Development of circulating microRNA-based biomarkers for medical decision-making: a friendly reminder of what should NOT be done

Päivi Lakkisto, Louise Torp Dalgaard, Thalia Belmonte, Sara Joan Pinto-Sietsma, Yvan Devaux, David de Gonzalo-Calvo*, on behalf of EU-CardioRNA COST Action CA17129

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

3 Citations (Scopus)


Circulating cell-free microRNAs (miRNAs) represent a major reservoir for biomarker discovery. Unfortunately, their implementation in clinical practice is limited due to a profound lack of reproducibility. The great technical variability linked to major pre-analytical and analytical caveats makes the interpretation of circulating cell-free miRNA data challenging and leads to inconsistent findings. Additional efforts directed to standardization are fundamental. Several well-established protocols are currently used by independent groups worldwide. Nonetheless, there are some specific aspects in specimen collection and processing, sample handling, miRNA quantification, and data analysis that should be considered to ensure reproducibility of results. Here, we have addressed this challenge using an alternative approach. We have highlighted and discussed common pitfalls that negatively impact the robustness of circulating miRNA quantification and their application for clinical decision-making. Furthermore, we provide a checklist usable by investigators to facilitate and ensure the control of the whole miRNA quantification and analytical process. We expect that these recommendations improve the reproducibility of findings, and ultimately, facilitate the incorporation of circulating miRNA profiles into clinical practice as the next generation of disease biomarkers.

Original languageEnglish
Pages (from-to)141-152
Number of pages12
JournalCritical Reviews in Clinical Laboratory Sciences
Issue number2
Early online date2 Nov 2022
Publication statusPublished - Mar 2023


  • Biomarker
  • limitation
  • methodology
  • microRNA
  • pitfall


Dive into the research topics of 'Development of circulating microRNA-based biomarkers for medical decision-making: a friendly reminder of what should NOT be done'. Together they form a unique fingerprint.

Cite this