OraQuick Advance - Page 8

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