Rapid diagnosis of acute HIV-1 infection cases: first real-world performance of point-of-care HIV-1 nucleic acid testing in China

Sep 28, 2026

Timely diagnosis of acute HIV infection is essential to curb transmission, yet conventional antibody-based assays fail during the antibody-negative diagnostic window. This multicenter cross-sectional study compared the diagnostic accuracy and operational performance of point-of-care HIV-1 nucleic acid testing (Xpert HIV-1 Viral Load POCT) against laboratory nucleic acid testing in adults with reactive screening and negative or indeterminate Western blot results. POCT showed sensitivity 98.87% and specificity 100%, strong quantitative concordance with LABT, and shortened turnaround time from 7 to 14 days.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages9

Reading Time23 min

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Background

Methods

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Introduction

TYPE Original Research PUBLISHED 19 December 2025 DOI 10.3389/fpubh.2025.1707432 OPEN ACCESS EDITED BY Zisis Kozlakidis, International Agency for Research on Cancer (IARC), France REVIEWED BY Xiaoxu Han, The First Affiliated Hospital of China Medical University, China Alice Lehman, University of Minnesota Twin Cities, United States Mohd Afzal, Galgotias University, India *CORRESPONDENCE Cong Jin [jinc@chinaaids.cn](jinc@chinaaids.cn)[ ](jinc@chinaaids.cn)Desheng Huang [dshuang@cmu.edu.cn](dshuang@cmu.edu.cn) †These authors have contributed equally to this work and share first authorship RECEIVED 17 September 2025 REVISED 23 November 2025 ACCEPTED 26 November 2025 PUBLISHED 19 December 2025 CITATION Niu M, Xu X, Shi Y, Zhang X, Guan P, Wang Y, Dong L, Chen H, Huang D and Jin C (2025) Rapid diagnosis of acute HIV-1 infection cases: first real-world performance of point-of-care HIV-1 nucleic acid testing in China. Front. Public Health 13:1707432 . doi: 10.3389/fpubh.2025.1707432 COPYRIGHT © 2025 Niu, Xu, Shi, Zhang, Guan, Wang, Dong, Chen, Huang and Jin. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Rapid diagnosis of acute HIV-1 infection cases: first real-world performance of point-of-care HIV-1 nucleic acid testing in China Mingzhu Niu 1†, Xiaoqin Xu 2†, Yuhua Shi3†, Xin Zhang4, Peng Guan 1, Yu Wang4, Lijuan Dong3, Huichao Chen3, Desheng Huang 1, 5* and Cong Jin4* 1Department of Epidemiology, School of Public Health, China Medical University, Shenyang, China, 2Department of HIV/STD Prevention and Control, Jiangsu Provincial Center for Disease Prevention and Control, Nanjing, China, 3Yunnan Center for Disease Control and Prevention, Kunming City, China, 4National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China, 5Department of Intelligent Computing, School of Intelligent Medicine, School of Fundamental Sciences, 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 laboratorybased 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 COBASTaqMan v2 .0 or Abbott RealTime HIV-1 assays, with follow-upseroconversion 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

FAQs

What problem does the study address about acute HIV-1 diagnosis?

The study targets the limited utility of conventional serological assays during the early acute phase, when antibody development has not yet occurred and conventional tests have a diagnostic window problem.

How was the point-of-care test evaluated in the study?

A multicenter cross-sectional design compared the POCT results with laboratory nucleic acid testing, using follow-up seroconversion as the reference standard and also assessing turnaround time and staff usability via questionnaire.

What were the main findings of POCT performance compared with laboratory testing?

POCT achieved sensitivity 98.87% and specificity 100.00%, showed almost perfect agreement with LABT, demonstrated strong correlation for quantitative viral load, and reduced the median time to result reporting compared with LABT.

Sep 28, 2026

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