Bridging the monitoring gap in resource-limited settings: A head-to-head evaluation of two Chinese HIV-1 RNA quantification assays and Roche TaqMan

Abstract

Background HIV-1 RNA quantification assays are essential for evaluating antiretroviral therapy (ART) efficacy and diagnosing HIV infection, playing a pivotal role in HIV/AIDS management and treatment. Methods This study compares two Chinese-manufactured HIV-1 RNA quantification assays (Livzon, SymBio) with the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test v2.0 (reference assay) using plasma samples from 279 HIV-infected individuals. Results The reference assay had a positive detection rate of 92.47% (258/279), while Livzon and SymBio assays both achieved 94.62% (264/279). The positive agreement was 98.06% (95% CI: 95.54–99.17%), and the overall agreement was 94.27% (95% CI: 90.89–96.44%). In the linear regression analysis, Livzon demonstrated a correlation coefficient (r) of 0.989, and Bland–Altman analysis indicated a mean bias of 0.18 log10 copies/mL; SymBio showed r = 0.988 with a mean bias of −0.09 log10 copies/mL. Both assays showed Pearson correlation coefficients greater than 0.985 and biases ranging from −0.17 to 0.24 log10 copies/mL compared with Roche across diverse HIV subtypes. Direct comparison between the two domestic assays revealed a strong correlation (r = 0.988), with a mean difference (Livzon – SymBio) of 0.27 log10 copies/mL. Regarding cost and turnaround time (TAT), the domestic assays were priced more than 30% lower, and batch TAT was reduced by 20–50% relative to the reference assay. Conclusions Both Chinese-manufactured assays demonstrated strong quantitative correlation, and consistency, meeting the performance standards required for HIV-1 viral load detection. These assays also offer substantial cost and turnaround time advantages, making them well-suited to bridge the HIV-1 monitoring gap in resource-limited settings.