Caveat Emptor ("Let the Buyer Beware")
Home testing offers a way for you to test for medical conditions in the privacy of your own home and to monitor chronic health conditions. If you use home tests, however, protect yourself against the possibility of bogus tests, false results, and your own lack of training by following these guidelines:
Make sure that the test you are purchasing is FDA-approved. The FDA requires manufacturers to meet stringent controls for quality, precision, and accuracy (See How Reliable is Laboratory Testing? for an explanation of these terms.). Approved home tests must also meet FDA labeling requirements.
Check the expiration date. Do not buy tests if they have expired. The chemicals in the test may have lost their effectiveness and the results may not be valid.
Follow the package directions on where and how to store the test kit. Don't leave temperature-sensitive kits in places with extreme temperatures, such as the trunk of a car or near a radiator or heater. Some tests may be sensitive to moisture and should not be left in places with high humidity, such as a bathroom.
Note and follow any special precautions before performing the test. For example, check to see when the test is to be performed (morning, evening) or under what conditions (fasting, no physical exertion, etc.).
Perform the test EXACTLY as instructed. If you have questions or are at all unsure about how to use the test, consider talking to your healthcare provider. If you have privacy or security concerns, call the 800 Help number listed on the package insert.
Make sure you understand the meaning of the test results and what to do about them. If you do not, call the Help number provided by the manufacturer or call your healthcare provider. The FDA encourages manufacturers to provide professional counseling and referral services through an 800 number.
If you have any questions or concerns about the legitimacy of the product or about whether there have been any adverse effects associated with the device, contact the Manufacturer and User Facility Device Experience Database (MAUDE). An online search is available. You can search the Center for Devices and Radiological Health's database on medical devices that may have malfunctioned or caused death or serious injury.
Consult the following agencies for additional consumer information. These are general links that will require additional searching for relevant information: