title: OraSure begins shipping rapid HIV test to hospitals. CLIA waiver could come in several months.
abstract: Long desired and long delayed, the first truly rapid HIV test is now available in many U.S. hospitals. The simple, 20-minute test, which uses fingerstick whole blood, was categorized as one of moderate complexity under the Clinical Laboratory Improvement Amendment. However, the tests aren't approved for use in the field where they are needed most. That soon may change if the FDA adopts a waiver requested by the manufacturer.
mesh_terms: D015492:AIDS Serodiagnosis / Q000295:instrumentation*; D018795:Device Approval; D004865:Equipment and Supplies, Hospital / Q000600:supply & distribution*; D015658:HIV Infections / Q000175:diagnosis; D006801:Humans; D007221:Industry; D011933:Reagent Kits, Diagnostic / Q000600:supply & distribution*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011933:Reagent Kits, Diagnostic