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Recent Highlights - IVD

News
16 April, 2026 - 13:49 (CEST)
Announcement
IVD

Between 1 March and 16 April 2026, several WHO Public Assessment Reports (WHOPARs) were updated to reflect changes in product labelling, documentation, and other relevant post-prequalification updates. These revisions ensure continued accuracy, transparency, and alignment with current product configurations and regulatory expectations. The WHOPARS are accessible at the links below: 

  1. Bioline Malaria Ag P.f (PQDx 0031-012-01)
  2. Bioline Malaria Ag P.f (HRP2/pLDH) (PQDx 0209-012-00)
  3. Bioline Malaria Ag P.f/P.f/P.v (PQDx 0297-012-00)
  4. Bioline Malaria Ag P.f/P.v (PQDx 0125-012-00)
  5. Bioline Malaria Ag P.f/Pan (PQDx 0030-012-01)
  6. FalciVax-Rapid test for Malaria Pv/Pf (PQDx 0290-025-00)
  7. Parascreen - Rapid test for Malaria Pan/Pf (PQDx 0291-025-00)
  8. Bioline HCV (PQDx 0257-012-00)
  9. INSTI HIV Self-Test (PQDx 0002-002-01)
  10. Bioline HIV 1/2 3.0 (PQDx 0027-012-00)
  11. Bioline HIV/Syphilis Duo, (PQDx 0179-012-00)
  12. STANDARD Q HIV/Syphilis Combo Test (PQDx 0382-117-00)

For more information please refer to the List of prequalified in vitro diagnostics products: Prequalified In Vitro Diagnostics | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)