Many manufacturers are promoting home tests on the Internet. This could be risky—unless you get savvy about which tests and sites are legitimate and which are bogus.

FDA Consumer Magazine, for instance, reported prosecuting an individual on wire fraud charges stemming from selling illegal HIV and Hepatitis C testing kits for home use to consumers and to pharmacies. Testers submitted blood samples on band-aid-like strips to the manufacturer, who neither sent samples to a lab for analysis nor used any scientific or factual principles to derive results. Nor did he provide counseling, which manufacturers are required to do when they inform users of test results.

The FDA, which regulates the home testing market, holds manufacturers of home tests to a rigorous pre-market approval process. For instance, manufacturers who want their tests approved for home use must demonstrate that consumers can get results comparable to those obtained in a professional laboratory.

In addition, manufacturers must pass an intensive review of proposed labeling. A major issue in the review is whether the instructions clearly communicate information to a consumer—and in a way that leads to actions that promote personal or public health and minimize illness.