Test for home use detects drugs of abuse

FDA Consumer, April, 1997

A home test system for drugs of abuse--such as marijuana, heroin and cocaine--will be available in drugstores, pharmacies, and other places selling over-the-counter medical products.

Earlier this year, FDA cleared Dr. Brown's Home Drug Testing System, the first nonprescription test system for detecting marijuana, PCP, amphetamines, cocaine, heroin, codeine, and morphine in urine. Results are available anonymously by identification number.

"The approval of this test gives parents another option to consider to help ensure that their children remain drug-free," said Health and Human Services Secretary Donna E. Shalala.

The system includes a kit to collect and mail a urine sample. Directions for use and for obtaining and interpreting results are also provided. The user labels the urine sample with an identification number provided in the kit and sends it to a specified government-certified laboratory for analysis. The laboratory evaluates the sample for possible tampering, tests it for drugs of abuse, does a confirmation test to minimize false positive readings, and then forwards the results by computer to the manufacturer's results center.

To obtain the results, which are available one to three days after the lab receives the urine sample, the user calls a toll-free phone number and provides the sample identification number. In addition to learning whether the test showed the presence of drugs, the user receives information explaining the results and the potential for erroneous results. If needed or requested, referrals are offered for drug abuse counseling and medical assistance.

A positive result indicates the presence of one or more of the drugs in amounts sufficient for detection. Some medicines and, rarely, certain foods can cause a false positive reading. A negative result indicates the absence of drugs, or an insufficient quantity to be detected. A result may be falsely negative if too much time has elapsed between exposure to the substance and urine collection. In rare cases, it is also possible that technical or procedural errors in the lab could interfere with test results. Therefore, both FDA and the test manufacturer recommend that test users who receive a positive result, as well as others who have questions about their results, consult a physician for follow-up evaluation.

Dr. Brown's Home Drug Testing System is manufactured by Personal Health and Hygiene Inc., Silver Spring, Md. FDA cleared the test system Jan. 21, and the company expected to start marketing it in March.