Ann Lab Med 2019; 39(5): 478-487  https://doi.org/10.3343/alm.2019.39.5.478
Comparison of cobas EGFR Mutation Test v2 and PANAMutyper-R-EGFR for Detection and Semi-Quantification of Epidermal Growth Factor Receptor Mutations in Plasma and Pleural Effusion Supernatant
A-Lum Han , M.D.1,*, Hak-Ryul Kim , M.D.2,*, Keum-Ha Choi , M.D.3, Ki-Eun Hwang , M.D.2, Mengyu Zhu , B.S.4, Yuya Huang , B.S.4, Moxin Wu , M.S.4, Young-Jin Lee , M.D.4, Min-Cheol Park , Ph.D.5, Ji-Hyun Cho , M.D.4, and Do-Sim Park , M.D.4,6
Departments of 1Family Medicine, 2Internal Medicine, 3Pathology, 4Laboratory Medicine and Institute of Wonkwang Medical Science, School of Medicine, Wonkwang University, Iksan, Korea; 5Department of Oriental Medical Ophthalmology & Otolaryngology & Dermatology, College of Oriental Medicine, Wonkwang University, Iksan, Korea; 6Wonkwang Institute of Clinical Medicine, Wonkwang University Hospital, Iksan, Korea
Corresponding author: Do-Sim Park, M.D.
Department of Laboratory Medicine, Wonkwang University Hospital, 895 Muwang-ro, Iksan 54538, Korea
Tel: +82-63-859-1863, Fax: +82-63-842-3786, E-mail: emailds@hanmail.net
*These authors contributed equally to this work.
Received: August 9, 2018; Revised: November 5, 2018; Accepted: April 17, 2019; Published online: September 1, 2019.
© Korean Society for Laboratory Medicine. All rights reserved.

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
Background: Plasma epidermal growth factor receptor (EGFR) mutation tests are less invasive than tissue EGFR mutation tests. We determined which of two kits is more efficient: cobas EGFR Mutation test v2 (cobasv2; Roche Molecular Systems, Pleasanton, CA, USA) or PANAMutyper-R-EGFR (Mutyper; Panagene, Daejeon, Korea). We also evaluated whether pleural effusion supernatant (PE-SUP) samples are assayable, similar to plasma samples, using these two kits.
Methods: We analyzed 156 plasma and PE-SUP samples (31 paired samples) from 116 individuals. We compared the kits in terms of accuracy, assessed genotype concordance (weighted κ with 95% confidence intervals), and calculated Spearman’s rho between semi-quantitatively measured EGFR-mutant levels (SQIs) measured by each kit. We also compared sensitivity using 47 EGFR-mutant harboring samples divided into more-dilute and less-dilute samples (dilution ratio: ≥ or <1:1,000).
Results: cobasv2 tended to have higher accuracy than Mutyper (73% vs 69%, P=0.53), and PE-SUP samples had significantly higher accuracy than plasma samples (97% vs 55–71%) for both kits. Genotype concordance was 98% (κ=0.92, 0.88–0.96). SQIs showed strong positive correlations (P<0.0001). In less-dilute samples, accuracy and sensitivity did not differ significantly between kits. In more-dilute samples, cobasv2 tended to have higher sensitivity than Mutyper (43% vs 20%, P=0.07).
Conclusions: The kits have similar performance in terms of EGFR mutation detection and semi-quantification in plasma and PE-SUP samples. cobasv2 tends to outperform Mutyper in detecting less-abundant EGFR-mutants. PE-SUP samples are assayable using either kit.
Keywords: Epidermal growth factor receptor, Mutation, Plasma, Pleural effusion supernatant, cobas EGFR Mutation test v2, PANAMutyper-R-EGFR



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