Multicenter evaluation of Xpert HIV‐1 viral load assay for HIV quantification in China.

New approaches to increase HIV‐1 testing and HIV‐1 viral load (VL) monitoring are needed for people living with HIV (PLHIV) in China. The Xpert HIV‐1 VL assay was prequalified by the World Health Organization in 2017 but has not been evaluated in China. A multicenter evaluation was conducted to assess the accuracy of the Cepheid Xpert HIV‐1 VL assay compared to the Abbott RealTime HIV‐1 assay in China. Overall agreement was seen in 558 of 562 specimens (99.29%) with a κ value of 0.962. Pearson's coefficient between the two assays was 0.943. Analyzed by the Bland‐Altman method, the mean bias was −0.54 log10 copies/mL, and 94.05% results fell within the 95% confidence limit of agreement (−1.248 to 0.168 log10 copies/mL). The coefficient of variation of the Cepheid Xpert HIV‐1 VL assay ranged from 0.61% to 1.55%, as determined by testing eight positive plasma specimens with three different lots on different days. Due to its simplicity, random‐access, rapid turnaround time, and accuracy, the Xpert HIV‐1 VL assay can be used in local hospitals and clinics that bear the burden of identifying and treating HIV patients in China. Highlights: A random‐access HIV‐1 quantitative assay (Xpert HIV‐1 VL assay, Cepheid, Sunnyvale, CA) was introduced to China.The positive and negative percent agreements of the Xpert assay were 99.60% and 96.61%, respectively, assessed at a multicenter clinical trial.The coefficient of variation of the Xpert assay ranged from 0.61 to 1.55%.The Xpert HIV‐1 VL assay was rapid and accurate in viral load monitoring at the point of care in China. [ABSTRACT FROM AUTHOR]