The World Health Organization (WHO) recently made a significant announcement regarding the prequalification of two rapid antigen diagnostic tests (Ag-RDTs) for SARS-CoV-2, the virus responsible for COVID-19. This historic milestone occurred on December 17, 2025, with the tests being the SD Biosensor STANDARD Q COVID-19 Ag Test and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). This achievement marks the first instance of rapid antigen tests for COVID-19 receiving WHO prequalification.
Significance of WHO Prequalification
This prequalification builds on previous regulatory approvals, specifically the WHO’s Emergency Use Listing (EUL). The SD Biosensor STANDARD Q COVID-19 Ag Test was the inaugural rapid antigen test to receive EUL status back in September 2020. This listing facilitated the swift deployment of the test across over 100 countries during the pandemic. The EUL process represents a risk-benefit analysis aimed at ensuring that essential health products can be accessed quickly in emergencies, relying on available data to determine when benefits surpass risks.
Long-term Quality Assurance
The new prequalification by WHO provides crucial long-term assurances regarding the quality, safety, and performance of these tests. With this status, the Ag-RDTs become eligible for procurement by various entities, including United Nations agencies and global health partners. This eligibility is essential for increasing access to reliable diagnostic tests, particularly in low- and middle-income countries (LMICs). The inclusion of these tests in pooled procurement initiatives can help lower costs and stabilize supply chains, addressing the significant barriers many countries face in obtaining high-quality diagnostic tools.
Ongoing Need for Diagnostic Tools
Despite WHO declaring the end of the emergency phase of COVID-19 two and a half years ago, the virus continues to circulate globally. Current data suggests stable trends in SARS-CoV-2 activity, yet the demand for affordable and accurate diagnostic tools remains pressing, especially in lower-income nations where laboratory access is often limited.
Rapid antigen tests offer results in just 15–30 minutes and are cost-effective, making them suitable for deployment outside of centralized laboratories. These tests can be utilized in clinics, community health sites, and mobile units, which are invaluable for the timely detection of infectious cases and for facilitating targeted public health responses. Rapid antigen testing serves as a crucial complement to molecular tests, such as PCR, especially in resource-limited environments.
The Role of Rapid Antigen Testing
The importance of rapid antigen testing cannot be overstated. It is a vital component of WHO’s broader diagnostics strategy, which emphasizes the necessity for decentralized, high-quality testing as part of universal health coverage and global health security initiatives.
WHO’s Commitment to Health Equity
The WHO Prequalification program has been instrumental in expediting access to health products in LMICs for many years, ensuring that medicines, vaccines, diagnostic tools, and vector control products meet stringent safety and effectiveness standards. This program enables multilateral organizations to procure these quality-assured products while also supporting developing regulatory authorities that may lack the resources to conduct independent evaluations.
Through its Emergency Use Listing, WHO employs risk-based assessments during public health emergencies to address urgent health needs effectively. The recent prequalification of the two rapid antigen tests exemplifies this commitment to enhancing global health security.
Conclusion
The WHO’s prequalification of the SD Biosensor and ACON Biotech rapid antigen tests marks a significant step forward in the fight against COVID-19. By ensuring the availability of quality-assured diagnostic tools, the organization is paving the way for improved public health responses, particularly in under-resourced regions. As the world continues to navigate the complexities of COVID-19, these advancements in diagnostic testing will be crucial in maintaining health equity and safeguarding communities.
- Rapid antigen tests provide timely results in 15–30 minutes.
- WHO prequalification enhances access to quality diagnostics in LMICs.
- Decentralized testing is vital for effective public health strategies.
- The EUL process facilitates swift deployment of essential health tools.
- WHO’s commitment to health equity supports global health security efforts.
Source: goldrushcam.com