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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]
The test was more accurate at clearing patients who didn't have the disease, correctly identifying HIV-negative users 99 percent of the time. [7] In July 2012, OraQuick was approved by the Food and Drug Administration for over-the-counter use. [1] [2] [4] There is also an OraQuick test for Ebola.
Gilead Sciences and the U.S. government have settled a billion-dollar patent dispute over Gilead's HIV prevention drugs Truvada and Descovy, according to a Wednesday filing in Delaware federal court.
The new test received FDA authorization after the company submitted data from clinical trials showing that the First To Know Syphilis Test identified a positive specimen 93.4% of the time.
The eclipse period is a variable period starting from HIV exposure in which no existing test can detect HIV. The median duration of the eclipse period in one study was 11.5 days. The window period is the time between HIV exposure and when an antibody or antigen test can detect HIV. The median window period for antibody/antigen testing is 18 days.
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