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pISSN 2950-9114 eISSN 2950-9122
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Original Article

Lab Med Qual Assur 2020; 42(2): 91-96

Published online June 30, 2020

https://doi.org/10.15263/jlmqa.2020.42.2.91

Copyright © Korean Association of External Quality Assessment Service.

Development of an Operational Plan for the Liquid Biopsy External Quality Assessment Program in Korea

Sunyoung Ahn1, Hyun-Ki Kim2, Ji Hyun Kim2, Woochang Lee2, Sail Chun2, Wee Gyo Lee3, and Won-Ki Min2

1Department of Laboratory Medicine, Kangwon National University School of Medicine, Chuncheon; 2Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul; 3Department of Laboratory Medicine, Ajou University School of Medicine, Suwon, Korea

Correspondence to:Woochang Lee
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43- gil, Songpa-gu, Seoul 05505, Korea
Tel +82-2-3010-4506
Fax +82-2-478-0884
E-mail wlee1@amc.seoul.kr

Received: November 27, 2019; Revised: January 21, 2020; Accepted: March 6, 2020

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background: Liquid biopsy is a useful assay for the diagnosis, treatment, and prognosis prediction of solid tumors and its clinical application is expanding. Therefore, the need for developing an External Quality Assessment (EQA) protocol for liquid biopsy is increasing. In this study, we developed and implemented the liquid biopsy EQA program for the epidermal growth factor receptor mutation.
Methods: We validated the feasibility of the protocol using citrate instead of ethylenediaminetetraacetic acid (EDTA). Additionally, we analyzed the homogeneity and stability of the aliquoted quality control (QC) materials. Mutation-positive QC material with four mutations (exon 19 deletion, L858R, T790M, and exon 20 insertion) was used to make two types of QC materials (low and high) and the wild type material was used for the negative controls. If the EQA results showed consensus in more than 80% of the participating laboratories, the results were reported as acceptable or unacceptable. If not, we reported the results as not graded.
Results: Citrate showed equivalent performance to EDTA. Highly mutated QC material and mutation-negative QC material passed the homogeneity and stability test, but low-level mutant specimens showed inconsistent results. In total, 11 laboratories participated, and all of them reported consistent results except for low-grade mutant samples. Thus, the evaluation results were acceptable except for low mutation QC material.
Conclusions: The applicability of liquid biopsy is expanding. To obtain accurate test results, EQA is indispensable. Here, QC materials for liquid biopsy EQA were produced, distributed, and had its results analyzed. This study could be the foundation for further development of liquid biopsy EQA.

Keywords: Liquid biopsy, External Quality Assessment, Laboratory proficiency testing, Epidermal growth factor receptor

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