Anti-Human Immunodeficiency Virus (HIV) type 1 and 2 IgM qualitative ELISA serum or plasma Dialab

Serological evidence of HIV infection may be obtained by testing for HIV antigens or antibodies in serum of individuals suspected of HIV infection. HIV antigens can generally be detected during both the acute phase and the symptomatic phase of AIDS. HIV antibodies to HIV-1 and/or HIV-2 can be detected throughout virtually the total infection period, starting at or shortly after the acute phase and lasting till the end stage of AIDS. Therefore, the use of highly sensitive antibody assays is the primary approach in serodiagnosis of HIV infection. Apart from sexual transmission the principal route of infection with HIV is blood transfusion. HIV can be present both in cellular and cell-free fractions of human blood. Therefore all donations of blood or plasma should be tested for the risk of HIV transmission.
This assay is intended for the qualitative determination of HIV1 and HIV 2 antibodies for diagnostic use. The test wells are coated with recombinant HIV-1 gp41, gp120 and HIV-2 gp-36. Antibodies in the patient serum will bind to the antigens coating the plate. Free and bound are separated by washing and then horseradish peroxidase (HRP) conjugated recombinant HIV antigens are added which bind the immobilised antigen- antibody complex. Unbound conjugate is removed by washing and then enzyme substrate added which in the presence of the conjugate hydrolyses to form a blue colour. Addition of stop solution forms a yellow end product which is photometrically measured at 450nm. The amount of colour is proportional to the concentration of antibodies in the patient sample. After validation checks an Index Value is calculated.
Negative: < 1 Index Value
Positive: ≥ 1 Index Value
Borderline 0.9 - 1.1 Index Value (Re-test to confirm)

Antigen coated Microtiter wells : 12x8 well strips
Positive Control: 1x1ml each for HIV 1 and HIV 2
Negative Control: 1x1ml
Enzyme Conjugate (Recombinant HIV 1 and HSV 2 antigens - HRP): 1x12ml
Substrate Solution A : 1x8ml
Substrate Solution B : 1x8ml
Stop Solution: 1x8ml
Wash buffer (20X); 1x50ml
Sample volume: 100µl human serum or plasma
Incubation time: 75 minutes (30 min, 30min, 15min all at 30°C)
Store at 2-8°C.