS mg/dl Triglycerides TRIGL mg/dl Transferrin ver.2 TRSF mg/dl Tina-Quant T-Uptake T-UP user defined Uric Acid ver.2 UA mg/dl M (serum, plasma) F Uric Acid ver.2 UAU mg/dl mg/day Unsaturated Iron-Binding Capacity UIBC g/dl Urea/BUN (serum, plasma) UREL mg/dl adults 13

15 COBAS INTEGRA Systems Information COBAS INTEGRA Systems Information Decimal Factor Reference Range Urea/BUN URELU mg/dl g/24 h Valproic Acid VALPM g/ml Vancomycin VANCM g/ml Peak 5-10 Trough 14