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Staining Performance of ALK and ROS1 Immunohistochemistry and Influence on Interpretation in Non-Small-Cell Lung Cancer.
Keppens, Cleo; von der Thüsen, Jan; Pauwels, Patrick; Ryska, Ales; 't Hart, Nils; Schuuring, Ed; Miller, Keith; Thunnissen, Erik; Zwaenepoel, Karen; Dequeker, Elisabeth M C.
Afiliação
  • Keppens C; Biomedical Quality Assurance Research Unit, Department of Public Health and Primary Care, University of Leuven, Leuven, Belgium.
  • von der Thüsen J; Department of Pathology, Erasmus Medical Center Rotterdam, Rotterdam, the Netherlands.
  • Pauwels P; Department of Pathology, University Hospital Antwerp, Edegem, Belgium; Centre for Oncological Research, University of Antwerp, Edegem, Belgium.
  • Ryska A; Department of Pathology, Charles University Medical Faculty Hospital, Hradec Kralove, Czech Republic.
  • 't Hart N; Department of Pathology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Department of Pathology, Isala Klinieken, Zwolle, the Netherlands.
  • Schuuring E; Department of Pathology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
  • Miller K; UK National External Quality Assessment Scheme for Immunocytochemistry and in Situ Hybridisation, University College London Cancer Institute, London, United Kingdom.
  • Thunnissen E; Department of Pathology, Vrije Universiteit Amsterdam Medical Center, Amsterdam, the Netherlands.
  • Zwaenepoel K; Department of Pathology, University Hospital Antwerp, Edegem, Belgium; Centre for Oncological Research, University of Antwerp, Edegem, Belgium.
  • Dequeker EMC; Biomedical Quality Assurance Research Unit, Department of Public Health and Primary Care, University of Leuven, Leuven, Belgium. Electronic address: els.dequeker@kuleuven.be.
J Mol Diagn ; 22(12): 1438-1452, 2020 12.
Article em En | MEDLINE | ID: mdl-33011443
Selection of non-small-cell lung cancer patients for treatment relies on the detection of expression of anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) protein by immunohistochemistry (IHC). We evaluated staining performance for different IHC protocols and laboratory characteristics, and their influence on ALK and ROS1 interpretation during external quality assessment schemes between 2015 and 2018. Participants received five formalin-fixed, paraffin-embedded cases for staining by their routine protocol, whereafter at least two pathologists scored them simultaneously under a multihead microscope and awarded a graded expert staining score (ESS) from 1 to 5 points based on staining quality. European Conformity in Vitro Diagnostic kits (such as D5F3) revealed a better ALK ESS compared with laboratory-developed tests. ESS was indifferent to the applied antibody dilution or a recent protocol change. Lower ESSs were observed for higher antibody incubation times and temperatures. ESS for various ROS1 protocols were largely similar. Overall, for both markers, ESS improved over time and for repeated external quality assessment participation but was independent of laboratory setting or experience. Except for ROS1, ESS positively correlated with laboratory accreditation. IHC stains with lower ESS correlated with increased error rates in ALK and ROS1 interpretation and analysis failures. Laboratory characteristics differently affected staining quality and interpretation, and laboratories should assess both aspects, and less common protocols need improvement in staining performance.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Proteínas Tirosina Quinases / Imuno-Histoquímica / Proteínas Proto-Oncogênicas / Carcinoma Pulmonar de Células não Pequenas / Quinase do Linfoma Anaplásico / Neoplasias Pulmonares Tipo de estudo: Diagnostic_studies / Evaluation_studies / Guideline Limite: Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Proteínas Tirosina Quinases / Imuno-Histoquímica / Proteínas Proto-Oncogênicas / Carcinoma Pulmonar de Células não Pequenas / Quinase do Linfoma Anaplásico / Neoplasias Pulmonares Tipo de estudo: Diagnostic_studies / Evaluation_studies / Guideline Limite: Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article