Product Manual

STORAGE INSTRUCTIONS
Store unused OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Tests unopened at 2°-27°C (36°-80°F). Do not open the Divided Pouch
u
ntil you are ready to perform a test. If stored refrigerated, ensure that the Divided Pouch is brought to operating temperature
(15°- 37°C, 59°- 99°F) before opening.
DIRECTIONS FOR USE
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 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.
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.
SPECIMEN COLLECTION AND TESTING PROCEDURE
The OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test can be used for testing oral fluid, fingerstick whole blood, venipuncture whole
blood, and plasma specimens. Refer to the specific testing procedure below.
ORAL FLUID PROCEDURE
STEP 1: COLLECT
1. Ensure prior to testing that the subject has not had anything to eat,
drink or has chewed gum for at least 15 minutes. Have the subject
wait for at least 30 minutes prior to testing if they have used any
oral care products.
2. Have the person being tested remove the Device from its Pouch.
DO NOT allow the person to touch the Flat Pad (see picture 1A ).
Check to make sure that an Absorbent Packet is included with the
Device (see picture 2A ). If no Absorbent Packet is present, discard
the Device and obtain a new Pouch for testing.
3. Direct the person to place the Flat Pad above the teeth against the
outer gum. Direct the person to gently swab completely around the
outer gums, both upper and lower, one time around, using the Flat
Pad (see pictures 3A and 4A ). DO NOT allow the person to swab
the roof of the mouth, the inside of the cheek or the tongue. NOTE:
Both sides of the Flat Pad may be used during this procedure.
1A 2A
3A 4A
a
b
c
Flat Pad
Absorbent
Packet
4
Two Chambers
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