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应用磁珠化学发光免疫分析法检测包虫病 IgG 抗体。

Determination of echinococcosis IgG antibodies using magnetic bead-based chemiluminescence immunoassay.

机构信息

Guangzhou Youdi Bio-Technology Co., Ltd., Guangzhou 510663, China; Jinan Laide Biotechnology Co., Ltd., Jinan 271100, China.

Guangzhou Youdi Bio-Technology Co., Ltd., Guangzhou 510663, China.

出版信息

J Immunol Methods. 2023 Sep;520:113513. doi: 10.1016/j.jim.2023.113513. Epub 2023 Jun 10.

Abstract

Echinococcosis is a kind of parasitic disease shared by humans and animals. The aim of this study was to establish a new detection method for echinococcosis screening using magnetic bead-based chemiluminescence immunoassay (CLIA). A magnetic bead-based CLIA to determine anti-echinococcosis IgG antibodies was optimized and established. The sensitivity, accuracy, precision and recovery rate were evaluated using the national reference serum, and the reference interval, specificity and comparison assays were performed using the clinical negative/positive echinococcosis serum samples. This study established a new CLIA to determine anti-echinococcosis IgG antibodies. The sensitivity of this CLIA method was higher than that of the registered ELISA kit and the national standard, the conformance rate of the negative/positive references was 100% (8/8), the CVs of the sensitivity reference were all below 5%, and the CVs of the precision reference were 5.7%. There was no obvious cross-reactivity with the common parasitic disease-positive serum and serum interferents. Clinical sample testing found that the cutoff value of this CLIA was 5537.15 (RLU), and there was no significant difference between the CLIA method and the registered ELISA kit. This study established a fully automated CLIA method with high sensitivity, specificity, accuracy, precision, recovery rate, and satisfactory clinical testing performance, which may provide a new choice for echinococcosis screening.

摘要

包虫病是一种人与动物共患的寄生虫病。本研究旨在建立一种基于磁珠化学发光免疫分析(CLIA)的包虫病筛查新检测方法。优化并建立了基于磁珠的 CLIA 来检测抗包虫病 IgG 抗体。使用国家参考血清评估了灵敏度、准确性、精密度和回收率,并使用临床阴性/阳性包虫病血清样本进行了参考区间、特异性和比较分析。本研究建立了一种新的 CLIA 来检测抗包虫病 IgG 抗体。该 CLIA 方法的灵敏度高于已注册的 ELISA 试剂盒和国家标准,阴性/阳性参考的符合率为 100%(8/8),灵敏度参考的 CV 均低于 5%,精密度参考的 CV 为 5.7%。与常见寄生虫病阳性血清和血清干扰物无明显交叉反应。临床样本检测发现,该 CLIA 的截止值为 5537.15(RLU),与已注册的 ELISA 试剂盒无显著差异。本研究建立了一种全自动 CLIA 方法,具有高灵敏度、特异性、准确性、精密度、回收率和令人满意的临床检测性能,可为包虫病筛查提供新的选择。

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