Ann Lab Med 2019; 39(1): 86-90  https://doi.org/10.3343/alm.2019.39.1.86
Performance Evaluation of the Beckman Coulter DxN VERIS Hepatitis B Virus (HBV) Assay in Comparison With the Abbott RealTime HBV Assay
Joonhong Park, M.D., Ph.D.1,2, Hanwool Cho, M.D.1, Seung Jun Choi, M.D.1, Gun Dong Lee, M.T.3, Sang Hyun Sin, M.T.3, Ji Hyeong Ryu, M.S.3, Hye-Sun Park, M.S.3, Hyeyoung Lee, M.D.4, Yonggoo Kim, M.D., Ph.D.1,2, and Eun-Jee Oh, M.D., Ph.D.1,2
1Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea; 2Catholic Laboratory Development and Evaluation Center, College of Medicine, The Catholic University of Korea, Seoul, Korea; 3Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea; 4Department of Laboratory Medicine, Samkwang Medical Laboratories, Seoul, Korea
Corresponding author: Eun-Jee Oh, M.D.
https://orcid.org/0000-0001-5870-915X
Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
Tel: +82-2-2258-1641
Fax: +82-2-2258-1719
E-mail: ejoh@catholic.ac.kr
Received: November 7, 2017; Revised: February 13, 2018; Accepted: August 16, 2018; Published online: January 1, 2019.
© Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
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-DxN VERIS Molecular Diagnostics System (Beckman Coulter, Brea, CA, USA)-with 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: 7.32–12.00 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.
Keywords: Analytical performance, HBV DNA monitoring, Beckman Coulter DxN VERIS HBV assay, Abbott RealTime HBV assay



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