Background
This CLIA is designed, developed, and produced for the quantitative measurement of human free PSA in serum samples. The assay utilizes a two-site “sandwich” technique with one antigen and one antibody that bind to different epitope and paratope of free PSA.
Assay calibrators, controls, or patient samples are added directly to a reaction vessel containing streptavidin coated magnetic particles. Simultaneously, an acridinium ester antibody and a biotin antibody are added. The magnetic particles capture the biotin antibody as well as an immunocomplex in the form of “magnetic particles – biotin free PSA antibody –free PSA– acridinium ester free PSA antibody”.
The materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the trigger solution is added to the reaction vessel and light generated by the reaction is measured with the ECL100 or ECL25 analyzer. The relative light units (RLU) are proportional to the concentration of free PSA in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve and reported in serum free PSA concentration