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用于人唾液样本的 ELISA 的验证和质量控制。

Validation and quality control of ELISAs for the use with human saliva samples.

机构信息

Centre for Oral Health Research, School of Dental Sciences and Institute of Cellular Medicine, Newcastle University, Framlington Place, NE2 4BW, UK.

出版信息

J Immunol Methods. 2012 Mar 30;377(1-2):62-5. doi: 10.1016/j.jim.2012.01.010. Epub 2012 Jan 28.

DOI:10.1016/j.jim.2012.01.010
PMID:22306358
Abstract

Enzyme-linked immunosorbent assays (ELISAs) have proven to be a powerful tool for fast and reliable sample analysis, in both clinical diagnostics and in research. Most assays are now available for use with a range of different analytical fluids, including serum, plasma or urine. In recent years, saliva has drawn attention as a potentially valuable diagnostic fluid; however few ELISAs have been validated for use with saliva, or their validation is often incomplete. Saliva has a number of different physical characteristics than, for example, cell culture medium or serum and assuming an ELISA which works well with serum samples will also do so with saliva potentially could lead to erroneous data and conclusions. In this report, we provide a detailed protocol to validate any ELISA for use with saliva samples and show the results of validation procedures for 13 ELISAs for using saliva. Our findings suggest that the majority of ELISAs work reliably with saliva, even if the assay was not specifically designed for this biological fluid. However, we also report a few cases where recovery or intra-and inter-assay variations were unexpectedly high, emphasising the importance of performing a validation procedure for each assay before using it with saliva to ensure accurate and reliable data.

摘要

酶联免疫吸附测定(ELISA)已被证明是一种快速可靠的样品分析工具,在临床诊断和研究中都有广泛的应用。现在,大多数 ELISA 都可用于分析多种不同的分析液,包括血清、血浆或尿液。近年来,唾液作为一种有潜在价值的诊断液引起了人们的关注;然而,很少有 ELISA 经过唾液验证,或者它们的验证往往不完整。唾液具有许多与细胞培养液或血清等不同的物理特性,因此假设与血清样本配合良好的 ELISA 也可能适用于唾液,这可能会导致错误的数据和结论。在本报告中,我们提供了一个详细的方案,用于验证任何用于唾液样本的 ELISA,并展示了 13 种用于唾液的 ELISA 的验证程序的结果。我们的研究结果表明,大多数 ELISA 都可以可靠地用于唾液,即使该检测方法不是专门为此生物流体设计的。然而,我们也报告了一些情况下回收率或内、间检测变异率异常高的情况,这强调了在使用 ELISA 进行唾液检测之前,对每个检测进行验证程序的重要性,以确保数据准确可靠。

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