Home Test for AIDS Virus Is Being Test Marketed in Two States

July 1, 1996

NEW BRUNSWICK, NJ--Confide, the first home collection HIV testing and counseling service, has received FDA approval and is now being test marketed in Texas and Florida. The test was developed by Direct Access Diagnostics, a Johnson & Johnson subsidiary based in Bridgewater, NJ, in conjunction with Chiron Corporation.

NEW BRUNSWICK, NJ--Confide, the first home collection HIV testingand counseling service, has received FDA approval and is now beingtest marketed in Texas and Florida. The test was developed byDirect Access Diagnostics, a Johnson & Johnson subsidiarybased in Bridgewater, NJ, in conjunction with Chiron Corporation.

"If you are infected with HIV, knowing your status allowsyou to seek treatment and take steps to prevent the spread ofthe infection," said Gary Noble, MD, vice president of medicalaffairs for Direct Access Diagnostics.

A study from the Centers for Disease Control showed that morethan 60% of people at risk of the infection have not sought testing,but 42% of those surveyed said they would be interested in a hometest if available.

To use the test, individuals in the privacy of their homes takea small blood sample from their fingertip using a retractablelancet, place the blood drops on the test card, and mail it ina prepaid preaddressed protective envelope to the designated medicallaboratory for analysis. Clinical trials have shown that the levelof accuracy is comparable to that in hospital laboratories, over99%, Dr. Noble said.

Within 7 days after mailing the kit, the person dials a toll-freenumber and punches in his or her unique personal identificationnumber (PIN) to obtain results in complete anonymity. Negativeresults are provided by a recorded message, but positive or inconclusiveresults are given by counselors who may make medical referrals.Patients with negative results may also speak to a counselor ifdesired.

The test kit includes pretest counseling and educational materialwritten by former US Surgeon General C. Everett Koop, MD. Confidecounselors undergo an extensive training program developed inconsultation with the American Social Health Association, whichruns the CDC National AIDS Hotline, and Cicatelli Associates,which conducts HIV counselor training programs for the New YorkState Department of Health.

The kit is being sold in pharmacies in Texas but only by phonein Florida. The company expects to begin nationwide sales sometimenext year. People may purchase the kit off the shelf, or may handa "silent request form" to the cashier or pharmacistto preserve privacy.

When orders are made by credit card through the toll-free number,the customer's name and credit card number are deleted from thedatabase after the transaction is completed.