Performance evaluation of the AccuPower HBV Quant assay compared to the Cobas 6800 HBV assay

초록

Background: Accurate detection and quantification of hepatitis B virus (HBV) DNA are essential for managing chronic HBV infection, guiding therapeutic decisions, and monitoring responses to antiviral therapy. This study evaluated the analytical performance of the AccuPower HBV Quant assay, a novel lyophilized molecular diagnostic reagent designed for HBV viral load quantification on the fully automated, random-access ExiStation FA 96 system, and compared it with the Cobas 6800 HBV assay. Methods: The analytical performance of the AccuPower HBV Quant assay was assessed by evaluating precision, linearity and analytical sensitivity. Its clinical performance was assessed and compared with that of the Cobas 6800 HBV assay using 421 clinical plasma samples. Results: The AccuPower HBV Quant assay demonstrated linear quantification of HBV DNA in plasma samples. The standard deviations for intra- and inter-assay variability ranged from 0.03 to 0.10 log10 IU/mL. The limit of detection was estimated at 4.37 IU/mL. The assay showed a strong correlation with the Cobas 6800 HBV assay (correlation coefficient r = 0.980), with a mean observed bias of -0.09 log10 IU/mL. Conclusion: The AccuPower HBV Quant assay, using the ExiStation FA system, was demonstrated to be a sensitive and reliable method for quantifying HBV DNA levels.

키워드