WHO Prequalifies First Rapid Antigen Tests For COVID-19, Strengthening Global Diagnostic Preparedness

More than two years after the World Health Organization (WHO) declared an end to the emergency phase of the Covid-19 pandemic, the virus continues to circulate globally. While current data suggest that SARS-CoV-2 activity has stabilised, the need for accessible, reliable diagnostic tools remains critical—particularly in low-resource settings.

In a significant step towards strengthening long-term diagnostic preparedness, the WHO has announced the prequalification of two rapid antigen diagnostic tests (Ag-RDTs) for Covid-19, marking a global regulatory milestone.

On December 17, 2025, WHO granted prequalification status to 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 rapid antigen tests for SARS-CoV-2 have achieved WHO prequalification, signalling that these products meet international benchmarks for quality, safety and performance beyond emergency conditions.

The decision builds on earlier regulatory approvals under WHO’s Emergency Use Listing (EUL) mechanism, which was introduced during the height of the pandemic to fast-track access to life-saving health technologies. Notably, the SD Biosensor STANDARD Q test became the world’s first rapid antigen test to receive EUL approval in September 2020, enabling widespread deployment across more than 100 countries at a time when laboratory-based testing capacity was severely constrained.

While EUL assessments are designed to weigh benefits against risks using limited data during public health emergencies, WHO prequalification represents a more rigorous and permanent validation process. It confirms that the diagnostic products consistently meet WHO’s standards under normal regulatory conditions, providing confidence to governments and health agencies planning long-term testing strategies.

Importantly, prequalification also makes these tests eligible for procurement by United Nations agencies, international donors and global health partners, significantly expanding their reach. This is expected to improve access to high-quality Covid-19 diagnostics in low- and middle-income countries (LMICs), where testing gaps persist due to high costs, limited supply chains and regulatory hurdles. The tests can now be included in pooled procurement initiatives, helping reduce prices, stabilise supply and ensure equitable distribution.

Despite the easing of pandemic-level restrictions, Covid-19 continues to pose a public health risk. WHO has cautioned that surveillance must not weaken, especially in regions with fragile health systems. Affordable and accurate diagnostics remain essential for monitoring virus circulation, identifying outbreaks early and protecting high-risk populations.

Rapid antigen-detection tests play a crucial role in this effort. Delivering results within 15 to 30 minutes, these tests are easy to use, cost-effective and can be deployed outside centralised laboratories, including in clinics, community settings and mobile health units. Their ability to provide quick answers makes them particularly valuable for timely clinical decisions and public-health interventions.

Ag-RDTs also serve as a vital complement to molecular tests such as PCR, which, while highly sensitive, require specialised laboratories, trained personnel and longer turnaround times. In settings with limited laboratory infrastructure, rapid tests often represent the most practical and scalable testing option.

According to WHO, rapid antigen testing remains essential for detecting and controlling local outbreaks, safeguarding vulnerable populations and healthcare workers, and maintaining readiness for future respiratory pandemics. The organisation’s broader diagnostics strategy continues to emphasise the importance of decentralised, quality-assured testing as a cornerstone of universal health coverage and global health security.

Experts said that as the world transitions from emergency response to sustained disease management, WHO’s move to prequalify

Covid-19 rapid tests underscores the need for durable diagnostic solutions that remain accessible long after a crisis fades.