By Marilyn Chase
The Wall Street Journal - October 1997
HOME TEST KITS, which help people monitor their health away from the doctor's office, have been a time-saving and money-saving boon to consumers. But be wary of the unapproved or fraudulent test kits being marketed on the Internet, in magazines and elsewhere.
Like many booming markets the test-kit sector has attracted its share of entrepreneurs who want to cash in on the patient-empowerment movement and reap sales without regulatory approval.
Overall, about 300 home-test products have been approved by the U.S. Food and Drug Administration in the past two decades. FDA approval generally means a home test-kit works as well as its laboratory counterpart, and contains instructions that are written so that consumers can use tests accurately. (In an exception to the rule, the FDA recently proposed an interim policy that exempts from strict premarket approval those companies that make home drug-screening urine tests.)
Consumers in doubt about the legal status of a test kit can call the FDA's MedWatch program at 1-800-FDA-1088.
LEAPS IN technology have improved the sensitivity and specificity of test kits, reducing the rate of false positive or false negative results. Cross reactions with foods, drugs and other chemicals also occur less frequently now.