Product Manual

STEP 3: TEST
1
. Remove the Device from the Pouch. DO NOT touch the Flat Pad
(see picture 6C ). Check to make sure that an Absorbent Packet is
i
ncluded with the Device (see picture 7C ). If no Absorbent Packet
is present, discard the Device and obtain a new Pouch for testing.
2
. Insert the Flat Pad of the Device all the way into the Vial containing
the blood sample (see picture 8C ). Make sure that the Flat Pad
touches the bottom of the Vial. The Result Window on the Device
s
hould be facing towards you (see picture 9C ).
3. Start timing the test (see picture 10C ). DO NOT remove the Device
f
rom the Vial while the test is running. Pink fluid will appear and
travel up the Result Window. The pink fluid will gradually disappear
a
s the test develops (see picture 11C ). Read the results after 20
minutes but not more than 40 minutes in a fully lighted area.
4. Refer to the Test Result and Interpretation of Test Result section in
t
his package insert.
GENERAL TEST CLEAN-UP
1
. Dispose of the used test materials in a biohazard waste container.
2. When using gloves, change your gloves between each test to
prevent contamination. Throw away the used gloves in a biohazard
waste container.
3. Use a freshly prepared 10% solution of bleach to clean up any
spills.
QUALITY CONTROL
Built-in Control Features
The OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test has a built-in procedural control that demonstrates assay validity. A reddish-
purple line in the Control (“C”) area of the Result Window indicates that a specimen was added and that the fluid migrated
appropriately through the Test Device. The Control line will appear on all valid tests, whether or not the sample is reactive or non-
reactive. (Refer to Test Result and Interpretation of Test Result section below.)
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. The HIV-1 and HIV-2 Positive Controls will produce
a reactive test result and have been manufactured to produce a very faint Test (“T”) line. The Negative Control will produce a non-
reactive test result. (Refer to Test Result and Interpretation of Test Result section below.) Use of kit control reagents manufactured by
any other source may not produce the required results, and therefore, will not meet the requirements for an adequate quality assurance
program for the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test.
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 2º- 27ºC (36º- 80ºF),
• If the temperature of the testing area falls outside of 15º- 37ºC (59º- 99ºF), and
• At periodic intervals as dictated by the user facility.
Refer to the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test Kit Controls package insert for instructions on the use of these
reagents. It is the responsibility of each laboratory using the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test to establish an
adequate quality assurance program to ensure the performance of the device under its specific locations and conditions of use.
Contact OraSure Technologies’ Customer Service if the Kit Control reagents do not produce the expected results.
TEST RESULT AND INTERPRETATION OF TEST RESULT
Refer to the Result Window on the Test Device.
NON-REACTIVE
The diagram at the right shows an example of a Non-Reactive test result.
A 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”.
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.
6,7
F
lat Pad
Absorbent
P
acket
6C 7C
8C 9C
10C 11C
7
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