This CLIA is designed, developed, and produced for the quantitative measurement of human osteocalcin level in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of osteocalcin.
Assay calibrators, controls, or patient samples are added directly to a reaction vessel containing streptavidin coated magnetic particles. Simultaneously, anacridinium ester antibody and a biotin antibody are added. The magnetic particles capture the biotin antibody as well as an immuno complex in the form of “magnetic particles – biotin osteocalcin antibody –osteocalcin – acridinium ester osteocalcin 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 ECL-25 analyzer. The relative light units (RLU) are proportional to the concentration of osteocalcin in the sample. The amount of analyte in the sample is determined from a stored, multipoint calibration curve and reported in serum osteocalcin concentration.