FDA approves first HIV home-use test
The US Food and Drug Administration (FDA) has announced its approval of the first ever HIV home-use self-testing kit.
The OraQuick Rapid HIV 1 / 2 Antibody Test is a visually read, qualitative immunochromatic test, which enables users to collect fluid samples from the mouth using a swab and then receive the results around 20 to 40 minutes later, in the privacy of their own home.
According to FDA officials, the home-use self-testing kit is aimed at people who might not otherwise get tested. The company behind it, OraSure Technologies, Inc., will focus its marketing efforts on populations at greatest risk of being infected, including gay and bisexual men, African-Americans and Hispanics.
The Human Immunodeficiency Virus (HIV) attacks the immune system, weakening the body’s ability to fight infections and disease. Unless treated with antiviral drugs, HIV usually develops into the ultimately fatal Acquired Immunodeficiency Syndrome, better known as AIDS. In 2010 it was estimated that around 34 million people in the world are living with HIV / AIDS, according to international charity AVERT.
"Approval of the OraQuick® In-Home HIV Test represents a major breakthrough in HIV testing. 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."
Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies.
OraSure’s self-testing HIV kit has been approved for marketing to anyone aged 17 and older, in both stores and online. The FDA stressed in its approval announcement, that the test is not 100% accurate, with the latest trial by OraSure showing that the test correctly detected HIV in those carrying the virus, 92% of the time. However, the test was 99% accurate in ruling out patients not carrying the virus.
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OraSure Technologies, Inc.
FDA HIV home test kit fact sheet