Intent to sole source - 72675 Bio Rad for Genetic Systems HIV ½ plus O EIA kits (item# 32588), Geenius HIV ½ Supplemental assay, Geenius HIV ½ quality controls and GS HIV-1 Western Blot

These test kits are validated and approved to maintain the College of American Pathologists and ISO 17025 accreditation for our laboratory. The College of American Pathologists and ISO are accrediting bodies that accredits labs to perform clinical testing. Genetic Systems HIV ½ plus O and GS HIV-1 western blot are currently the only 3rd generation antibody assays approved by the Food and Drug administration (FDA) for use in CDC and U.S. Other products from other manufacturers cannot be used since they are not FDA approved and are not allowed to be used in the U.S. The Geenius HIV-1/HIV-2 Supplemental assay is the only Food and Drug Administration (FDA) approved HIV test that distinguishes between HIV-1 and HIV-2. These kits and reader are only manufactured and available from Biorad-U.S. If another product were available, the laboratory would have to perform a lengthy validation study (over a year) to approve its use in our laboratory. In the interim of the validation, we would not be able to perform any clinical testing since it is the first test used in our testing algorithm.