Unitaid and Global Fund have concluded round 6 of the World Health Organization Expert Review Panel for Diagnostics, reviewing rapid diagnostic tests for HIV self-testing. See our original invitation to manufacturers more information:

• Invitation to Manufacturers to Submit an Expression of Interest for Product Evaluation by the Global Fund Expert Review Panel for Rapid Diagnostics Products: Rapid Diagnostic Tests for HIV Self-testing
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Several blood-based HIV self-testing kits have been identified that may be considered for procurement, upon request by countries, and under a specific process determined by the Global Fund and Unitaid respectively. The conclusion of the quality risk assessment review is that the product has been categorized by the Expert Review Panel for Diagnostics as category 3, meaning that procurement with Global Fund and/or Unitad resources of this product will be permitted in exceptional circumstances. Because of the exceptional nature of this categorization, the referenced product will not be included in the procurement list dedicated to this type of products, published by the Global Fund on its website.

One oral fluid HIV self-testing kit has also been identified as eligible for procurement as a result of the Expert Review Panel for Diagnostics round 4 in February 2017 and is now reflected in the Global Fund list of eligible products for procurement with grant funds:

• List of HIV Diagnostic Test Kits and Equipments Classified according to the Global Fund Quality Assurance Policy
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All information related to the procurement with Global Fund grants of products reviewed by the WHO Expert Review Panel, including instructions for Global Fund recipients, is available on our Diagnostic Products page.

Any grantee should seek authorization from Unitaid, when using Unitaid grants, before engaging in procurement of a product reviewed by the WHO Expert Review Panel.