Performance Evaluation of Aptima HBV and HCV Quant Assays in the Panther System

Abstract

Background: Hepatitis B virus (HBV) and hepatitis C virus (HCV) infections remain a serious health problem despite advancements in their prevention and treatment. Guidelines on their management recommend using viral DNA/RNA titers. Thus, accurate measurement and prompt reporting are crucial. Methods: The performances of the Aptima HBV and HCV Quant assays (Hologic Inc., USA) were analyzed. The results were compared with those of Cobas 4800 (Roche Molecular Systems, USA). Linearity, limit of detection (LoD), and precision were evaluated as recommended in each corresponding CLSI guideline. Results: Passing-Bablok regression analysis showed a high correlation between the two assays: regression line was y =0.0684+1.025x (95% CI: 0.9604-1.092) for HBV and y =-0.9650+1.141x (95% CI: 1.071-1.226) for HCV. Agreement between the assays’ qualitative results based on categorical analysis was 82.30% (185/224) (κ: 0.738, 95% CI: 0.701-0.775) for HBV and 94.52% (69/73) (κ: 0.855, 95% CI: 0.796-0.914) for HCV. The LoD values for HBV and HCV were 4.448 IU/mL and 6.166 IU/mL, respectively. The percent coefficient of variation (%CV) for the HBV assay for both low and high positive controls was less than 2%, whereas for the HCV assay, %CV for low positive control was 3.20%. Conclusions: Overall, the Aptima HBV and HCV Quant assays demonstrated a high correlation with Cobas 4800. These tests were both sensitive and precise. Therefore, we conclude that the Aptima assay is a practical tool in the management of HBV- and HCV-infected patients.