Intended Use
Microlisa HIV is an in-vitro qualitative enzyme immunoassay for the detection of antibodies to HIV-1 and /or HIV-2 in human serum or plasma. It is intended for screening of blood donors or other individuals at risk for HIV-1 and HIV-2 infection and for clinical diagnostic testing.
Salient Features
- Use of Envelope Antigens gp41,C terminus of gp120 for HIV-1& gp36 for HIV-2.
- Detection of Group O & subtype C for HIV-1 prevalent in India.
- Color coded reagents to monitor procedural steps.
- Assay procedure: 90mins.
- Longer shelf life: 24 months at 2-8°C.
- Sensitivity & Specificity of 100% by WHO.
Principle
Microlisa HIV test is an enzyme immunoassay based on Indirect Elisa. HIV envelop proteins gp-41, C terminus of gp-120 for HIV-1 and gp-36 for HIV-2 representing Immunodominant epitopes are coated onto microtiter wells. Specimens and controls are added to the microtiter wells and incubated. Antibodies to HIV-1 and HIV-2 if present in the specimen, will bind to the specific antigens adsorbed onto the surface of the wells. The plate is then washed to remove unbound material. Horseradish peroxidase (HRPO) conjugated anti-human IgG is added to each well. This conjugate will bind to HIV antigen-antibody complex present. Finally substrate solution containing chromogen and hydrogen peroxide is added to the wells and incubated. A blue colour will develop in proportion to the amount of HIV-1 and / or HIV-2 antibodies present in the specimen. The colour reaction is stopped by stop solution. The enzyme substrate reaction is read by EIA reader for absorbance at a wavelength of 450 nm. If the sample does not contain HIV-1 or HIV-2 antibodies then enzyme conjugate will not bind and the solution in the wells will be either colorless or only a faint background colour develops.
