ACCU-TELL ANTI-HIV 1+2 SERUM TEST

Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

 

CATALOG

INTENDED USE

                                                                                LIMITATIONS

                                                                                STORAGE

 

CATALOG

Catalog No.                    Product Name

ABT-IDT-A14                  Anti-HIV 1+2 Serum Strip

ABT-IDT-B14                  Anti-HIV 1+2 Serum Cassette

 

Accu-Tell ^® Rapid Anti-HIV 1+2 Serum Test is a rapid visual test for the qualitative detection of antibodies specific to human immunodeficiency virus (HIV) in human blood serum. This is a screening test, and all positives must be confirmed using an alternate test such as Western Blot. The test is intended for healthcare professional use only.

The human immunodeficiency virus (HIV) is the causative agent of acquired immune deficiency syndrome (AIDS). The general method of detecting infection with HIV is to observe the presence of antibodies to the virus by an EIA method followed by confirmation with Western Blot. The Accu-Tell ^® Rapid Anti-HIV(1&2) Test is a simple, visual qualitative test that detects antibodies in human serum or plasma. The test is based on immunochromatography and can give a result within 15 minutes.

The assay starts with a sample applied to the sample well and add provided sample diluent immediately. The HIV antigen -colloidal gold conjugate embedded in the sample pad reacts with the HIV antibody present in serum or plasma sample forming conjugate/HIV antibody complex. As the mixture is allowed to migrate along the test strip, the conjugate/HIV antibody complex is captured by a second antibody immobilized on the membrane forming a colored test band in the test region. A negative sample does not produce a test band due to the absence of conjugate/HIV antibody complex. The antigens used in the conjugate test are recombinant proteins that correspond to highly immunoreactive regions of HIV1 and HIV2. A colored control band in the control region appears at the end of test procedure regardless of test result. The control band indicates that the colloidal gold conjugate is functional.

1.   All positive results must be confirmed by an alternative method.

2.  Treat all specimens as though potentially infectious. Wear gloves and protective clothing when handling specimens.

3.   Devices used for testing should be autoclaved before disposal.

4.   Do not use kit materials beyond their expiration dates.

5.   Do not interchange reagents from different lot of kit.

1.  Serum or plasma may be used in this test. Anticoagulants typically used for blood collection do not interfere with this test.

2.  Remove the serum or plasma from the clot or red cells as soon as possible to avoid hemolysis.

3. Hemolyzed, extremely thickened or fatty specimens are NOT suitable for this assay. Specimens containing particulate matter may give inconsistent results and should be clarified prior to testing.

4. Serum or plasma specimens should be refrigerated at 2-8℃ up to 3 days and frozen at -20℃ for longer periods.

5. Shipped specimens should be packed in compliance with federal and international regulations covering the transportation of etiologic agents.

6.  Avoid frequent (more than 3 times) thaw-and-freeze of specimens.

7.  0.1% sodium azide can be added to the specimen as a preservative without affecting the results of the assay.

Test device together with developer buffer, patient’s samples, control or reference materials should be brought to room temperature (20℃ to 30℃) prior to testing.

Remove the test device from pouch when ready to perform the test. Label the device with patient or control identification.

1.  Dispense 5 μl of serum or plasma specimen to the circular sample well of the test card using a pipette.

2.  Add two drops of Sample Diluent to the sample well immediately after the specimen is added.

3.  Interpret test results at 15 minutes.

Notes:

1.  Applying sufficient amount of sample diluent is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of diluent to sample well.

2. The positive results could appear as soon as 1 minute for a sample with high levels of HIV antibodies.

Negative: Only the purplish red control band appears on the membrane. The absence of a test band indicates a negative result.

Positive: Both purplish red test band and purplish red control band appear on the membrane. The lower the antibody concentration, the weaker the test band.

Invalid: A total absence of colored lines in both regions is an indication of procedure error and/or that test reagent deterioration has occurred.

Note: It is normal to have a slightly lightened control band with very strong positive samples as long as it is distinctly visible.

1. Specificity

Clinical studies were done to evaluate the performance of Rapid Anti-HIV(1&2) Test In USA and Canada. In both studies, 119 confirmed negative serum samples (USA: 63 samples and Canada: 56 samples) were tested by Rapid Anti-HIV(1&2) Test using EIA and Western Blot as reference tests. Both studies gave 100% specificity for the test.

2. Sensitivity

In both the studies mentioned above, Rapid Anti-HIV(1&2) Test was evaluated with 64 confirmed positive serum samples (32 samples each in USA and Canada). The sensitivity of Rapid Anti-HIV(1&2) Test was found to be 100% relative to consensus with EIA results, supported by Western Blot assay.

The procedural control is included in the test. A colored band appearing on the control region of the membrane indicates proper performance of the test and the device.

1.  This test kit is to be used for the qualitative detection of antibodies to HIV.

2.  A negative result does not rule out infection by HIV because the antibodies to HIV may be absent or may not be present in sufficient quality to be detected at early stage of infection.

3.  For confirmation, further analysis of the specimens should be preformed. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

4.  Only samples that are clear and with good fluidity can be used in this test.

5.  Fresh samples are best but frozen samples can be used. If a sample has been frozen, it should be allowed to thaw in a vertical position. Do not agitate the sample. Insert a pipette just below the surface of the sample to collect the specimen.

The test kit can be stored at room temperature in the sealed pouch for duration of shelf life. The test kit should be kept away from direct sunlight, moisture and heat.

1.  Guyader, M., Emerman, M., Sonigo, P., et al. Genome organization and transactivation of the human immunodeficiency virus type 2. Nature, 326:662-669. 1987.

2.  Blattner, W., Gallo, R.C. and Temin. H.M. HIV causes AIDS. Science. 241:515, 1988.

3. Curran, J.W., Morgan. W.M., Hardy, A.M., et al. The epidemiology of AIDS: Current status and future prospects. Science 229:1352-1357. 1985.

4. Sarngadharan. M.G., Popovic. M., Bruch, L., Schupback, J., and Gallo, R.C. Antibodies reactive with human T-lymphotropic retroviruses (HTLV-lll) in the serum of patients with AIDS. Science. 224:506-508. 1984.

5.  Weber, J.N., Weiss, R.A., Roberts, C., et al. Human immunodeficiency virus infection in two cohorts of homosexual men: Neutralising sera and association of anti-gag antibody with prognosis, Lancet 1:119-124. 1987.

6.  Clavel, F., Guetard. D., Brun-Vezinet, F., et al. Isolation of a new human retrovirus from West African patient with AIDS. Science 233:343-346. 1986.

 

The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.