For the first time, the World Health Organization (WHO) has prequalified two rapid antigen tests for detecting COVID-19, the agency noted last week.
The tests are the SD Biosensor Standard Q COVID-19 Ag Test and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). The WHO prequalification confirms that the products meet WHO standards for quality, safety, and performance. It also makes the rapid tests eligible for procurement by United Nations agencies, global health partners, and countries, which expands access in low- and middle-income countries.
Critical step for fast detection and public health response
This achievement builds on earlier regulatory milestones for these products previously listed under the WHO’s Emergency Use Listing (EUL). In September 2020, the SD test became the first-ever rapid antigen test to be listed under the WHO’s EUL, enabling its rapid deployment in more than 100 countries during the COVID-19 pandemic.
“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,” the WHO said. “They are a vital complement to molecular (polymerase-chain reaction, or PCR) tests, particularly in resource-limited settings with limited laboratory capacity.”
Rapid antigen-detection tests provide results in 15–30 minutes, are affordable, and can be used outside centralized laboratories.
The agency notes that rapid tests are essential for detecting and controlling local outbreaks, protecting vulnerable populations and health care workers, and maintaining preparedness for future pandemics caused by respiratory diseases.