The World Health Organization (WHO) grants approval to Nigerian company Colexa Biosensor Ltd./Codix Pharma Group to locally package the WHO-prequalified STANDARD Q HIV 1/2 Ab 3-Line Test. This move enhances regional production and accessibility of life-saving diagnostic tools across Africa.
The approval allows Colexa Biosensor to package and distribute this rapid HIV diagnostic test, enabling governments and international organizations like the Global Fund and PEPFAR to procure it directly. WHO emphasizes that local manufacturing strengthens health systems, improves pandemic preparedness, and ensures essential diagnostics reach underserved communities.
PEPFAR sets a target of procuring 15 million Africa-made HIV tests by 2025, and this approval marks a critical step toward achieving that. WHO highlights the product’s use in several African countries and sees local packaging as an opportunity to scale up adoption across the continent.
WHO and partners, including the Global Fund, aim to support the widespread adoption of this test by providing rapid verification studies. This initiative aligns with efforts to create sustainable diagnostic markets and expand access in low- and middle-income countries.
WHO leaders, including Dr. Meg Doherty, emphasize the importance of scaling up access to safe and affordable diagnostics to combat HIV, which still claims over 630,000 lives annually, mostly in Africa. The availability of a WHO-approved, locally packaged HIV test supports global goals for testing, treatment, and viral suppression.
This development reflects WHO’s ongoing commitment to fostering regional innovation, expanding diagnostic options, and advancing the global fight against HIV/AIDS.
 grants approval to Nigerian company Colexa Biosensor Ltd./Codix Pharma Group to locally package the WHO-prequalified STANDARD Q HIV 1/2 Ab 3-Line Test. This move enhances regional production and accessibility of life-saving diagnostic tools across Africa.){kind=link}