Asante HIV-1/2 Oral Fluid User manual

LN-6027.05
Wait 20 to
45 minutes
HIV-1
&
2
1-VIH
&
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.
HIV-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 standards9. 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-VIH
&
2
2/1-VIH
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-AIDS1,2. 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 K3. Group O, discovered in 1994, appears
to be restricted to west-central Africa4and group N -
discovered in 19985 and group P discovered in 20096,
both in Cameroon - are extremely rare. More than
90% of HIV-1 infections belong to HIV-1 group M3.
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 sample7. HIV-2 can
be classified into at least 7 subtypes (A-G) but only A
and B are prevalent8.
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

July 2015 LN-6027.05
Copyright 2015. Sedia Biosciences Corporation.
All Rights Reserved
SEDIA Biosciences Corporation
4900 NE 122nd Avenue
Portland, OR 97230 USA
Ph: [phone]
Fax: [phone]
Webpage: www.sediabio.com
Email: [email protected]
/21HIV-
Oral Fluid
™
Asanté
Consult instructions for use
(temperature storage)
Temperature Limitation
Use by (expiration date)
Lot number (batch code)
Part Number
In Vitro Diagnostics
Fluid product labeling.
The following symbols appear in Asanté™ HIV-1/2 Oral
SYMBOLS AND ABBREVIATIONS
5. Simon F, Mauclère P, Roques P, Loussert-Ajaka I,
Müller-Trutwin MC, et al. Identification of a new
human immunodeficiency virus type 1 distinct from
group M and group O. Nature Medicine. 1998;
4:1032-1037.
6. Plantier J-C, Leoz M, Dickerson JE, De Oliveira F,
et al. A new human immunodeficiency virus
derived from gorillas. Nature Medicine. 2009;
15:871-872.
7. Schim van der Loeff, MF, and Aaby P. Towards a
better understanding of the epidemiology of HIV-2.
AIDS. 1999; 13 (Suppl A):S69–84.
8. Simon F, Gueudin M, De Oliveira F, Damond F, and
Plantier JC. Discrimination of HIV-2 subtypes A
and B by real time PCR. Intl. Conf. AIDS, 2004.
Abstr. No. TuPeA4384.
9. CDC. Universal precautions for prevention of
transmission of human immunodeficiency virus,
hepatitis B virus and other bloodborne pathogens
in health-care settings. MMWR. 1988: 37:377-388.
10. Burtis CA and Ashwood ER. Tietz Fundamentals
of Clinical Chemistry, 5th Edition. W.B. Saunders,
Philadelphia PA. 2001.
11. George JR. Alternative specimen sources:
methods for confirming positives. 1998 Conference
on the Laboratory Science of HIV. pp. 47-60.
12. Sedia Biosciences Corporation. 2010. Data on
file.
2. Curran JW, Morgan WM, Hardy AM, et al. The
epidemiology of AIDS: current status and future
prospects. 1985; 224:1352-1357.
3. Robertson DL, Anderson JP, Bradac JA, et al.
HIV-1 nomenclature proposal: A reference guide to
HIV-1 classification In: Kuiken CL Foley B, Hahn
BH, et al, editor. Human retroviruses and AIDS: A
compilation and analysis of nucleic and amino
acid sequences. Los Alamos, NM: Los Alamos
National Laboratory; 2000. pp. 492-505.
4. Gurtler LG, Hauser PH, Eberle J, von Brunn A,
Knapp S, Zekeng L, et al.A new subtype of
human immunodeficiency virus type 1 (MVP-5180)
from Cameroon. J. Virol. 1994; 68:1581-1585.
BIBLIOGRAPHY
1. Gallo RC, Salahuddin SZ, Popovic M, et al.
Frequent detection and isolation of cytopathic
retroviruses (HTLV III) from patients with AIDS and
at risk for AIDS. Science 1984, 224:500-503.
aCommercial panels were used to prepare contrived
specimens by diluting each panel member 1:1000 into
Sample Buffer and testing the panel member/Sample
Buffer mix following the procedure in this insert.
