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Comparison Study of the Performance of the QIAGEN EGFR RGQ and EGFR Pyro Assays for Mutation Analysis in Non-Small Cell Lung Cancer.
MedLine Citation:
PMID:  23765529     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Objectives: To compare 2 laboratory assays commonly used in the evaluation of epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC). Methods: Fifty-three formalin-fixed, paraffin-embedded NSCLC specimens were selected. Extracted DNA was analyzed using the EGFR RGQ Amplification Refractory Mutation System Scorpions probe-based real-time polymerase chain reaction (PCR) assay and the EGFR Pyro pyrosequencing assay. Results: Fourteen EGFR mutations were identified in 13 specimens using at least 1 of the assays, with a mutation concordance rate of 92.9%. Using dideoxy sequencing as the gold standard, clinical sensitivity was 73.7% and 68.4% by the RGQ and Pyro assays, respectively, but 100% by both for common drug sensitivity mutations. Performance observations included the following: the RGQ system requires higher DNA input, the RGQ system is a single-step procedure, the EGFR Pyro assay is a 2-step procedure, only the RGQ system can identify exon 20 insertions, the RGQ system is more sensitive, and the Pyro system can specify exact mutations for all interrogated sites. Conclusions: Both the RGQ real-time PCR and Pyro assays adequately detect common EGFR mutations; however, the RGQ system is more clinically and analytically sensitive. Performance characteristics should be considered when evaluating these EGFR mutation assays for clinical adoption.
Authors:
Allison M Cushman-Vokoun; Ann M Crowley; Sharleen A Rapp; Timothy C Greiner
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  American journal of clinical pathology     Volume:  140     ISSN:  1943-7722     ISO Abbreviation:  Am. J. Clin. Pathol.     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-06-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370470     Medline TA:  Am J Clin Pathol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  7-19     Citation Subset:  AIM; IM    
Affiliation:
Dept of Pathology and Microbiology, University of Nebraska Medical Center, 985454 Nebraska Medical Center, Omaha, NE 68105-5454; acushman@unmc.edu.
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