Clinical evaluation of the COBAS Amplicor HBV monitor test for measuring serum HBV DNA and comparison with the Quantiplex branched DNA signal amplification assay in Taiwan. Issue 2 (27th January 2004)

• Record Type: Journal Article
• Authors: Dai, C-Y; Yu, M-L; Chen, S-C; Lin, Z-Y; Hsieh, M-Y; Wang, L-Y; Tsai, J-F; Chuang, W-L; Chang, W-Y
• Is Part Of: Journal of clinical pathology. Volume 57:Issue 2(2004)
• Page Start: 141
• Page End: 145
• Publication Date: 2004-01-27
• Subjects: COBAS AM test -- branched DNA assay -- hepatitis B virus -- hepatitis B virus DNA -- hepatitis B virus e antigen; ALT, alanine aminotransferase -- bDNA, branched DNA signal amplification -- COBAS-AM, COBAS Amplicor HBV monitor -- eq, equivalent -- HBV, hepatitis B virus -- HBeAg, hepatitis B virus e antigen -- HBsAg, hepatitis B virus surface antigen -- LLOD, lower limit of detection -- PCR, polymerase chain reaction; Pathology -- Periodicals; Pathology, Molecular -- Periodicals; 616.0705
• DOI: 10.1136/jcp.2003.10835
• Languages: English
• ISSNs: 0021-9746

Abstract

Abstract : Aims: To evaluate the performance characteristics and clinical usefulness of the COBAS Amplicor HBV monitor (COBAS-AM) test in Taiwan and to examine its correlation with the Quantiplex branched DNA signal amplification (bDNA) assay for measuring serum hepatitis B virus (HBV) DNA concentrations. Methods: HBV DNA was measured by the COBAS-AM test in 149 sera from chronic HBV infected patients that had previously been analysed by the bDNA assay. Results: The COBAS-AM test showed good reproducibility, with acceptable intra-assay and interassay coefficients of variation (1.6% and 0.9%, respectively) and good linearity ( r 2 = 0.98). The overall sensitivity of the COBAS-AM test was significantly higher than that of the bDNA assay (95.3% v 83.2%): 69.6% of samples with HBV DNA below the detection limit of the bDNA assay could be measured by the COBAS-AM test. There was a significant correlation between the results of the two assays ( r = 0.901; p < 0.0001). On average, the results derived from the COBAS-AM test were 0.55 log lower than those of the bDNA assay. HBV DNA concentrations were significantly higher among HBV e antigen (HBeAg) positive patients than negative ones, and higher among patients with abnormal alanine aminotransferase (ALT) concentrations than those with normal ALT concentrations (p = 0.0003). Conclusions: The COBAS-AM assay, more sensitive in HBeAg negative samples than the bDNA assay, can effectively measure HBV DNA concentrations in Taiwanese patients. HBV DNA values measured by the COBAS-AM test and bDNA assay correlate significantly.