Approval Pending for First 'Home Results' HIV Test
Approval Pending for First ‘Home Results’ HIV Test An over the counter human immunodeficiency virus (HIV) test that offers home based results—the first of its kind—may soon receive federal Food and Drug Administration (FDA) approval. The agency’s advisory committee
Approval Pending for First ‘Home Results’ HIV Test
An over-the-counter human immunodeficiency virus (HIV) test that offers home-based results—the first of its kind—may soon receive federal Food and Drug Administration (FDA) approval. The agency’s advisory committee voted unanimously to approve the test, and though formal approval is pending, the FDA traditionally follows the committee’s recommendations.
With the advent of highly active antiretroviral therapy, people with HIV can live healthy lives. Unfortunately, data from the United States Centers for Disease Control and Prevention (CDC) indicate that about 20% of the estimated 1.2 million Americans living with HIV are unaware of their infection. Lacking diagnosis and appropriate medical treatment, serious health consequences ensue, and transmission of the virus cannot be prevented. As a result, the CDC has recommended routine HIV screening for patients ages 13 to 64, especially in high-risk populations.
Because other FDA-approved, over-the-counter tests—such as those in which patients take their own blood samples or mouth swabs and send them to a lab—have not improved HIV testing rates, it is hoped that a kit offering home-based results will encourage more testing among at-risk populations.
