Product Manual
issue by providing results during the initial visit and enabling immediate counseling. Additionally, for pregnant women who do not
k
now their HIV status at the time of delivery, rapid HIV testing permits therapy to be initiated for these mothers during labor, and to
their infants post partum, substantially reducing the chance that the infants will become infected with HIV. Likewise, rapid HIV testing
i
s instrumental in the decision to initiate treatment for health care workers after accidental exposures to body fluids from infected
individuals. In the U.S., it is estimated that 600,000 to 1,000,000 “needlestick injuries” occur each year. Critical decisions about
t
reatment depend on the availability of accurate, rapid HIV test results.
BIOLOGICAL PRINCIPLES OF THE TEST
The OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test is a manually performed, visually read, 20 minute immunoassay for the
qualitative detection of antibodies to HIV-1 and HIV-2 in human oral fluid, whole blood obtained from a finger puncture or a
v
enipuncture, and plasma. The OraQuick ADVANCE
®
r
apid test is comprised of a single-use test device and a single-use vial
containing a pre-measured amount of a buffered developer solution. Each component is sealed in separate compartments of a single
p
ouch to form the test. The OraQuick ADVANCE
®
r
apid test utilizes a proprietary lateral flow immunoassay procedure. The device
plastic housing holds an assay test strip comprised of several materials that provide the matrix for the immunochromatography of the
s
pecimen and the platform for indication of the test results.
The assay test strip, which can be viewed through the test device result window, contains synthetic peptides representing the HIV
e
nvelope region and a goat anti-human IgG procedural control immobilized onto a nitrocellulose membrane in the Test (T) zone and
the Control (C) zone, respectively.
An oral fluid specimen is collected using the flat pad on the test device, followed by the insertion of the test device into the vial of
developer solution. A fingerstick whole blood, venipuncture whole blood or plasma specimen is collected and transferred into the vial
of developer solution, followed by the insertion of the test device. The developer solution facilitates the flow of the specimen into the
device and onto the test strip. As the diluted specimen flows through the device, it rehydrates the protein-A gold colorimetric reagent
contained in the device. As the specimen continues to migrate up the strip, it encounters the T zone. If the specimen contains
antibodies that react with the antigens immobilized on the nitrocellulose membrane, a reddish-purple line will appear, qualitatively
indicating the presence of antibodies to HIV-1 and/or HIV-2 in the specimen. The intensity of the line color is not directly proportional
to the amount of antibody present in the specimen.
Further up the assay strip, the sample will encounter the C zone. This built-in procedural control serves to demonstrate that a
specimen was added to the vial and that the fluid has migrated adequately through the test device. A reddish-purple line will appear
in the C zone during the performance of all valid tests, whether or not the sample is positive or negative for antibodies to HIV-1 and/or
HIV-2 (refer to the Test Result and Interpretation of Test Result section below).
The test results are interpreted after 20 minutes but not more than 40 minutes after the introduction of the test device into the developer
solution containing the test specimen. No precision pipeting, predilutions, or specialized instrumentation are required to perform the
OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test.
MATERIALS PROVIDED
OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test Kits are available in the following packaging configurations:
Kit Size 100 Count 25 Count
Divided Pouches, 100 25
each containing:
Test Device (1)
Absorbent Packet (1)
Developer Solution Vial (1)
(each vial contains 1 mL of
a phosphate buffered saline
solution containing polymers
and an antimicrobial agent)
Reusable Test Stands 10 5
Specimen Collection Loops 100 25
Subject Information Pamphlets 100 25
Package Insert 11
Customer Letter 11
MATERIALS REQUIRED AND AVAILABLE AS AN ACCESSORY TO THE KIT
OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test Kit Controls
Package contains HIV-1 Positive Control (1 vial, black cap, 0.2 mL), HIV-2 Positive Control (1 vial, red cap, 0.2 mL) and Negative
Control (1 vial, white cap, 0.2 mL), and a Package Insert
Developer
Solution Vial
Reusable
Test Stand
Specimen
Collection
Loop
Flat Pad
Results
Window
Test Device
Absorbent Packet
2
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