LN-6027.05
Wait 20 to
45 minutes
HI
V
-1
&
2
1-
VI
H
&
2
12-16 hr
0 : 20
3. Insert the Test Strip into
the liquid in the Sample
Buffer tube with the arrows
pointing down toward the
liquid. Set a timer to 20
minutes, or note the time
on a watch.
4. Wait for a minimum of 20
minutes, to a maximum of
45 minutes, and remove
the Test Strip from the tube
of Sample Buffer.
packet is present, discard the Test Strip and obtain
another Test Strip.
HI
V-1
&2
1. Remove the gray cap from
the specimen/Sample
Buffer mixture prepared as
described above and set
aside.
2. Open the foil pouch
containing the Test Strip
and remove the strip. Do
not touch the middle of the
Test Strip where the results
are read. Check to see
that there is a desiccant
packet inside the foil
pouch. If no desiccant
Testing Procedure
Once the oral fluid has been collected and mixed with
the Sample Buffer, the test can be performed on the
diluted specimen.
Invert 3-5
times to mix
6 to 8
Times
5. Place the swab into the
open tube of Sample
Buffer and mix by moving
the swab up and down in
the buffer solution 6 to 8
times.
6. Carefully wring out the
swab head by pressing it
on the inside of the tube
several times, removing as
much liquid from the swab
as possible. Next, remove
the swab and discard.
7. Place the gray cap back on
the Sample Buffer tube,
sealing tightly so that it will
not leak. Invert the tube
3-5 times to thoroughly
mix. The sample is now
ready for testing with the
Test Strip.
1. Remove the cap from the
Sample Buffer tube and set
the tube on a flat work
surface.
2. Have the subject being
tested remove the Oral
Specimen Collection Swab
from the plastic Test Set
pouch by grasping the
handle.
3. The subject should swab
their upper gums along the
gumline, going back and
forth one time.
4. Using the same swab, but
rotating it so that the
opposite surface of the
swab is used, the subject
should now swab their
lower gums along the
gumline, going back and
forth one time.
7. Test Strips and Sample Buffer tubes are matched
to work with each other in each kit. Don’t inter-
change or use Sample Buffer and Test Strips with
a different lot of kits.
8. Avoid handling kit components to avoid microbial
contamination. In particular, avoid handling the
swab end of the Oral Specimen Collection Swab or
handling the read area (i.e. membrane) of the Test
Strip.
9. Perform the test and read the results using
adequate lighting to ensure accurate results.
10. If a second oral specimen is to be collected from a
subject, wait at least 60 minutes after the previous
oral fluid specimen collection before collecting
another specimen.
11. Do not collect an oral specimen from a subject
who has been eating, drinking, smoking or
chewing gum, tobacco or other products for at
least 15 minutes, or using oral care products for at
least 30 minutes afterwards.
STORAGE CONDITIONS
Unused Asanté™ HIV-1/2 Oral Fluid tests may be
stored unopened at 2-30°C until the product expiration
date. Do not open the Test Strip pouch or other
component outer packaging until ready to perform a
test. If the test is stored refrigerated, bring the test out
of the refrigerator and bring to ambient temperature
(15-37°C) before opening the component packaging.
INSTRUCTIONS FOR USE
Preparation for Testing
• Ensure you have all specimen collection and test
materials needed.
• Allow the Test Set to come to ambient temperature
(15-37°C) before running the test.
• Prepare to run Kit Controls or known positive and
negative specimens as controls when required.
Oral Specimen Collection Procedure
PRECAUTIONS
1. This test should be performed at ambient temperature
(i.e. 15-37°C).
2. Do not drink, eat, smoke, or apply cosmetics in areas
where specimens are handled.
3. Disposal of oral fluid specimens and materials in a
biohazard waste container is not required but
recommended. Liquid waste should be first mixed
with appropriate chemical disinfectants such as 10%
household bleach (0.5% sodium hypochlorite) at least
before disposal. (CAUTION: Do not autoclave
solutions containing bleach). For additional biosafety
procedures and information, refer to Universal
Precautions standards
9
. Use of disposable gloves is
recommended.
4. Wipe all work areas before and after testing with an
appropriate chemical disinfectant such as 10%
household bleach. Wipe all spills thoroughly with
disinfectant.
