A UK NEQAS ICC and ISH multicentre study using the Kreatech Poseidon HER2 FISH probe: intersite variation can be rigorously controlled using FISH

John M. S. Bartlett, Fiona M. Campbell, Merdol Ibrahim, Jeremy Thomas, Pete Wencyk, Ian Ellis, Elaine Kay, Yvonne Connolly, Anthony O'Grady, Sarah Barnett, Jane Starczynski, Paul Cunningham, Keith Miller

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

Aim: To assess a new HER2 fluorescence in situ hybridization (FISH) test and report on multicentre intrasite and intersite variation.

Methods and results: HER2 results were scored from 45 breast cancers in eight laboratories using the Kreatech Poseidon (TM) HER2 FISH probe (Kreatech Diagnostics, Amsterdam, the Netherlands). Overall, 80.9% of cores were successfully analysed. Mean intrasite variation for HER2 ratio assessment was low (4.74%). Intersite variation in ratio was in line with previous reports (11.9 +/- 0.8%) for both reference and non-reference laboratories; only one laboratory displayed significantly higher intersite variation (P = 0.009) than the remaining seven laboratories. The overall incidence of misclassification of cores was <1.3%, demonstrating an excellent level of concordance (>98.7%) across all eight laboratories, irrespective of whether they were 'reference' or 'routine diagnostic' laboratories.

Conclusions: The Kreatech Poseidon (TM) HER2 FISH test is robust and reproducible. Highly quantitatively reproducible FISH results were obtained from eight 'diagnostic' and 'reference' laboratories; however, continued quality assessments are essential to good performance.

Original languageEnglish
Pages (from-to)297-304
Number of pages8
JournalHistopathology
Volume56
Issue number3
DOIs
Publication statusPublished - Feb 2010

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