Pubdate: Wed, 26 Oct 2005
Source: Las Vegas Sun (NV)
Copyright: 2005 Las Vegas Sun, Inc
Contact:  http://www.lasvegassun.com/
Details: http://www.mapinc.org/media/234
Author: John J. Lumpkin, Associated Press
Bookmark: http://www.mapinc.org/hr.htm (Harm Reduction)

GOVERNMENT MULLS DO-IT-YOURSELF AIDS TEST

WASHINGTON - Swab the inside of your mouth. Put that swab into a vial 
of test fluid, and 20 minutes later you'll learn whether you're 
infected with the virus that causes AIDS.

The OraQuick Advance test is already widely available in health 
clinics and doctors' offices. The Food and Drug Administration is 
considering permitting it to be sold over the counter.

Supporters of home kits say they will spur more people to get tested 
and get treatment sooner if infected. However, concerns have been 
raised about whether a doctor or counselor should be nearby when 
people find out they are HIV-positive.

If approved, the test would become the first FDA-approved test that a 
person can take without the presence of a health care worker, or the 
requirement of mailing a sample to a lab.

The maker, OraSure Technology of Bethlehem, Pa., has not decided how 
much it will charge consumers for the kit, said Ron Spair, the 
company's chief financial officer. The company sells the kits for 
between $12 and $17 to clinics and doctors, he said.

The test is accurate more than 99 percent of the time, Spair said. 
Still, a positive result from the test should be confirmed through an 
additional test by doctors or public health officials, he said.

To take the test, a person swabs the inside of his mouth, between his 
cheek and gum, picking up not saliva but cells lining the mouth. The 
user then inserts the swab into a vial of fluid that comes with the 
kit. Twenty minutes later, an indicator will light up if the test 
detects the presence of HIV-1 or HIV-2 antibodies.

Those antibodies become present in the body several weeks after a 
person acquires HIV; the test will not detect the virus if it was 
more recently acquired.

On Nov. 3, FDA's Blood Products Advisory Committee, will consider 
whether to recommend the product for over-the-counter sales. The FDA 
has the final say; it usually follows the advice of its advisory committees.

FDA briefing documents posted on the Internet said these kits could 
lead to more people knowing whether they have HIV, which could mean 
earlier treatment of the infection. People afraid or unwilling to 
take the test, particularly those without any symptoms, may more 
readily test themselves with a kit they can use privately.

"Knowing your status is critically important," Spair said. "We want 
to provide that opportunity to the broadest number of people possible."

But the documents also note concerns about someone learning they 
probably have HIV when they are alone, with no health professional or 
counselor nearby.

The kits are a good idea, said Terje Anderson, executive director of 
the National Association of People with AIDS. He said he doubts they 
will be as popular as at-home pregnancy test kits, suggesting most 
people who want an HIV test would prefer to be with a doctor. Their 
use may also depend on their price.

"Overall, I would say they are a step forward," he said. "Anything 
that helps more people learn their status is a good thing."

But the discovery one has HIV is "potentially traumatic," he said.

"There have got to be safeguards built in so they can get all the 
support they need," he said.

Spair said the company would work with FDA to develop instructions 
with the kit for someone who receives a positive result. He said he 
expects a telephone number and a web site address would be part of 
those instructions.

"We, together with the FDA, want to make sure that the infrastructure 
is in place so that folks on a 24-7 basis have access to counseling," he said.

Some companies market unapproved HIV tests for home use; the FDA says 
it is impossible to know if they are reliable.

One test, made by Home Access Health Corp., is approved for sale in 
the United States by the FDA. People taking this test must take a 
sample from themselves and mail it to a lab for testing.

About 1 million people in the United States are believed to have HIV. 
The Centers for Disease Control and Prevention estimates nearly 
300,000 people have the virus but don't know it.