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

Authors

Jiafeng Zhang, Xiaobei Ding, Qin Fan, Jiezhe Yang, Yan Xia, Chengliang Chai

Published in

PloS one. Volume 21. Issue 8. Pages e0354737. Epub Aug 05, 2026.

Abstract

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.
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.
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.
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.

PMID:
42555609
Bibliographic data and abstract were imported from PubMed on 06 Aug 2026.

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