Engel Kelly B, Vaught Jim, Moore Helen M
1 Preferred Staffing Group, Arlington, Virginia.
Biopreserv Biobank. 2014 Apr;12(2):148-50. doi: 10.1089/bio.2013.0091.
Variable biospecimen collection, processing, and storage practices may introduce variability in biospecimen quality and analytical results. This risk can be minimized within a facility through the use of standardized procedures; however, analysis of biospecimens from different facilities may be confounded by differences in procedures and inferred biospecimen quality. Thus, a global approach to standardization of biospecimen handling procedures and their validation is needed. Here we present the first in a series of procedural guidelines that were developed and annotated with published findings in the field of human biospecimen science. The series of documents will be known as NCI Biospecimen Evidence-Based Practices, or BEBPs. Pertinent literature was identified via the National Cancer Institute (NCI) Biospecimen Research Database ( brd.nci.nih.gov ) and findings were organized by specific biospecimen pre-analytical factors and analytes of interest (DNA, RNA, protein, morphology). Meta-analysis results were presented as annotated summaries, which highlight concordant and discordant findings and the threshold and magnitude of effects when applicable. The detailed and adaptable format of the document is intended to support the development and execution of evidence-based standard operating procedures (SOPs) for human biospecimen collection, processing, and storage operations.
生物样本采集、处理和存储方法的多样性可能会导致生物样本质量和分析结果出现差异。通过采用标准化程序，可将这种风险在机构内部降至最低；然而，不同机构生物样本的分析可能会因程序差异和推断的生物样本质量而受到干扰。因此，需要一种全球通用的方法来实现生物样本处理程序的标准化及其验证。在此，我们展示了一系列程序指南中的首个指南，这些指南是根据人类生物样本科学领域已发表的研究结果制定并注释的。这一系列文件将被称为美国国家癌症研究所生物样本循证实践（NCI Biospecimen Evidence-Based Practices，简称BEBPs）。通过美国国家癌症研究所（NCI）生物样本研究数据库（brd.nci.nih.gov）确定了相关文献，并按特定生物样本分析前因素和感兴趣的分析物（DNA、RNA、蛋白质、形态学）对研究结果进行了整理。荟萃分析结果以注释摘要的形式呈现，突出了一致和不一致的研究结果以及适用时的效应阈值和大小。该文件详细且具有适应性的格式旨在支持制定和执行基于证据的人类生物样本采集、处理和存储操作标准操作规程（SOP）。
