Ann Lab Med.  2019 Jan;39(1):86-90. 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

• Park J
• Cho H
• Choi SJ
• Lee GD
• Sin SH
• Ryu JH
• Park HS
• Lee H
• Kim Y
• Oh EJ

• KMID: 2420276
• DOI: http://doi.org/10.3343/alm.2019.39.1.86

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.

Keyword

Analytical performance; HBV DNA monitoring; Beckman Coulter DxN VERIS HBV assay; Abbott RealTime HBV assay

MeSH Terms

DNA
Genotype
Hepatitis B virus*
Hepatitis B*
Hepatitis*
Humans
Laboratories, Hospital
Pathology, Molecular
DNA

Figure

• 

  Fig. 1 Performance evaluation of the Beckman Coulter DxN VERIS HBV assay in comparison with the Abbott RealTime HBV assay in 187 HBV samples. (A) Linearity analysis of HBV DNA levels using serially diluted samples (1.18–7.18 log IU/mL). HBV DNA levels obtained by the VERIS HBV assay were related to calculated HBV DNA levels. The dashed line represents the equality line. (B) Passing-Bablok regression analysis of the VERIS and RealTime HBV assays. The dashed line represents the equality line, and the dotted lines represent 95% confidence interval. (C) Bland-Altman plot analysis of the VERIS and RealTime HBV assays. The straight and dashed lines both represent mean differences±1.96 SD.Abbreviation: HBV, hepatitis B virus.

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