THE FOLLOWING ITEMS ARE NEEDED TO DO THE TEST:
INTENDED USE:
The OraQuick
ADVANCE
®
Rapid HIV-1/2 Antibody Test is a single-
use, qualitative, immunoassay to detect antibodies to Human
Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral
fluid, fingerstick whole blood, venipuncture whole blood, and
plasma specimens.
For
In Vitro
Diagnostic Use
This is a restricted device. Sales, distribution and
use restrictions apply. See customer letter and
package insert.
For answers to questions regarding the OraQuick
ADVANCE
®
Rapid HIV-1/2 Antibody Test
or for more information on other products from OraSure Technologies,
call 1-800-ORASURE (1-800-672-7873) or visit our website: www.orasure.com
NOTE: Handle all blood specimens and materials contacting specimens as if capable of transmitting infectious
agents. Dispose of all test specimens and materials used in the test procedure in a biohazard waste container.
1
Oral fluid is not considered potentially infectious unless it contains blood.
3
Developer
Solution Vial
Reusable
Test Stand
Flat
Pad
Test
Device
Specimen Collection
Loop
Absorbent
Packet
Result
Window
The OraQuick
ADVANCE
®
Rapid HIV-1/2
Antibody Test Consists of a Divided Pouch
Containing the Following:
•
Test Device (including an absorbent packet)
•
Developer Solution Vial (containing 1 mL)
NOTE: The pouch is divided into two chambers.
One chamber holds the Test Device while the other
chamber holds the Developer Solution Vial.
Materials Provided in the Master Shipping Carton:
•
Reusable Test Stand
•
Subject Information Pamphlet
•
Customer Letter
•
Specimen Collection Loop (5 microliter)
•
Package Insert
Materials Required But Not Provided:
•
Timer or watch capable of timing 20 to 40 minutes
•
Clean, disposable, absorbent workspace cover
•
Biohazard waste container
Additional Items Required for Fingerstick and
Venipuncture Whole Blood Collection, and
Plasma Specimens:
•
Antiseptic wipe
•
Sterile lancet to obtain a fingerstick whole blood specimen, or
materials required to obtain a venipuncture whole blood specimen
•
Latex, vinyl or nitrile disposable gloves (optional for
oral fluid testing)
•
Sterile gauze pads
•
Centrifuge to process a plasma specimen
1.
See “Universal Precautions,”CDC, MMWR, 1988; 37(24):377-388.
2.
“Guideline for Isolation Precautions, ”CDC, HICPAC, 2007; 12-93.
3.
CDC, MMWR, 2005; 54 (RR-9): 1-17.
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