HIV-1 was thought to be the only cause of these syndromes until 1986, when a second type of Human Immunodeficiency Virus (HIV-2) was isolated and also reported to cause AIDS (acquired immunodeficiency syndrome). Both viruses have the same morphology and lymphotropism, and the modes of transmission appear to be identical. In addition, HIV-1 and HIV-2 genomes exhibit about 60% homology in conserved genes such as gag and pol. Serologic studies have also shown that the core proteins of HIV-1 and HIV-2 display frequent cross-reactivity whereas the envelope proteins are more type-specific. Despite this immunologic cross-reactivity, detection of antibodies to HIV-2 with any of the licensed HIV-1 enzyme immunoassays is highly variable. This HIV1/HIV-2 ELISA kit was developed to detect antibodies to HIV-1 and /or HIV-2, for blood screening and diagnostic purposes. Testing for the presence of HIV antigens or antibodies from serum brings serological evidence of infection from individuals that may be harboring the HIV virus. Detection of antigens can be evidenced in both the acute phase and symptomatic phases of AIDS. However, the HIV-1 and HIV-2 antibodies can be identified all through the entire infection period - beginning at the acute phase all the way through the last stages of AIDS. For the serodiagnosis of HIV infection, the best approach is use of highly sensitive antibody ELISA tests. The predominant path of HIV infection is blood transfusion (independent of the other dominant carrier - sexual transmission). All donated blood or plasma is tested because HIV can be present in both cellular and cell-free fractions of human blood. This creates a high risk transmission rate if not tested properly. Thus, HIV ELISA kits can be an important screening tool.
Intended Use:
The HIV 1, 2 ELISA Test is an enzyme-linked immunosorbent assay which is used for the qualitative detection of antibodies to HIV (human immunodeficiency virus) type 1 (group M-O) or type 2 in human serum/plasma. This HIV ELISA can best be used as a diagnostic aid in detecting HIV-1 and HIV-2 infections (etiological agents of AIDS) and/or for blood donor screening.
Sensitivity: 99.95%
Specificity: 99.89%
Range: Qualitative Positive; Negative & Cut off Calibrators
Test Principle:
Polystyrene microwell strips pre-coated with recombinant HIV antigens indicated make up this two-step incubation antigen sandwich enzyme immunoassay kit (HIV1, 2 ELISA). In the first incubation step, the patient's plasma or serum sample is added. If specific HIV1/2 antibodies are present, they will be captured inside the wells. Afterwards, microwells are washed to remove unbound serum proteins. After this stage the second set of recombinant antigens conjugated to the enzyme Horseradish Peroxidase (HRP-Conjugate) is added. While the second incubation occurs, these antigens will bind to the captured antibody. The chromogen solution is added to the wells, after wash (to remove unbound conjugate). In the wells where the antigen-antibody-antigen (HRP) sandwich immunocomplex is taking place, the colorless chromogens are hydrolyzed by the bound HRP conjugate to a blue-colored product. After, the reaction is stopped and the blue color turns yellow.
Kit Components:
1. 96 HIV 1/2 Elisa tests
2. Microwell strips breakable: 8 X 12/12 X 8-well strips per plate, contains recombinant HIV 1/2 antigens.
3. HIV 1/2 Elisa test Negative Control: 1vial
4. HIV 1/2 Elisa test Positive Control Serum-1 (HIV 1): 1x1ml
5. HIV 1/2 Elisa test Positive Control Serum-2 (HIV 2): 1x1ml
6. HIV 1/2 EIA HRP-Conjugate Reagent: 13ml
7. Wash Buffer 20 x: 50 ml
8. Chromogen Solution A HIV 1/2 EIA Test: 8ml
9. Chromogen Solution B HIV 1/2 EIA Test: 8ml
10. Stop Solution: 8 ml
11. Plastic sealable Bag, 1unit
12. Cardboard Plate Cover, 2sheets
13. Package Inserts
Storage and Stability:
Store other components at 4 degrees C. Stable for at least 6 months For maximum recovery of product, centrifuge the original vial after thawing and prior to removing the cap.
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