Author: admin

On 17 December 2025, 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.

Notes to editors

About WHO prequalification and EUL: For many years, the WHO Prequalification programme has been crucial in speeding up access to health products in LMICs by assessing their quality, safety, and effectiveness. It enables multilateral organizations to purchase quality-assured medicines, vaccines, diagnostic tools, and vector control products, while also providing guidance to developing regulatory authorities that may not yet have the resources to perform their own evaluations. Through its Emergency Use Listing (EUL), WHO prequalification conducts risk-based assessments of products during public health emergencies of international concern to meet urgent public health needs.