*Urine-Based HIV-1 Self-Testing: A Paradigm Shift in Diagnostic Accessibility*

On April 30, 2025, the World Health Organization (WHO) prequalified the first-ever urine-based HIV-1 self-test, developed by Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. This innovation represents a significant advancement in non-invasive, user-friendly HIV diagnostics, particularly pertinent for populations with limited access to traditional testing services.

*Performance Characteristics*

In a comprehensive evaluation involving 2,606 participants across diverse populations, the urine-based HIV-1 self-test demonstrated:

Sensitivity: 92.16%

Specificity: 99.92%

Area Under the Curve (AUC): 0.960 (95% CI: 0.952–0.968)

Notably, the test exhibited exceptional performance among high-risk groups:

Persons with Injection Drug Use (IDU): AUC of 1.000

Pregnant Women (PW): AUC of 0.999

Female Sex Workers (FSWs): AUC of 1.000

These findings underscore the test’s robustness and reliability in real-world settings, particularly among populations that are often underserved by conventional testing modalities.

*Implications for HIV Prevention and the 95–95–95 Targets*

The introduction of this urine-based self-test aligns with global efforts to achieve the UNAIDS 95–95–95 targets by:

1. Enhancing Testing Uptake: By offering a non-invasive, discreet, and user-friendly testing option, the urine-based self-test can significantly increase the proportion of individuals who are aware of their HIV status.

2. Facilitating Early Diagnosis: Early detection through accessible self-testing enables timely initiation of antiretroviral therapy (ART), thereby improving individual health outcomes and reducing HIV transmission rates.

3. Promoting Equity in Healthcare: This innovation addresses barriers to testing faced by marginalized populations, contributing to more equitable healthcare delivery and progress toward epidemic control.

*Conclusion*

The WHO’s prequalification of the urine-based HIV-1 self-test marks a pivotal moment in the global HIV response. By expanding the toolkit of diagnostic options, this advancement holds promise for accelerating progress toward the elimination of HIV as a public health threat.

*References* :

1. Lu H, et al. Diagnostic performance evaluation of urine HIV-1 antibody rapid test kits in a real-life routine care setting in China. BMJ Open. 2024;14:e078694.

2. World Health Organization. Prequalification of In Vitro Diagnostics. April 30, 2025.

Dr Jean Njab
CLSS I ASLM