What test characteristics favor possible approval of an OTC home-use HIV test?
• The risk of an incorrect test result is extremely low in the hands of trained operators. This would be supported by a demonstration of analytical and clinical sensitivity and specificity, as well as demonstration that the test is not affected by conditions of operational stress. • The test is simple to use compared to other types of HIV tests and earlier versions of rapid HIV tests, suggesting that untrained persons will be able to perform the test properly. • The test does not require special storage conditions. • The test provides highly accurate results for the detection of antibody to HIV within 20 minutes. • The use of a non-infectious oral fluid specimen eliminates concerns about biohazardous conditions (no blood and no sharps). • Informational materials supplied with the test are sufficient to provide adequate information to potential users on performing the test and to substitute for live counseling. What information will be discussed at the BPAC meeting? After considering co
