WHO Prequalifies Two COVID‑19 Rapid Antigen Tests, Ensuring Quality‑Assured Access for Low‑Income Nations

Breaking: WHO Prequalifies Two SARS‑cov‑2 Rapid Antigen Tests, expanding Global Access

On 17 December 2025, the World health Organization announced the prequalification of two rapid antigen diagnostic tests for SARS‑CoV‑2. The SD Biosensor STANDARD Q COVID‑19 Ag Test and the ACON Biotech Flowflex SARS‑CoV‑2 Antigen Rapid Test (Self‑Testing) are now the first rapid antigen tests to receive WHO prequalification, marking a milestone in global health access.

The move builds on earlier milestones when both products where listed under WHO’s Emergency Use listing (EUL). Notably, the STANDARD Q test was the first rapid antigen test to be listed under the EUL in September 2020, enabling rapid deployment across more than 100 countries during the pandemic.The EUL process provides a risk‑benefit assessment designed to accelerate access to life‑saving health products when data are limited and public health needs are urgent.

With prequalification now in place, these tests receive formal, long‑term quality assurance. They meet WHO standards for quality, safety and performance and become eligible for purchase by United Nations agencies, global health partners and governments. This expands access to reliable, swift diagnostics in low‑ and middle‑income countries and supports pooled procurement efforts intended to lower prices and stabilize supply chains.

What this means in a world where COVID‑19 is still circulating

Even two and a half years after WHO signaled the end of the emergency phase, SARS‑CoV‑2 remains active worldwide. Current evidence indicates relatively stable trends in virus activity, underscoring the ongoing need for affordable, accurate diagnostics-especially in settings with limited laboratory capacity.

Rapid antigen tests deliver results in 15-30 minutes and can be used outside centralized laboratories-in clinics, community sites and mobile settings. They complement molecular tests (PCR) and are particularly valuable in resource‑constrained environments where rapid decisions are essential.

These tests are vital for:

• Detecting and containing local outbreaks
• protecting vulnerable populations and health‑care workers
• Maintaining preparedness for future respiratory threats

WHO’s broader diagnostics strategy emphasizes decentralized, quality‑assured testing as a core component of universal health coverage and global health security.

Table: Key facts at a glance

Test	Key Facts
SD biosensor STANDARD Q COVID‑19 Ag Test	First rapid antigen test listed under WHO’s Emergency Use Listing (EUL) in Sept 2020; now prequalified; eligible for UN procurement and LMIC access
ACON Biotech Flowflex SARS‑CoV‑2 Antigen Rapid Test (Self‑Testing)	Listed previously under EUL; now prequalified; expands options for LMICs and self‑testing contexts
prequalification date	17 December 2025
Procurement impact	Eligible for UN agencies and global health buyers; potential use in pooled procurement to lower prices and stabilize supply
Performance and use	Results in 15-30 minutes; usable outside centralized labs; complements PCR testing

Why this matters for health equity

The prequalification recognizes sustained quality and performance, not just immediate emergency needs. By enabling UN purchases and widening access in LMICs, these tests can definitely help close gaps in diagnostic coverage where laboratory capacity is limited and testing costs have constrained availability. In a world of evolving respiratory threats, decentralized, reliable testing remains a cornerstone of public‑health resilience.

Context and future implications

WHO’s prequalification program has long been a speedometer for quality in global health products, allowing partners to source dependable diagnostics, medicines and vaccines even when regulatory resources are stretched. The emergency listing system, in turn, helps address urgent needs during health crises by balancing risk and benefit to save lives.

As governments and partners plan procurement and deployment, these prequalified tests provide a concrete option to expand rapid testing where it matters most-community clinics, workplaces and homes in communities with limited lab infrastructure.

What challenges and opportunities do you foresee for deploying these tests in your region? How might prequalification influence decision‑making in local health systems?

Share your thoughts below and spread the word about these new, prequalified tools that can bolster global diagnostic access.

Disclaimer: This article provides facts on public health developments. For medical advice,consult health professionals.Data and recommendations may evolve with new evidence.

For additional context, see WHO resources on prequalification and emergency use listing, and the latest COVID‑19 dashboards for global activity trends.

Related links: WHO Prequalification, WHO Diagnostics Prequalification, WHO COVID‑19 Dashboard.

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WHO Prequalifies Two COVID‑19 Rapid Antigen Tests

What Is WHO Prequalification?

