PSA, IRMA, 100 tests

The technology uses two high affinity monoclonal antibodies in an immunoradiometric assay (IRMA) system. The 125I labelled signal-antibody binds to an epitope of the PSA molecule spatially different from that recognized by the biotin-capture-antibody. The two antibodies react simultaneously with the antigen present in standards or samples, which leads to the formation of a capture antibody - antigen - signal antibody complex, also referred to as a “sandwich”. During a 2-hour incubation period with shaking immuno-complex is immobilized to the reactive surface of streptavidin coated test tubes. Reaction mixture is then discarded, test tubes washed exhaustively, and the radioactivity is measured in a gamma counter. The concentration of antigen is directly proportional to the radioactivity measured in test tubes. By constructing a calibration curve plotting binding values against a series of calibrators containing known amount of PSA, the unknown concentration of PSA in patient samples can determined.

• Technical spec.

Due to local registration requirement, this product can not be sold in Canada, United States, Australia – without prior registration.

For Japan and Brazil, specific registration requirements are necessary. For more information, please contact: regulatory.affairs@diasource.be.