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Interlaboratory concordance in HER2 testing: Results of a Serbian ring-study

Authors: Ivkovic-Kapic Tatjana; Slavica, Knežević-Ušaj; Moldvaji Eva; Jovanić Irena; Milovanović Zorka; Milentijević Maja; Tatić Svetislav; +3 Authors

Interlaboratory concordance in HER2 testing: Results of a Serbian ring-study

Abstract

urpose: The purpose of this study was to assess the immunohistochemistry and chromogenic in situ hybridization (CISH) interlaboratory consensus between national pathology laboratories in Serbia.Methods: This study was conducted between 2013 and 2016. In 2013, HER2 results were evaluated using two sets of four different breast cancer specimens in five laboratories. A total of 20 immunohistochemistry and 20 CISH cases were tested. In 2014, there were 6 testing rounds, and a total of 24 specimens were analyzed, whereas in 2015 and 2016, seven testing rounds were conducted, with four additional cases (i.e. a total of 28 specimens). In 2014, 2015 and 2016, all institutions performed immunohistochemical analysis only.Results: We found discrepancies in HER2 immunohistochemical (IHC) results in all four surveys. IHC testing resulted in diagnostic discordance between participating centers in two (2/17) cases in 2013, two (2/24) in 2014, four (4/27) cases in 2015 and three cases (3/27) in 2016. The overall agreement among the centers was 79%, 85.5%, 83.5% and 89.4%, respectively. For CISH analyses, the results for 16 (84.2%) of 19 samples were consistent for all participants. Three results were found to be discordant, indicating a misdiagnosis rate of 15.8%. In all the discrepant cases, interinstitutional discordances were related to technical and evaluation issues.Conclusions: Our study highlights the difficulty encountered during HER2 testing using immunohistochemistry and CISH. This also emphasizes the need for rigorous quality control procedures for specimen preparation and analysis.

Keywords

inter-laboratory consensus, breast cancer, Consensus, inter-laboratory consensus, Breast Neoplasms, Immunohistochemistry, Erb-b2 Receptor Tyrosine Kinases, breast cancer, Chromogenic Compounds, HER2 testing, Humans, Female, HER2 testing, quality control, Laboratories, Serbia, In Situ Hybridization, Fluorescence

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popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
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influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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