5. Each test component (Test Strip, Sample Buffer and
Oral Specimen Collection Swab) is intended for a
single use. Do not use more than once. If a test must
be repeated, use all new components for the retest.
6. Check the expiration date of the kit and each dated
component (Test Strip and Sample Buffer) prior to
use. Don’t use any materials after the expiration date
printed on the material’s package labeling.
Test Set Components
1-
VI
H
&
2
2/
1-
VI
H
The Asanté™ HIV-1/2
Oral Fluid rapid antibody
Test is packaged as an
individual test set. Each
test pack contains an
Oral Fluid Collection
Swab, a capped tube
containing Sample
Buffer and a Test Strip
will have had adequate time to migrate up the entire
strip encountering both the colored protein A-gold
colloid conjugate and the test and control lines to give
a test result. The test line if visible (when a valid
control line is also present) indicates that HIV antibod-
ies are present and represents a presumed positive for
HIV antibodies in the specimen. If the test line is not
visible (when a valid control line is present), then HIV
antibodies are not present and the result is negative for
the presence of HIV antibodies in the specimen.
(Refer to the Interpretation of Results section below).
MATERIALS PROVIDED
sealed in a foil pouch. The Asanté™ HIV-1/2 Oral Fluid
rapid antibody Individual Test Sets are available in kits
of 50
(Cat no. 1100-50)
and 100 (
Cat. no. 1100-100
).
MATERIALS AVAILABLE AS AN ACCESSORY TO
THE KIT
Asanté™ HIV-1/2 Controls Kit (
Cat. No. 1101
)
Package contains one (1) Positive Control (0.25 mL)
and one (1) Negative Control (0.25 mL) and a
Product Insert.
MATERIALS REQUIRED BUT NOT PROVIDED
Timer or watch
Tube stand or rack (for 13 mm tubes)
WARNINGS
1. This product is for diagnostic use only.
2. Be sure to read this product insert completely
before performing the test. It is important to follow
the instructions carefully to avoid obtaining
inaccurate results.
3. This product is intended only for use with oral fluid
specimens. Testing with any other specimen type
will not give accurate results.
4. Oral fluid specimens must be collected and tested
using the procedure described herein, using only
the materials provided with this test. Use of other
collection swabs may not give accurate results.
BIOLOGICAL PRINCIPLES OF THE TEST
The Asanté™ HIV-1/2 Oral Fluid rapid antibody test is
a manual point-of-care, visually read immunoassay for
the qualitative detection of antibodies to HIV-1 and
HIV-2 in human oral fluid. Results can be obtained in
as little as 20 minutes. The Asanté™ test is com-
prised of an Oral Sample Collection Swab, a tube
containing a pre-measured volume of Sample Buffer
and a Test Strip. The Test Strip itself is composed of
several materials which in combination are capable of
detecting HIV antibodies when those antibodies are
added to the tube of Sample Buffer.
After the oral fluid specimen has been collected
according to the instructions and mixed with the
Sample Buffer, the test is initiated by simply placing
the Test Strip into the tube of Sample Buffer containing
the specimen, with the arrows on the Test Strip
pointing down.
When the Test Strip is placed into the specimen/
Sample Buffer mixture, the specimen/Sample Buffer
mixture is absorbed into the absorbent pad at the end
of the Test Strip. This absorbent pad contains
additional reagents to condition the specimen and
prepare it for optimal reactivity in the remainder of the
Test Strip. The liquid mixture continues to migrate up
the Test Strip by a wicking action, until it encounters a
dehydrated reagent composed of protein A conjugated
to a colloidal gold reagent (“conjugate”), which is
rehydrated by the liquid. The conjugate confers a
reddish-purple coloration to the reagent which is used
later in the Test Strip to visualize the results. Protein A
will bind to both HIV-positive (if any) and HIV-negative
antibodies that may be present in the liquid containing
the specimen.
The liquid continues to wick up the strip onto a
nitrocellulose membrane which contains two invisible
reagent lines (a test and control line), where the test
results are read. Once the liquid starts to appear on
the membrane, the user will see a reddish-purple
cloud migrate up the strip with the liquid, due to the
presence of the conjugate bound to antibodies in the
sample. The liquid will continue to be drawn up to the
top of the strip until the reddish-purple cloud on the
membrane has cleared 20 minutes after the start of
the test.
