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

IF 2.1 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2025-01-30 DOI:10.1016/j.diagmicrobio.2025.116723

Yue Chang , Ting Zhu , Yufei Miao , Haiyin Zhu , Zhixin Hao , Taisheng Li , Yang Han

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Abstract

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.

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来源期刊

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.