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
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.