FDA Approves Premarket Approval Application for OraQuick HIV Self-Test, Expanding Access to Adolescents

The OraQuick In-Home HIV Test (Orasure Technologies Inc) received approval from the FDA for a premarket approval application 180-say supplement requesting a labeling change to lower the approved age to individuals who are 14 to 17 years of age and older. The decision increases access to adolescents, allowing them to test for HIV in the comfort and privacy of their own homes.¹

HIV test strip | Image Credit: © Mulin - stock.adobe.com

According to the CDC, approximately 1.2 million individuals in the United States had HIV in 2022, of which 13% were unaware they were HIV-positive. This underscores the crucial need for increased awareness of the infection, as well as expanded opportunities for testing. The FDA originally approved the in-home HIV test on July 3, 2012 for individuals over the age of 17, making it the first rapid OTC HIV test in the United States, as well as the first rapid diagnostic test for any infectious disease.^2,3

“Approval of the OraQuick In-Home HIV Test represents a major breakthrough in HIV testing," Douglas A. Michels, president and CEOof OraSure Technologies, said in a news release. "For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed. This new in-home rapid test—the same test doctors have used for years—will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting."³

The test is capable of detecting both HIV-1 and HIV-2, the viruses that cause AIDS, with an oral swab, providing results in as little as 20 minutes. According to clinical studies, the HIV test has an expected performance of 99.98% for test specificity, meaning 1 false positive result would be expected out of every 5000 test results in uninfected individuals. Additionally, it has an expected performance of approximately 92% for test sensitivity.⁴

However, the test’s ability to detect HIV depends on the immune system producing enough antibodies, which can take time and varies between individuals. This period, known as the "window period," occurs when someone is infected with HIV, but the antibodies are not yet detectable. According to the CDC, while it can take up to 6 months for antibodies to develop, the majority (97%) of individuals will have detectable antibodies within the first 3 months after.⁴

By extending the test’s availability to adolescents aged 14 to 17, the decision addresses a critical need to reach individuals who might otherwise face barriers to testing in clinical or professional settings and contributes to efforts to reduce the spread of HIV.

REFERENCES

1. OraSure Technologies, Inc. Letter to Jamie Keller regarding PMA approval for OraQuick HIV Self-Test. Premarket Approval Database. US Food and Drug Administration. June 28, 2024. Amended November 21, 2024. Accessed December 20, 2024. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

2. The HIV/AIDS epidemic in the United States: the basics. KFF. August 16, 2024. Accessed December 20, 2024. https://www.kff.org/hivaids/fact-sheet/the-hiv-aids-epidemic-in-the-united-states-the-basics/

3. OraSure receives FDA approval of OraQuick(R) In-Home HIV Test. GlobeNewswire. July 2, 2012. Accessed December 20, 2024. https://www.kff.org/hivaids/fact-sheet/the-hiv-aids-epidemic-in-the-united-states-the-basics/

4. Information regarding the OraQuick In-Home HIV Test. FDA. Accessed December 20, 2024. https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/information-regarding-oraquick-home-hiv-test