WHO prequalifies the first two rapid antigen detection tests for COVID-19
The World Health Organization (WHO) announced the prequalification of two rapid antigen diagnostic tests (Ag-RDT) for SARS-CoV-2, the virus that causes COVID-19. The two tests are the SD Biosensor STANDARD Q COVID-19 Ag Test and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). This marks the first time that rapid antigen tests for SARS-CoV-2 have achieved WHO prequalification.
This achievement builds on earlier regulatory milestones for these products previously listed under WHO’s Emergency Use Listing (EUL). In September 2020, the SD Biosensor STANDARD Q COVID-19 Ag Test became the first rapid antigen test ever listed under WHO’s EUL, enabling its rapid deployment across more than 100 countries during the COVID-19 pandemic. WHO EUL is a risk-benefit assessment, designed to accelerate access to life-saving health products during public health emergencies, based on limited available data where the benefits outweigh the risks.
The new WHO prequalification now provides long-term quality assurance, confirming that the products meet WHO standards for quality, safety and performance. It also makes these Ag-RDTs eligible for procurement by United Nations agencies, global health partners and countries, expanding access to rapid, reliable diagnostic tests in low- and middle-income countries (LMICs). The test can be prioritized in pooled procurement initiatives aimed at reducing prices and improving supply stability in LMICs, ultimately helping countries overcome barriers to accessing high-quality diagnostic tests due to cost, supply and regulatory constraints.
Two and a half years after WHO announced the end of the emergency phase of COVID-19, the virus continues to circulate worldwide, though current evidence indicates relatively stable trends of SARS-CoV-2 activity. The need for affordable, accurate diagnostic tools remains strong, especially in the world’s lower income countries where access to laboratory testing is limited.
Rapid antigen-detection tests provide results in 15–30 minutes, are affordable, and can be used outside centralized laboratories – in clinics, community sites and mobile settings – making them critical for timely detection of infectious cases and targeted public-health action. They are a vital complement to molecular (polymerase-chain reaction or PCR) tests, particularly in resource-limited settings with limited laboratory capacity.
Rapid antigen testing remains essential for:
- detecting and controlling local outbreaks
- protecting vulnerable populations and health-care workers
- maintaining preparedness for future respiratory pandemics.
WHO’s broader diagnostics strategy highlights the ongoing need for decentralized, quality-assured testing as part of universal health coverage and global health-security efforts.
