ACCU-TELL ANTI-HIV 1+2 WHOLE BLOOD 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

Accu-Tell ^® Rapid Anti-HIV 1+2 Whole Blood Test is a colloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) in human whole blood, serum or plasma. This test is a screening test, and all positives must be confirmed using an alternate test such as Western Blot. The test is intended for in vitro diagnostic 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 whole blood, serum or plasma. The test is based on immunochromatography and can give a result within 15 minutes.

The assay starts with a diluent prepared sample applied to the sample well. The HIV antigen -colloidal gold conjugate embedded in the sample pad reacts with the HIV antibody present in blood, 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 a membrane forming a colored test band in the test region. A negative sample does not produce a test band due to the absence of colloidal gold 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. This control band is the result of colloidal gold conjugate binding to the anti-HIV antibody immobilized on the membrane. The control band indicates that the colloidal gold conjugate is functional.

Store test cards at room temperature (2-30°C) and away from direct sunlight.

1.   All positive results must be confirmed by an alternate 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 one kit lot to another.

 

1.  Collect whole blood specimens following regular clinical laboratory procedures.

2.  Heparinized capillary tubes treated with anticoagulant must be used for collecting blood samples.

3.  Whole blood specimens should be used immediately after collection.

1.   Collect serum or plasma specimens following regular clinical laboratory procedures.

2.  Storage: A specimen should be refrigerated if not used the same day of collection. Specimens should be frozen if not used within 3 days of collecting. 0.1% of sodium azide can be added to specimen as preservative without affecting the results of the assay.

1.  Bring the device, sample diluent, and specimens to room temperature.

2.  Remove test card from the sealed pouch.

1.  Dispense 5μl of whole blood, serum or plasma to the circular sample well of the test card using provided pipette with the kit accoding to the figure.

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.

3.   Do not interpret result after 20 minutes.

1. Positive: Both test band and control band appear on the membrane.

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

3. Invalid: There should always be a control band in the control region regardless of test result. If control band is not seen, the test is considered invalid. Repeat the test using a new test device.

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

In an in-house laboratory study, 63 confirmed negative samples were evaluated with Rapid Anti-HIV(1&2) Test using EIA and Western Blot as reference tests. The study gave 100% specificity for the test.

2. Sensitivity

In the above-mentioned study, Rapid Anti-HIV(1&2) Test was evaluated with 32 confirmed positive samples. 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.

1.  Only samples that are not hemolyzed and that are with good fluidity can be used in this test.

2.  Fresh samples are best but refrigerated samples can be used. For whole blood, frozen samples can not be used .

3. Do not agitate the sample. Insert a pipette just below the surface of the sample to collect the specimen.

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.