Contrived positive clinical specimens were prepared
and tested in like manner, using known positive serum
specimens, except that the dilution was made into
known negative oral specimens collected using the
Asanté HIV-1/2 Oral Fluid Specimen Collection Swab.
No specimen pooling was done, and each result
represents an individual unpooled sample. The
dilution factor use is based on observed correlations
and established clinical data on the relative concentra-
tion of antibody in oral fluid versus serum.10, 11, 12
Sample ID
Days since
first bleed
Asanté
HIV-1/2
Oral Fluid
Abbott HIV 1+ 2
EIA (S/C)
Biorad HIV-1
Western Blot
PBR924-01 0 - 0.2 neg
PBR924-02 2 - 0.2 neg
PBR924-03 8 - 0.2 neg
PBR924-04 10 - 0.2 neg
PBR924-05 26 - 0.3 neg
PBR924-06 33 + 13.1 neg
PBR924-07 35 + 11.3 IND
PBR924-08 40 + 6.6 IND
PBR929-01 0 - 0.2 neg
PBR929-02 4 - 0.2 neg
PBR929-03 14 - 0.2 neg
PBR929-04 18 - 0.2 neg
PBR929-05 21 - 0.9 neg
PBR929-06 25 + >16.3 neg
PBR929-07 28 + >16.3 IND
PBR933-01 0 - 0.1 neg
PBR933-02 21 + >17.7 neg
PBR933-03 27 + 16.0 POS
PBR935-01 0 - 0.1 neg
PBR935-02 10 - 0.1 neg
PBR935-03 16 - 0.1 neg
PBR935-04 21 - 0.1 neg
PBR935-05 24 - 0.1 neg
PBR935-06 28 - 0.1 neg
PBR935-07 43 + 3.9 POS
PBR950-01 0 - 0.2 neg
PBR950-02 18 - 0.2 neg
PBR950-03 21 - 0.2 neg
PBR950-04 28 + >15.5 neg
BBI Seroconversion Panels
ID Genotype* Origin
Asanté
HIV-1/2
Oral Fluid
Abbott HIV 1+ 2
EIA (S/C)
Genetic Systems
HIV-1/2 EIA (S/C)
1 O Spain + 1.8 5.6
2 A Ghana + >16.1 8.7
3 G Ghana + >16.1 8.8
4 G Ghana + >16.1 8.8
5 A Ghana + >16.1 8.7
6 G Ghana + >16.1 8.8
8 G Ivory Coast + >16.1 8.7
9 A Ivory Coast + >16.1 8.6
10 NEG Ivory Coast - 0.2 0.4
11 HIV-2 Mozambique + >14.6 9.7
12 C Mozambique + >16.1 8.9
13 A Uganda + >16.1 8.8
14 D Uganda + >16.1 8.5
15 D Uganda + >16.1 8.1
16 D Uganda + >16.1 8.8
17 D Uganda + >16.1 9.8
19 C Zimbabwe + >16.1 9.9
21 B China + >16.1 8.8
22 E Thailand + >16.1 9.8
24 E Thailand + >16.1 9.8
25 HIV-2 India 15.4+ 10.0
26 B USA + >16.1 9.8
27 B/D USA + >16.1 9.8
28 F Argentina + >16.1 8.9
29 B Argentina + >16.1 8.5
30 NEG Argentina - 0.2 0.2
26/26 26/26 26/26
*Genotype based on sequencing by PCR
BBI Worldwide HIV Performance Panel WWRB302 (Modified)
Number Correct
Sensitivity of the Asanté HIV-1/2 Oral Fluid rapid test
across multiple genotypes of HIV was assessed using
the commercial BBI Worldwide HIV Performance
Panel (WWRB302 Modified). Simulated specimens
from commercial seroconverter panels were diluted as
described below and tested in the Asanté HIV-1/2
Oral Fluid test according to the procedure in this
insert. Results were comparable to those obtained
with commercially available blood HIV EIA results,
provided by the panel manufacturer.
