Test is INVALID if:
•
NO
reddish-purple line appears next to the triangle labeled “C”
(see pictures a and b)
, or
•
A red background in the Results 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 pictures d1 an d d2)
, or
•
Any partial line on one side of the “C” or “T” triangle areas
(see pictures e and f)
.
Interpretation of Test Result:
An
Invalid
test result means that there was a problem running the test,
either related to the specimen or to the Device. An Invalid result
cannot be interpreted.
Repeat the test with a new 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.
Test is NON-REACTIVE if:
•
A reddish-purple line appears next to the triangle labeled “C”
and NO
line
appears next to the triangle labeled “T.”
Interpretation of Test Result:
A
Non-Reactive
test result means that HIV-1 and HIV-2 antibodies were not
detected in the specimen. The test result is interpreted as
NEGATIVE for
HIV-1 and HIV-2 antibodies.
Follow CDC guidelines to inform the test
subject of the test result and its interpretation.
3
READING TEST RESULT
– LOOK AT THE RESULT WINDOW OF THE TEST DEVICE
CAUTION: ADEQUATE LIGHTING REQUIRED.
Read results after 20 minutes but not more than 40 minutes.
NON-REACTIVE
INVALID
a
b
c
d1
d2
e
f
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.
NOTE:
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 these lines are.
Interpretation of Test Result:
A
Reactive
test result means that HIV-1 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.
REACTIVE
220 East First Street
Bethlehem, PA 18015
Tel:
1-800-ORASURE
Fax:
(610) 882-3572
Web:
www.orasure.com
©2012, 2001 OraSure Technologies, Inc. U.S. Patent #6,303,081,
#7,192,555, #7,541,194 and various international and
U.S. patents pending. OraQuick
ADVANCE
® is a registered trademark
of OraSure Technologies, Inc.
Item #3001-1216 rev. 09/12
3001-1216_0912 OQA SBS EN-ES_OQA SbS 1/4/13 10:01 AM Page 8
