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.
"If you are infected with HIV, knowing your status allows you to seek treatment and take steps to prevent the spread of the infection," said Gary Noble, MD, vice president of medical affairs for Direct Access Diagnostics.
A study from the Centers for Disease Control showed that more than 60% of people at risk of the infection have not sought testing, but 42% of those surveyed said they would be interested in a home test if available.
To use the test, individuals in the privacy of their homes take a small blood sample from their fingertip using a retractable lancet, place the blood drops on the test card, and mail it in a prepaid preaddressed protective envelope to the designated medical laboratory for analysis. Clinical trials have shown that the level of accuracy is comparable to that in hospital laboratories, over 99%, Dr. Noble said.
Within 7 days after mailing the kit, the person dials a toll-free number and punches in his or her unique personal identification number (PIN) to obtain results in complete anonymity. Negative results are provided by a recorded message, but positive or inconclusive results are given by counselors who may make medical referrals. Patients with negative results may also speak to a counselor if desired.
The test kit includes pretest counseling and educational material written by former US Surgeon General C. Everett Koop, MD. Confide counselors undergo an extensive training program developed in consultation with the American Social Health Association, which runs the CDC National AIDS Hotline, and Cicatelli Associates, which conducts HIV counselor training programs for the New York State Department of Health.
The kit is being sold in pharmacies in Texas but only by phone in Florida. The company expects to begin nationwide sales sometime next year. People may purchase the kit off the shelf, or may hand a "silent request form" to the cashier or pharmacist to preserve privacy.