Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA.
Context.--The mutation analysis of epidermal growth factor receptor (EGFR) has become a common test to guide therapeutic decision making for lung cancer. Molecular testing with circulating tumor DNA in plasma allows diagnosis of mutations when tumor tissue is not available as well as monitoring trea...
| Publicado en: | Archives of Pathology & Laboratory Medicine Vol. 141; no. 7; pp. 978 - 985 |
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| Autores principales: | , , , , , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
College of American Pathologists
Jul2017
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=123962689&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 123962689 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00039985 1FS jtl: Archives of Pathology & Laboratory Medicine issn: 00039985 maglogo: N pubinfo: dt: Jul2017 vid: 141 iid: 7 pid: 2550 pub: College of American Pathologists place: Northfield, Illinois artinfo: ui: 123962689 123962689 123962689 10.5858/arpa.2016-0083-OA 123962689 ppf: 978 ppct: 7 formats: fmt: @attributes: type: P tig: atl: Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA. aug: au: Xiaowei Wang Yunhua Gao Bei Wang Zhenrong Zhang Chaoyang Liang Hongxiang Feng Yongqing Guo Jiping Da Minli Mo Mengyun Zhang Feng Ding Zhao Chen Hui Li Deruo Liu affil: Department of Thoracic Surgery, China-Japan Friendship Hospital, Beijing, China sug: subj: Polymerase Chain Reaction Methods Mutation Evaluation Receptors, Cell Surface Analysis Receptors, Cell Surface Blood Carcinoma, Non-Small-Cell Lung Diagnosis Epidermal Growth Factors Molecular Diagnostic Techniques Evaluation Carcinoma, Non-Small-Cell Lung Familial and Genetic Validation Studies Sensitivity and Specificity Data Analysis Software Poisson Distribution Confidence Intervals Analysis of Variance T-Tests Predictive Value of Tests Human Funding Source ab: Context.--The mutation analysis of epidermal growth factor receptor (EGFR) has become a common test to guide therapeutic decision making for lung cancer. Molecular testing with circulating tumor DNA in plasma allows diagnosis of mutations when tumor tissue is not available as well as monitoring treatment response with repeat biopsies. Objectives.--To develop a timely and cost-effective assay that can accurately detect EGFR mutations in circulating tumor DNA and to evaluate the analytic and clinical performance of the assay. Design.--Analytic assessment was conducted with a set of reference materials carrying classic EGFR mutations. A recently developed Poisson distribution-based approach was employed to understand the assay sensitivity. Clinical evaluation was performed with 224 pairs of plasma and matched tissues from patients with stage I to IV disease. EGFR mutation rates of 390 consecutive plasma samples processed in the central service laboratory were compared with previously reported prevalence in an Asian population. Results.--Our results suggested that limit of detection for the EGFR quantitative polymerase chain reaction assay was 10 mutation copies, and the lowest detectable copy numbers could be extended to a single-digit level. The clinical sensitivity was 53.3% for all stages combined and 81.4% for late stages, with a high specificity of 100%. Clinical observations showed an overall positive finding rate of 32.5% and 41.4% for stage IV disease, which is consistent with previously reported EGFR mutation prevalence in an Asian population. Conclusions.--Our results supported the clinical utility of the ultrasensitive, quantitative polymerase chain reaction assay for EGFR mutation analysis with circulating tumor DNA. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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