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Clinical Performance of the Idylla MSI Test for a Rapid Assessment of the DNA Microsatellite Status in Human Colorectal Cancer.
Zwaenepoel, Karen; Holmgaard Duelund, Julie; De Winne, Koen; Maes, Vincent; Weyn, Christine; Lambin, Suzan; Dendooven, Robina; Broeckx, Glenn; Steiniche, Torben; Pauwels, Patrick.
Afiliação
  • Zwaenepoel K; Laboratory of Pathological Anatomy, Antwerp University Hospital (UZA), Edegem, Belgium; Center for Oncological Research Antwerp (CORE), University of Antwerp, Wilrijk, Belgium. Electronic address: karen.zwaenepoel@uza.be.
  • Holmgaard Duelund J; Department of Pathology, Aarhus University Hospital, Aarhus, Denmark.
  • De Winne K; Laboratory of Pathological Anatomy, Antwerp University Hospital (UZA), Edegem, Belgium.
  • Maes V; Laboratory of Pathological Anatomy, Antwerp University Hospital (UZA), Edegem, Belgium.
  • Weyn C; Laboratory of Pathological Anatomy, Antwerp University Hospital (UZA), Edegem, Belgium; Center for Oncological Research Antwerp (CORE), University of Antwerp, Wilrijk, Belgium.
  • Lambin S; Laboratory of Pathological Anatomy, Antwerp University Hospital (UZA), Edegem, Belgium.
  • Dendooven R; Laboratory of Pathological Anatomy, Antwerp University Hospital (UZA), Edegem, Belgium.
  • Broeckx G; Laboratory of Pathological Anatomy, Antwerp University Hospital (UZA), Edegem, Belgium.
  • Steiniche T; Department of Pathology, Aarhus University Hospital, Aarhus, Denmark.
  • Pauwels P; Laboratory of Pathological Anatomy, Antwerp University Hospital (UZA), Edegem, Belgium; Center for Oncological Research Antwerp (CORE), University of Antwerp, Wilrijk, Belgium.
J Mol Diagn ; 22(3): 386-395, 2020 03.
Article em En | MEDLINE | ID: mdl-31881332
In this study, the clinical performance of the Idylla MSI test (investigational use only) was evaluated in 330 colorectal carcinoma samples (all stages). This test is fully automated, from formalin-fixed, paraffin-embedded slide to result, and gives a result in <2.5 hours. Compared with the Promega MSI Analysis System version 1.2, an overall agreement, sensitivity, and specificity of 99.7%, 98.7%, and 100%, respectively, was reached. Whereas seven samples were invalid with the Promega MSI Analysis System, only two were invalid with the Idylla MSI test. Compared with the historical immunohistochemistry (IHC) data, overall agreement, sensitivity, and specificity of 98.7%, 94.4%, and 100%, respectively, were observed. Tumor mutation burden analysis of the discordant IHC cases was in favor of the Idylla MSI test result in three of the four samples. Furthermore, for those cases where the IHC data were invalid or hard to interpret because sole loss of one DNA mismatch repair deficiency marker was observed, Idylla MSI test results were always valid and accurate. Herein, the Idylla MSI test has been shown to be an accurate, fast screening assay for the detection of microsatellite status in colorectal cancer patients, with a low number of invalid results.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Colorretais / Biomarcadores Tumorais / Testes Genéticos / Repetições de Microssatélites / Instabilidade de Microssatélites Tipo de estudo: Diagnostic_studies / Prognostic_studies Limite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Colorretais / Biomarcadores Tumorais / Testes Genéticos / Repetições de Microssatélites / Instabilidade de Microssatélites Tipo de estudo: Diagnostic_studies / Prognostic_studies Limite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2020 Tipo de documento: Article