Analytical performance of an heterogeneous enzyme immunoassay using the same separation system.

A single "one step" solid phase sandwich enzyme immunoassay was developed. The assay employs two monoclonal antibodies with affinity and specificity for different epitopes of the analyte: one is covalently coupled to peroxidase, while the other one is coupled to biotin. The addition of the reagent to an avidin-coated strip gave a specific and efficient mean for binding the sandwich complex to the solid phase, via the high affinity interaction between biotin and avidin. The methodology was applied to the determination of hypophysis hormones (LH, FSH, PRL), tumor markers (CEA, AFP, FRT, hCG beta free subunit, alpha subunit and others alpha-P Amylase). Analytical performances concerning the developed kits are described, demonstrating the good reproducibility, sensitivity, accuracy and the wide application field for this new technology.