The decision, according to WHO, builds on previous emergency approvals and demonstrates the ongoing need for quick, inexpensive COVID-19 testing even after the pandemic's emergency phase.
On December 24, 2025, the World Health Organization (WHO) announced that two rapid antigen diagnostic tests (Ag-RDTs) for SARS-CoV-2, the virus that causes COVID-19, have been prequalified.
The SD Biosensor STANDARD Q COVID-19 Ag Test and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) are the two tests, according to WHO.
According to WHO, this is the first time that any fast antigen tests for COVID-19 have received WHO prequalification, which is a noteworthy regulatory achievement almost three years after the pandemic's emergency phase ended.
What makes WHO prequalification important?
According to WHO, unlike emergency authorizations, which have a temporal restriction, prequalification offers long-term assurance of quality, safety, and performance. Prequalification, according to WHO, enables national governments, international health partners, and United Nations organizations to confidently get these tests, particularly in low- and middle-income countries (LMICs).
Prequalified tests can also be incorporated into pooled procurement procedures, according to WHO, which can help lower costs, stabilize supply chains, and lower regulatory barriers that frequently restrict access to diagnostics in developing nations.
In what ways does this expand upon previous approvals?
WHO clarified that both tests had previously been approved through its Emergency Use Listing (EUL) process. The SD Biosensor STANDARD Q test was the first rapid antigen test ever listed under the EUL, according to WHO in September 2020. This allowed for a quick implementation in over 100 countries during the peak of the COVID-19 pandemic.
The EUL procedure, according to WHO, is a risk-benefit analysis created for public health emergencies that enables quicker access to life-saving equipment when complete regulatory data may not yet be available.
Why is quick antigen testing still important, according to the WHO?
According to WHO, SARS-CoV-2 is still spreading throughout the world even after the COVID-19 emergency phase ended roughly two and a half years ago. According to WHO, current data indicates rather stable developments, but there is still a significant demand for reasonably priced and precise diagnostics.
In lower-income nations, where access to laboratory-based PCR testing is restricted or inconsistent, WHO stressed the urgency of this need.
What function do quick antigen tests serve?
Rapid antigen tests are affordable, can be utilized outside of centralized laboratories, and provide results in 15 to 30 minutes, according to WHO. According to WHO, they are essential for the prompt identification of infectious infections because they can be used in clinics, community settings, and mobile units.
Ag-RDTs are an essential addition to PCR assays, according to WHO, especially in environments with inadequate laboratory infrastructure.
When is quick testing considered critical by the WHO?
According to WHO, quick antigen testing is still essential for:
Identifying and managing regional epidemics
Safeguarding vulnerable groups and healthcare personnel
Keeping up readiness for upcoming respiratory pandemics
Decentralized and quality-assured diagnostics are essential components of global health security initiatives and universal health care, according to WHO.
What are the EUL and WHO prequalification?
WHO clarified that by independently evaluating the goods' efficacy, safety, and quality, its Prequalification program has long facilitated access to high-quality healthcare in LMICs. According to WHO, the program helps country regulators with limited resources while also enabling international agencies to purchase dependable medications, vaccinations, and diagnostics.
In order to address urgent health requirements during public health emergencies of international concern, WHO performs risk-based evaluations through the Emergency Use Listing (EUL).
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