The World Health Organization (WHO) has for the first time prequalified two rapid antigen detection tests (Ag‑RDTs) for SARS‑CoV‑2, the virus that causes COVID‑19, a move that sets a long‑term global standard for quality, safety and performance of these diagnostics.
The tests that achieved prequalification are the SD Biosensor STANDARD Q COVID‑19 Ag Test and the ACON Biotech Flowflex SARS‑CoV‑2 Antigen Rapid Test (Self‑Testing), marking the first time any rapid antigen tests for COVID‑19 have been prequalified by WHO.
Both tests build on earlier regulatory milestones, having previously been listed under WHO’s Emergency Use Listing (EUL), a risk‑benefit assessment mechanism used during public health emergencies to accelerate access to health products based on limited data when benefits outweigh risks. The SD Biosensor STANDARD Q was the first rapid antigen test ever listed under WHO’s EUL in September 2020 and was deployed in more than 100 countries during the pandemic.
WHO prequalification now provides long‑term quality assurance that the two tests meet WHO standards for quality, safety and performance, making them eligible for procurement by United Nations agencies, global health partners and countries. This expands access to rapid, reliable COVID‑19 diagnostics in low‑ and middle‑income countries, supporting pooled procurement initiatives aimed at reducing prices and improving supply stability, and helping countries overcome barriers related to cost, supply and regulatory constraints.
The prequalification decision comes as SARS‑CoV‑2 continues to circulate globally two and a half years after WHO declared an end to the emergency phase of COVID‑19, with evidence indicating relatively stable virus activity trends. The continuing presence of the virus underscores ongoing demand for affordable, accurate diagnostic tools, particularly in lower‑income settings with limited access to laboratory testing.
Rapid antigen tests, which provide results within 15–30 minutes, are affordable and can be deployed outside centralized laboratories in clinics, community sites and mobile settings, making them a critical complement to molecular tests such as PCR in resource‑limited environments.
WHO’s broader diagnostics strategy highlights the essential role of decentralized, quality‑assured testing in detecting and controlling local outbreaks, protecting vulnerable populations and healthcare workers, and maintaining preparedness for future respiratory pandemics as part of efforts toward universal health coverage and global health security.
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