Molecular in vitro diagnostics has enabled significant progress in medicine. Further progress is expected through new technologies analysing signatures of nucleic acids, proteins, and metabolites in human tissues and body fluids. However, the profiles of these molecules can change drastically during primary sample collection, transport, storage, and processing, thus making the outcome of diagnostics or research unreliable or even impossible, because the subsequent analytical test will not determine the situation in the patient but an artificial profile generated during the pre-analytical workflow.
Therefore, the standardisation of the entire diagnostic workflow from sample collection to analyte measurement is needed (sample-to-insight workflows) to ensure the reproducibility of results and thus improve the clinical decisions and the healthcare systems.
Pre-analytical errors still account for nearly 60% – 70% of all problems occurring in laboratory diagnostics, most of them attributable to mishandling procedures during collection, handling, preparing or storing the specimens.
Lippi G. et al. Pre-analytical quality improvement: from dream to reality. Clin Chem Lab Med. 2011 Jul; 49(7):1113-26.