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
10.3343/alm.2019.39.5.478
- Author:
A Lum HAN
1
;
Hak Ryul KIM
;
Keum Ha CHOI
;
Ki Eun HWANG
;
Mengyu ZHU
;
Yuya HUANG
;
Moxin WU
;
Young Jin LEE
;
Min Cheol PARK
;
Ji Hyun CHO
;
Do Sim PARK
Author Information
1. Department of Family Medicine, School of Medicine, Wonkwang University, Iksan, Korea.
- Publication Type:Original Article
- Keywords:
Epidermal growth factor receptor;
Mutation;
Plasma;
Pleural effusion supernatant;
cobas EGFR Mutation test v2;
PANAMutyper-R-EGFR
- MeSH:
Epidermal Growth Factor;
Genotype;
Plasma;
Pleural Effusion;
Receptor, Epidermal Growth Factor
- From:Annals of Laboratory Medicine
2019;39(5):478-487
- CountryRepublic of Korea
- Language:English
-
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.
