Hepatitis B virus (HBV) DNA levels are used to predict the response to therapy, determine therapy initiation, monitor resistance to therapy, and establish treatment success. Shin, Kyung-Hwa Lee, Hyun-Ji Chang, Chulhun L Kim, Hyung-Hoi Performance of the cobas Hepatitis B virus (HBV) test using the cobas 4800 system and comparison of HBV DNA quantification ability between the COBAS AmpliPrep/ COBAS TaqMan HBV test version 2.0 and cobas HBV test. TextabstractTo evaluate the analytical performance and explore the clinical applicability of the new Roche cobas AmpliPrep/ cobas TaqMan HCV test, v2.0 (CAP/CTM v2.0), a platform comparison was performed on panels and diagnostic samples with the Roche cobas AmpliPrep/ cobas TaqMan HCV test (CAP/CTM Performance evaluation of the new Roche cobas AmpliPrep/ cobas TaqMan HCV test, version 2.0, for detection and quantification of hepatitis C virus RNA The new cobas HBV real-time PCR assay on the cobas 4800 System showed reliable analytical performances. Correlation was very high between the two systems in both serum and plasma samples (correlation coefficient =0.995). LOB, LOD and LOQ were all acceptable within the observed proportion rate (85%). Linearity (coefficient of determination, R2) was 0.999. Repeatability and total imprecision (coefficient of variation) ranged from 0.5% to 3.8% and from 0.5% to 3.5%, respectively. Correlation between the two systems was compared using 205 clinical samples (102 sera and 103 EDTA plasma). 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). Precision was evaluated using three levels of cobas HBV/HCV/HIV-1 Control Kit, and linearity was evaluated across the anticipated measuring range (10.0-1.0Ã-109 IU/mL) at seven levels using clinical samples. 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). Hepatitis B virus (HBV) nucleic acid amplification testing (NAAT) is important for the diagnosis and management of HBV infection. Kim, Hanah Hur, Mina Bae, Eunsin Lee, Kyung-A Lee, Woo-In Performance evaluation of cobas HBV real-time PCR assay on Roche cobas 4800 System in comparison with COBAS AmpliPrep/ COBAS TaqMan HBV Test.
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