As the liquid containing antibodies bound to the
conjugate crosses the membrane, it first encounters
the test line, which contains HIV proteins bound to the
membrane that will also bind any HIV antibodies
present in the specimen. Since these HIV antibodies
will also be bound to the conjugate, the reddish-
purplish colored reagent will accumulate on the test
line by means of the capture of the HIV antibodies to
the viral proteins. A reddish-purple line will form
indicative of the presence of HIV antibodies.
The liquid specimen will continue to wick up the strip,
next encountering the control line. The control line
contains goat antibodies reactive to human antibodies
(“goat anti-human ab”) which will bind human antibod-
ies in the liquid regardless of whether those antibodies
are HIV positive or negative. If an adequate sample
has been collected and the test is run correctly,
antibodies will be present in the specimen, and will
have bound to the conjugate and captured on the
control line, giving a visible reddish-purple control line.
In the case of both the control line and the test line, the
color intensity of the lines does not necessarily
correlate to the amount of antibody captured or to the
severity of the infection, if present.
The results of the test are interpreted no sooner than
20 minutes but no later than 45 minutes after adding
the Test Strip to the Sample Buffer containing the
specimen. At this time, the antibodies in the specimen
SUMMARY AND EXPLANATION OF THE TEST
The Human Immunodeficiency Virus (HIV) causes
Acquired Immune Deficiency Syndrome (AIDS), AIDS
related complex (ARC) and pre-AIDS
1,2
. Multiple
subtypes have been documented through the use of
genetic analysis. The strains of HIV-1 can be classified
into four groups: the "major" group M, the "outlier"
group O and the "new" groups N and P. Within group
M there are known to be at least nine genetically
distinct subtypes (or clades) of HIV-1 as well as
occasionally appearing but short-lived recombinant
forms known as “circulating recombinant forms” or
CRF’s. The known HIV-1 subtypes are A, B, C, D, F,
G, H, J and K
3
. Group O, discovered in 1994, appears
to be restricted to west-central Africa
4
and group N -
discovered in 1998
5
and group P discovered in 2009
6,
both in Cameroon - are extremely rare. More than
90% of HIV-1 infections belong to HIV-1 group M
3
.
HIV-2 is predominantly found in Africa and rarely
elsewhere. HIV-1 and HIV-2 share a number of
conserved sequences. However, serological cross-
reactivity between HIV-1 and HIV-2 has been shown to
be highly variable from sample to sample
7
. HIV-2 can
be classified into at least 7 subtypes (A-G) but only A
and B are prevalent
8
.
HIV transmission occurs predominantly through
exposure by sexual contact, exposure to blood
including shared usage of contaminated needles and
syringes, and contaminated blood products. Transmis-
sion may also occur from an infected mother to her
unborn child during the prenatal period. When
individuals are infected with HIV, their body produces
antibodies to proteins in the HIV virus. The presence
of these antibodies in various body fluids, including
blood and oral fluid, are indicative of exposure to the
HIV virus and can be used as an aid in the diagnosis of
HIV infection when used in the context of other clinical
indications. There are, however, situations where HIV
antibodies may be absent even though an infection is
present. The development of antibodies to HIV (i.e.
“seroconversion”) in a person exposed to the virus may
take several weeks to months during which time the
person may be infected and capable of transmitting the
virus. Conversely, the presence of HIV antibodies in
neonates may not necessarily indicate HIV infection,
but may reflect acquisition of maternal antibodies.
The Asanté™ HIV-1/2 Oral Fluid rapid antibody test is
a single use, qualitative immunoassay for the detection
of antibodies to Human Immunodeficiency Virus Type
1 (HIV-1) and Type 2 (HIV-2) in oral fluid specimens.
The Asanté™ HIV-1/2 Oral Fluid rapid antibody test is
intended as a point-of-care test to aid in the diagnosis
of infection with both HIV-1 and HIV-2. The test may
be used in multi-test algorithms when multiple ap-
proved rapid tests are available when use of such
multi-test algorithms has been validated and approved
by local regulations.
NAME AND INTENDED USE
The
Asanté™ HIV-1/2 Oral Fluid test
is a rapid,
visually read, in vitro immunoassay for the
qualitative detection of antibodies to Human
Immunodeficiency Virus Type 1 (HIV-1) and
Type 2 (HIV-2) in oral fluid specimens.
HIV-1/2 Oral Fluid
™
Asanté