Specifications include, but are not limited to: 1. Rapid Point-of-Care Assay Kits (Ref: Chembio HIV ½ STAT-PAK Assay) • Single-use diagnostic tests for the rapid (approximately fifteen (15) minutes) • Visual detection of antibodies to HIV 1 and HIV 2 at point-of-care (POC) • For use with serum, plasma, fingerstick whole blood, and venous whole blood • Sample size 5μL (microliters) • Clinical Laboratory Improvement Amendments (CLIA) waived • Approximately a 2-step test procedure • Ready-to-use reagents • Room temperature storage: 46° to 86°F (8° to 30°C) • U.S Food and Drug Administration (FDA) approved 2. Rapid Test for Qualitative Detection of Antibodies Kits (Ref: INSTI HIV-1/HIV-2 Antibody Test) • Built-in Immunoglobulin (IgG) procedural control • Detection of antibodies to HIV Type 1 and Type 2 • For use with plasma, fingerstick blood, and whole blood • Immunofiltration “flow-through” design • Built-in IgG capture procedural control • HIV antigen • Lancet, pipette and alcohol swab included • Spill-free membrane • Produces results in approximately sixty (60) seconds • Stored at room temperature 15-30°C (59-86°F)
