USAID List of Approved HIV/AIDS Rapid Test Kits - March 30, 2012

The list was last updated on March 30, 2012. The kits are categorized by manufacturer, with 22 kits approved by USAID and 21 kits approved by the FDA. ACON's ACON 1/2/4 Tri-line is a tri-line test kit approved by USAID. Alere's Determine HIV-1/2 test kit is approved by USAID, while Alere's Determine HIV-1/2 Ag/Ab Combo Test Kit is approved by USAID. Alere's Double Check HIV 1&2 test kit is approved by USAID, and Alere's Double Check Gold HIV 1&2 test kit is also approved by USAID. Alere's Aware HIV-1/2 BSP test kit is approved by USAID, while Bionor's Bionor HIV-1&2 test kit is approved by USAID. Bundi's Rapid HIV 1/2 test kit is approved by USAID, and Calypte's Aware HIV-1/2 OMT test kit is also approved by USAID. Calypte's Clearview COMPLETE HIV1/2 test kit is approved by USAID, while Chembio's DPP HIV 1/2 Screen test kit is approved by USAID. Chembio's DPP HIV 1/2 Screen Assay is approved by USAID, and Chembio's HIV 1/2 STAT-PAK Assay is also approved by USAID. Chembio's HIV 1/2 STAT-PAK Dipstick Assay is approved by USAID, while Hema's RAPID 1-2-3 HEMA Dipstick test kit is approved by USAID. Hema's RAPID 1-2-3 HEMA EZ test kit is approved by USAID, and Hema's RAPID 1-2-3 HEMA test kit is also approved by USAID. ImmunoComb's HIV 1&2 test kit is approved by USAID, while InstantCHEK's HIV 1+2 test kit is approved by USAID. JAL Innovation's iCARE Rapid Anti-HIV (1&2) test kit is approved by USAID, and K. Shorehill's KSII HIV 1/2 Rapid Diagnostic Test Kit is also approved by USAID. Medinostics' HIV 1/2 Gold Rapid Screen Test is approved by USAID, while Medinostics' HIV 1/2 Rapid Test Kit is approved by USAID. MedMira's Reveal Rapid HIV Test is approved by USAID, and MedMira's Reveal G3 Rapid HIV-1 Antibody Test is approved by FDA. MPI Diagnostics' Anti-HIV (1&2) Test is approved by USAID, while OraSure's OraQuick ADVANCE Rapid HIV-1/2 test kit is approved by FDA. OraSure's OraQuick HIV-1/2 Rapid Antibody Test is approved by USAID, and Orgenics' Double Check HIV 1&2 test kit is approved by USAID. Orgenics' Double Check Gold HIV 1&2 test kit is approved by USAID, while Savyvon's HIVSav 1&2 Rapid SeroTest is approved by USAID. Shangai Kehua's HIV(1+2) Rapid Test Strip is approved by USAID, and Signal's HIV 1/2 Rapid Test is approved by USAID. Span Diagnostics' Combaids RS test kit is approved by USAID, while Span Diagnostics' Signal HIV Rapid Test is approved by USAID. Trinity Biotech's Uni-Gold HIV test kit is approved by USAID, and Trinity Biotech's Uni-Gold Recomb HIV test kit is approved by FDA. Trinity Biotech's Uni-Gold Recomb HIV test kit is approved by FDA, while USAID has removed Standard Diagnostics' Bioline HIV 1/2 3.0 test kit from the list.