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Urine-based HIV-1 self-testing in China: A cross-sectional diagnostic accuracy and usability study
Mingzhu Niu1, Zhijun He1, Xin Zhang2
1Department of Epidemiology, School of Public Health, China Medical University, Shenyang, 110122, China.
Scientific Reports
|December 24, 2025
Summary
Urine-based HIV self-testing (HIVST) is accurate and easy to use for reaching undiagnosed individuals. This convenient, non-invasive method shows high reliability, supporting expanded HIV testing coverage in China.
Area of Science:
- Public Health
- Infectious Diseases
- Diagnostic Accuracy
Background:
- Expanding HIV testing is crucial for the UNAIDS 95-95-95 goals.
- Urine-based HIV self-testing (HIVST) offers a novel approach to reach undiagnosed populations.
Purpose of the Study:
- To evaluate the diagnostic accuracy, usability, and acceptability of urine-based HIVST.
- To assess its performance in untrained users under real-world conditions in China.
Main Methods:
- A multicenter cross-sectional study involving 1,495 participants.
- Evaluation of diagnostic accuracy (sensitivity, specificity) and agreement between self-testing and professional testing.
- Assessment of usability and acceptability in unsupervised settings.
Main Results:
- Urine-based HIVST demonstrated high diagnostic accuracy: 99.44% sensitivity and 100.00% specificity.
- Perfect agreement was observed between self-testers and professionals, and between home-based and facility-based testing.
- Most participants performed the test correctly and independently, reporting high satisfaction.
Conclusions:
- Urine-based HIVST is an accurate, convenient, and acceptable testing method.
- It serves as a promising alternative to blood or oral fluid tests, accommodating diverse needs.
- This non-invasive approach is expected to expand HIV testing coverage and contribute to UNAIDS targets in China.
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