What’s
the significance of the FDA’s approval of the OraQuick
rapid HIV test for oral fluid in March of 2004?
The FDA has approved the OraQuick Advance HIV Antibody Test
for use with oral fluid and for use on plasma specimens. Until
now, the test, manufactured by OraSure Technologies, Inc.,
was approved only for whole blood specimens. This is the only
rapid HIV test to be approved in the US by the FDA for use
with oral fluid.
What’s the difference
between this test and the OraQuick Rapid HIV-1 Antibody Blood
test approved in November 2002?
The
FDA approved the new version of the test for the detection
of HIV-2 antibodies and for use with additional types of
specimens. Until now, the OraQuick rapid HIV antibody test
required a whole blood specimen, either from a fingerstick
or a tube of blood. The OraQuick Advance test can now be
used with oral fluid specimens taken from the mouth, with
plasma, and with whole blood. Additionally, the new version
of the test can be performed in a wider range of operating
temperatures (59°F to 99°F).
Is
the OraQuick test a saliva test?
No.
The test uses oral fluid, which is slightly different from
saliva. To perform the test, the person being tested for
HIV gently swabs the device completely around the outer
gums, both upper and lower, one time around and inserts
it into a vial containing a developer solution. After 20
minutes, the test device will indicate if HIV antibodies
are present in the solution by displaying two reddish-purple
lines in a small window in the device.
This test is not yet available for
home use.
What
does a reactive or preliminary positive result mean?
A
reactive HIV test result on oral fluid is a preliminary
positive and needs to be confirmed by an additional, more
specific test to verify whether HIV antibodies are present.
How
well does the test work?
In the clinical studies by the manufacturer,
the OraQuick oral fluid test correctly identified 99.3%
of people who were infected with HIV (sensitivity) and 99.8
% of people who were not infected with HIV (specificity).
The Food and Drug Administration expects clinical laboratories
to obtain similar results.
Who
can perform the OraQuick oral fluid rapid HIV test?
The
OraQuick rapid HIV test for use with blood was waived under
the Clinical Laboratory Improvements Amendments of 1988
(CLIA) in January 2003, and waived for use with oral fluid
in June 2004. A waived test can be used in any facility
with a CLIA certificate, rather than only in traditional
laboratories. As such, a waived test can be used in many
non-clinical settings.
Will
the test for oral fluid be sold over the counter?
No, the OraQuick test, either for
oral fluid or blood specimens, is restricted for use by
trained persons. However, if waived, the oral fluid test
could be performed by trained persons in the home setting
as a part of partner notification or HIV prevention outreach
activities.
What
are the advantages of testing oral fluid rather than blood?
The
approval for oral fluids will provide a safe, accurate, and
rapid HIV test for persons who don't like to have blood drawn.
In addition, health care workers face a much lower risk of
exposure to infectious diseases from oral fluid than from
blood. Contact with saliva has never been proven to result
in HIV transmission.
Are there disadvantages to testing oral fluid rather than
blood?
As when used on blood, the OraQuick
test device can quickly and reliably detect antibodies to
HIV in oral fluid. It can be stored at room temperature,
requires no specialized equipment, and takes the same amount
of time to process (20 to 40 minutes). However, it has slightly
lower sensitivity and specificity than when used with blood.
In particular, testing programs can expect more false positive
results with oral fluid than with blood. As with the blood
test, an additional specimen must be collected for confirmatory
testing of persons who test preliminarily positive.
Can
the new oral fluid test detect antibodies to both HIV-1
and HIV-2?
The OraQuick test is approved to detect
antibodies to HIV-1 and HIV–2 when used with blood,
oral fluid, and plasma. (HIV-2
is a variant of HIV that is prevalent in parts of Africa
but rarely found in the United States).
Has
the test been approved to screen blood donors?
No. The OraQuick test should not be
used to screen blood donors.
If
you are interested in getting tested this way, talk to your
health care provider about the possibility. Rapid testing
makes an enormous difference for someone who suspects they
will test positive and do not want to wait for blood test
results.
Remember,
antibodies may not appear until three to six months after
infection with HIV. OraQuick does not test your saliva,
but fluid from the cheek and gum. To date, HIV is not known
to be transmitted by saliva.
(Source:
CDC - Centers for Disease Control and Prevention).
For information on HIV Home testing,
see that page...
