Archive · 25 Dec 2025
WHO Approves Two COVID-19 Rapid Antigen Tests
The World Health Organization (WHO) has approved two quick tests for COVID-19.
These tests, called rapid antigen tests, can show results in just 15 to 30 minutes.
This is the first time such tests have been approved by WHO for long-term use.
The tests are the SD Biosensor STANDARD Q COVID-19 Ag Test and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test.
WHO says these tests are important because they are affordable, easy to use, and can be done outside of big labs.
They help detect COVID-19 quickly, which is especially important in countries where access to lab tests is limited.
The approval means that these tests can be bought and used with confidence by countries and health organizations around the world.
WHO approved two rapid antigen tests for COVID-19 on December 24, 2025.
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).
This is the first time rapid antigen tests for COVID-19 have achieved WHO prequalification.
Prequalification provides long-term assurance of quality, safety, and performance, facilitating procurement in low- and middle-income countries (LMICs).
Rapid antigen tests are crucial for timely detection of infectious cases, especially in settings with limited laboratory infrastructure.
- Who
- World Health Organization (WHO)
- What
- Approval of two rapid antigen diagnostic tests for SARS-CoV-2
- When
- December 24, 2025
- Where
- Global, with a focus on low- and middle-income countries (LMICs)
- Why
- To provide long-term assurance of quality, safety, and performance, and to facilitate procurement and access to diagnostics in LMICs
- Tests Approved
- SD Biosensor STANDARD Q COVID-19 Ag Test, ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)
- Approval Date
- December 24, 2025
- Significance
- First rapid antigen tests for COVID-19 to achieve WHO prequalification
- Purpose
- Long-term assurance of quality, safety, and performance
- Impact
- Facilitates procurement in low- and middle-income countries (LMICs)
- Previous Approval
- Both tests were previously cleared under WHO's Emergency Use Listing (EUL) mechanism
- Testing Time
- 15 to 30 minutes
- Role
- Critical for timely detection of infectious cases, complement to PCR tests