一项用于评估乳腺癌中HER2分析的显色原位杂交准确性和可重复性的质量保证活动。
A quality assurance exercise to evaluate the accuracy and reproducibility of chromogenic in situ hybridisation for HER2 analysis in breast cancer.
作者信息
Di Palma S, Collins N, Bilous M, Sapino A, Mottolese M, Kapranos N, Schmitt F, Isola J
机构信息
Department of Histopathology, Royal Surrey County Hospital and University of Surrey, Guildford, Surrey, UK.
出版信息
J Clin Pathol. 2008 Jun;61(6):757-60. doi: 10.1136/jcp.2007.053850. Epub 2008 Mar 6.
BACKGROUND
Chromogenic in situ hybridisation (CISH) is an alternative to immunohistochemistry or FISH for the assessment of HER2 oncogene status in breast cancer. Although CISH is being used increasingly in routine diagnostics, there are no established inter-laboratory quality assurance programmes for this test.
METHODS
The reproducibility of HER2 CISH analysis was assessed when performed by seven different centres that use the test routinely in diagnostic service.
RESULTS
The results from 28 cases showed overall concordance of 98.5% (192/195 tests; kappa coefficient 0.91). One of the discrepancies was due to the invasive carcinoma having been cut out in the sections received by two of the centres, and the other two were in the non-amplified/equivocal/low-amplified category.
CONCLUSION
This is believed to be the first report of a quality assurance study assessing laboratories that use HER2 CISH routinely in clinical diagnostics. The results show that CISH is a robust technique providing a suitable assay for the frontline testing of HER2 status in breast cancer.
背景
在评估乳腺癌中HER2癌基因状态时，显色原位杂交（CISH）是免疫组织化学或荧光原位杂交（FISH）的一种替代方法。尽管CISH在常规诊断中使用越来越多，但该检测尚无既定的实验室间质量保证方案。
方法
由七个在诊断服务中常规使用该检测的不同中心进行HER2 CISH分析，评估其可重复性。
结果
28例病例的结果显示总体一致性为98.5%（192/195次检测；kappa系数0.91）。其中一个差异是由于两个中心收到的切片中浸润性癌被切除，另外两个差异属于非扩增/不确定/低扩增类别。
结论
这被认为是首份评估在临床诊断中常规使用HER2 CISH的实验室的质量保证研究报告。结果表明，CISH是一种可靠的技术，为乳腺癌HER2状态的一线检测提供了合适的检测方法。
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