Endocrine Cancer Group, Edinburgh University Cancer Research Centre, Western General Hospital, Edinburgh, UK.
Histopathology. 2010 Feb;56(3):297-304. doi: 10.1111/j.1365-2559.2010.03493.x.
To assess a new HER2 fluorescence in situ hybridization (FISH) test and report on multicentre intrasite and intersite variation.
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.
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.
评估一种新的 HER2 荧光原位杂交（FISH）检测方法，并报告其多中心内部和外部的变异性。
使用 Kreatech Poseidon HER2 FISH 探针（Kreatech Diagnostics，阿姆斯特丹，荷兰），对 8 个实验室的 45 例乳腺癌进行了 HER2 评分。总体而言，80.9%的组织芯成功进行了分析。HER2 比值评估的内部变异性平均值较低（4.74%）。比值的外部变异性与之前的报告一致（参考和非参考实验室均为 11.9+/-0.8%）；只有一个实验室的外部变异性明显高于其余 7 个实验室（P=0.009）。所有 8 个实验室的核心分类错误发生率均<1.3%，表明无论它们是“参考”还是“常规诊断”实验室，都具有极好的一致性（>98.7%）。
Kreatech Poseidon HER2 FISH 检测方法稳健且可重复。从 8 个“诊断”和“参考”实验室获得了高度定量可重复的 FISH 结果；然而，持续的质量评估对于良好的性能至关重要。
