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On November 7, 2002, the FDA approved the OraQuick test as the first rapid HIV test, providing results in as little as 20 minutes using whole-blood specimens obtained from a fingerstick or venipuncture. Prior to this approval, HIV tests required blood samples to be sent to a laboratory, resulting in longer wait times for results.
The change expands the approved age range to include individuals 14 years of age and older for the OraQuick ® HIV Self-Test. Previously the test was approved for use in those 17 and older. According to the most recent data available from the Centers for Disease Control & Prevention, it is estimated that 19 percent of new HIV diagnoses in the ...
Previously, HIV was the only other sexually transmitted infection to have an FDA-approved at-home test. Other at-home STI tests are available through telemedicine companies and major pharmacy chains.
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.
The Food and Drug Administration (FDA) approves the first rapid diagnostic HIV test kit for use in the United States. The kit has a 99.6% accuracy and can provide results in as little as twenty minutes. The test kit can be used at room temperature, did not require specialized equipment, and can be used outside of clinics and doctor's offices.
Additional FDA approval for Hologic's (HOLX) molecular diagnostic test is expected to aid in the diagnosis of HIV infection.
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