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生物银行人类子宫内膜组织和血液标本:标准操作程序及对生殖生物学研究和诊断发展的重要性。

Biobanking human endometrial tissue and blood specimens: standard operating procedure and importance to reproductive biology research and diagnostic development.

机构信息

Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, California 94143, USA.

出版信息

Fertil Steril. 2011 May;95(6):2120-2, 2122.e1-12. doi: 10.1016/j.fertnstert.2011.01.164. Epub 2011 Mar 2.

Abstract

OBJECTIVE

To develop a standard operating procedure (SOP) for collection, transport, storage of human endometrial tissue and blood samples, subject and specimen annotation, and establishing sample priorities.

DESIGN

The SOP synthesizes sound scientific procedures, the literature on ischemia research, sample collection and gene expression profiling, good laboratory practices, and the authors' experience of workflow and sample quality.

SETTING

The National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank.

PATIENT(S): Women undergoing endometrial biopsy or hysterectomy for nonmalignant indications.

INTERVENTION(S): Collecting, processing, storing, distributing endometrial tissue and blood samples under approved institutional review board protocols and written informed consent from participating subjects.

MAIN OUTCOME MEASURE(S): Standard operating procedure.

RESULT(S): The SOP addresses rigorous and consistent subject annotation, specimen processing and characterization, strict regulatory compliance, and a reference for researchers to track collection and storage times that may influence their research.

CONCLUSION(S): The comprehensive and systematic approach to the procurement of human blood and endometrial tissue in this SOP ensures the high quality, reliability, and scientific usefulness of biospecimens made available to investigators by the National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. The detail and perspective in this SOP also provides a blueprint for implementation of similar collection programs at other institutions.

摘要

目的

制定人子宫内膜组织和血样采集、运输、储存、受试对象和标本注释以及样本优先级建立的标准操作程序(SOP)。

设计

SOP 综合了合理的科学程序、关于缺血研究、样本采集和基因表达谱的文献、良好的实验室规范以及作者在工作流程和样本质量方面的经验。

地点

美国国立卫生研究院、加利福尼亚大学旧金山分校人类子宫内膜组织和 DNA 银行。

患者

因非恶性指征行子宫内膜活检或子宫切除术的女性。

干预措施

根据经机构审查委员会批准的方案和参与受试对象的书面知情同意书,采集、处理、储存和分发子宫内膜组织和血样。

主要观察指标

标准操作程序。

结果

SOP 涉及严格且一致的受试对象注释、标本处理和特征描述、严格的法规遵从性,以及为研究人员提供的跟踪采集和储存时间的参考,这些时间可能会影响他们的研究。

结论

本 SOP 中对人血和子宫内膜组织的全面系统采集方法确保了美国国立卫生研究院、加利福尼亚大学旧金山分校人类子宫内膜组织和 DNA 银行提供给研究人员的生物样本的高质量、可靠性和科学有用性。SOP 中的细节和观点也为其他机构实施类似的采集计划提供了蓝图。

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