OraQuick – First home-use HIV kit approved for self-testing

Is there a chance that you may be HIV positive? And are you unlikely to visit a doctor’s office, clinic, hospital or other healthcare setting to be tested? You can now test yourself and get a preliminary (or screening) result in 20-40 minutes—in the privacy of your own home.

The US 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 and older.

US FDA wants consumers to know that positive test results using the OraQuick test must be confirmed by follow-up laboratory-based testing. Also, the test can be falsely negative for reasons that include the occurrence of HIV infection within three months before testing. 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. They should not interpret a negative test to indicate that engaging in high risk behavior is safe.

According to the Centers for Disease Control and Prevention, about 1.2 million people in the U.S. are living with HIV infection, and about 1 in 5 of these people don’t know that they are infected, increasing the chance that they will unknowingly spread the infection.


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