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Multicenter evaluation of Xpert HIV-1 viral load assay for HIV quantification in China |
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| Authors: | Lifeng Liu Renni Deng Yun Lan Li Li Mei Li Bin Su Devasena Gnanashanmugam Yi-Wei Tang Hao Wu Jing Wang Xiaoli Cai Tong Zhang |
| Affiliation: | 1. Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing, China;2. Department of Medical Laboratory, Chongqing Public Health Medical Center, Chongqing, China;3. Infectious Disease Institute, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China;4. Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing, China Beijing Key Laboratory for HIV/AIDS Research, Beijing, China;5. Cepheid, Sunnyvale, California |
| Abstract: | 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. |
| Keywords: | accuracy China HIV viral load multicenter Xpert |