On a single day in December 2025, global health changed. The World Health Organization gave its highest stamp of approval to two new tools for fighting COVID-19. This prequalification was a major breakthrough for public health worldwide.
These tools are a specific type of diagnostic tool. They detect the presence of the virus by looking for specific proteins, called antigens. The big difference is speed. Unlike lab tests that take days, these give answers in just 15 to 30 minutes.
They are also affordable and easy to use. This means they can be deployed in clinics, community centers, or even mobile units. This accessibility is crucial for keeping communities safe as the virus continues to circulate.
This guide will walk you through everything about these groundbreaking tools. We will cover their journey from emergency use to full approval and explain their lasting impact on our health systems.
Key Takeaways
- The WHO prequalified the first two rapid antigen diagnostic tests for SARS-CoV-2 in December 2025.
- These tools provide results much faster than traditional laboratory methods.
- They are cost-effective and can be used in various non-laboratory settings.
- This milestone represents a significant advancement in global health preparedness.
- Accessible testing remains vital for managing the virus long-term.
Context and Regulatory Milestones of First Rapid Antigen Tests
Achieving full international recognition required navigating a two-step regulatory process designed for both speed and rigor. The World Health Organization (WHO) created pathways to address urgent crises and ensure long-term product quality.
WHO Prequalification and Emergency Use Milestones
In September 2020, the SD Biosensor STANDARD Q COVID-19 Ag Test received an emergency use listing. This mechanism accelerates access during a health crisis. It is a risk-benefit assessment based on limited data.
This allowed the test’s rapid deployment to over 100 countries. The immediate benefit of having a tool outweighed the potential risk from incomplete data.
Transition from Emergency Listing to Full Prequalification
The December 2025 prequalification marked a major shift. It confirmed that the SD Biosensor and ACON Biotech Flowflex tests meet strict international standards for quality, safety, and performance.
This status provides long-term assurance. It makes the tests eligible for procurement by UN agencies and national governments.
| Feature | Emergency Use Listing (EUL) | Prequalification (PQ) |
|---|---|---|
| Primary Goal | Speed of access during a crisis | Sustained quality and safety |
| Data Requirements | Limited, urgent data | Comprehensive, long-term evidence |
| Focus | Immediate benefit outweighs risk | Rigorous standards for performance |
| Procurement | Emergency response channels | Official UN and government programs |
This journey from emergency use to full prequalification demonstrates a balanced approach to global health. It ensures reliable tools are available for future needs.
Technology and Performance: Standards and Accuracy
Understanding how these detection methods work requires examining their core technological principles and performance metrics. The technology identifies specific viral proteins from nasal or throat samples.
Rapid Detection and Timely Results in 15-30 Minutes
These tools deliver answers within a brief window. The process takes just 15 to 30 minutes from sample collection to final reading.
Healthcare workers can view outcomes directly on the testing card. This immediate feedback enables quick clinical decisions and rapid isolation when needed.
Comparison to PCR and Other Diagnostic Tools
Molecular tests like PCR remain the gold standard for detection accuracy. They are more sensitive and better at identifying cases with low viral loads.
However, these quick alternatives offer significant advantages in speed and accessibility. They work well during peak infection periods when viral levels are highest.
According to performance validation studies, negative outcomes may require confirmation with molecular testing if symptoms persist. This balanced approach ensures proper diagnosis while maintaining the benefits of swift detection.
When considering different rapid diagnostic options, it’s important to understand their optimal use cases. These instruments excel in settings where immediate results outweigh the need for maximum sensitivity.
Global Availability and Public Health Impact
Quality-assured diagnostic instruments are reaching populations previously underserved by laboratory infrastructure. The WHO prequalification opens new channels for distribution worldwide.
Enhancing Access in Low- and Middle-Income Countries
Many nations face significant barriers to obtaining reliable detection tools. High costs and unstable supply chains limit access to quality health services.
WHO approval enables countries with developing regulatory systems to confidently adopt these instruments. They bypass lengthy local evaluation processes that delay critical care.
Impact on Outbreak Detection and Local Pandemic Preparedness
Even years after the emergency phase ended, the virus causes ongoing circulation. Recent outbreaks in Europe and the U.S. demonstrate continued need.
These tools help identify infectious cases quickly. Early detection prevents widespread transmission during local outbreaks.
Procurement Benefits for Global Health Agencies
United Nations agencies can now include these products in emergency stockpiles. Pooled procurement initiatives leverage collective purchasing power.
This approach reduces prices and ensures stable supply for middle-income countries. It builds more resilient systems for future pandemic threats.
Conclusion
Global health systems now have access to validated tools that can transform pandemic response capabilities. The WHO prequalification marks a critical shift from emergency deployment to sustainable integration of these diagnostic methods.
After several years of real-world use and data collection, these antigen rapid tests meet the highest quality standards. This ensures their long-term role in managing COVID-19 as the virus continues to circulate.
These tests work alongside PCR methods in a complementary strategy. Different approaches serve unique purposes based on clinical context and available resources. Recent performance validation studies confirm their optimal use during peak infection periods.
The practical impact of this prequalification is significant. It expands access to reliable testing in resource-limited settings and builds confidence in diagnostic quality. This strengthens global preparedness for future respiratory virus threats.
Understanding these diagnostic tools empowers informed decisions about public health strategies. Their validated performance and accessibility will support health systems for years to come.