The World Health Organization (WHO) said on 24 December 2025 that it has prequalified two rapid antigen diagnostic tests (Ag-RDTs) for SARS-CoV-2, the virus that causes COVID-19.
According to the WHO, 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-test).
The WHO said this is the first time any rapid antigen tests for COVID-19 have achieved WHO pre-qualification, marking a major regulatory milestone nearly three years after the end of the emergency phase of the pandemic.
Why is WHO prequalification important?
WHO said prequalification provides long-term assurance of quality, safety and performance, unlike emergency authorizations, which are time-limited. According to the WHO, prequalification allows United Nations agencies, global health partners and national governments to conduct these tests with confidence, particularly in low- and middle-income countries (LMICs).
The WHO noted that prequalified tests can also be included in joint procurement mechanisms, helping to reduce prices, stabilize supply chains and reduce regulatory barriers that often limit access to diagnostics in poorer countries.
How does this build on earlier approvals?
The WHO explained that both tests were previously approved under its Emergency Use Mechanism (EUL). In September 2020, the WHO reported that the SD Biosensor STANDARD Q test became the first rapid antigen test ever to be EULed, enabling rapid introduction in more than 100 countries during the height of the COVID-19 pandemic.
According to the WHO, the EUL process is a risk-benefit assessment designed for public health emergencies that allows faster access to life-saving tools when full regulatory data may not yet be available.
Why does the WHO say rapid antigen tests are still important?
The WHO said that although the emergency phase of COVID-19 ended about two and a half years ago, SARS-CoV-2 continues to circulate globally. Current evidence, the WHO said, shows relatively stable trends, but the need for affordable and accurate diagnostics remains strong.
The WHO emphasized that this need is particularly urgent in lower-income countries where access to laboratory PCR testing is limited or uneven.
What role do rapid antigen tests play?
According to the WHO, rapid antigen tests provide results in 15 to 30 minutes, are cost-effective and can be used outside of centralized laboratories. The WHO said they can be deployed in clinics, community facilities and mobile units, making them critical for early detection of infectious cases.
WHO emphasized that Ag-RDTs are an essential adjunct to PCR tests, especially in settings with limited laboratory infrastructure.
According to WHO, when is rapid testing necessary?
The WHO stated that rapid antigen testing remains essential for:
Detection and control of local outbreaks
Protection of the vulnerable population and healthcare workers
Maintaining preparedness for future respiratory pandemics
According to the WHO, decentralized and high-quality diagnostics are an essential part of universal health coverage and global health security strategies.
What is WHO prequalification and EUL?
The WHO explained that its prequalification program has long supported access to quality health products in low- and middle-income countries by independently assessing their quality, safety and efficacy. The WHO said the program enables international agencies to obtain reliable medicines, vaccines and diagnostics, while supporting national regulatory authorities with limited resources.
Through the Emergency Use List (EUL), WHO conducts risk-based assessments during public health emergencies of international concern to meet urgent health needs.
