WHO has approved its first two rapid COVID-19 antigen tests, boosting global access to reliable, affordable tools for faster detection and response.
The World Health Organization (WHO) has officially prequalified the world’s first two rapid antigen diagnostic tests (Ag-RDTs) for COVID-19, marking a major milestone in global access to reliable and affordable testing tools nearly three years after the pandemic emergency phase ended. ()
In an announcement issued on December 17, WHO confirmed that the SD Biosensor STANDARD Q COVID-19 Ag Test and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) have met its prequalification standards for quality, safety, and performance. This is the first time any rapid antigen tests for SARS-CoV-2 have achieved full WHO prequalification status.
The decision builds on earlier regulatory approvals granted under WHO’s Emergency Use Listing (EUL) mechanism, which was created to speed up access to critical medical tools during public health emergencies. The SD Biosensor test became the first rapid antigen test listed under the EUL in September 2020, enabling its rapid rollout in more than 100 countries during the height of the COVID-19 pandemic.
While the EUL process allows temporary authorization based on limited data during emergencies, WHO prequalification represents a more comprehensive and long-term quality assessment. It confirms that the products meet international standards for manufacturing consistency, performance, and safety — making them suitable for sustained global use.
TOP INSIGHT
A major milestone for global health: The #WHO has prequalified its first two rapid #antigen_tests for #COVID19.
The approved tests—SD Biosensor STANDARD Q and ACON Biotech Flowflex—have met rigorous long-term standards for quality and safety, paving the way for wider, more affordable access in low-income countries.
#COVIDTesting #PublicHealth #GlobalHealth #Diagnostics #HealthEquity
Expanding Access in Low- and Middle-Income Countries
With prequalification now granted, both tests become eligible for procurement by United Nations agencies, global health partners, and national health authorities, significantly expanding access in low- and middle-income countries (LMICs). The designation also allows these diagnostics to be included in pooled procurement mechanisms designed to reduce costs, stabilize supply chains, and overcome regulatory and financial barriers.
WHO said this step is particularly important for countries where access to laboratory-based testing remains limited due to infrastructure, staffing, or funding constraints.
“Prequalification provides assurance that these tests meet international standards and can be reliably used as part of national diagnostic strategies,” the agency noted, emphasizing the role of affordable diagnostics in strengthening health systems.
Continued Need for COVID-19 Testing
Although WHO declared the end of COVID-19 as a global public health emergency more than two years ago, the virus continues to circulate worldwide. Current surveillance data show relatively stable levels of SARS-CoV-2 activity, underscoring the ongoing need for accessible and accurate testing — especially in settings where laboratory capacity is limited.
Rapid antigen tests deliver results within 15 to 30 minutes and can be used outside centralized laboratories, including in clinics, community centers, mobile health units, and home settings. Their ease of use and quick turnaround time make them a key tool for identifying infectious individuals and enabling timely public health responses.
Role in Public Health Preparedness
WHO emphasized that rapid antigen tests remain essential for:
- Detecting and controlling local outbreaks
- Protecting vulnerable populations and health-care workers
- Supporting surveillance and preparedness for future respiratory pandemics
These tests also complement molecular diagnostics such as PCR, which remain the gold standard but require specialized equipment and trained personnel.
The prequalification aligns with WHO’s broader diagnostics strategy, which prioritizes decentralized, quality-assured testing as a cornerstone of universal health coverage and global health security.
As countries continue to adapt to living with COVID-19 while preparing for future health threats, WHO said reliable diagnostic tools will remain a critical component of early detection, outbreak control, and equitable access to care worldwide.
References:
- WHO prequalifies the first two rapid antigen detection tests for COVID-19 – (https://www.who.int/news/item/24-12-2025-who-prequalifies-the-first-two-rapid-antigen-detection-tests-for-covid-19)
Source-Medindia