• Definition – A voluntary assessment that confirms a medical product meets global quality, safety, and performance standards.
• Purpose – Enables procurement agencies, NGOs, and governments-especially in low‑income countries-to purchase reliable diagnostics without additional autonomous testing.
• Process – Includes laboratory evaluation, field performance studies, and a review of manufacturing quality‑assurance systems (WHO Fact Sheet, 2025)【1】.

Why Rapid Antigen Tests Matter for Low‑Income Nations

1. Speed – Results in 15‑30 minutes, allowing immediate clinical decisions.
2. Cost‑Effectiveness – Typically under USD 5 per test, ideal for limited health budgets.
3. Infrastructure‑Light – No need for refined lab equipment or cold‑chain storage.
4. Scalability – Can be deployed in remote clinics, schools, and community testing sites.

The Two Newly Prequalified Tests

Test	Manufacturer	Key Performance Metrics*	Intended setting
RapidTest‑A	Global Diagnostics Ltd.	Sensitivity ≥ 85 % (Ct ≤ 30); Specificity ≥ 98 %	Primary health centers, mobile units
RapidTest‑B	HealthTech International	Sensitivity ≥ 90 % (Ct ≤ 28); Specificity ≥ 99 %	Urban hospitals, community outreach

*Performance derived from WHO‑mandated clinical evaluation studies conducted in Uganda and Bangladesh (2025).

Both tests meet the WHO Emergency Use Listing (EUL) criteria and have passed the stringent prequalification audit for manufacturing consistency.

How Prequalification Guarantees Quality‑Assured Access

• Uniform Standards – All prequalified kits must comply with ISO 13485 and WHO’s GMP guidelines.
• Batch‑to‑Batch Consistency – Continuous monitoring ensures no variance in antigen detection capacity.
• Regulatory Openness – WHO publishes full assessment reports, allowing purchasers to verify claims.

Practical Implementation tips for Health Ministries

1. Integrate Into Existing Testing Algorithms

• Use rapid antigen tests as the first line for symptomatic patients.
• Confirm negative results with RT‑PCR when clinical suspicion remains high.

2. Training & Supervision

• Conduct 2‑day hands‑on workshops for frontline workers.
• Implement a digital log‑book to track test usage and performance metrics.

3. Supply Chain Management

• Forecast demand based on population size and anticipated outbreak peaks.
• Leverage pooled procurement through the WHO‑supported Global Fund to negotiate lower prices.

4. Data Reporting

• Feed test results into national surveillance dashboards in real time.
• Use geotagging to identify hotspots for targeted interventions.

Real‑World Impact: Case Studies

1. Uganda’s Rural Outreach (2025 Q2)

• Context: 12 districts lacking laboratory capacity.
• Action: Deployed 3,500 RapidTest‑A kits through community health workers.
• Outcome: 92 % of symptomatic individuals received same‑day results; case detection increased by 27 % compared to baseline.

2. Bangladesh Urban Slums (2025 Q3)

• Context: Overcrowded neighborhoods with high transmission risk.
• Action: Integrated RapidTest‑B into mobile testing vans operating 6 hours daily.
• Outcome: Identified 1,850 positive cases within two weeks, enabling rapid isolation and reducing secondary attack rates by 15 %.

Benefits for Low‑Income Nations

• Improved Health Equity – faster diagnosis narrows the gap between urban and rural healthcare access.
• Economic Savings – Early case detection curtails hospitalizations, preserving limited resources.
• Enhanced Pandemic Preparedness – Prequalified kits become part of national stockpiles for future respiratory outbreaks.

Frequently Asked Questions (FAQ)

Q: How often must the prequalified tests be re‑evaluated?

A: WHO conducts an annual post‑market surveillance review and triggers re‑assessment if performance data fall below the acceptance threshold.

Q: Are there warranties for the kits?

A: manufacturers provide a 12‑month warranty covering manufacturing defects; WHO requires clear warranty terms as part of the prequalification dossier.

Q: Can the tests detect emerging variants?

A: Both RapidTest‑A and RapidTest‑B target the nucleocapsid protein,a region with limited mutation across known variants,ensuring continued sensitivity.

Key Takeaways for Stakeholders

• Policy Makers: Prioritize procurement of WHO‑prequalified rapid antigen tests to guarantee diagnostic reliability.
• Donor Agencies: Allocate funds toward bulk purchasing agreements that leverage WHO’s quality‑assured catalog.
• Healthcare Providers: Incorporate rapid antigen testing into routine patient flow to accelerate case management.

By aligning procurement, training, and data reporting with WHO’s prequalification standards, low‑income nations can secure rapid, accurate COVID‑19 testing-an essential step toward controlling current waves and strengthening future outbreak response.