Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load.

HIV-1 viral load testing is essential for monitoring antiretroviral therapy response in HIV-1-infected patients. This study aimed to evaluate the clinical performance of the AccuPower HIV-1 Quant Kit (Bioneer), a newly developed HIV-1 viral load assay designed for use on the fully automated ExiStation FA 96 system. A total of 376 archived plasma samples were tested in parallel using the AccuPower HIV-1 assay and the Aptima HIV-1 Quant Dx Assay (Hologic), an FDA-cleared HIV-1 viral load assay performed on the fully automated Panther system. The AccuPower HIV-1 assay demonstrated viral load measurements comparable to those of the Aptima HIV-1 assay, with a strong correlation (r = 0.979) and a mean bias of -0.107 log₁₀ copies/mL. Agreement between the two assays at clinically relevant thresholds of 50, 200, and 1,000 copies/mL was high (96.0%-98.9%). These results indicate that the AccuPower HIV-1 assay provides diagnostic performance comparable to that of the Aptima HIV-1 assay. Given that the ExiStation FA 96 system incorporates automated de-capping and re-capping functions and supports high-throughput testing of up to 576 samples per 8 h, the AccuPower HIV-1 assay represents a practical option for HIV-1 viral load testing in clinical laboratories.