Rapid Diagnosis of Acute HIV-1 Infection Cases: First real-world performance of point-of-care HIV-1 nucleic acid testing in China

Mingzhu Niu¹Xiaoqin Xu²Yuhua Shi³Xin Zhang⁴Peng Guan¹Yu Wang⁴Lijuan Dong³Huichao Chen³De-Sheng Huang^5*Cong Jin^4*

• ¹Department of Epidemiology, China Medical University, Shenyang, China
• ²Department of HIV/STD Prevention and Control, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China
• ³Yunnan Center for Disease Control and Prevention, Kunming, China
• ⁴National Center for AIDS STD Control and Prevention, Beijing, China
• ⁵Department of Mathematics, China Medical University, Shenyang, China

Background: Timely diagnosis of acute HIV infection (AHI) is critical for curbing transmission. However, the diagnostic window prior to antibody development limits the utility of conventional serological assays. Conventional laboratory-based nucleic acid testing (LABT) is often hindered by operational complexity and long turnaround times. Point-of-care nucleic acid testing (POCT) provides a rapid alternative. Methods: This multicenter cross-sectional study enrolled 1,829 adults from 13 cities in Jiangsu Province and Kunming, Yunnan Province, who had reactive screening results but negative or indeterminate Western blot outcomes. The diagnostic accuracy, quantitative correlation, and agreement of the POCT (Xpert® HIV-1 Viral Load point-of-care test) were compared with LABT using the Roche COBAS TaqMan v2.0 or Abbott RealTime HIV-1 assays, with follow-up seroconversion serving as the reference standard. Turnaround time from initial screening to NAT result reporting was compared using Kaplan-Meier analysis. Laboratory staff perceptions of POCT usability were evaluated via questionnaire. Results: Using follow-up seroconversion as a reference, POCT demonstrated a sensitivity of 98.87% and specificity of 100.00%, with almost perfect agreement with LABT (99.76%, Cohen's κ=0.994). Quantitative viral load results exhibited strong correlation between POCT and LABT (r=0.89), with 94.64% of paired measurements falling within the limits of agreement. POCT significantly reduced the median time from initial screening to result reporting compared to LABT (7 vs. 14 days, p<0.001) and increased the likelihood of results being returned within 7 days (Hazard Ratio=2.29, p<0.001). Most laboratory personnel reported ease of use (30/33, 90.9%) and a preference for the POCT workflow (21/33, 63.6%). Conclusions: The Xpert HIV-1 POCT provides a highly accurate and rapid alternative to LABT for diagnosing AHI in China. Its implementation can dramatically shorten diagnostic delays, potentially reducing loss to follow-up and onward transmission, thus offering significant value within the national HIV diagnostic framework.