TechNote - Minimum Preanalytical Information for the Publication of Studies on Circulating Cell-Free microRNA-based Biomarkers

Abstract

Circulating cell-free microRNAs (miRNAs) are emerging as promising biomarkers with broad potential for clinical applications. However, pre-analytical variability significantly affects miRNA quantification and hampers reproduc- ibility across studies. This work aims to define the Minimum Preanalytical Information required for the publication of studies on circulating cell-free miRNA-based biomarkers. We review key pre-analytical factors that influence circu- lating miRNA levels quantified using RT-qPCR. Critical variables include blood collection timing, sample type, centrifugation protocols, transport and storage conditions, hemolysis, lipemia, medication, physical activity and pathogen inactivation methods. We introduce a standardized checklist to promote methodological transparency and inter-study comparability. The final aim is to enhance the reliability of miRNA-based biomarker research and support its successful translation into clinical practice