Performance Evaluation of the Beckman Coulter DxN VERIS Hepatitis B Virus (HBV) Assay in Comparison With the Abbott RealTime HBV Assay.
- Author:
Joonhong PARK
1
;
Hanwool CHO
;
Seung Jun CHOI
;
Gun Dong LEE
;
Sang Hyun SIN
;
Ji Hyeong RYU
;
Hye Sun PARK
;
Hyeyoung LEE
;
Yonggoo KIM
;
Eun Jee OH
Author Information
- Publication Type:Brief Communication
- Keywords: Analytical performance; HBV DNA monitoring; Beckman Coulter DxN VERIS HBV assay; Abbott RealTime HBV assay
- MeSH: DNA; Genotype; Hepatitis B virus*; Hepatitis B*; Hepatitis*; Humans; Laboratories, Hospital; Pathology, Molecular
- From:Annals of Laboratory Medicine 2019;39(1):86-90
- CountryRepublic of Korea
- Language:English
- 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.
