OneStep HIV 1/2 #177699 Test
Atlas Link
InstaTest HIV
OneStep HIV ½ Test
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.
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.
INTENDED USE
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
- HIV-1/2 Insta test device. Individual test device packed in a sealed pouch
- Sample dilution Reagent: Ready for use.
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.
SPECIMEN COLLECTION
1. 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.
2. 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.
3. 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. This test is intended for in vitro use only.
2. Do not pipette by mouth. Do not smoke, eat or drink in the areas where specimens are handled.
3. Use disposable gloves while handling all materials of the kit and performing the assay.
4. 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.
5. Do not use the test beyond the expiration date printed on the package.
PROCEDURE
1. Use one device for each specimen.
2. Use a separate pipette for each specimen.
3 Bring pouched test device to the room temperature and remove the device from its protective pouch.
3. Label the device with specimen identification.
Test Device5. Holding the pipette, dispense one drop of whole blood or serum (10 ml) into the sample well .
6. Dispense four drops (200 ml ) of wash buffer into the sample well (S).
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. Negative: Only one purple colored band appears on the control region (C). No apparent band on the test region (T).
2. Positive: In addition to the control band (C), a distinct purple colored band also appears on the test region (T).
3. 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.
Interpretation Of ResultsLIMITATION
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 HIV-1/2 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.
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
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