Product Manual

REACTIVE
T
he diagrams at the right show examples of a Reactive test result.
A
test is Reactive if:
a reddish-purple line appears next to the triangle labeled “C” and
a
reddish-purple line appears next to the triangle labeled “T”. One
of these lines may be darker than the other.
N
OTE: The test is Reactive if a complete reddish-purple line appears
next to the “T” triangle and
next to the “C” triangle, no matter how faint
t
hese lines are.
A
Reactive test result means that HIV-1 and/or HIV-2 antibodies have
been detected in the specimen. The test result is interpreted as
PRELIMINARY POSITIVE for HIV-1 and/or HIV-2 antibodies
.
F
ollow CDC guidelines to inform the test subject of the test result and its
interpretation.
6,7
INVALID
The diagrams at the right show examples of an Invalid test result.
A test is Invalid if any of the following occurs:
• NO reddish-purple line appears next to the triangle labeled “C” (see
picture a and b ), or
• a red background in the Result Window makes it difficult to read the
result after 20 minutes (see picture c ), or
• if any of the lines are NOT inside the “C” or “T” triangle areas (see
picture d1 and d2 )
• any partial line on one side of the “C” or “T” triangle areas (see
picture e and f )
An Invalid test result means that there was a problem running the test,
either related to the specimen or to the Test Device. An Invalid result
cannot be interpreted
. Repeat the test with a new Divided Pouch
and a new oral fluid, fingerstick or venipuncture whole blood, or
plasma sample. Contact OraSure Technologies’ Customer
Service if you are unable to get a valid test result upon repeat
testing.
LIMITATIONS OF THE TEST
1. The OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test must be used in accordance with the instructions in this package insert
to obtain an accurate result.
2. Reading test results earlier than 20 minutes or later than 40 minutes may yield erroneous results.
3. This test is approved by FDA for use with oral fluid, fingerstick whole blood, venipuncture whole blood, and plasma specimens
only. Use of other types of specimens, testing of venipuncture whole blood specimens collected using a tube containing an
anticoagulant other than EDTA, sodium heparin, or sodium citrate, or testing of plasma specimens collected using a tube
containing an anticoagulant other than EDTA may not yield accurate results.
4. Individuals infected with HIV-1 or HIV-2 who are receiving highly active antiretroviral therapy (HAART) may produce false
negative results.
5. Individuals undergoing preventive treatment for HIV may produce false negative results.
6. Clinical data has not been collected to demonstrate the performance of the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test
in persons under 12 years of age.
7. A reactive result using the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test suggests the presence of HIV-1 and/or
HIV-2 antibodies in the specimen. OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test is intended as an aid in the diagnosis of
infection with HIV-1 and/or HIV-2. AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be
established clinically.
8. For a reactive result, the intensity of the test line does not necessarily correlate with the titer of antibody in the specimen.
9. A non-reactive result does not preclude the possibility of exposure to HIV or infection with HIV. An antibody response to recent
exposure may take several months to reach detectable levels.
10. A person who has antibodies to HIV-1 or HIV-2 is presumed to be infected with the virus, except that a person who has
participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV. Clinical
correlation is indicated with appropriate counseling, medical evaluation and possibly additional testing to decide whether a
diagnosis of HIV infection is accurate.
a
b
c
d1
d2
8
e
f
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