Format

Send to

Choose Destination
Ann Lab Med. 2019 Sep;39(5):478-487. doi: 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.

Author information

1
Department of Family Medicine, School of Medicine, Wonkwang University, Iksan, Korea.
2
Department of Internal Medicine, School of Medicine, Wonkwang University, Iksan, Korea.
3
Department of Pathology, School of Medicine, Wonkwang University, Iksan, Korea.
4
Department of Laboratory Medicine and Institute of Wonkwang Medical Science, School of Medicine, Wonkwang University, Iksan, Korea.
5
Department of Oriental Medical Ophthalmology & Otolaryngology & Dermatology, College of Oriental Medicine, Wonkwang University, Iksan, Korea.
6
Wonkwang Institute of Clinical Medicine, Wonkwang University Hospital, Iksan, Korea. emailds@hanmail.net.
#
Contributed equally

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; PANAMutyper-R-EGFR; Plasma; Pleural effusion supernatant; cobas EGFR Mutation test v2

PMID:
31037867
PMCID:
PMC6502955
[Available on 2019-09-01]
DOI:
10.3343/alm.2019.39.5.478
Free full text

Supplemental Content

Full text links

Icon for The Korean Society for Laboratory Medicine
Loading ...
Support Center