Background:
The NMI applies miniaturized multiplex immunoassays for more than two decades. At the NMI commercially available multiplex immunoassays are applied for sample screening as well as newly developed custom specific assays. Over the last years a standard validation procedures was established which is routinely applied to our “home brew” as well as to commercially available multiplex immunoassays.

Methods:
Multiplex bead-based immunoassays on the Luminex platform were developed and thoroughly validated based on bioanalytical guidelines (EMA, FDA). To guarantee long term reproducibility and validity of assay performance a quality control system based on the Westgard Rules and Levey-Jennings-Plots was implemented.

Results:
Established assay development and validation procedures allow us a robust assessment of the capabilities of an assay and the evaluation of lot-to-lot variances during long term screening periods.

Conclusion:
In the time of extensive discussions on the lack of repeatability of scientific results, validation of reagents and assays, no matter whether they are commercially available or newly generated “home brew” assay, is a mandatory step forward to address such issues and allows to identify  strengths’ and weaknesses of the applied assay reagents during any sample screening process.