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Droplet digital PCR-based EGFR mutation detection with an internal quality control index to determine the quality of DNA.

Authors
 Sung-Su Kim  ;  Hyun-Jeung Choi  ;  Jin Ju Kim  ;  M. Sun Kim  ;  In-Seon Lee  ;  Bohyun Byun  ;  Lina Jia  ;  Myung Ryurl Oh  ;  Youngho Moon  ;  Sarah Park  ;  Joon-Seok Choi  ;  Seoung Wan Chae  ;  Byung-Ho Nam  ;  Jin-Soo Kim  ;  Jihun Kim  ;  Byung Soh Min  ;  Jae Seok Lee  ;  Jae-Kyung Won  ;  Soo Youn Cho  ;  Yoon-La Choi  ;  Young Kee Shin 
Citation
 SCIENTIFIC REPORTS, Vol.8 : 543, 2018 
Journal Title
 SCIENTIFIC REPORTS 
Issue Date
2018
Abstract
In clinical translational research and molecular in vitro diagnostics, a major challenge in the detection of genetic mutations is overcoming artefactual results caused by the low-quality of formalin-fixed paraffin-embedded tissue (FFPET)-derived DNA (FFPET-DNA). Here, we propose the use of an 'internal quality control (iQC) index' as a criterion for judging the minimum quality of DNA for PCR-based analyses. In a pre-clinical study comparing the results from droplet digital PCR-based EGFR mutation test (ddEGFR test) and qPCR-based EGFR mutation test (cobas EGFR test), iQC index ≥ 0.5 (iQC copies ≥ 500, using 3.3 ng of FFPET-DNA [1,000 genome equivalents]) was established, indicating that more than half of the input DNA was amplifiable. Using this criterion, we conducted a retrospective comparative clinical study of the ddEGFR and cobas EGFR tests for the detection of EGFR mutations in non-small cell lung cancer (NSCLC) FFPET-DNA samples. Compared with the cobas EGFR test, the ddEGFR test exhibited superior analytical performance and equivalent or higher clinical performance. Furthermore, iQC index is a reliable indicator of the quality of FFPET-DNA and could be used to prevent incorrect diagnoses arising from low-quality samples.
Files in This Item:
T201803978.pdf Download
DOI
10.1038/s41598-017-18642-x
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Min, Byung Soh(민병소) ORCID logo https://orcid.org/0000-0003-0180-8565
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/165419
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