The administrator of this test should first instruct the subject about the test and how to collect an oral fluid sample for OraQuick Rapid HIV Test kit. Following which, the test device is then offered to the subject for the collection of the sample with reference to the guidelines following:
SET UP YOUR WORKSPACE
• 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 in this package insert 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 as required in accordance with the Safety Precautions section in this package insert.
Prior to testing provide the “Subject Information”
pamphlet to the person being tested.
GENERAL TEST PREPARATION
1. Open the two chambers of the OraQuick Rapid HIV Test Kit 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.
2. 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.
3. Slide the Vial into the top of one of the slots in the Stand. 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 ).
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.
A control lone in the “C” area of the result area indicates a valid result. A valid result indicates that a suitable sample was collected and that the test functioned properly. The control line will appear on all valid tests, whether or nor the result is negative.
Kit Control: Re-agents are available separately (Cat No. RBL 308-C). These are used to verify adequate test performance. Kit controls should be run once per shift by the test administrator, and whenever changing to a different lot of tests. Refer to the kit control product insert when using these re-agents.
What does the lines on the OraQuick test indicators mean?
NON REACTIVE RESULTS- only the control line appears
If a single line appears on the test strip in the area adjacent to the triangle labelled “C”, the result is non reactive. This suggests the absence of anti HIV antibodies in the specimen.
Note: Using the Negative Kit Control gives thus result (see insert for OraQuick HIV 1/2 Kit Controls)
REACTIVE RESULTS –two lines appear
If two lines appear on the test strip, adjacent to the triangles labelled “T” and “C” triangles respectively, the result is considered to be reactive. This suggests the presence of anti HIV antibodies in the specimen. One of the lines may be darker than the other.
Note: Using the HIV-1 Kit Control or HIV-2 Kit control results in a dark line adjacent to the triangle marked “C” and a faint line adjacent to the triangle marked “T”.
INVALID- No line present in the “C” area of window.
If there is no line in the area marked “C”, the result is invalid. An invalid test should be repeated with a new test device. If the invalid test was obtained with an oral fluid specimen, use the blood test procedure for repeat testing.
To know more view the following video: