Pharmaceutical

FDA approves first at-home HIV test kit

HIV at home test FDA FDA approves first at home HIV test kitPeople can now test themselves for HIV in the privacy of their own homes. The Food and Drug Administration (FDA) has approved the OraQuick In-Home HIV Test, a home-use HIV test kit that does not require sending a sample to a laboratory for analysis.

The kit, which tests a sample of fluid from your mouth, is approved for sale in stores and online to anyone age 17 or older. The results come in about 20 to 40 minutes. The results, whether positive or negative for HIV, are considered preliminary. Positive results should be confirmed by follow-up laboratory-based testing. Also, falsely negative results may happen for reasons that include the occurrence of HIV infection within three months before testing.

The FDA advises that people who engage in behaviors that put them at increased risk of getting HIV – including having unprotected sex with new partners, or injecting illegal drugs – should be re-tested on a regular basis. These individuals should not interpret a negative test to indicate that engaging in high-risk behavior is safe.

The test is targeted to people who would not otherwise be tested, often because they may be reluctant to visit their doctor or health care facility to be tested. There are a large number of people who are infected with HIV but do not know they have it.

The FDA predicts that making the OraQuick In-Home HIV Test available to consumers will contribute measurably to public health by helping more infected individuals become aware of their HIV status and thereby reducing HIV transmission.

Since 2002, the FDA has approved a number of rapid HIV tests that can be used by trained individuals outside of a traditional laboratory or clinic. The OraQuick In-Home HIV Test provides another option for people who might be unlikely to go to a health care setting for this testing.

Source: FDA