Overall, analytical performance of qCCP assays should meet pre-defined analytical performance criteria for imprecision, bias and allowable total error, to be clinically useful. This allows consistent implementation of the traceability concept and enabling global standardization of test results, reference intervals and decision limits. Therefore, automation of the
pre-analytical, analytical and post-analytical steps in MS-based proteomics workflows is necessary in order to guarantee robust applications and future CE-marking or FDA-approval.