Home Diagnostic Tests : Popular Products, Buying Test Kits Online

by Food and Drug Administration (FDA)

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"As a consumer, I want to see the data that supports this being a good brand," she says. "For the average person, this information truly lets them know what they're purchasing." But Moore happens to be more familiar with sensitivity and related product information than most people, since she has worked as a registered laboratory technician. Still, she insists that today's consumer wants more information visible on the product's label than is currently available.

Dave Lyle, a medical technologist in the FDA's clinical laboratory devices division, explains that "the decision was made several years ago to exclude this information from over-the-counter kits because it might confuse the consumer." However, Lyle agrees that "in today's world, most consumers are very sophisticated and want as much information as possible to make an informed decision."

Complications of home testing may interfere with obtaining accurate results. Consumers may not be able to follow the instructions. Proper collection, storage and shipment of specimens are all critical for accuracy. Samples held too long, for example, or subjected to severe temperature changes could generate false positive or negative readings. Urine samples taken too early or too late in the day or foods eaten that mimic the metabolites being measured also can produce inaccurate readings.

And people need to beware of bogus tests — those not cleared by the FDA. Unapproved home test kits do not come with any guarantee of accuracy or sensitivity, nor do they have a documented history of dependability. Proper training to interpret results is not provided with the kits, and they do not have a validated record of precision. This means that unapproved tests may be inconsistent and inaccurate.

Approved tests, on the other hand, have undergone extensive study and review by the manufacturer of the product to satisfy the FDA's requirement that they are as safe and accurate for consumer use as their laboratory counterparts are for professional use. For any in-home test, the manufacturer must convince the FDA that the results of a test will benefit consumers and that consumers have the knowledge necessary to decide whether testing themselves is appropriate.

For example, Stewart says people purchasing blood pressure monitors should look for a statement in the label that says the device has been validated in a human study "where the statistics have been calculated to ensure that good accuracy can be demonstrated." Stewart says the label also should include a statement that says measurements obtained by the blood pressure monitor are equivalent to those obtained by a trained observer using a cuff and stethoscope.

"Indeed, reading the label is the most important thing," he says, "but it might also be useful to ask the pharmacist or one's doctor to get a recommendation."

Popular But Not Perfect

Amid sweeping changes in U.S. health care, the trend toward cost-effective self-care products used in the home emphasizes prevention and early intervention. The home test kit market is offering faster and easier products that lend themselves to being used in less-sophisticated environments to meet consumers' needs.

However, Gutman emphasizes, "even the best screening tests are occasionally wrong. No tests, whether performed at the lab or in the home, are perfect."

Buying Test Kits Online

The consequences of consumer health fraud range from significant financial loss to the failure to seek legitimate medical treatment. The Food and Drug Administration wants consumers to be aware that a number of unapproved test kits are being marketed on the Internet, as well as through magazine or newspaper promotions, for home use. Internet sites sell test kits that falsely claim everything from being FDA-approved to detecting illness within 15 minutes or less. Also, consumers may receive contaminated or counterfeit products, the wrong product, or no product at all. These elements "are complicated by the fact that with the Internet, you're not always sure you're in U.S. commerce," says Steven Gutman, M.D., director of the FDA's clinical laboratory devices division. Many home test kits not approved for use in the United States are available in other countries.

But Gutman adds that consumers can feel confident that home test kits purchased from a reputable drugstore or pharmacy have been cleared by the FDA. For peace of mind, he says people can log onto the agency's Web site at www.fda.gov/oc/buyonline/ for consumer tips and warnings for buying medical products online, and www.fda.gov/cdrh/ode/otclist.html for a regularly updated list of approved home test kits sold over the counter.

Gutman says that consumers should feel free to contact manufacturers of diagnostic devices intended for home use to determine if they have been reviewed by the FDA. The inability to reach a reliable party for this information, he says, "may in itself be a signal that the test may not be a wise purchase."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.