Quality assurance in diagnostic in situ hybridization-experience of QuIP

Abstract

The Quality Assurance Initiative Pathology (QuIP) gives pathologists the opportunity to check the methodological processes of immunohistological and molecular diagnostics in aresult-oriented manner and obtain acertificate reflecting the quality. For in situ hybridization (ISH), 5round robin tests were organized in 2019, two recurrent (HER2-ISH gastric carcinomas and HER2-ISH breast carcinomas) and three prototypical (ROS1-NSCLC, ALK1-NSCLC, NTRK). The different round robin tests, which were provided by QuIP, are based on the development in diagnostics and the importance of the therapeutic relevance of the molecules which are tested. The results of the round robin tests in 2019 showed asensitivity of at least 94.4%, aspecificity of at least 96.6%, and asuccess rate of 85-99%. This reflected the high standard of quality of the round robin test and the participating institutes.