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Background: The quantification of hepatitis B virus (HBV) DNA is used to monitor antiviral treatment for HBV infection. Recently, an HBV-DNA quantification reagent and assay protocol have been developed for the µTASWako g1 (Fujifilm Wako Pure Chemical Corporation, Osaka, Japan), a fully automated genetic analyzer that uses PCR-capillary electrophoresis. We evaluated the performance of the newly developed µTASWako HBV-DNA assay using standard and clinical samples.
Methods: The performance of µTASWako HBV-DNA was evaluated using 3rd World Health Organization International Standard for HBV. Thereafter, we evaluated the correlation between the serum HBV DNA concentrations obtained using the µTASWako HBV-DNA and the Roche Cobas AmpliPrep/COBAS TaqMan HBV test, version 2.0 (CAP/CTM HBV test v.2.0) using 190 serum samples from possible HBV carriers.
Results: The limit of detection of the µTASWako HBV-DNA was 7.1 IU/mL and that of the CAP/CTM HBV test v.2.0 was 14.6 IU/mL. Seventy-six of the 190 samples yielded values between 1.3 - 7.8 log IU/mL from both assays. The correlation between the results of the assays for these samples was good, with a Deming regression equation of y = 0.929x + 0.041, 95% confidence intervals (CI) for the slope and intercept of 0.892 - 1.12 and -0.474 - 0.110, respectively, and a correlation coefficient r = 0.924. In the low concentration range of 1.3 - 4.0 log IU/mL (n = 64), the Deming regression equation was y = 0.893x + 0.126, and the 95% CIs for the slope and intercept were 0.915 - 1.342 and -0.930 - 0.025, respectively, and r = 0.809. There was also a close correlation for HBV DNA genotype C (n = 41), with a Deming regression equation of y = 0.975x - 0.048, 95% CIs of the slope and intercept of 0.872 - 1.183 and -0.591 - 0.188, respectively, and r = 0.950. The correlations of the four HBV DNA level categories (not detected, < LLOQ (< 1.3 log IU/mL), 1.3 - 3.2 log IU/mL, and ≥ 3.3 log IU/mL) between the two assays for the 190 samples was also compared, and the overall concordance rate was 81.6% (155/190), with a κ statistic of 0.73 (standard error, 0.040; 95% CI, 0.647 - 0.803).
Conclusions: The µTASWako HBV-DNA has a performance comparable with that of the CAP/CTM HBV test, v.2.0. Thus, µTASWako HBV-DNA is useful for the monitoring of HBV infection.
DOI: 10.7754/Clin.Lab.2023.230312
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