WHO Prequalifies First COVID-19 Rapid Antigen Tests for Long-Term Global Use

WHO noted that prequalified tests can now be prioritized in pooled procurement mechanisms, which help lower prices, stabilize supply chains and overcome regulatory barriers.

 

The World Health Organization (WHO) on 17 December 2025 announced the prequalification of two rapid antigen diagnostic tests (Ag-RDTs) for SARS-CoV-2, the virus responsible for COVID-19, marking a major milestone in global diagnostics. The approved products are the SD Biosensor STANDARD Q COVID-19 Ag Test and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). This is the first time that rapid antigen tests for COVID-19 have achieved full WHO prequalification.

The decision builds on earlier regulatory approvals under WHO’s Emergency Use Listing (EUL) mechanism. In September 2020, at the height of the COVID-19 pandemic, the SD Biosensor STANDARD Q test became the first rapid antigen test ever listed under the EUL, enabling its swift deployment in more than 100 countries. The EUL process is designed to accelerate access to essential health products during public health emergencies, based on a risk–benefit assessment when comprehensive data may not yet be available.

From Emergency Approval to Long-Term Assurance

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.

With prequalification, these rapid antigen tests become eligible for procurement by United Nations agencies, international donors, global health partners and national governments. This is expected to significantly expand access to reliable COVID-19 diagnostics, particularly in low- and middle-income countries (LMICs).

Improving Access and Affordability in LMICs

WHO noted that prequalified tests can now be prioritized in pooled procurement mechanisms, which help lower prices, stabilize supply chains and overcome regulatory barriers. Such mechanisms are critical for countries that struggle with high costs, limited availability and fragmented regulatory systems.

The move is particularly important as many LMICs continue to face constraints in laboratory infrastructure, trained personnel and access to molecular testing technologies.

Continued Need for COVID-19 Testing

More than two and a half years after WHO declared the end of the emergency phase of COVID-19, SARS-CoV-2 continues to circulate globally. While current data indicate relatively stable transmission trends, the virus remains a public health concern, especially for vulnerable populations.

Affordable and accurate diagnostic tools remain essential, particularly in settings where access to laboratory-based PCR testing is limited or delayed.

Role of Rapid Antigen Tests

Rapid antigen-detection tests can deliver results within 15 to 30 minutes, are relatively low-cost, and can be used outside centralized laboratories. They are suitable for use in clinics, community health centres, mobile units and even home settings, enabling faster detection of infectious cases and timely public-health responses.

WHO emphasized that Ag-RDTs are a vital complement to PCR testing, especially in resource-limited environments with restricted laboratory capacity.

Rapid antigen testing remains critical for:

• detecting and controlling local outbreaks

• protecting vulnerable groups and health-care workers

• maintaining preparedness for future respiratory disease pandemics

Part of a Broader Diagnostics Strategy

The prequalification aligns with WHO’s broader diagnostics strategy, which underscores the importance of decentralized, quality-assured testing as a pillar of universal health coverage and global health security. Strengthening diagnostic capacity is seen as essential not only for COVID-19, but also for future emerging infectious threats.

WHO said the milestone reinforces the importance of investing in robust regulatory systems and accessible diagnostics to ensure equitable health outcomes worldwide.