WHO Prequalifies First COVID-19 Rapid Antigen Tests for Long-Term Global Use
核心洞察
The World Health Organization announced on December 17, 2025, the prequalification of two rapid antigen diagnostic tests for SARS-CoV-2 (搜索), marking the first time COVID-19 (搜索) rapid antigen tests have achieved full WHO prequalification.
The approved tests are the SD Biosensor STANDARD Q COVID-19 Ag Test (搜索) and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (搜索), which provide results in 15-30 minutes and can be used outside centralized laboratories.
WHO prequalification confirms these tests meet stringent standards for quality, safety and performance, making them eligible for procurement by UN agencies and expanding access in low- and middle-income countries.
The World Health Organization announced on December 17, 2025, the prequalification of two rapid antigen diagnostic tests for SARS-CoV-2 (搜索), representing a significant milestone in global COVID-19 (搜索) diagnostics. The approved products are the SD Biosensor STANDARD Q COVID-19 Ag Test (搜索) and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (搜索) (Self-Testing), marking the first time that rapid antigen tests for COVID-19 have achieved full WHO prequalification.
From Emergency Authorization to Long-Term Assurance
This achievement builds on earlier regulatory milestones under WHO's Emergency Use Listing (EUL) mechanism. In September 2020, the SD Biosensor STANDARD Q COVID-19 Ag Test (搜索) 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 (搜索) pandemic. The EUL process is designed to accelerate access to life-saving health products during public health emergencies, based on limited available data where the benefits outweigh the risks.
WHO prequalification represents a higher and more comprehensive level of regulatory review than emergency listing. It confirms that the two tests meet WHO's stringent standards for quality, safety and performance, providing long-term confidence in their reliability. Unlike the EUL, which is time-limited and emergency-focused, prequalification supports sustained use beyond crisis conditions.
Expanding Access in Resource-Limited Settings
With prequalification, these rapid antigen tests become eligible for procurement by United Nations (搜索) agencies, global health partners and countries, significantly expanding access to rapid, reliable diagnostic tests in low- and middle-income countries (LMICs). The tests 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.
The move is particularly important as many LMICs continue to face constraints in laboratory infrastructure, trained personnel and access to molecular testing technologies. Such mechanisms are critical for countries that struggle with high costs, limited availability and fragmented regulatory systems.
Continued Clinical Need for COVID-19 Testing
More than two and a half years after WHO announced the end of the emergency phase of COVID-19 (搜索), the virus continues to circulate worldwide, though current evidence indicates relatively stable trends of SARS-CoV-2 (搜索) 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.
Strategic Role in Global Health Security
According to WHO, rapid antigen testing remains essential for detecting and controlling local outbreaks, protecting vulnerable populations and health-care workers, and maintaining preparedness for future respiratory pandemics. The prequalification aligns with WHO's broader diagnostics strategy, which highlights the ongoing need for decentralized, quality-assured testing as part of universal health coverage and global health-security efforts.
WHO emphasized that strengthening diagnostic capacity is seen as essential not only for COVID-19 (搜索), but also for future emerging infectious threats, reinforcing the importance of investing in robust regulatory systems and accessible diagnostics to ensure equitable health outcomes worldwide.