Developing Quality Programs for Cell-Free DNA (cfDNA) Extraction from Peripheral Blood

Aliaksandra Samoila, Jose Sosa, Jessica Padilla, Michael Wutkowski, Katelynd Vanness, Agnes Viale, Michael Berger, Brian Houck-Loomis, Melissa Pessin, Ellinor I. Peerschke

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


BACKGROUND: Cell-free DNA (cfDNA) analysis using peripheral blood represents an exciting, minimally invasive technology for cancer diagnosis and monitoring. The reliability of testing is dependent on the accuracy and sensitivity of specific molecular analyses to detect tumor-associated genomic variants and on the quantity and quality of cfDNA available for testing. Specific guidelines for standardization and design of appropriate quality programs focused specifically on cfDNA isolation are lacking, as are standardized quality control reagents. CONTENT: This report describes and illustrates quality control and quality assurance processes, supported by generation of in-house quality control material, to ensure the reliability of the preanalytical phase of cfDNA analysis. SUMMARY: We have developed a robust quality program to support high-volume automated cfDNA extraction from peripheral blood by implementing processes and procedures designed to monitor the adequacy of specimen collection, specimen stability, efficiency of cfDNA extraction, and cfDNA quality.

Original languageEnglish
Pages (from-to)788-797
Number of pages10
JournalThe journal of applied laboratory medicine
Issue number4
StatePublished - 1 Jul 2020
Externally publishedYes


  • cfDNA
  • preanalytical quality
  • quality assurance
  • quality control


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