FDA Approves Quick HIV Test

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FDA Approves Quick HIV Test

08:13 AM Nov. 08, 2002 PT

The government on Thursday approved a 20-minute HIV test that AIDS

experts say is so easy to use it will greatly cut the number of people

who unknowingly carry and spread the disease.

It's not the first rapid HIV test. A competing version has been sold

since the mid-1990s, but it is so difficult to use that hardly any

clinics offer it. Today's routine HIV tests take up to two weeks to

provide results and at least 8,000 people a year who test positive at

public clinics never return to get the news.

The new OraQuick test should slash that number and encourage even more

of the almost quarter-million Americans who don't know they're infected

to seek testing, federal scientists said Thursday in announcing Food and

Drug Administration approval of OraQuick.

This is " a very, very important milestone, " said FDA science chief Dr.

Murray Lumpkin.

To use OraQuick, a health worker pricks a person's finger, drops a spot

of blood into a vial of developing solution and drops in the sticklike

testing device.

The dipstick gives results similar to common pregnancy tests: One

reddish line means no HIV. Two reddish lines mean the person may be

infected and needs a confirmatory test to be sure.

OraQuick at first will be available only in hospitals and large health

clinics because of a law that restricts who can use certain types of

medical tests.

But the test is so simple that Health and Human Services Secretary Tommy

urged manufacturer OraSure Technologies to seek a waiver of

that law allowing OraQuick to be sold in far more places from small

doctors' offices to mobile testing vans and maybe even HIV counseling

centers staffed by social workers instead of health professionals.

" You don't need a college education to administer the test, " said

OraSure chief executive Mike Gausling, who said he has begun the

paperwork to seek that waiver.

The company, in partnership with Abbott Laboratories, will begin selling

OraQuick around year's end. Gausling wouldn't provide an exact price,

but said OraQuick should cost less than the $20 it costs to perform

old-fashioned laboratory HIV tests.

OraQuick's speed and simplicity mean not only that people don't have to

drum up the courage for two clinic visits, but that those facing

emergencies can get immediate answers, said Dr. Fauci of the

National Institutes of Health.

For example, women in labor who weren't checked for HIV earlier in

pregnancy could get tested in the delivery room. That would let newborns

of infected mothers get anti-HIV medication immediately, in hopes of

keeping them free of the virus.

Also, doctors and nurses exposed to the blood of patients who might have

HIV could learn right away if that person had put them at risk, so

they'd know if they needed HIV-blocking medication.

OraQuick also may help when the government begins offering smallpox

vaccine to health workers and others as protection against a possible

bioterrorist attack. While such vaccine plans aren't final yet, smallpox

inoculations pose life-threatening risks to anyone with the AIDS virus

so a rapid test could prove critical in screening out potential vaccine

recipients who didn't know they had HIV, Fauci said.

Studies show OraQuick is 99.6 percent accurate, the FDA said. People who

test positive should get an old-fashioned lab test to confirm HIV

infection.

Those who test HIV-free using OraQuick might need to check again a month

later if they have recently done anything that could expose them to HIV,

such as unprotected sex or intravenous drug use, Lumpkin cautioned.

That's because OraQuick detects antibodies to HIV, immune system

proteins that can take weeks after infection to form.

AIDS experts expect rapid HIV testing to grow quickly. The FDA is

believed close to approving an OraSure competitor, MedMira's Reveal

test. OraSure also plans to seek FDA approval soon to use OraQuick to

test a swab from a patient's gums instead of blood; OraSure currently

sells a lab-based oral HIV test.

AIDS activists have spent the last year pushing FDA to approve the new

technology, saying rapid tests could become a standard offering in

emergency rooms or homeless shelters spreading access to HIV testing to

populations otherwise missed.

" We're excited about it, " said Ray s of the National Association

of People With AIDS. But he cautioned that clinics still must take the

time to properly counsel people about the ramifications of HIV testing

before administering OraQuick.