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OneStep HIV 1/2 #177699 Test
Atlas Link
InstaTest HIV
OneStep HIV ½ Test
STORAGE
This kit is designed to be stored at refrigeration (20C to 28C)
or refrigeration (4C to 8C) in the sealed pouch for the duration
of shelf-life. The wash buffer should only be stored at room
temperature. Do not freeze the test kit. Exposure to
temperatures over 30C should be avoided.
Catalog # 177699-50
For the Qualitative Detection of HIV-1/2 Antibodies.
Rapid Result in 5 minutes.
For Serum and Whole Blood use.
For Research use only.
SPECIMEN COLLECTION
1.
2.
PRINCIPLE
It has been shown that the Acquired Immunodeficiency
Syndrome (AIDS) is caused by viruses transmitted by sexual
contact, transfusion, use of contaminated blood products and
sharing contaminated needles. HIV-1 and 2 viruses have been
isolated from patients with AIDS and AIDS-related complex
(ARC), and from high risk persons for AIDS. HIV-1/2 viruses
deplete T helper cells, a subpopulation of T cells for body
defense, thus causing AIDS patients susceptible to opportunistic
infections and developing malignant tumors. The incidence of
specific antibodies to HIV-1 and 2 is high in AIDS, ARC and
persons with high risk for AIDS. The HIV-1/2 Insta test was
designed to detect antibodies to HIV-1/2 in human blood or
serum in AIDS patients, ARC or high risk persons and to
identify any potential blood donors carrying these antibodies in
specimens.
HIV-1/2 Insta test is a chromatographic
immunoassay for the detection of antibodies to HIV1/2 in
human serum. HIV-1 and 2 specific antigens are precoated onto
membrane as a capture reagent on the test region (T). During the
testing, the specimen is allowed to react with the colloidal gold
reagents which have been labeled with HIV-1 and 2 specific
antigens. Antibodies to HIV-1/2, if present, a purple colored
band will develop on the membranein proportion to the amount
of HIV-1/2antibodies present in the specimen. Absence of this
purple colored band in the test region (“T”) suggests a negative
result. To serve as a procedural control, a purple colored band
in the control region (“C”) will always appear regardless of the
presence or absence of the antibodies to HIV-1 and 2.
3.
Whole blood specimens can be collected by venipuncture
or fingerstick method. Serum can also be used in this assay.
Blood is clotted and serum can be separated.
Specimens can be kept at room temperature if a test is
performed within 5 hours after collection. Specimens may
be stored at 2-8oC for 48 hours. If test is not performed
within 48 hours, sera should be frozen for prolonged
storage, but not whole blood samples.
When specimens are taken out of freezer and thawed at
room temperature, any sediment should be precipitated by
centrifugation for 10 minutes and removed before use.
Avoid using any turbid specimen for assay, which may be
caused by the growth of microorganisms in specimens.
PRECAUTION
1.
2.
3.
4.
5.
PROCEDURE
1.
2.
INTENDED USE
3
HIV-1/2 Insta test is a qualitative test for detection of antibodies
to Human Immunodeficiency Virus Type 1 and 2 in human
blood or serum. It is considered as an initial screening test for
HIV-1 and 2 antibodied. All positive specimens must be retested
and confirmed with Western Blot analysis or other qualified
EIA assay.
TEST MATERIAL PROVIDED
1.
2.
HIV-1/2 Insta test device. Individual test device
packed in a sealed pouch
Sample dilution Reagent: Ready for use.
This test is intended for in vitro use only.
Do not pipette by mouth. Do not smoke, eat or drink in
the areas where specimens are handled.
Use disposable gloves while handling all materials of
the kit and performing the assay.
Immediately clean up any spillage of materials with a
1:10 dilution of 5% sodium hypochlorite. Autoclave
any contaminated materials for 60 minutes at 121oC
before disposal. All liquid waste should be treated with
5% sodium hypochlorite solution (the final
concentration should not be lower that 0.5% sodium
hypochlorite) for 30 minutes before disposing.
Do not use the test beyond the expiration date printed
on the package.
3.
Use one device for each specimen.
Use a separate pipette for each specimen.
Bring pouched test device to the room temperature and
remove the device from its protective pouch.
Label the device with specimen identification.
Test Device
5. Holding the pipette, dispense one drop of whole blood
or serum (10 l) into the sample well .
6. Dispense four drops (200 l ) of wash buffer into the
sample well (S).
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]
OneStep HIV 1/2 #177699 Test
7. Wait for purple colored bands to appear. Depending on
the concentration of antibodies to HIV- ½, positive
results may be observed in as short as 30 seconds.
However to confirm negative results the complete
reaction time ( 5 minutes ) is required.
INTERPRETATION OF RESULTS
1.
2.
3.
Negative: Only one purple colored band appears on the
control region (C). No apparent band on the test region (T).
Positive: In addition to the control band (C), a distinct
purple colored band also appears on the test region (T).
Invalid: When neither test band nor the control band
appears, the test is not valid and it should be voided. An
assay error or deterioration of reagents has probably
occurred.
C
T
C
T
C
T
S
S
S
POSITIVE
NEGATIVE
INVALID
REFERENCES
1.
Popovic M. et al., Detection, isolation, and continuous
production of cytopathic retroviruses (HTLV-III) from
patients with AIDS and pro-AIDS. Science 1984; 497-500
2. Gallo RC, et al., Detection and isolation of cytopathic
retroviruses (HTLV-III) from patients with AIDS and at
risk for AIDS. Science 1984; 224;500-503
3. Curran JW, et al., The epidemiology of AIDS: Current
status and future prospects. Science 1985; 229;1352-1357
4. Clavel, F., HIV-2, the west African AIDS virus, AIDS
1987; 1;135-140
5.. Plot, P. et al., AIDS, An International Prospective, Science
1988; 239; 573-579
6.. 1985 Provisional Public Health Service Interagency
recommendations for screening donated blood and plasma
for antibody to the virus causing Aquired
Immunodeficiency Syndrome, MNWR 34; 1-5
Interpretation Of Results
LIMITATION
Using HIV-1/2 Insta test, the procedure and the interpretation
of results must be followed closely. This assay is designed for
testing antibodies specific to HIV-1 and 2 viruses in human
blood or serum. Any result derived from testing other body
fluids, pooled blood, serum or plasma may not be interpreted
correctly based on the current criteria. So other body fluids or
pooled samples are not recommended in this assay.
The HIV-1/2 Insta test is designed to detect antibodies to HIV1/2 in blood or serum and thus is useful in screening blood or
serum donated for transfusion and further manufacturing, in
establishing prior infection of HIV-1 and 2, or in evaluating
patients with AIDS symptoms and signs. For repeatedly reactive
specimens, it is recommended that more specific supplemental
test should be done and clinical evaluation on patient’s situation
should be performed before a final diagnosis is made. HIV-1/2
Insta test alone can not be used to diagnose AIDS even if the
antibodies against HIV-1 and 2 exist in patient’s blood or
serum. A negative test result at any time does not preclude the
possibility of exposure to, or infection with HIV-1 and 2
viruses.
A test result read after 10 minutes may not be consistent with
the original reading obtained within the 5 minutes test period.
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]