Multi‐measurement method comparison of three commercial hepatitis B virus DNA quantification assays

Abstract

Serum specimens (327) from patients with chronic hepatitis B were evaluated for hepatitis B virus (HBV) DNA using three commercial assays--Chiron Quantiplex (CA), Digene Hybrid Capture (DA) and Abbott HBV DNA assay (AA). The HBV DNA values obtained following evaluation were used to compare the linearity, responsiveness and precision of each assay and to determine the conversion between the three different assay values. The comparison was accomplished using a new statistical approach termed the multi-measurement method (MMM). MMM is a minimal bias, non-linear regression technique that allows simultaneous multiassay performance evaluation as well as assay value interconversion. MMM analysis demonstrated that the CA was more sensitive and responsive than either the DA or the AA. Both the CA and DA were more precise than the AA. Validation of the MMM results was performed using two additional data sets of 551 and 100 specimens, respectively. MMM is a novel statistical tool that has a broad application for the generation of statistically normalized laboratory data and for interassay standardization.

Outcome of lamivudine-resistant hepatitis B virus is generally benign except in cirrhotics

“…After March 2000, this assay was substituted to a branched-chain assay (Chiron Quantiplex TM , Chiron Corp). Results of the Abbott HBV DNA assay were converted using the Multimeasurement Method [17] .…”

Evaluation of the COBAS Amplicor HBV Monitor Assay and Comparison with the Ultrasensitive HBV Hybrid Capture 2 Assay for Quantification of Hepatitis B Virus DNA

“…Hybridization methods including Genostics liquid hybridization (Abbott Diagnostics, Abbott Park, Ill.), bDNA (Bayer Diagnostics, Tarrytown, N.Y.), and the PCRbased Amplicor HBV Monitor (Roche Molecular Diagnostics, Indianapolis, Ind.) assays have been useful for measuring the upper range of HBV viremia and have been compared extensively (1,3,14,16,18,19,22,23,34,39,43) but have lacked sensitivity, precluding the analysis of some chronic carrier patients with low serum levels of HBV DNA (4,20,41). Improvements in the limit of HBV DNA detection afforded by advanced hybridization and amplification methods have resulted in the discoveries that HBV DNA can be detected in low levels in some patients years after clinical recovery and even when circulating anti-HBs are present (36,47,53).…”

Multicenter Evaluation of the VERSANT Hepatitis B Virus DNA 3.0 Assay

“…In addition, a quantitative evaluation of HBV DNA concentrations can provide valuable information on the levels of viral replication and may be useful as a prognostic indicator of liver disease (4,21). A number of commercial assays are currently available for the quantification of HBV DNA in patient serum or EDTA-plasma, including hybridization-, signal-, and target-amplification-based technologies (5,11,(16)(17)(18)22). Selection of the optimal assay is dependent on the intrinsic performance characteristics of the methodology as well as the necessity to make appropriate clinical decisions in the context of HBV-associated disease (4,15,21).…”