The FDA has approved a premarket approval application supplement for the OraQuick In-Home HIV Test, allowing individuals aged 14 and older to use the test. This decision significantly broadens access to HIV testing for adolescents, enabling them to test in the privacy of their homes. The approval addresses a critical need, as many young people with HIV are unaware of their status, hindering efforts to curb the spread of the virus.
Addressing a Critical Need
According to the CDC, approximately 1.2 million people in the United States had HIV in 2022, with 13% unaware of their infection. Among young people aged 13 to 24, 19% of new HIV diagnoses occur, and only 6% of high school students have ever been tested for HIV. This highlights the urgent need for increased testing opportunities, particularly among adolescents who may face barriers to accessing clinical testing services.
Carrie Eglinton Manner, President and CEO of OraSure Technologies, stated, "Increasing access to different testing options is critical to ending the HIV epidemic for all people, and early connection to care is essential for adolescents who test positive for HIV."
Test Performance and Window Period
The OraQuick HIV Self-Test detects both HIV-1 and HIV-2 using an oral swab, providing results in approximately 20 minutes. Clinical studies indicate a test specificity of 99.98%, meaning about 1 false positive result per 5000 tests in uninfected individuals. The test sensitivity is approximately 92%. However, the test's ability to detect HIV depends on the presence of sufficient antibodies, which may take time to develop after infection. This "window period" can last up to 6 months, although the majority (97%) of individuals develop detectable antibodies within 3 months.
Impact and Accessibility
By lowering the approved age to 14, the FDA's decision aims to reach a vulnerable population that may not otherwise seek testing in clinical settings. The OraQuick HIV Self-Test has been available directly to consumers since 2012, and OraSure Technologies has focused on providing educational materials and linkage to care information with the test. This approval will further expand access to testing and promote early diagnosis and treatment, contributing to efforts to reduce the spread of HIV and combat the stigma associated with the infection.
