Abstract:
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.
journal_name
Histopathologyjournal_title
Histopathologyauthors
Bartlett JM,Campbell FM,Ibrahim M,Thomas J,Wencyk P,Ellis I,Kay E,Connolly Y,O'Grady A,Barnett S,Starczynski J,Cunningham P,Miller Kdoi
10.1111/j.1365-2559.2010.03493.xsubject
Has Abstractpub_date
2010-02-01 00:00:00pages
297-304issue
3eissn
0309-0167issn
1365-2559pii
HIS3493journal_volume
56pub_type
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