INTENDED USE
4TH GENERATION MICROLISA HIV Ag & Ab is an in- vitro qualitative enzyme immunoassay for the detection of antibodies to HIV-1 and/or HIV-2 and HIV-1 p24 antigen in human serum or plasma. It is intended for screening of blood donors or other individuals at risk for HIV-1 and/or HIV-2 infection and for clinical diagnostic testing.
4TH GENERATION MICROLISA HIV Ag & Ab test is an enzyme immunoassay based on "Sandwich ELISA". HIV envelop proteins gp41 representing immunodominant epitopes and anti-p24 antibodies are coated into 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 absorbed onto the surface of the wells. The plate is then washed to remove unbound material. Horseradish peroxidase (HRPO) conjugated gp41, C-terminus of gp120 of HIV-1 and gp36 of HIV-2 and anti-p24 antibodies is added to each well. The conjugate will bind to HIV antigen-antibody or anti-p24 antibody-antigen 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 and /or HIV-1 p24 antigen present in the specimen. The colour reaction is stopped by a 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 or HIV-1 p24 antigen, then enzyme conjugate will not bind and the solution in the wells will be either colourless or only a faint background colors develops.
EVALUATIONS
Sensitivity- 100 % & Specificity-100 %
