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Performance evaluation of cobas HBV real-time PCR assay on Roche cobas 4800 System in comparison with COBAS AmpliPrep/COBAS TaqMan HBV Test
- Source :
- Clinical chemistry and laboratory medicine. 56(7)
- Publication Year :
- 2017
-
Abstract
- Background: Hepatitis B virus (HBV) nucleic acid amplification testing (NAAT) is important for the diagnosis and management of HBV infection. We evaluated the analytical performance of the cobas HBV NAAT (Roche Diagnostics GmbH, Mannheim, Germany) on the cobas 4800 System in comparison with COBAS AmpliPrep/COBAS TaqMan HBV Test (CAP/CTM HBV). Methods: Precision was evaluated using three levels of cobas HBV/HCV/HIV-1 Control Kit, and linearity was evaluated across the anticipated measuring range (10.0–1.0×109 IU/mL) at seven levels using clinical samples. Detection capability, including limit of blank (LOB), limit of detection (LOD) and limit of quantitation (LOQ), was verified using the 4th WHO International Standard for HBV DNA for NAT (NIBSC code: 10/266). Correlation between the two systems was compared using 205 clinical samples (102 sera and 103 EDTA plasma). Results: Repeatability and total imprecision (coefficient of variation) ranged from 0.5% to 3.8% and from 0.5% to 3.5%, respectively. Linearity (coefficient of determination, R2) was 0.999. LOB, LOD and LOQ were all acceptable within the observed proportion rate (85%). Correlation was very high between the two systems in both serum and plasma samples (correlation coefficient [r]=0.995). Conclusions: The new cobas HBV real-time PCR assay on the cobas 4800 System showed reliable analytical performances.
- Subjects :
- 0301 basic medicine
Hepatitis B virus
Cobas taqman
Coefficient of variation
Clinical Biochemistry
Roche Diagnostics
medicine.disease_cause
Real-Time Polymerase Chain Reaction
03 medical and health sciences
0302 clinical medicine
Limit of Detection
Medicine
Humans
Detection limit
Chromatography
Plasma samples
business.industry
Biochemistry (medical)
General Medicine
Repeatability
Viral Load
030104 developmental biology
Real-time polymerase chain reaction
DNA, Viral
030211 gastroenterology & hepatology
business
Subjects
Details
- ISSN :
- 14374331
- Volume :
- 56
- Issue :
- 7
- Database :
- OpenAIRE
- Journal :
- Clinical chemistry and laboratory medicine
- Accession number :
- edsair.doi.dedup.....8c44d09451ca80e5401f28194df9b38c