Product Manual

TEST RESULT AND INTERPRETATION – Refer to the Result Window on the Test Device
CAUTION:
Adequate lighting required. Color blindness may affect the ability to interpret Test results.
Test is Reactive if:
A line appears in the C Zone and a line appears in the T Zone.
Lines may vary in intensity. Two lines must be present for a
“reactive” result.
The test is reactive regardless of how faint these lines
appear.
A Reactive test result means that HCV antibodies have been
detected in the specimen. Patient is presumed to be infected
with HCV.
Follow appropriate guidelines for supplemental testing.
REACTIVE: Lines in C and T Zones
Line in T Zone Line in T Zone Faint Line
in T Zone
Test is Non-Reactive if:
A line appears in the C Zone and NO line appears in the T Zone.
A Non-Reactive test result means that HCV antibodies were not
detected in the specimen.
Patient is presumed not to be infected with HCV.
NON-REACTIVE: Lines in C Zone Only
Line in C Zone
No HCV antibodies detected.
Test is Invalid if:
No line appears in the C Zone, or
• A pink background obscures the results during the 20-40 minute
read time, or
• Any partial line appears on one side of the C or T Zones.
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 Pouch and a new Specimen.
Contact OraSure Technologies’ Customer Service if you are
unable to get a valid test result upon repeat testing.
INVALID: No Lines in C Zone or Partially Developed Lines
No Line in Red background
C Zone obscures results
Partial Line on one side
of C or T Zones
For answers to questions or technical assistance
regarding the OraQuick
®
HCV Rapid Antibody Test,
call: 1-800-ORASURE (800-672-7873) or visit our
web site: www.orasure.com
3001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:01 PM Page 8