Establishing and optimizing hGH capture antibody-coated assay microplates as solid phases for the CMZ Differential Immunoassays for hGH Isoforms (CMZ hGH LIA)

Code: T20M02DM

The differential immunoassays to detect doping with recombinant human growth hormone (hGH) have been in use at WADA accredited laboratories for more than 10 years now. From the beginning, the assays were produced in the coated tube (CT) format. In the past, this format, where the specific antibodies are coated to plastic tubes, and the final assay signal is determined by a tube luminometer, was very popular for immunoassays used in laboratory medicine and research applications. However, it meanwhile has been largely abandoned, and the respective assays were switched to the so-called microtiter plate (MTP) format. Here, the antibodies are coated to 96 wells of a plastic plate, and the final assay signal is read by a plate luminometer. The microplate format has advantages in terms of production, but also in terms of workflow in the laboratory. As a consequence of the grossly reduced use of CT assays in laboratories worldwide, production capacities for such CT assays become rare, and might become unavailable in the near future. To ensure continued production and availability of the differential immunoassays it is suggested to convert these assays to the MTP format now. While assay ingredients (and particularly the monoclonal antibodies involved) remain unaffected by the conversion to the MTP format, and it has been demonstrated for many assays used in clinical routine that key parameters such as assay specificity, linearity, reproducibility etc. remain unaffected by the change, the MTP format nevertheless has to be optimized and validated for each individual assay. The current project aims to establish the MTP format for the differential immunoassays.