Bartlett John M S, Ibrahim Merdol, Jasani Bharat, Morgan John M, Ellis Ian, Kay Elaine, Connolly Yvonne, Campbell Fiona, O'Grady Anthony, Barnett Sarah, Miller Keith
Endocrine Cancer Group, Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, Scotland.
Am J Clin Pathol. 2009 Jan;131(1):106-11. doi: 10.1309/AJCPLN78ZQXEMNMA.
The American Society of Clinical Oncology/College of American Pathologists guidelines highlighted the critical importance of quality assurance in diagnostic testing for HER2. Unstained formalin-fixed, paraffin-embedded human breast carcinoma cell line sections were circulated to scheme participants on 9 occasions. "Reference laboratories" reported results for the HER2/chromosome 17 ratio and HER2 copy number for 3 years for each cell line, including 418 sets of results (1,671 results total). The number of participants was 62 laboratories in the final analysis. The mean and SD of results from reference laboratories demonstrated consistency during the 3-year period. The percentage of laboratories achieving "appropriate" results ranged from 45% to 88%, and the percentage achieving "inappropriate" results ranged from 5% to 29%. No consistent effect of the HER2 in situ hybridization testing method was demonstrated. Participation in external quality assurance schemes is a valuable mechanism for demonstrating and acquiring consistency for HER2 testing by in situ hybridization. Poor performance can be corrected via assistance and advice.
美国临床肿瘤学会/美国病理学家学会指南强调了HER2诊断检测中质量保证的至关重要性。未染色的福尔马林固定石蜡包埋人乳腺癌细胞系切片分9次分发给方案参与者。“参考实验室”报告了每种细胞系3年的HER2/17号染色体比率和HER2拷贝数结果，包括418组结果（共1671个结果）。最终分析中参与者数量为62个实验室。参考实验室结果的均值和标准差在3年期间表现出一致性。获得“合适”结果的实验室百分比在45%至88%之间，获得“不合适”结果的实验室百分比在5%至29%之间。未证明HER2原位杂交检测方法有一致的影响。参与外部质量保证方案是通过原位杂交证明和获得HER2检测一致性的宝贵机制。表现不佳可通过协助和建议得到纠正。
