On December 17, 2025, the World Health Organization (WHO) announced a significant advancement in the fight against COVID-19 by prequalifying two rapid antigen diagnostic tests (Ag-RDT) for SARS-CoV-2, the virus responsible for the disease. The tests, developed by SD Biosensor and ACON Biotech, are the STANDARD Q COVID-19 Ag Test and the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). This milestone marks the first occasion that rapid antigen tests for SARS-CoV-2 have received WHO prequalification.
This development builds upon the earlier regulatory achievements of these tests, which were previously listed under WHO’s Emergency Use Listing (EUL). Notably, in September 2020, the SD Biosensor STANDARD Q COVID-19 Ag Test became the first rapid antigen test to be approved under this emergency framework, facilitating its distribution across over 100 countries during the pandemic. The EUL process is designed to expedite access to essential health products during public health emergencies by evaluating their risk-benefit profile based on limited data.
Ensuring Quality and Expanding Access
The recent WHO prequalification provides a long-term assurance of quality, confirming that both tests meet stringent WHO standards for safety and performance. This approval also enables these Ag-RDTs to be procured by United Nations agencies and global health partners, thereby enhancing access to reliable diagnostic tools in low- and middle-income countries (LMICs).
These tests can be prioritized in pooled procurement initiatives, aimed at reducing prices and stabilizing supply in LMICs. This is crucial in helping countries address barriers to accessing high-quality diagnostic tests, which often stem from financial, supply, and regulatory challenges.
Despite the WHO declaring the end of the emergency phase of COVID-19 two and a half years ago, the virus remains in circulation worldwide. Current evidence suggests stable trends in SARS-CoV-2 activity, yet the demand for affordable and effective diagnostic tools persists, especially in lower-income regions where laboratory access is limited.
The Role of Rapid Antigen Tests
Rapid antigen-detection tests offer results within 15 to 30 minutes and are designed to be cost-effective. They can be utilized outside of centralized laboratories, in settings such as clinics, community sites, and mobile units. This accessibility makes them vital for the timely detection of infectious cases and enables targeted public health interventions.
These tests serve as a crucial complement to traditional molecular testing methods, such as polymerase chain reaction (PCR) tests, particularly in resource-limited environments with constrained laboratory capabilities. The WHO’s broader diagnostic strategy underscores the ongoing necessity for decentralized, quality-assured testing as part of the goals for universal health coverage and global health security.
With the WHO’s endorsement, the approved rapid antigen tests are expected to play a pivotal role in enhancing public health responses to COVID-19, particularly in regions that have faced significant barriers in accessing reliable diagnostic solutions.
