5 种抗弓形虫免疫球蛋白 G（IgG）免疫测定的标准化。
The standardization of 5 immunoassays for anti-Toxoplasma immunoglobulin G(IgG).
机构信息
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China.
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China.
出版信息
Clin Chim Acta. 2017 Sep;472:20-25. doi: 10.1016/j.cca.2017.07.007. Epub 2017 Jul 8.
BACKGROUND
Quantitative immunoassays to detect IgG antibodies are the most commonly used tests for diagnosing toxoplasmosis. We investigated the current state of standardization of quantitative immunoassays used to measure anti-Toxoplasma IgG levels.
METHODS
Four fully automated immunoassays (Architect i4000ISR, Immulite 2000 Xpi, Siemens; Liaison, DiaSorin; Cobas e601, Roche) and one manual immunoassay (ELISA classic Toxo IgG, Virion Serion) were performed on the following: individual patient serum samples, the WHO international standards, control samples, and calibrators provided by 5 immunoassay manufacturers. Statistical analysis was used to illustrate the results.
RESULTS
No perfect correlation (slope=1.0) was found between any 2 assays. Large differences in anti-Toxoplasma IgG titers were observed among the 5 immunoassays using serum samples from individual patients. Using IS 01/600 as a calibrator minimized the inter-assay variability of anti-Toxoplasma IgG values CONCLUSIONS: There is still significant effort needed towards standardization of anti-Toxoplasma IgG quantitative immunoassays.
背景
定量免疫分析检测 IgG 抗体是诊断弓形虫病最常用的检测方法。我们研究了用于测量抗弓形虫 IgG 水平的定量免疫分析的标准化现状。
方法
对以下四个全自动免疫分析（Architect i4000ISR、Immulite 2000 Xpi、西门子；Liaison、DiaSorin；Cobas e601、罗氏）和一个手动免疫分析（ELISA classic Toxo IgG、Virion Serion）进行了检测：个体患者血清样本、世界卫生组织国际标准、对照样本和 5 个免疫分析制造商提供的校准品。使用统计分析来阐明结果。
结果
没有发现任何两种检测方法之间存在完美的相关性（斜率=1.0）。使用来自个体患者的血清样本，在 5 种免疫分析方法中观察到抗弓形虫 IgG 滴度存在较大差异。使用 IS 01/600 作为校准品可最大限度地降低抗弓形虫 IgG 值的检测间变异性。
结论
在抗弓形虫 IgG 定量免疫分析的标准化方面仍需付出巨大努力。
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