Liessem S, Winkens W, Jonigk D, Wasielewski R V, Fisseler-Eckhoff A, Rüschoff J, Kreipe H-H
Institut für Pathologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, 30625, Hannover, Deutschland,
Pathologe. 2014 Feb;35(1):61-71. doi: 10.1007/s00292-013-1837-3.
Round robin testing for quality assurance in the determination of the breast cancer biomarkers estrogen receptor (ER), progesterone receptor (PR) and epithelial growth factor receptor 2 (HER2) have been carried out in Germany for 13 years. As the first quality assurance trial worldwide tissue microarrays with 20 different breast cancer specimens were used. As a further innovation the challenges were split into a test part representing routine cases and a training part enriched with difficult borderline cases in order to uncover latent weaknesses in the participating laboratories. Certificates are issued based exclusively on the test part. Similar to NordiQC and UKNequas stained slides are assessed externally and the quality of staining and evaluation are considered separately. Since 2010 an additional internet-based trial without assessment of the staining quality is offered for ER and PR. Since the introduction of the round robin trials the numbers of participants (n = 200-250) and the success rates have steadily increased. The breast cancer quality assurance trial ranks first with regard to the number of participants in Germany. It could be demonstrated that regular participation in the round robin test leads to an improvement of staining results of ER, PR and HER2 and hence appears to be mandatory for maintaining quality standards. The use of fully automated immunohistochemical staining procedures has steadily increased and these are now used by approximately 50 % of participants.
德国开展乳腺癌生物标志物雌激素受体（ER）、孕激素受体（PR）和人表皮生长因子受体2（HER2）测定的质量保证循环检验已达13年。作为全球首个质量保证试验，使用了含有20种不同乳腺癌标本的组织微阵列。作为进一步的创新，将挑战分为代表常规病例的测试部分和富含疑难临界病例的培训部分，以发现参与实验室潜在的薄弱环节。证书仅基于测试部分颁发。与北欧质量控制（NordiQC）和英国国家质量评估（UKNequas）类似，染色玻片由外部评估，染色和评估质量分别考量。自2010年起，针对ER和PR开展了一项额外的基于互联网的试验，不评估染色质量。自开展循环检验以来，参与者数量（n = 200 - 250）和成功率稳步上升。乳腺癌质量保证试验在德国的参与者数量方面排名第一。可以证明，定期参与循环检验可使ER、PR和HER2的染色结果得到改善，因此对于维持质量标准似乎是必不可少的。全自动免疫组织化学染色程序的使用稳步增加，目前约50%的参与者使用这些程序。
