Effectivization of GAD ELISA : Method-transfer from Dynex DSX to Tecan Freedom EVOlyzer

Abstract: Due to a growing demand and need for faster results, effectivization as a concept has been pushed to the forefront of medical research. Here, a method transfer between 2 fully automized ELISA instruments is highlighted. The instruments were the Tecan Freedom EVOlyzer and the Dynex DSX.  The Tecan instrument is a more modern instrument with a more extensive LIMS integration, better automatization and increased capacity for samples and assays. The method being transferred was an Anti-GAD ELISA for the diagnosis of Type 1 Diabetes Mellitus. The study design was a result comparison of 20 samples with varying Anti-GAD concentration and 15 replicates of a single sample for a precision study. To successfully transfer the method, acceptance criteria concerning percentual difference in result, intermediate precision, and repeatability had to fall below 20 %. The assay was set up as a sandwich ELISA in accordance with the kit used at the laboratory (Euroimmun), where each sample was set as duplicates. Preliminary programming and testing was performed to ensure proper function. An average bias of +33 % was reported, as was an intra-run variation and an inter-run variation of ca 11 %. Additionally, a recurring issue with samples and calibrators in specific locations on the plate was reported. The issue was deemed systemic and possible solutions include changing programming parameters, or instrument part replacement. Ultimately the method transfer was left incomplete, and several technical details must be overcome before taking Anti-GAD analysis into routine use on the instrument.