4.4 Review

Clinical Practice Guidelines for Pre-Analytical Procedures of Plasma Epidermal Growth Factor Receptor Variant Testing

Journal

ANNALS OF LABORATORY MEDICINE
Volume 42, Issue 2, Pages 141-+

Publisher

KOREAN SOC LABORATORY MEDICINE
DOI: 10.3343/alm.2022.42.2.141

Keywords

Key Words; Cell-free nucleic acid; Circulating tumor DNA; Pre-analytical phase; Epidermal growth factor receptor; Clinical practice guidelines

Funding

  1. Research Fund of Quality Control Committee, Korean Society for Laboratory Medicine [2020-01-006]
  2. Korean Society for Genetic Diagnostics

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Standardization of pre-analytical procedures is essential for obtaining clinically reliable results in cfDNA testing. This article provides evidence-based clinical practice guidelines for the pre-analytical phase procedures of plasma EGFR variant testing. By standardizing pre-analytical procedures, the analytical performance of cfDNA testing can be improved.
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 re-view, we provide evidence-based clinical practice guidelines for pre-analytical phase pro-cedures 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.

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