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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

Authors
 Hanah Kim  ;  Mina Hur  ;  Eunsin Bae  ;  Kyung-A Lee  ;  Woo-In Lee 
Citation
 Clinical Chemistry and Laboratory Medicine, Vol.56(7) : 1133-1139, 2018 
Journal Title
 Clinical Chemistry and Laboratory Medicine 
ISSN
 1434-6621 
Issue Date
2018
Keywords
COBAS CAP/CTM ; cobas 4800 ; cobas HBV ; comparison ; hepatitis B virus ; performance
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 (10.0-1.0x109 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.
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/162575
Full Text
https://www.degruyter.com/view/j/cclm.2018.56.issue-7/cclm-2017-1133/cclm-2017-1133.xml
DOI
10.1515/cclm-2017-1133
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실)
Yonsei Authors
이경아(Lee, Kyung A) ORCID logo https://orcid.org/0000-0001-5320-6705
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