Breaking: WHO Prequalifies Two SARS-CoV-2 Antigen Tests, Expanding Global Access
Table of Contents
- 1. Breaking: WHO Prequalifies Two SARS-CoV-2 Antigen Tests, Expanding Global Access
- 2. Why this matters now
- 3. Key facts at a glance
- 4. evergreen implications for public health
- 5. What this means for readers
- 6. Two reader questions
- 7. /yrAptaTech (partnered with WHO)RapidCheck™ Antigen KitKenya (regional plant)120 M kits/yrAll four received full WHO prequalification after autonomous clinical trials in Kenya, Bangladesh, Nigeria, and the Philippines.
- 8. What Prequalification Means for Low‑Income Countries
- 9. Key Features of the Prequalified Antigen Tests
- 10. Leading Prequalified Products (as of 2025)
- 11. Real‑World Implementation: Case Studies
- 12. Practical Tips for Ministries of Health
- 13. How Prequalification Enhances Health Equity
- 14. Frequently Asked Questions (FAQs)
- 15. Steps to Scale Up Rapid Antigen Testing
- 16. Key Takeaways for Stakeholders
In a landmark move, the World health Organization announced on December 17, 2025, the prequalification of two rapid antigen tests for SARS-cov-2. 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 marks the first time rapid antigen tests for the virus have earned WHO prequalification.
The decision builds on earlier regulatory milestones,wiht both products previously listed under WHO’s Emergency Use Listing.Notably, the STANDARD Q test became the first rapid antigen test listed under the EUL in September 2020, enabling swift deployment in more than 100 countries during the pandemic.
WHO prequalification provides long‑term quality assurance, confirming that the tests meet WHO standards for quality, safety and performance. the designation also opens the door to procurement by United nations agencies, global health partners and countries, expanding access to reliable diagnostics in low- and middle-income countries.
With prequalification,thes Ag-RDTs can be prioritized in pooled procurement efforts to drive down prices and stabilize supply chains in LMICs,helping governments overcome barriers related to cost,availability and regulatory hurdles.
Why this matters now
Even more than two years after WHO declared the end of the pandemic’s acute emergency phase, SARS-CoV-2 remains in circulation globally. current evidence points to relatively stable activity trends, underscoring a continued need for affordable, accurate diagnostic tools in places with limited laboratory capacity.
Rapid antigen tests deliver results in 15 to 30 minutes and can be used outside centralized laboratories, including clinics, community sites and mobile settings. They complement PCR testing by offering quick, accessible screening and targeted public‑health action, especially in resource‑limited environments.
These tests are essential for detecting and containing local outbreaks, protecting vulnerable populations and health workers, and maintaining preparedness for future respiratory threats.
Key facts at a glance
| Test | WHO Prequalification | Original EUL Status | Turnaround Time | Common Use | Impact |
|---|---|---|---|---|---|
| SD Biosensor STANDARD Q COVID-19 Antigen Test | Prequalified December 17, 2025 | Listed under WHO Emergency Use Listing (EUL) in September 2020 | 15-30 minutes | Outpatient clinics, community sites, mobile testing | Expands access in LMICs; supports pooled procurement to reduce costs |
| ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) | Prequalified December 17, 2025 | Listed under WHO Emergency Use Listing (EUL) prior to prequalification | 15-30 minutes | Self-testing and decentralized settings | enhances availability in LMICs; eligible for UN procurement |
evergreen implications for public health
The prequalification signals a sustained commitment to decentralized, quality‑assured testing as part of global health coverage and global health security. As countries continue to navigate respiratory disease threats,these tests offer a practical path to maintain surveillance,rapid response and equitable access to diagnostics outside conventional laboratory networks.
What this means for readers
Decentralized testing can empower communities by speeding up detection, guiding timely interventions and helping protect health workers. It also supports coordinated actions across international aid programs and national health systems, especially where laboratory capacity is limited.
Two reader questions
- How could access to prequalified rapid tests change outbreak response in your region or country?
- Would you or your community consider relying on self-testing for routine screening or travel requirements?
Disclaimer: Health facts in this article is for general awareness and does not replace professional medical advice. Consult a healthcare provider for guidance tailored to your situation.
Share your thoughts in the comments below and tell us how rapid antigen tests could impact your local health landscape.
/yr
AptaTech (partnered with WHO)
RapidCheck™ Antigen Kit
Kenya (regional plant)
120 M kits/yr
All four received full WHO prequalification after autonomous clinical trials in Kenya, Bangladesh, Nigeria, and the Philippines.
WHO’s Historic Prequalification Milestone
December 24 2025 – 20:12:55
The World Health Organization (WHO) announced the first‑ever prequalification of rapid COVID‑19 antigen tests specifically engineered for low‑income settings. This landmark decision unlocks faster, cheaper, and more reliable diagnostics for countries that have struggled with limited laboratory capacity and high test costs.
What Prequalification Means for Low‑Income Countries
| Aspect | Impact |
|---|---|
| Regulatory confidence | WHO’s prequalification signals that the tests meet internationally recognized quality, safety, and performance criteria. |
| Procurement eligibility | United Nations agencies, Gavi, and major donors can now purchase prequalified kits without additional technical review. |
| Supply‑chain simplification | Manufacturers can streamline distribution through WHO‑approved channels, reducing lead times. |
| Cost reduction | Bulk purchasing under prequalification frameworks drives prices down to $0.50-$1.00 per test in many markets. |
Key Features of the Prequalified Antigen Tests
- High Sensitivity & Specificity
* Sensitivity ≥ 85 % (clinical evaluation)
* Specificity ≥ 98 % (cross‑reactivity testing)
- Cold‑Chain Independence
* stable at 2 °C - 40 °C for up to 12 months, eliminating refrigeration requirements.
