The Truth About, New HIV Test
The Food and Drug Administration (FDA) has just approved a new rapid HIV
test. The good news is that it is relatively simple, quite accurate and very
fast. It only requires a drop of blood and results can be available in as little
as 20 minutes.
The bad news is that the test detects an HIV antibody and not the virus
itself. This means that a person can already be infected with HIV and yet not
test positive for as long as 3 months!
As of now, this new test has only been approved for use by experienced
technicians in certified laboratories. In this way, tests results can be
continually monitored for accuracy, including any false positives and false
negatives.
Tommy Thompson, the Secretary of the Dept. of Health and Human Services, has
urged the manufacturer to apply for a waiver that would allow this new test to
be used in a wider variety of settings. What kind of settings does Mr. Thompson
envision? Office personnel in doctors' offices? Counselors in public health
clinics? The general public in the privacy of their own homes? If this new test
is to be made available for wider use, some way to keep track of positive
results will need to be devised.
Barbara K. Hecht,
Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com
FDA Approves New Rapid HIV Test Kit HHS
Secretary Tommy G. Thompson today announced that the U.S. Food and Drug
Administration has approved a new rapid HIV diagnostic test kit that provides
results with 99.6 percent accuracy in as little as 20 minutes.
Using less than a drop of blood collected, this new test can quickly and
reliably detect antibodies to HIV-1, the HIV virus that causes infection in most
cases in the U.S. Unlike other antibody tests for HIV, this test can be stored
at room temperature, requires no specialized equipment, and may be considered
for use outside of traditional laboratory or clinical settings. The newly
approved HIV test is called The OraQuick Rapid HIV-1 Antibody Test, manufactured
by OraSure Technologies, Inc., Bethlehem, Pennsylvania.
"Each year, 8,000 HIV-infected people who come to public clinics for HIV
testing do not return a week later to receive their test results,"
Secretary Thompson said. "With this new test, in less than a half an hour
they can learn preliminary information about their HIV status, allowing them to
get the care they need to slow the progression of their disease and to take
precautionary measures to help prevent the spread of this deadly virus."
To perform the test, a fingerstick sample of blood is collected from an
individual and transferred to a vial where it is mixed with a developing
solution. The test device, which resembles a dipstick, is then inserted into the
vial. In as little as 20 minutes, the test device will indicate if HIV-1
antibodies are present in the solution by displaying two reddish-purple lines in
a small window on the device. Although the results of rapid screenings will be
reported in point-of-care settings, as with all screening tests for HIV, if the
OraQuick test gives a reactive test result, that result must be confirmed with
an additional specific test. The OraQuick test has not been approved to screen
blood donors.
FDA currently categorizes the OraQuick test as "moderate
complexity" under the Clinical Laboratory Improvements Amendments of 1988 (CLIA).
Under CLIA, new tests are categorized as either moderate or high complexity.
This designation means that the OraQuik test can only be given in CLIA-approved
labs by CLIA-certified laboratory technicians or medical staff. If the test
manufacturer applies for a CLIA waiver, the FDA can evaluate it for use under
less stringent conditions.
"I strongly urge the OraSure company to apply for a CLIA waiver,"
said Secretary Thompson, "If the FDA finds that the company's data proves
that the OraQuick test is both easy and safe to use, it can get a CLIA waiver.
Then the test could be given in many more health care settings, perhaps even
administered by social workers in HIV counseling centers. But the process can't
begin until OraSure applies for the waiver, so I ask them to please apply
now!"
The Centers for Disease Control and Prevention (CDC) has estimated that one
fourth of the approximately 900,000 HIV-infected people in the U.S. are not
aware that they are infected. Because of the potential public health benefits of
rapid HIV testing, the CDC and the Centers for Medicare and Medicaid Services
(CMS) are working with state and other health officials to make the test widely
available and to offer technical assistance and counseling training for its use.
"This test will be a great help in identifying pregnant HIV-infected
women going into labor who were not tested during pregnancy so that
precautionary steps can be take to block their newborns from being infected with
HIV," said FDA Deputy Commissioner Dr. Lester M. Crawford. "It will
also be a critical resource in helping identify HIV infection in health-care and
emergency workers who are accidentally exposed to HIV-infected blood while doing
their job."
For additional information, please visit the following MedicineNet.com areas:
The above information has been provided with the kind permission of the Food
and Drug Administration, press release #P02-49, November 7, 2002. (www.fda.gov)
Last Editorial Review: 11/8/2002
HIV / AIDS RSS