The Bio-Rad GS HIV-2 EIA is manufactured from virus that was isolated from the peripheral blood lymphocytes of a West African man. The virus, which is designated HIV-2, is propagated in a CEM cell line. The infected cell line is cultured and the virus is purified by centrifugation. The viral concentrate is disrupted and inactivated using a chaotropic agent and heat before being absorbed onto wells of a microwell plate. Specimens to be tested are diluted in specimen diluent and added to each well, incubated with the absorbed antigen, and washed. If antibodies to the virus are present, they bind to antigen and are not removed by washing. The conjugate reagent, peroxidase-labeled goat-antihuman immunoglobulin, is then added to the wells and will bind to the antibody-antigen complex, if present. Unbound conjugate is removed by a wash step. Next, chromogen buffered substrate reagent is added to the plate and allowed to incubate. A blue or blue-green color develops in proportion to the amount of antibody that has been bound to the antigen-coated plate. The enzyme reaction is stopped by the addition of acid. This will result in a color change to yellow. The optical absorbance of controls and specimens is determined with a spectrophotometer with wavelength set at 450 nm.(Package insert: Human Immunodeficiency Virus Type 2 GS HIV-2 EIA, Bio-Rad Laboratories, Redmond, WA)
One day. Approximately 1 week for the reflex confirmation result to be returned.