The USAID-Approved HIV Rapid Test Kits (RTKs) are those approved by:

(1) USAID on the “USAID-Approved List of HIV/AIDS Rapid Test Kits” below; and

(2) the World Health Organization (WHO) Prequalification of Medicines Programme (See https://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/.)

USAID no longer has a process for evaluating HIV RTKs. To be USAID-approved an HIV RTK must now be approved by the United States Food and Drug Administration (FDA) or WHO.

We do not list the RTKs approved by WHO. The WHO list is incorporated by reference.

The HIV RTKs are approved for clinical use. HIV RTKs for use in research settings are approved separately by the Supply Chain for Health Division, Office of HIV/AIDS, Bureau for Global Health (GH/OHA/SCH).