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The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay that can be purchased over-the-counter (OTC). This test kit contains a test swab that collects oral fluid containing antibodies for HIV-1 and HIV-2 from the user’s gums. The material is gathered and combined with buffered developer solution in a test tube.
In 2012 the U.S. Food and Drug Administration announced that it had approved the first, over-the-counter (OTC) sale of home HIV test kits that do not require sending sample to a lab. [14] [15] The Pennsylvania-based Orasure Company holds the patent and monopoly on the oral swab technology. [16]
In 2004, the US Federal Trade Commission asked Federal Express and US Customs to confiscate shipments of the Discreet home HIV test kits, produced by Gregory Stephen Wong of Vancouver, Canada. [47] In February 2005, the US FDA issued a warning against using the rapid HIV test kits and other home use kits marketed by Globus Media of Montreal ...
Grab an at-home test kit at a drugstore or ask your doctor for a test. If you test positive at home, you will need to see a healthcare provider to confirm the results and discuss treatment options ...
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HIV NATs for viral load approved & licensed by the FDA for sale in the United States [23] Test name Molecular method Use Approved Manufacturer Roche Amplicor HIV-1 Monitor Test [24] PCR: Viral load: 3/2/1999: Roche Molecular Systems, Inc. Pleasanton, CA NucliSens HIV-1 QT [25] NASBA: Viral load: 11/19/2001: bioMerieux, Inc Durham, NC
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