Developing quality programs for cell-free DNA (cfDNA) extraction from peripheral blood Journal Article


Authors: Samoila, A.; Sosa, J.; Padilla, J.; Wutkowski, M.; Vanness, K.; Viale, A.; Berger, M.; Houck-Loomis, B.; Pessin, M.; Peerschke, E. I.
Article Title: Developing quality programs for cell-free DNA (cfDNA) extraction from peripheral blood
Abstract: 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. © American Association for Clinical Chemistry 2020. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Keywords: genetics; mutation; neoplasm; organization and management; neoplasms; reproducibility; quality control; reproducibility of results; practice guideline; blood; blood sampling; quality assurance; total quality management; dna mutational analysis; isolation and purification; blood specimen collection; guidelines as topic; quality improvement; humans; human; circulating tumor dna; cfdna; preanalytical quality; clinical laboratory service; clinical laboratory services
Journal Title: Journal of Applied Laboratory Medicine
Volume: 5
Issue: 4
ISSN: 2576-9456
Publisher: Amer Assoc Clinical Chemistry  
Date Published: 2020-07-01
Start Page: 788
End Page: 797
Language: English
DOI: 10.1093/jalm/jfaa050
PUBMED: 32603443
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 1 September 2021 -- Source: Scopus
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