c
NOTE: DO NOT
cover the
two holes in the back of the
Device with labels or other
materials. Doing so may cause
an Invalid result.
Set Up Your Work Space
b
General Test Preparation
Two Chambers
a
•
Gather the materials you will need.
•
Allow the test kit to come to operating temperature (15
˚
– 37
˚
C; 59
˚
– 99
˚
F) before use.
•
Refer to the
External Quality Control
section above to determine when the Kit Controls should be run.
•
Cover your workspace with a clean, disposable, absorbent workspace cover.
•
Set an OraQuick®
ADVANCE
™
Reusable Test Stand (“Stand”) up on your workspace cover. Use only the Stand provided.
•
Put on your disposable gloves if you are planning to perform the test using a blood specimen. Use of gloves is optional for oral fluid testing.
External Quality Control
OraQuick®
ADVANCE
™
Rapid HIV-1/2 Antibody Test Kit Controls are available separately for use only with the OraQuick®
ADVANCE
™
Rapid HIV-1/2 Antibody Test. The Kit Controls are specifically formulated and manufactured to ensure performance of the Test, and are
used to verify your ability to properly perform the test and interpret the results. Refer to the Kit Control Package Insert for complete
instructions.
Run the Kit Controls under the following circumstances:
•
Each new operator prior to performing testing on patient specimens,
•
When opening a new test kit lot,
•
Whenever a new shipment of test kits is received,
•
If the temperature of the test kit storage area falls outside of 2
˚
– 27
˚
C (35
˚
– 80
˚
F),
•
If the temperature of the testing area falls outside of 15
˚
– 37
˚
C (59
˚
– 99
˚
F),
•
At periodic intervals as dictated by the user facility.
Prior to testing, provide the “Subject Information” pamphlet
to the person being tested.
•
Open the two chambers of the OraQuick®
ADVANCE
™
Divided Pouch
(“Pouch”) by tearing at the notches on the top of each side of the Pouch
(
see picture a and b
).
•
To prevent contamination, leave the Test Device (“Device”) in the Pouch until
you are ready to use it.
•
Remove the Developer Solution Vial (“Vial”) from the Pouch.
•
Hold the Vial firmly in your hand.
•
Carefully remove the cap from the Vial by gently rocking the cap back and
forth while pulling it off.
•
Set the cap on your workspace cover.
•
Slide the Vial into the top of one of the slots in the Stand (
see picture c
).
•
DO NOT
force the Vial into the stand from the front of the slot as splashing
may occur.
•
Make sure the Vial is pushed all the way to the bottom of the slot in the stand
(
see picture c
).
OQA Eng_SPA_StepbyStep-10-05 10/31/05 4:16 PM Page 4
