AIDS (Acquired Immunodeficiency Syndrome) is caused by infection with Human Immunodeficiency Virus, HIV-1 or HIV-2. HIV-1 is the most frequently found strain worldwide. Infection with HIV-2 has been found primarily in West Africa, although infections have been identified in other areas of the world. Patients with AIDS and AIDS related diseases usually have a high level of the antibody to the viruses.

In studies evaluating the presence of antibody in the general population, some individuals have been found to have reactivity in screening tests for HIV-1 antibody. Further testing of these individuals confirmed them as negative for HIV or the antibodies. Therefore it has been recommended by Centers for Disease Control (CDC) that more than one test such as the QualiCode HIV-1/2 Kit be performed as a screening or confirmatory test on these samples. In order to detect both, this kit has an HIV-1 lysate and a recombinant HIV-2 antigen to detect the specific infection.

A clinical diagnosis of AIDS can only be made if a person meets the case definition of AIDS established by the CDC. People demonstrating antibodies to HIV-1 or HIV-2 should be referred for medical evaluation, which may include additional testing by other techniques.

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• Qualitative detection of lgG antibodies to both HIV-1 and HIV-2 on the same strip.
• Serum control bands on each strip.
• Sensitivity and specificity of a confirmatory test.
• Fast turn around time for test results under 3 hours.
• Batch testing of samples.

The QualiCode™ HIV-1/2 Kit contains HIV-1 viral lysate and recombinant HIV-2 envelope proteins. The source of the viral lysate is HIV-1 (HTLV-IIIB strain) propagated in H9 cells. The virus is partially purified and is inactivated by detergent disruption. The HIV-1 viral polypeptides are fractionated according to molecular weight by electrophoresis on a polyacrylamide slab gel in the presence of sodium dodecyl sulfate. The separated HIV-1 polypeptides are then transferred via electrophoretic blotting from the gel to a membrane. The membrane already contains a line of HIV-2 recombinant protein. The membrane can then be cut into strips for individual sample testing.

1. Diluted serum/plasma, containing antibodies, is added to a strip containing HIV -1/2 antigens and incubated.

2. Goat anti-human immunoglobulin-alkaline phosphatase Conjugate is added and will bind to any HIV - 1/2 antibody/protein complex.

3. Added BCIP/NBT Substrate Solution reacts with the enzyme. Antibody/protein complexes appear as colored bands. The bands of protein, like a bar code, are unique for HIV - 1/2.

   The strip is compared to the lot-specific immunostained Reference Strip included with every kit for band identification and the intensity of the bands is monitored by comparison to the HIV - 1/2 Weakly Reactive Control.

• Reference Strips - every kit contains a lot-specific immunostained Reference Strip. This strip is taken from the left edge of the same membrane used to create the kit’s strips. The strips have already been developed using the Positive Control providing a quick reference for all patient samples and controls.

• Positive and Negative Controls (100 µl each) - provide internal QC to verify that the assay has run correctly.

• Record Sheet - this sheet provides a grid for aligning the sample strips with the Reference Strips. This not only simplifies interpretation of results but also provides full documentation of the assay. On one slip of paper all results are recorded along with date, operator, kit lot number/expiration date, and interpretation of the band patterns.


Kit information:

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