Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Sloan Kettering Institute, Memorial Sloan Kettering Cancer Center, New York, NY.
J Appl Lab Med. 2020 Jul 1;5(4):788-797. doi: 10.1093/jalm/jfaa050.
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.
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.
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.
利用外周血进行无细胞 DNA（cfDNA）分析是一种令人兴奋的、微创的癌症诊断和监测技术。检测的可靠性取决于特定分子分析的准确性和灵敏度，以检测肿瘤相关的基因组变异，以及用于检测的 cfDNA 的数量和质量。目前缺乏专门针对 cfDNA 分离的标准化和设计适当质量计划的具体指南，也缺乏标准化的质量控制试剂。
本报告描述并说明了质量控制和质量保证过程，通过生成内部质量控制材料来支持，以确保 cfDNA 分析前分析阶段的可靠性。
我们已经开发了一个强大的质量计划，通过实施旨在监测标本采集充足性、标本稳定性、cfDNA 提取效率和 cfDNA 质量的过程和程序，支持从外周血中自动化提取大量 cfDNA。
