%0 Journal Article
%T Performance Evaluation of the Beckman Coulter DxN VERIS Hepatitis B Virus (HBV) Assay in Comparison With the Abbott RealTime HBV Assay
%A Eun-Jee Oh
%A Gun Dong Lee
%A Hanwool Cho
%A Hye-Sun Park
%A Hyeyoung Lee
%A Ji Hyeong Ryu
%A Joonhong Park
%A Sang Hyun Sin
%A Seung Jun Choi
%A Yonggoo Kim
%J Archive of "Annals of Laboratory Medicine".
%D 2019
%R 10.3343/alm.2019.39.1.86
%X The detection and quantification of hepatitis B virus (HBV) DNA plays an important role in diagnosing and monitoring HBV infection as well as in assessing the therapeutic response. We compared the analytical performance of a random access, fully automated HBV assay¡ªDxN VERIS Molecular Diagnostics System (Beckman Coulter, Brea, CA, USA)¡ªwith that of Abbott RealTime HBV assay (Abbott Laboratories, Des Plaines, IL, USA). The between-day precision of the VERIS assay ranged from 0.92% (mean 4.68 log IU/mL) to 4.15% (mean 2.09 log IU/mL) for pooled sera from HBV patients. HBV DNA levels measured by the VERIS HBV assay correlated with the calculated HBV DNA levels (r2=0.9994; P<0.0001). The lower limit of quantification was estimated as 8.76 IU/mL (Probit analysis, 95% confidence interval: 7.32¨C12.00 IU/mL). Passing-Bablok regression analysis showed good concordance between the VERIS and RealTime assays for 187 chronic HBV samples (y=£¿0.2397+0.9712x; r=0.981), as well as for 20 drug-resistant HBV genotype C positive samples (y=£¿0.5415+0.9954x; r=0.961). The VERIS assay demonstrated performance similar to the RealTime assay and is suitable for high-throughput HBV DNA monitoring in large hospital laboratories
%K Analytical performance
%K HBV DNA monitoring
%K Beckman Coulter DxN VERIS HBV assay
%K Abbott RealTime HBV assay
%U https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6143473/