Answer

 FDA approved tests have demonstrated their reliability; unapproved tests have not been reviewed by FDA. Therefore, FDA cannot state that unapproved tests are reliable. Since the approved HIV home collection test system has been independently tested, validated, and approved by FDA, the consumer can feel confident that the approved HIV test system will provide accurate results available from an HIV home test. In addition, the user is provided with counseling and referrals if needed.

Last revised: March 28, 2007