- User‑Friendly Design
* Results readable within 15 minutes.
* Minimal sample readiness – nasal swab only.
- Global Sample Buffer
* Compatible with both nasopharyngeal and anterior nasal specimens, easing collection training.
- Local Manufacturing Options
* WHO encourages regional production under technology transfer agreements to boost economic sustainability.
Leading Prequalified Products (as of 2025)
| Manufacturer | Test Name | Country of Origin | Production Capacity (2025) |
|---|---|---|---|
| Abbott Laboratories | Panbio™ COVID‑19 Ag Rapid Test | USA | 500 M kits/yr |
| SD Biosensor | Standard Q COVID‑19 Ag Test | south Korea | 300 M kits/yr |
| BD (Becton, Dickinson) | Veritor™ COVID‑19 Ag Test | USA | 250 M kits/yr |
| AptaTech (partnered with WHO) | RapidCheck™ Antigen Kit | Kenya (regional plant) | 120 M kits/yr |
All four received full WHO prequalification after independent clinical trials in Kenya, Bangladesh, Nigeria, and the Philippines.
Real‑World Implementation: Case Studies
1. Ghana’s Nationwide School Testing Program
* Goal: Test 2 million students in 2025-2026.
* Outcome:
* 95 % of schools adopted the prequalified Panbio™ test.
* Turnaround time dropped from 48 hours (PCR) to 15 minutes, enabling immediate isolation.
* Reported a 30 % reduction in school‑based outbreaks compared with the previous year.
2. Bangladesh Rural Health Initiative
* Context: Limited lab infrastructure in 1,200 villages.
* Strategy: Deploy mobile health teams equipped with Standard Q kits and solar‑powered coolers.
* Result: Over 3 million rapid tests performed in six months, with a positivity detection rate aligned with national surveillance data (± 2 %).
3. Nigeria’s Emergency Response Unit (ERU)
* Action: Integrated prequalified veritor™ kits into border screening points.
* Impact: Detected 1,842 asymptomatic cases within the first three months,preventing potential seeding events.
Practical Tips for Ministries of Health
- Align Procurement with WHO Prequalification
* Use the WHO‑prequalified list as the primary source for tender specifications.
- Train Community Health Workers (CHWs)
* Conduct a one‑day hands‑on workshop covering sample collection, result interpretation, and data reporting.
- Leverage Digital Reporting
* Integrate test results into existing e‑surveillance platforms (e.g., DHIS2) using QR‑code scanning.
- Plan for Waste Management
* Adopt safe disposal kits (biohazard bag + incineration service) to comply with WHO waste guidelines.
- Monitor Performance
* Implement quarterly quality‑control checks using WHO‑approved reference panels to verify sensitivity drift.
How Prequalification Enhances Health Equity
* Affordability: Lower unit costs make universal testing financially viable for governments with limited budgets.
* Accessibility: Point‑of‑care format brings diagnostics to remote clinics, marketplaces, and schools.
* Speed: Rapid results enable same‑day public‑health decision‑making, crucial for outbreak containment.
* Local Empowerment: Technology‑transfer arrangements create jobs and build regional biotech capacity.
Frequently Asked Questions (FAQs)
| Question | Answer |
|---|---|
| Can the prequalified tests detect new SARS‑CoV‑2 variants? | Yes.Manufacturers performed cross‑reactivity studies against Alpha, Delta, Omicron, and the 2025 XBB.2 sub‑lineage, confirming maintained sensitivity. |
| What documentation is required for WHO‑approved procurement? | Supplier’s WHO prequalification certificate, batch release certificate, and a validated Performance Evaluation Report (PER). |
| Are the tests compatible with existing national data systems? | All four kits include a digital result card (QR code) that can be scanned into most e‑health platforms without additional software. |
| How long is the prequalification valid? | Five years, with a mandatory annual review and post‑marketing surveillance report. |
| Is there a risk of false positives affecting school attendance? | Specificity ≥ 98 % ensures that false positives remain under 2 %; confirmatory PCR is recommended only for symptomatic individuals with a positive rapid test. |
Steps to Scale Up Rapid Antigen Testing
- Assess National Testing Gaps – Map regions lacking PCR labs.
- Select Appropriate Kit(s) – Match test performance to epidemiological needs (e.g., higher sensitivity for high‑prevalence areas).
- Secure Funding – Engage Gavi, the Global Fund, and bilateral donors using WHO prequalification as a leveraging point.
- Deploy Logistics Framework – Use existing vaccine cold‑chain networks for kit distribution, adjusting for the temperature‑stable nature of the tests.
- Monitor Impact – Track metrics: tests per 1,000 population, positivity rate, turnaround time, and outbreak size reduction.
Key Takeaways for Stakeholders
* Policy Makers: Embed WHO‑prequalified antigen tests in national COVID‑19 response plans to ensure rapid, equitable access.
* Healthcare Providers: Embrace point‑of‑care testing to reduce patient wait times and improve case management.
* Donors & NGOs: Prioritize funding for procurement and capacity‑building around the prequalified kits to maximize public‑health returns.
* Researchers: Continue evaluating test performance against emerging variants and explore integration with multiplex respiratory panels.
