Unapproved HIV Test Kits May Face Legal Challenge
A consumer warning posted jointly by the FDA
and the Federal Trade Commission cautions that HIV test
kits that have not been approved for distribution may give inaccurate results. The statement goes on to say that the agencies may take action to halt the sale of kits that aren't up to par.
The FDA has conducted several investigations of the reliability and accuracy of unapproved HIV home test kits since 1996.