PMID- 20459530 OWN - NLM STAT- MEDLINE DCOM- 20100813 LR - 20161125 IS - 1365-2559 (Electronic) IS - 0309-0167 (Linking) VI - 56 IP - 3 DP - 2010 Feb TI - A UK NEQAS ICC and ISH multicentre study using the Kreatech Poseidon HER2 FISH probe: intersite variation can be rigorously controlled using FISH. PG - 297-304 LID - 10.1111/j.1365-2559.2010.03493.x [doi] AB - 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 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 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. FAU - Bartlett, John M S AU - Bartlett JM AD - Endocrine Cancer Group, Edinburgh University Cancer Research Centre, Western General Hospital, Edinburgh, UK. john.bartlett@ed.ac.uk FAU - Campbell, Fiona M AU - Campbell FM FAU - Ibrahim, Merdol AU - Ibrahim M FAU - Thomas, Jeremy AU - Thomas J FAU - Wencyk, Pete AU - Wencyk P FAU - Ellis, Ian AU - Ellis I FAU - Kay, Elaine AU - Kay E FAU - Connolly, Yvonne AU - Connolly Y FAU - O'Grady, Anthony AU - O'Grady A FAU - Barnett, Sarah AU - Barnett S FAU - Starczynski, Jane AU - Starczynski J FAU - Cunningham, Paul AU - Cunningham P FAU - Miller, Keith AU - Miller K LA - eng PT - Journal Article PT - Multicenter Study PL - England TA - Histopathology JT - Histopathology JID - 7704136 SB - IM MH - Breast Neoplasms/*genetics MH - Female MH - Gene Expression Profiling/methods/*standards MH - *Genes, erbB-2 MH - Humans MH - In Situ Hybridization, Fluorescence/methods/*standards MH - Pathology, Clinical/methods/*standards MH - Reproducibility of Results MH - Tissue Array Analysis MH - United Kingdom EDAT- 2010/05/13 06:00 MHDA- 2010/08/14 06:00 CRDT- 2010/05/13 06:00 PHST- 2010/05/13 06:00 [entrez] PHST- 2010/05/13 06:00 [pubmed] PHST- 2010/08/14 06:00 [medline] AID - HIS3493 [pii] AID - 10.1111/j.1365-2559.2010.03493.x [doi] PST - ppublish SO - Histopathology. 2010 Feb;56(3):297-304. doi: 10.1111/j.1365-2559.2010.03493.x.