USAID List of approved HIV & AIDS test kits

Publication date: 2008

USAID List of Approved HIV/AIDS Rapid Test Kits - April 1, 2008 Test Kit Name Supplier Approved by 1. Aware™ HIV-1/2 BSP Calypte Biomedical* USAID 2. Bioline HIV 1/2 3.0 Standard Diagnostics USAID 3. Bionor™ HIV-1&2 Bionor A/S USAID 4. Bundi™ Rapid HIV 1/2 Bundi International Diagnostics Ltd. USAID 5. Calypte® Aware™ HIV-1/2 OMT Calypte Biomedical Corp.* USAID 6. Capillus™ HIV-1/HIV-2 Trinity Biotech USAID 7. Care Start™ HIV 1-2-O Access Bio, Inc.* USAID 8. Clearview® COMPLETE HIV1/2 Inverness Medical Innovations, Inc.* USAID (formerly SURE CHECK® HIV1/2) 9. Clearview® COMPLETE HIV1/2 - US labeling** Inverness Medical Innovations, Inc.* FDA (formerly SURE CHECK® HIV1/2) 10. Clearview ® HIV 1/2 STAT-PAK® Assay - Inverness Medical Innovations, Inc.* FDA US labeling (formerly HIV 1/2 STAT-PAK® Assay - US labeling)** 11. Combaids RS Advantage Span Diagnostics Ltd. USAID 12. Determine™ HIV-1/2 Inverness Medical Innovations, Inc.*/ Abbott Laboratories* USAID 13. Double Check™ HIV 1&2 InvernessMedical Innovations, Inc.*/ USAID Orgenics, Ltd 14. Double Check Gold™ HIV1&2 InvernessMedical Innovations, Inc.*/ USAID Orgenics, Ltd. 1 15. EZ-H2 CS Innovation USAID 16. First Response® HIV 1-2.0 Premier Medical Corporation USAID 17. Genie II HIV-1/HIV-2 Bio-Rad Laboratories* USAID 18. HIV 1/2 Gold Rapid Screen Test Medinostics Int’l * USAID 19. HIV 1/2 Rapid Test Kit 20. HIV 1/ 2 STAT-PAK® Assay 21. HIV 1/2 STAT-PAK® Dipstick Assay Medinostics Int’l * Chembio Diagnostic Systems, Inc* Chembio Diagnostic Systems, Inc.* USAID USAID USAID 22. Diagnostic kit for HIV (1+2) Antibody Shanghai Kehua Bioengineering USAID (Colloidal Gold) 23. HIVSav 1&2 Rapid SeroTest™ Savyvon Diagnostics Ltd. USAID 24. ImmunoComb™ HIV 1&2 Inverness Medical Innovations, Inc.*/ Orgenics, Ltd. USAID 25. InstantCHEK™ HIV1+2 EY Laboratories USAID 26. INSTI™ HIV Antibody Biolytical Laboratories USAID 27. Multispot™ HIV-1/HIV-2 Bio-Rad laboratories* FDA 28. OraQuick® ADVANCE™ Rapid HIV-1/2** OraSure Technologies* FDA 29. OraQuick® HIV-1/2 Rapid Antibody Test OraSure Technologies* USAID 30. RAPID 1-2-3® HEMA EZ™ Hema Diagnostics Systems* USAID 31. RAPID 1-2-3® HEMA EXPRESS™ Hema Diagnostics Systems* USAID 32. Reveal®G3 Rapid HIV-1 Antibody Test MedMira FDA 33. Signal HIV Rapid Test Span Diagnostics Ltd. USAID 34. Uni-Gold™ HIV Trinity Biotech USAID 35. Uni-Gold™ Recombigen® HIV** Trinity Biotech FDA * Parent Company is a United States-based firm. ** Generally distributed only in the United States. 2

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