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Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA.

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  • Additional Information
    • Source:
      Publisher: College of American Pathologists Country of Publication: United States NLM ID: 7607091 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1543-2165 (Electronic) Linking ISSN: 00039985 NLM ISO Abbreviation: Arch. Pathol. Lab. Med. Subsets: Core Clinical (AIM); MEDLINE
    • Publication Information:
      Publication: Northfield, Ill. : College of American Pathologists
      Original Publication: Chicago, American Medical Assn.
    • Subject Terms:
      DNA Mutational Analysis/*methods ; DNA, Neoplasm/*blood ; Genes, erbB-1/*genetics ; Lung Neoplasms/*genetics ; Real-Time Polymerase Chain Reaction/*methods; Aged ; ErbB Receptors/genetics ; Female ; High-Throughput Nucleotide Sequencing ; Humans ; Male ; Middle Aged ; Neoplastic Cells, Circulating ; Sensitivity and Specificity
    • Abstract:
      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.
    • Accession Number:
      0 (DNA, Neoplasm)
      EC 2.7.10.1 (EGFR protein, human)
      EC 2.7.10.1 (ErbB Receptors)
    • Publication Date:
      Date Created: 20170525 Date Completed: 20170918 Latest Revision: 20191210
    • Publication Date:
      20200827
    • Accession Number:
      10.5858/arpa.2016-0083-OA
    • Accession Number:
      28537806
  • Citations
    • ABNT:
      WANG, X. et al. Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA. Archives of pathology & laboratory medicine, [s. l.], v. 141, n. 7, p. 978–984, 2017. DOI 10.5858/arpa.2016-0083-OA. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdc&AN=28537806. Acesso em: 25 set. 2020.
    • AMA:
      Wang X, Gao Y, Wang B, et al. Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA. Archives of pathology & laboratory medicine. 2017;141(7):978-984. doi:10.5858/arpa.2016-0083-OA
    • APA:
      Wang, X., Gao, Y., Wang, B., Zhang, Z., Liang, C., Feng, H., Guo, Y., Da, J., Mo, M., Zhang, M., Ding, F., Chen, Z., Li, H., & Liu, D. (2017). Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA. Archives of Pathology & Laboratory Medicine, 141(7), 978–984. https://doi.org/10.5858/arpa.2016-0083-OA
    • Chicago/Turabian: Author-Date:
      Wang, Xiaowei, Yunhua Gao, Bei Wang, Zhenrong Zhang, Chaoyang Liang, Hongxiang Feng, Yongqing Guo, et al. 2017. “Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA.” Archives of Pathology & Laboratory Medicine 141 (7): 978–84. doi:10.5858/arpa.2016-0083-OA.
    • Harvard:
      Wang, X. et al. (2017) ‘Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA’, Archives of pathology & laboratory medicine, 141(7), pp. 978–984. doi: 10.5858/arpa.2016-0083-OA.
    • Harvard: Australian:
      Wang, X, Gao, Y, Wang, B, Zhang, Z, Liang, C, Feng, H, Guo, Y, Da, J, Mo, M, Zhang, M, Ding, F, Chen, Z, Li, H & Liu, D 2017, ‘Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA’, Archives of pathology & laboratory medicine, vol. 141, no. 7, pp. 978–984, viewed 25 September 2020, .
    • MLA:
      Wang, Xiaowei, et al. “Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA.” Archives of Pathology & Laboratory Medicine, vol. 141, no. 7, July 2017, pp. 978–984. EBSCOhost, doi:10.5858/arpa.2016-0083-OA.
    • Chicago/Turabian: Humanities:
      Wang, Xiaowei, Yunhua Gao, Bei Wang, Zhenrong Zhang, Chaoyang Liang, Hongxiang Feng, Yongqing Guo, et al. “Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA.” Archives of Pathology & Laboratory Medicine 141, no. 7 (July 2017): 978–84. doi:10.5858/arpa.2016-0083-OA.
    • Vancouver/ICMJE:
      Wang X, Gao Y, Wang B, Zhang Z, Liang C, Feng H, et al. Analytic and Clinical Validation of an Ultrasensitive, Quantitative Polymerase Chain Reaction Assay for EGFR Mutation Analysis With Circulating Tumor DNA. Archives of pathology & laboratory medicine [Internet]. 2017 Jul [cited 2020 Sep 25];141(7):978–84. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdc&AN=28537806