FDA cannot ensure the reliability of any test kit that has not undergone FDA review. Diagnostic testing depends on precise science. FDA approved tests have demonstrated that they are reliable. Tests that are not FDA approved have not demonstrated to FDA that they are reliable. Unapproved HIV home test kits do not come with any guarantee of the accuracy of the test. The kits do not train a home user on how to interpret results and they have not demonstrated that home users can use them without that training. None of the unapproved tests has undergone the review required for FDA marketing approval. Although unapproved tests might be promoted as sensitive and reliable, the consumer has no assurance that test results are accurate. Simply put, you just can't trust the results of an unapproved test to be correct. Users may get a positive result when they are, in fact, not infected (called a false positive). Or the test may indicate that users are not infected with the virus, when, in fact, they are (called a false negative). Both of these outcomes can have grave consequences in terms of mental anguish, delays in obtaining medical treatment, and transmission of the disease to additional persons. FDA is unaware of any data to confirm the reliability or accuracy of unapproved HIV home test kits. | 
