Standardization of cell-free DNA (cfDNA) testing processes is necessary to obtain clinically reliable results. The pre-analytical phase of cfDNA testing greatly influences the results because of the low proportion and stability of circulating tumor DNA (ctDNA). In this review, we provide evidence-based clinical practice guidelines for pre-analytical phase procedures of plasma epidermal growth factor receptor gene (EGFR) variant testing. Specific recommendations for pre-analytical procedures were proposed based on evidence from the literature and our experimental data. Standardization of pre-analytical procedures can improve the analytical performance of cfDNA testing.
Bibliographical noteFunding Information:
This study was supported by the Research Fund of Quality Control Committee, Korean Society for Laboratory Medicine (KSLM Research Project 2020-01-006) and Korean Society for Genetic Diagnostics.
© Korean Society for Laboratory Medicine.
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