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FDA
Approves Rapid Oral HIV Test
By
Todd Zwillich
Federal officials
on Friday announced the approval of the first rapid oral test for
HIV, which can give a result in as fast as 20 minutes.
Officials said
that the product could help to expand AIDS screening in the US and
overseas, where hurdles to testing are thought to severely hinder
intervention efforts.
"It's
only early diagnosis that allows treatment to take place at an early
and effective time," said Jesse Goodman, director of the Center
for Biologic Evaluation and Research at the US Food and Drug Administration.
The test, called
OraQuick Rapid HIV-1/2 Antibody Test, will be available initially
in approximately 40,000 certified clinics and hospitals nationwide.
The test is
identical to a rapid blood test that OraSure has marketed since
November 2002. Friday's approval clears the test for saliva testing.
To use the
test, a subject wipes the inside of the mouth with a swab and then
places the sample in a vial of reactant. After about 20 minutes,
the test reveals the presence or absence of antibodies to HIV-1,
the strain most often found in US patients.
Goodman said
that "limited" data provided by the company to FDA showed
that the test has a sensitivity of 99.3% and specificity of 99.8%.
Patients who
test positive must have the results confirmed by a different HIV
test.
Approximately
25% of the 900,000 Americans believed to have HIV infection do not
know it, according to data from the Department of Health and Human
Services. Studies suggest that about 30% of people who take HIV
tests never return to get their laboratory results.
HHS Secretary
Tommy G. Thompson said that the test would "almost certainly
reduce" the number of patients who get tested and never get
their results. Thompson, who also serves as the chair of the Global
Fund to fight AIDS, Tuberculosis, and Malaria, said that the test
would be a "godsend" for AIDS relief efforts in Africa
and other developing regions.
Thompson said
that US government agencies currently have no plans to purchase
the test for widespread distribution but that they may in the future.
R. Sam Niedbala,
OraSure Technology's chief science officer, said that the company
would move quickly for the regulatory clearance necessary to spread
the test to more settings. The company also plans to seek FDA approval
to sell the drug over the counter, he said.
"We have
to collect enough information first to be sure you don't hurt the
public health doing that," he said.
03/29/04
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