Specifications include, but are not limited to: The Department of Health’s Harm Reduction Services Branch (HRSB) uses CDC awarded funding to purchase and distribute HIV testing kits and testing controls for rapid diagnosis and treatment of HIV and prevention of future infection. These kits are used for individuals at the highest risk of being infected with HIV. HRSB orders, receives, and stores these kits on Oahu, and distributes them to community partners statewide for testing of individuals are high risk of HIV infection. This solicitation is for HIV test kits that meet the following specifications: - The test kit must be a rapid, fourth generation point of care test. - The test kit must detect both HIV-1/2 antibodies and HIV-1 p24 antigen. - The test kit must be waived of Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements, and be approved by the US Food and Drug Administration (FDA) for use with fingerstick whole blood specimens. - The test kit must yield results in 20 minutes or less. - The test kit must be spill resistant if tipped over. - The test kit shelf life must be at least 12 months. - The rapid HIV antigen/antibody (Ag/Ab) controls must be compatible with the rapid HIV test kit to ensure its proper performance.
