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

Improving miRNA biomarker reliability

Miron Sopi´c
Cardiovascular Research Unit, Department of Precision Health, Luxembourg Institute of Health, Strassen, Luxembourg. 2. Department of Medical Biochemistry, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, Belgrade, Serbia.
Susana Novella
3. Department of Physiology, University of Valencia - INCLIVA Biomedical Research Institute, Valencia, Spain.
Constantino Martínez
4. Hematology Department, Hospital Universitario Morales-Meseguer, Centro Regional de Hemodonación, IMIB-Pascual Parrilla, Universidad de Murcia, Murcia, Spain.
Christos Tsatsanis
5. Department of Clinical Chemistry, School of Medicine, University of Crete, Heraklion, Greece. 6. Institute of Molecular Biology and Biotechnology, Foundation for Research and Technology Hellas, Heraklion, Greece.
Marta Molinero
7. Translational Research in Respiratory Medicine, University Hospital Arnau de Vilanova and Santa Maria, IRBLleida, Lleida, Spain. 8. CIBER of Respiratory Diseases (CIBERES), Institute of Health Carlos III, Madrid, Spain.
Thalía Belmonte
7. Translational Research in Respiratory Medicine, University Hospital Arnau de Vilanova and Santa Maria, IRBLleida, Lleida, Spain. 8. CIBER of Respiratory Diseases (CIBERES), Institute of Health Carlos III, Madrid, Spain.
Jelena Munjas
9. Department of Medical Biochemistry, Faculty of Pharmacy, University of Belgrade, 11000 Belgrade, Serbia.
Yvan Devaux
1. Cardiovascular Research Unit, Department of Precision Health, Luxembourg Institute of Health, Strassen, Luxembourg.
Matthias Hackl
10. TAmiRNA GmbH, 1110 Vienna, Austria.
David de Gonzalo-Calvo
Translational Research in Respiratory Medicine, University Hospital Arnau de Vilanova and Santa Maria, IRBLleida, Lleida, Spain. 8. CIBER of Respiratory Diseases (CIBERES), Institute of Health Carlos III, Madrid, Spain.
Keywords:
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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 reproducibility 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 circulating 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.

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