Vaccines, Blood & Biologics

Testing for HIV

The United States Food and Drug Administration (FDA) regulates the tests that detect infection with Human Immunodeficiency Virus (HIV), the virus that causes AIDS. AIDS is a serious disease that can be fatal because the body has lost the ability to fight infections and cancers. There are a number of options for people to be tested for HIV, using tests approved by FDA:

  1. Trained health professionals collect a sample and run the test in a professional medical setting. You receive your test results from a trained health professional.
  2. You collect a sample in the home, forward the sample to a medical laboratory, and trained health professionals run the test in the medical laboratory.
  3. You collect a sample, run the test, and obtain your own test results in your home.

How do I decide which test is best for me?

There are many different factors to consider when deciding which test to use. These include your need for anonymity, the accuracy of the test should you be infected with HIV (the test sensitivity) or not infected with HIV (the test specificity), whether you need to have additional testing done to confirm a positive result, the type of sample needed (for example, blood vs. oral fluid), the time it takes to get a test result, and how you receive your test results (self-read and self-interpreted or from a healthcare professional). You should take the time to understand these differences and decide what factors are most important to you when choosing the way to test, whether through a healthcare professional or by using an over-the-counter HIV test.

When should I be tested?

If you actively engage in behavior that puts you at risk for HIV infection, or your partner engages in such behavior, then you should consider testing on a regular basis. Most HIV tests detect antibodies to the virus. However, it can take some time for the immune system to produce enough antibodies for the test to detect, and this time period can vary from person to person. This timeframe is commonly referred to as the “window period,” when a person is infected with HIV but the antibodies to the virus cannot be detected, however, the person may be able to infect others. According to the Centers for Disease Control and Prevention, although it can take up to six months to develop antibodies for HIV, most people (97%) will develop detectable antibodies in the first three months following the time of their infection.

What other tests are approved in the U.S. to test for HIV?

A complete list of the HIV test kits approved in the U.S. is available on our web site.

Related Information

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448

Page Last Updated: 08/08/2013
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