The Department of Health’s Harm Reduction Services Branch (HRSB) is seeking Hepatitis C Virus (HCV) testing kits for rapid diagnosis and treatment of HCV and prevention of future infection. HRSB orders, receives, and stores these kits on Oʻahu, and distributes them to community partners statewide for testing of individuals at high risk of HCV infection. This solicitation is for HCV test kits that meet the following specifications: - The test kit must be a single-use, qualitative immunoassay to detect antibodies to Hepatitis C Virus (anti-HCV). - 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 shelf life must be at least 12 months. - Each box of 100 test kits should come with at least 5 reusable test stands and 100 specimen collection loops.
