Evaluating a novel quantitative assay for HIV-1 VL among Chinese individuals infected with HIV

Monitoring viral load (VL) is essential for HIV/AIDS treatment management. China's reliance on costly imported VL assays limits accessibility. In this study, we evaluated the Revvity, a novel quantitative PCR-based HIV-1 VL assay developed in China, against the Roche Cobas assay for qualitative and quantitative concordance using concordance, linear regression, and Bland-Altman analysis. Assessing 399 samples from HIV-positive outpatients, we found 99.19 % (368/371) agreement on positivity and a strong correlation (r = 0.981, p < 0.0001) over the assays' linear ranges. The mean log10 copies/mL difference between assays was -0.025 (95 % CI: -0.055 to -0.005). At VL ≥1000 copies/mL, VL <1000 copies/mL, and VL <200 copies/mL, 94.0 %, 96.1 %, and 92.9 % of paired results fell within 95 % limits of agreement, respectively. Notably, Revvity was more effective at identifying low VL samples as positive compared to Roche. The Revvity assay offers a consistent, cost-effective alternative for HIV VL monitoring, especially beneficial in resource-limited settings.