Standard Reference Material for Her2 Testing: Report of a National Institute of Standards and Technology-sponsored Consensus Workshop
Standard Reference Material for Her2 Testing: Report of a National Institute of Standards and Technology-sponsored Consensus Workshop
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Her2 测试的标准参考材料：美国国家标准与技术研究院主办的共识研讨会的报告
DOI：
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发表时间：
2003
期刊：
影响因子：
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通讯作者：
S. Gutman
中科院分区：
文献类型：
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作者：
M. Elizabeth;H. Hammond;P. Barker;S. Taube;S. Gutman
由美国国家标准与技术研究所、美国国家癌症研究所癌症诊断项目、美国食品药品监督管理局和美国病理学家学院主办的研讨会，旨在解决Her2基因蛋白质检测参考材料的需求。与会者一致认为，这样的标准是可取的，也是必要的，以确保Her2检测的可靠性，从而使患者有资格接受曲妥珠单抗治疗。将生产两种由充分表征的细胞系组成的标准品，一种是美国国家标准与技术研究所认证的标准品，另一种是用于所有Her2检测的商业开发标准品。还一致认为，所有Her2检测必须对仅在10%福尔马林缓冲液中固定的样品进行，如食品药品监督管理局批准的检测方法中所述。与会者同意制定战略，教育病理学家、临床医生和实验室了解这种标准的必要性和使用。将创建国家临床实验室标准委员会标准参考物质使用指南，以促进这一过程。
A workshop was sponsored by the National Institute of Standards and Technology, the Cancer Diagnosis Program of the National Cancer Institute, the Food and Drug Administration, and the College of American Pathologists to address the need for a reference material for Her2 gene protein testing. It was agreed that such a standard was desirable and necessary to ensure the reliability of Her2 testing to qualify patients for trastuzumab therapy. Two standards consisting of well characterized cell lines will be produced, 1 that will be a National Institute of Standards and Technology-certifiable standard, and 1 that will be a commercially developed standard for use in all Her2 testing. It was also agreed that all Her2 testing must be performed on samples fixed only in 10% buffered formalin, as specified in the Food and Drug Administration-approved testing methods. Participants agreed to plan strategies to educate pathologists, clinicians, and laboratories about the need and use of such a standard. A National Committee for Clinical Laboratory Standards guideline for the use of the standard reference material will be created to facilitate this process.
影响因子：
10.3
作者：
Paik, S;Bryant, J;Wolmark, N
通讯作者：
Wolmark, N
影响因子：
10.3
作者：
Roche, PC;Suman, VJ;Perez, EA
通讯作者：
Perez, EA