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使用通用试剂和检测方案的酶联免疫吸附测定(ELISA)在生育力评估中的性能改善:来自质量控制研究的证据

Improved performance of ELISAs for fertility assessment using common reagents and assay protocol as evidence from quality control studies.

作者信息

Desai Meena P, Donde Uday M, Khatkhatay M Ikram

机构信息

Department of Immunodiagnostics (ELISA), Institute for Research in Reproduction (ICMR), Parel, Mumbai, India.

出版信息

J Immunoassay Immunochem. 2002;23(2):163-80. doi: 10.1081/IAS-120003659.

DOI:10.1081/IAS-120003659
PMID:12033641
Abstract

At our Institute, a panel of reproductive hormones, viz., estrone glucuronide (E1G), pregnanediol glucuronide (PdG), luteinising hormone (LH), and follicle stimulating hormone (FSH) are estimated by ELISA for the assessment of fertility from a single urine sample collected from a subject. In order to make the estimates less cumbersome, the selection and mode of presentation of immunoreagents of the assay were modified in such a way that, either on reconstitution or single dilution, would result in ready-to-use reagents in the assay. Retrospective analysis on the performance of these ELISAs with uniform protocols (n = 86) was compared with assays having individual assay protocols (n = 116). The performance of the assay, based on the standard curve characteristics and quality control pools, was better and the rate of acceptance of these assays improved from 87.9 to 97.6%. The simplification of assay protocols, thus, had better impact on the quality and reproducibility of immunoassay of the four analytes.

摘要

在我们研究所,通过酶联免疫吸附测定法(ELISA)对一组生殖激素进行测定,即雌酮葡萄糖醛酸苷(E1G)、孕二醇葡萄糖醛酸苷(PdG)、促黄体生成素(LH)和促卵泡生成素(FSH),以评估从受试者采集的单个尿液样本的生育能力。为了使测定过程不那么繁琐,对该检测的免疫试剂的选择和呈现方式进行了改进,使得在复溶或单次稀释时,均可在检测中得到即用型试剂。将这些采用统一方案(n = 86)的ELISA检测性能的回顾性分析与采用单独检测方案(n = 116)的检测进行了比较。基于标准曲线特征和质量控制样本,该检测的性能更佳,这些检测的接受率从87.9%提高到了97.6%。因此,检测方案的简化对这四种分析物免疫检测的质量和可重复性产生了更好的影响。

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