Seroconverter sensitivity was assessed by diluting
simulated specimens from commercial seroconverter
panels as described below and testing in the Asanté
HIV-1/2 Oral Fluid test according to the procedure in
this insert. Results were comparable to those ob-
tained with a commercially available blood HIV EIA
and Western blot, provided by the panel manufacturer.
a
a
Sensitivity (n=159): 100%
Specificity (n=484): 100%
Accuracy (n=643): 100%
True
Positive
True
Negative
Asanté HIV-1/2 Oral Fluid Positive 0
159
Asanté HIV-1/2 Oral Fluid Negative 0 484
Overall Performance
Oral fluid specimens were collected from subjects in
Thailand and tested with the Asanté HIV-1/2 Oral Fluid
test according the procedure in this product insert. A
total of 84 known negative specimens were tested and
resulted in 84 true negatives and no false positives, for
a specificity of 100%. A total of 62 contrived known
HIV-1 positive oral fluid specimens were prepared as
described belowaand resulted in 62 true positives and
no false negatives, for a sensitivity of 100%. Overall
test accuracy in this population was 100%.
algorithm. AIDS and AIDS-related conditions are
clinical syndromes and can only be diagnosed by
clinical examination.
6. The intensity of either the test line or control line
does not necessarily correlate with the levels of
any antibodies that may be present or with the
severity of disease, if present.
7. A non-reactive result does not exclude the possibil-
ity of exposure to HIV or the presence of HIV
infection. Antibody response to recent HIV
exposure may take several weeks to several
months to reach detectable levels.
8. The presence of HIV-1 or HIV-2 antibodies in an
individual is presumed to be an indication of viral
infection. However, individuals who have partici-
pated in HIV vaccine studies may have antibodies
present as a result of vaccination, but may not be
infected. Individuals who have participated in HIV
vaccine trials who test reactive in this test should
undergo additional testing to determine if a
diagnosis of HIV infection is appropriate.
CLINICAL TEST RESULTS
Oral fluid specimens were also collected from subjects
in India and tested with the Asanté HIV-1/2 Oral Fluid
test. A total of 400 known negative specimens were
tested and resulted in 400 true negatives and no false
positives, for a specificity of 100%. A total of 97 known
HIV-1 positive oral fluid specimens were also collected
and tested with the Asanté HIV-1/2 Oral Fluid test and
gave 97 true positive results and no false negatives, for
a sensitivity of 100%. Overall test accuracy in this
population was 100%.
The combined data of the two studies above is
presented in the table below:
LIMITATIONS OF THE TEST
1. The Asanté™ HIV-1/2 Oral Fluid rapid antibody test
must be used according to the instructions in this
product insert to obtain accurate results.
2. Results must be read no earlier than 20 minutes
nor later than 45 minutes after inserting the Test
Strip into the Sample Buffer containing the
specimen. Reading results outside of this window
may give inaccurate results.
3. This test is intended for use only with oral fluid
specimens. Oral fluid specimens collected
following procedures other than those specified in
this product insert may yield erroneous results.
4. Individuals infected with HIV but who are on
antiretroviral therapy may produce false negative
results.
5. A reactive result using the Asanté™ HIV-1/2 Oral
Fluid test indicates the presence of HIV-1 and/or
HIV-2 antibodies in the specimen. The Asanté™
HIV-1/2 Oral fluid test should not be used alone to
form a diagnosis of HIV, but used as an aid in such
diagnosis. Confirmation of test results should be
obtained using the appropriately approved testing
Repeat the test with a new Test Strip on the
sample specimen/Sample Buffer. If an invalid
result is obtained again, repeat using another new
Test Strip but on a new freshly collected sample.
