WHO Prequalifies First Rapid Antigen Tests for Covid-19

The World Health Organization (WHO) has prequalified two rapid antigen test diagnostics (Ag-RDTs) for SARS-CoV-2 infections. This is historic, as Ag-RDTs are now prequalified for use for the first time.

The two prequalified products are SD Biosensor STANDARD Q COVID-19 Ag Test and ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). These tests have been validated to meet standards related to quality, safety, and performance by the World Health Organization.

Notably, this is based on past successes of regulatory approvals of the WHO’s Emergency Use Listing (EUL) approvals. The first rapid antigen test to receive EUL approval for distribution in over 100 countries worldwide during the pandemic is the aforementioned SD Biosensor STANDARD Q approved in September 2020.

Compared to the use of EUL approval, WHO prequalification gives longer-term credibility and enables the tests to be purchased by United Nations agencies and global health partners and countries, especially Low and Middle-Income Countries.

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Rapid tests for antigens provide results in 15 to 30 minutes, are economically viable, and do not require lab facilities, making them suitable for clinics, community centers, and mobile facilities. They are complementary to molecular PCR tests and continue to remain valuable for outbreak identification and preparedness for potential MERS-CoV pandemics and for the health and safety of vulnerable populations.

WHO stresses, “Decentralized, quality-assured testing is critical to achieving universal health coverage and health security.” “This prequalification underlines the ongoing global demand for testing for COVID-19 quality, accessibility, and affordability and ensures that low- and middle-income countries have adequate responses to SARS-CoV-2 and new health threats.”