A Practical Guide to Immunoassay Method Validation.
A Practical Guide to Immunoassay Method Validation.
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DOI：
10.3389/fneur.2015.00179
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发表时间：
2015
影响因子：
3.4
通讯作者：
Teunissen CE
中科院分区：
文献类型：
--
作者：
Andreasson U;Perret-Liaudet A;van Waalwijk van Doorn LJ;Blennow K;Chiasserini D;Engelborghs S;Fladby T;Genc S;Kruse N;Kuiperij HB;Kulic L;Lewczuk P;Mollenhauer B;Mroczko B;Parnetti L;Vanmechelen E;Verbeek MM;Winblad B;Zetterberg H;Koel-Simmelink M;Teunissen CE
生化标志物在临床医学中对患者的诊断和管理中具有中心地位，并且在临床研究和药物开发中也具有中心地位，也用于脑部疾病，例如阿尔茨海默病。酶联免疫吸附试验（ELISA）常用于测量低丰度生物标志物。然而，ELISA方法的质量各不相同，这可能会引入系统误差和随机误差。这就迫切需要更严格地控制检测性能，无论其用于研究环境、临床常规还是药物开发。方法验证的目的是提供客观证据，证明方法符合其预期用途的要求。虽然已经发表了很多关于在方法验证中研究哪些参数的文章，但关于如何进行相应实验的详细信息较少。为了解决这一问题，本工作中包括了标准操作规程（SOP）以及一些不同验证参数的分步说明，以及验证报告模板，这些模板允许有序地呈现结果。尽管SOP是针对免疫化学方法的预期用途开发的，并用于多中心评价，但其中大多数是通用的，也可用于其他技术。
Biochemical markers have a central position in the diagnosis and management of patients in clinical medicine, and also in clinical research and drug development, also for brain disorders, such as Alzheimer’s disease. The enzyme-linked immunosorbent assay (ELISA) is frequently used for measurement of low-abundance biomarkers. However, the quality of ELISA methods varies, which may introduce both systematic and random errors. This urges the need for more rigorous control of assay performance, regardless of its use in a research setting, in clinical routine, or drug development. The aim of a method validation is to present objective evidence that a method fulfills the requirements for its intended use. Although much has been published on which parameters to investigate in a method validation, less is available on a detailed level on how to perform the corresponding experiments. To remedy this, standard operating procedures (SOPs) with step-by-step instructions for a number of different validation parameters is included in the present work together with a validation report template, which allow for a well-ordered presentation of the results. Even though the SOPs were developed with the intended use for immunochemical methods and to be used for multicenter evaluations, most of them are generic and can be used for other technologies as well.