Article

Review Article

Ann Lab Med 2022; 42(2): 141-149

Published online March 1, 2022 https://doi.org/10.3343/alm.2022.42.2.141

Copyright © Korean Society for Laboratory Medicine.

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

Saeam Shin, M.D., Ph.D.1,* , Hye In Woo, M.D., Ph.D.2,* , Jong-Won Kim, M.D., Ph.D.2 , Yoonjung Kim M.D., Ph.D.1 , Kyung-A Lee, M.D., Ph.D.1

1Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea; 2Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Correspondence to: Kyung-A Lee, M.D., Ph.D.
Department of Laboratory Medicine, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 06273, Korea
Tel: +82 2-2019-3531
Fax: +82 2-2019-4822
E-mail: KAL1119@yuhs.ac

Yoonjung Kim, M.D., Ph.D.
Department of Laboratory Medicine, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 06273, Korea
Tel: +82-2-2019-3775
Fax: +82-2-2019-4822
E-mail: WSYJ1101@yuhs.ac

*These authors contributed equally to this work.

Received: December 31, 2020; Revised: February 2, 2021; Accepted: July 27, 2021

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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.

Keywords: Cell-free nucleic acid, Circulating tumor DNA, Pre-analytical phase, Epidermal growth factor receptor, Clinical practice guidelines