OneStep HIV 1/2 #177698 Test
Atlas Link
InstaTest HIV
OneStep HIV ½ Test
Catalog # 177698 - 50 (50 tests)
Simple assay, accurate detection, instant results
third generation, double antigen test, for in vitro qualitative diagnostic use.
PRINCIPLE
This test using double, antigen recombinant proteins, is a third generation test with dramatically improved sensitivity and specificity.
This assay is a chromatographic lateral flow immunoassay, containing filter membrane coated with HIV-1 and 2 specific antigens and colored gold colloidal reagents labeled with HIV-1 and 2 specific antigens. There are two colored regions, a test region and a control region, on the membrane of the test strip. The T line, a burgundy color band in the test region of membrane, will be developed rapidly when antibodies to HIV-1 and/or 2 are present in the specimen. If antibodies to HIV-1 and/or 2 are not present, no T line will be developed in the test region. The C line, a burgundy color band in the control region of the test, should always appear regardless of the presence of antibodies to HIV-1/2 and serves as an internal qualitative control of the test system.
INTENDED USE
The acquired immunodeficiency syndrome (AIDS) is caused by HIV (Human Immunodeficiency Virus). The HIV-1/2 Serum Rapid Test is a qualitative test, simultaneously detecting antibodies to HIV-1 and 2. It offers early detection of antibodies to Juman Immunodeficiency Virus Type 1 and 2 (HIV-1/2) in serum specimen. It yields results instantly, that enable individuals to obtain early treatment and counseling.
TEST MATERIAL PROVIDED
- Individual test device packed in a sealed pouch.
- Wash buffer.
STORAGE
This kit is designed to be stored at temperature of 8°C to 28°C. Do not freeze the kit. Avoid exposing the kit to the temperatures over 30°C. (For example, one week at 45°C will reduce the shelf life of the test device by 10 weeks.) Wash buffer will have white milky precipitate when stored at low temperatures. To dissolve the precipitate, warm it up to room temperature before use.
SPECIMEN COLLECTION
1. Only serum specimen may be tested with this assay. Following standard clinical procedure to collect specimens.
2. Specimens can be stored at room temperature (20°C to 28°C) for 8 hours at 2-8 o C for one week, and at -20°C or lower for prolonged storage. Repeatedly frozen and thawed specimens are not recommended for this assay.
3. Any sediment in serum specimens should be removed by centrifugation. Avoid using any turbid specimens, which may be contaminated by microorganisms.
PRECAUTION
1. This test is for in vitro use only.
2. Handle all specimens with caution as they bay be capable of transmitting infection. Do not pipette by mouth. Do not smoke, eat or drink in the areas where specimens are handled. Wear disposable gloves while handling all specimens and thoroughly wash hands afterwards.
3. Use separate disposable pipette, and test kit for each specimen.
4. All spills should be wiped up thoroughly with sodium hypochlorite (0.5%), alcohol (70%) or an iodophor disinfectant.
5. Dispose of all specimens and used assay materials as if they contained infectious agents. The preferred method is autoclaving for 60 minutes at 121 °C or incineration.
6. Do not use expired kit.
PROCEDURE
1. Refrigerated specimens or other materials must be equilibrated to room temperature before testing.
2. Remove a testing device from pouch and place the device on a flat surface. Label the device with specimen identification.
3. Add one drop of serum (40 ml of specimen) into the sample well of the device.
4. Using too much or too little sample may give inaccurate results.
5. Discard the first three drops of wash buffer from the wash buffer squeeze bottle. Then add three drops (about 120 ml) of wash buffer into the sample well.
6. Strong positive results may be observed in 2-3 minutes. Weak positive results may take longer time, up to 10 minutes. Do not interpret results after 30 minutes.
INTERPRETATION OF RESULTS
1. Positive: Both C line and T line are present, indicating the presence of antibodies to HIV-1/2 in the specimen. When the level of antibodies to HIV-1/2is very low, the T line might present as a pink shadow. A positive result indicated by a pinkish-red line in the “T” area of the result window. A specimen containing a detectable level of HIV specific antibody will generate the light pinkish-red line in the test area within 5 to 10 minutes. Even a light-colored shadow in the test area still needs to be considered a possibility of a weak positive sample.
A positive result, by itself, does not necessarily mean that the tested individual is HIV positive. It does mean in the judgment of the person reading the test that the serum specimen is reactive. Rapid (non-laboratory HIV antibody) test are designed to provide a low cost and convenient alternative to laboratory testing to assist more individuals In determining their HIV status. On occasion this test may indicate a person’s serum to have HIV antibodies present when indeed they do not. Therefore it is always proper medical protocol, that all positive and suspicion results must be confirmed using Western Blot Test.
2. Negative: Only one line, the C line, but no T line developed on the test strip, indicating that the antibodies to HIV-1/2 are not detected in the specimen and the test result is negative. This HIV negative interpretation indicates the absence of HIV antibodies, or that the concentration of HIV antibody is below the detection limit of the test. The negative result, by itself, does not necessarily mean that the tested individual is HIV negative. The Centers for Disease control has stated that a HIV infected person may have an incubation period from 10 days up to 6 months from date of infection before the human body produces a sufficient level of HIV antibodies to be detected. Therefore, a second HIV test should be taken within 6 months.
3. Invalid If C line does not appear within 5 to 10 minutes, the test should be voided. Repeat the assay with a new test kit.
LIMITATION
- This test is for in vitro diagnostic use only. This kit is not recommended for testing pooled specimen or other body fluids other than fresh human serum
- This test will only indicate the presence of antibodies to HIV in the specimen and should not be used as the sole criteria for the diagnosis of HIV infection.
- As with all diagnostic tests, all results must be considered with other clinical information.
4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is recommended. A negative result at any time does not preclude the possibility of HIV infection.
REFERENCES
1. Popovic M., Samgadharan, M.G., Read, E., and Galo, R.C. Detection, isolation, and continuous production of cytopathic retroviruses (HTLV-III) from patients with AIDS and pre-AIDS. Science 244; 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. 1985 Provisional Public Health Service Interagency recommendations for screening donated blood and plasma for antibody to the virus causing Acquired Immunodeficiency Syndrome, MNWR 34:1-5.
4. Curran JW, et al., The epidemiology of AIDS: Current status and future prospects. Science 1985; 229;1352-1357
5. Clavel, F., HIV-2, the west African AIDS virus, AIDS 1987; 1;135-140
6. Plot, P., Plummer, F. A., Mhalu, F.S., Lamboray, J-L, Chin, J., and Mann, J.M., AIDS, An International Perspective, Science 1988; 239; 573-579.
7. World Health Organization, Laboratory biosafety Manual, Geneva. World Health Organization, 1983
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