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Title:Detection of EGFR variants in plasma : a multilaboratory comparison of a real-time PCR EGFR mutation test in Europe
Authors:ID Keppens, Cleo (Author)
ID Palma, John (Author)
ID Das, Partha (Author)
ID Scudder, Sidney (Author)
ID Wen, Wei (Author)
ID Normanno, Nicola (Author)
ID van Krieken, Han J. J. M. (Author)
ID Sacco, Alessandra (Author)
ID Fenizia, Francesca (Author)
ID Gonzalez de Castro, David (Author)
ID Hönigschnabl, Selma (Author)
ID Kern, Izidor, Klinika Golnik (Author)
ID Lopez-Rios, Fernando (Author)
ID Lozano, Maria D. (Author)
ID Marchetti, Antonio (Author)
ID Halfon, Philippe (Author)
ID Schuuring, Ed (Author)
ID Setinek, Ulrike (Author)
ID Sorensen, Boe (Author)
ID Taniere, Phillipe (Author)
ID Tiemann, Markus (Author)
ID Vosmikova, Hana (Author)
ID Dequeker, Elisabeth (Author)
Files:URL URL - Source URL, visit https://jmd.amjpathol.org/article/S1525-1578(17)30514-7/fulltext
 
Language:English
Typology:1.01 - Original Scientific Article
Organization:Logo UKPBAG - University Clinic of Respiratory and Allergic Diseases Golnik
Abstract:Molecular testing of EGFR is required to predict the response likelihood to targeted therapy in non-small cell lung cancer. Analysis of circulating tumor DNA in plasma may complement limitations of tumor tissue. This study evaluated the interlaboratory performance and reproducibility of a real-time PCR EGFR mutation test (cobas EGFR Mutation Test v2) to detect EGFR variants in plasma. Fourteen laboratories received two identical panels of 27 single-blinded plasma samples. Samples were wild type or spiked with plasmid DNA to contain seven common EGFR variants at six predefined concentrations from 50 to 5000 copies per milliliter. The circulating tumor DNA was extracted by a cell-free circulating DNA sample preparation kit (cobas cfDNA Sample Preparation Kit), followed by duplicate analysis with the real-time PCR EGFR mutation test (Roche Molecular Systems, Pleasanton, CA). Lowest sensitivities were obtained for the c.2156G>C p.(Gly719Ala) and c.2573T>G p.(Leu858Arg) variants for the lowest target copies. For all other variants, sensitivities varied between 96.3% and 100.0%. All specificities were 98.8% to 100.0%. Coefficients of variation indicated good intralaboratory and interlaboratory repeatability and reproducibility but increased for decreasing concentrations. Prediction models revealed a significant correlation for all variants between the predefined copy number and the observed semiquantitative index values, which reflect the samples' plasma mutation load. This study demonstrates an overall robust performance of the real-time PCR EGFR mutation test kit in plasma. Prediction models may be applied to estimate the plasma mutation load for diagnostic or research purposes.
Keywords:non-small cell lung cancer, plasma, EGFR, molecular testing
Year of publishing:2018
Publication status in journal:Published
Article version:Publisher's version of article
Publisher:Elsevier
Number of pages:str. 483-494
Numbering:Vol. 20, no. 4
Source:ZDA
PID:20.500.12556/DiRROS-12695 New window
UDC:616-006
ISSN on article:1943-7811
DOI:10.1016/j.jmoldx.2018.03.006 New window
COBISS.SI-ID:2048314481 New window
Copyright:2018 American Society for Investigative Pathology and the Association for Molecular Pathology
Note:Soavtorji: John F. Palma, Partha M. Das, Sidney Scudder, Wei Wen, Nicola Normanno, J. Han van Krieken, Alessandra Sacco, Francesca Fenizia, David Gonzalez de Castro, Selma Hönigschnabl, Izidor Kern, Fernando Lopez-Rios, Maria D. Lozano, Antonio Marchetti, Philippe Halfon, Ed Schuuring, Ulrike Setinek, Boe Sorensen, Phillipe Taniere, Markus Tiemann, Hana Vosmikova, and Elisabeth M.C. Dequeker; Nasl. z nasl. zaslona; Opis vira z dne 9. 7. 2018;
Publication date in DiRROS:23.11.2020
Views:962
Downloads:157
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Record is a part of a journal

Title:The journal of molecular diagnostics
Shortened title:J. mol. diagn.
Publisher:American Society for Investigative Pathology and the Association for Molecular Pathology
ISSN:1943-7811
COBISS.SI-ID:3615508 New window

Secondary language

Language:Undetermined
Keywords:nedrobnocelični pljučni rak, plazma, molekularno testiranje


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