实验室对美国临床肿瘤学会/美国病理学家学院人类表皮生长因子受体 2 检测指南的依从性：美国病理学家学院对 757 个实验室的调查。

Laboratory compliance with the American Society of Clinical Oncology/college of American Pathologists guidelines for human epidermal growth factor receptor 2 testing: a College of American Pathologists survey of 757 laboratories.

机构信息

Department of Pathology, Mayo Clinic Florida, Jacksonville, FL 32224, USA.

出版信息

Arch Pathol Lab Med. 2010 May;134(5):728-34. doi: 10.5858/134.5.728.

DOI:10.5858/134.5.728

PMID:20441503

Abstract

CONTEXT

To ensure quality human epidermal growth receptor 2 (HER2) testing in breast cancer, the American Society of Clinical Oncology/College of American Pathologists guidelines were introduced with expected compliance by 2008.

OBJECTIVE

To assess the effect these guidelines have had on pathology laboratories and their ability to address key components.

DESIGN

In late 2008, a survey was distributed with the HER2 immunohistochemistry (IHC) proficiency testing program. It included questions regarding pathology practice characteristics and assay validation using fluorescence in situ hybridization or another IHC laboratory assay and assessed pathologist HER2 scoring competency.

RESULTS

Of the 907 surveys sent, 757 (83.5%) were returned. The median laboratory accessioned 15 000 cases and performed 190 HER2 tests annually. Quantitative computer image analysis was used by 33% of laboratories. In-house fluorescence in situ hybridization was performed in 23% of laboratories, and 60% of laboratories addressed the 6- to 48-hour tissue fixation requirement by embedding tissue on the weekend. HER2 testing was performed on the initial biopsy in 40%, on the resection specimen in 6%, and on either in 56% of laboratories. Testing was validated with only fluorescence in situ hybridization in 47% of laboratories, whereas 10% of laboratories used another IHC assay only; 13% used both assays, and 12% and 15% of laboratories had not validated their assays or chose "not applicable" on the survey question, respectively. The 90% concordance rate with fluorescence in situ hybridization results was achieved by 88% of laboratories for IHC-negative findings and by 81% of laboratories for IHC-positive cases. The 90% concordance rate for laboratories using another IHC assay was achieved by 80% for negative findings and 75% for positive cases. About 91% of laboratories had a pathologist competency assessment program.

CONCLUSIONS

This survey demonstrates the extent and characteristics of HER2 testing. Although some American Society of Clinical Oncology/College of American Pathologists guidelines have been implemented, gaps remain in validation of HER2 IHC testing.

摘要

背景

为确保乳腺癌中人表皮生长因子受体 2（HER2）检测的质量，美国临床肿瘤学会/美国病理学家学会指南于 2008 年出台，预计届时将得到遵守。

目的

评估这些指南对病理实验室及其解决关键问题的能力的影响。

设计

2008 年末，在 HER2 免疫组化（IHC）能力验证计划中分发了一份调查。它包括关于病理实践特征和使用荧光原位杂交或另一种 IHC 实验室检测进行检测验证的问题，并评估了病理学家的 HER2 评分能力。

结果

共发出 907 份调查，其中 757 份（83.5%）被退回。中位实验室每年检测 15000 例病例，进行 190 次 HER2 检测。33%的实验室使用定量计算机图像分析。23%的实验室进行内部荧光原位杂交，60%的实验室通过在周末包埋组织来满足 6-48 小时组织固定的要求。40%的实验室在初始活检中进行 HER2 检测，6%的实验室在切除标本中进行，56%的实验室在两者中进行。47%的实验室仅使用荧光原位杂交验证 HER2 检测，而 10%的实验室仅使用另一种 IHC 检测；13%的实验室同时使用两种检测，12%和 15%的实验室分别未验证其检测或在调查问题上选择“不适用”。88%的实验室实现了与荧光原位杂交结果的 90%一致性，对于 IHC 阴性结果，81%的实验室实现了与荧光原位杂交结果的 90%一致性。对于使用另一种 IHC 检测的实验室，阴性结果的 90%一致性为 80%，阳性结果的 90%一致性为 75%。大约 91%的实验室有病理学家能力评估计划。