1-VIH
&
2
Invalid
1-VIH
&
2
Invalid
INVALID
The figures at right show
examples of invalid test
results. A test is invalid if
no reddish-purple line
appears in the control line
region of the Test Strip,
regardless of whether or not
there is a test line present.
An invalid test result means
that there was a problem
with the test. This may
include an inadequate or
improper sample collection,
an improperly performed
test or a Test Strip failure.
An INVALID result cannot
be interpreted and used
for diagnostic purposes.
A reactive test result means that HIV antibodies
were detected in the specimen. A reactive result is
interpreted as PRELIMINARY POSITIVE for HIV-1
and/or HIV-2 antibodies. Preliminary positive
results should be confirmed using a suitable
algorithm as required by local regulations.
1-VIH
&
2
larO-doolB
Reactive
1-VIH &2
larO-doolB
Reactive
REACTIVE
The figures at right show
examples of reactive test
results. A test is reactive if
both a reddish-purple line
appears in the control line
region and a reddish-
purple line appears in the
test line region of the Test
Strip.
Note: the test is reactive if
any reddish-purple line
appears in both the test
line and control line
regions of the Test Strip,
regardless of how faint
these lines are. One line
may be significantly darker
than the other. This is not
abnormal.
A non-reactive test result means that no HIV
antibodies were detected in the specimen. A
non-reactive result is interpreted as NEGATIVE for
HIV-1 and HIV-2 antibodies.
Non-Reactive
1-VIH
&
2
The figure at right shows
an example of a non-
reactive test result. A test
is non-reactive if a reddish
purple line appears in the
control line region but no
line appears in the test line
region of the Test Strip.
INTERPRETATION OF RESULTS
Refer to the Result Region of the Test Strip
NON-REACTIVE
QUALITY CONTROL
The Asanté™ HIV-1/2 Oral Fluid rapid antibody test
has a built-in procedural control that establishes assay
validity. A reddish-purple line in the control line region
of the Test Strip membrane indicates that a proper
specimen was collected and run in the test, and that
the Test Strip functioned properly. This control line will
appear on all valid tests whether or not the test line
gives a reactive or non-reactive result.
Asanté™ HIV-1/2 Controls Kit is available separately
for use with the Asanté™ HIV-1/2 Oral Fluid rapid test.
These controls are formulated specifically to ensure
the performance of the Asanté™ HIV-1/2 Oral Fluid
rapid test and are used to verify that the user can
perform the test correctly and that the test is working
properly. The Positive Control will produce a reactive
test result and has been designed to give a visible test
line. The Negative Control will produce a non-reactive
test result. Alternatively, known positive or negative
specimens validated to perform in the Asanté™
HIV-1/2 Oral Fluid test may be used. Use of kit
controls other than those provided by Sedia or
properly validated with the Asanté™ HIV-1/2 Oral Fluid
test may not produce the desired results and may not
provide an adequate quality assurance program for the
Asanté™ HIV-1/2 Oral Fluid rapid test.
Sedia recommends that controls be run: a) with each
new operator prior to beginning testing on clinical
specimens, b) when opening a new test kit lot, c)
whenever a new shipment of test kits is received, d)
anytime the condition of test kits is suspect, for
example, due to short-term exposure to improper
temperature, and e) at periodic intervals during testing
as established by the user’s quality assurance
program.
containing the specimen. If the results are read
outside of this window, inaccurate results may be
obtained.) After reading the results, dispose of the
used Test Strip and tube of Sample Buffer. If the
sample is to be retested, a new Test Strip may be
used on the same specimen/Sample Buffer
mixture. Diluted specimens in Sample Buffer may
be stored at 2-8°C for up to one week for addi-
tional testing.
Blood-Oral
HIV-1
&
2
5. Read the test results on
the Test Strip. Refer to
Interpretation of Results
section below. (Note: It is
important to read the
results only between 20
minutes and 45 minutes
after placing the Test Strip
into the Sample Buffer
/2 Oral Fluid1HIV-
™
Asanté
Page 2
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