ELISA system for detection of immune responses to FVIII: a study of 246 samples and correlation with the Bethesda assay.
ELISA system for detection of immune responses to FVIII: a study of 246 samples and correlation with the Bethesda assay.
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用于检测 FVIII 免疫反应的 ELISA 系统：对 246 个样本的研究以及与 Bethesda 测定的相关性。
DOI：
10.1111/j.1365-2516.2007.01450.x
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发表时间：
2007
期刊：
影响因子：
--
通讯作者：
Thompson,AR
中科院分区：
文献类型：
--
作者：
Sahud,MA;Pratt,KP;Zhukov,O;Qu,K;Thompson,AR
FVIII的抑制剂通常是IgG多克隆抗体，其在先天性血友病A患者中作为同种免疫应答或作为导致获得性血友病的自身免疫应答发展。它们的识别可能很困难，特别是当滴度较低时。此外，Bethesda检测的结果通常需要数天，因为样本被提交给专业实验室。本研究的目的是评估ELISA系统用于检测对FVIII的免疫应答的效用。使用基于ELISA的测定法检测了来自176名对FVIII有免疫应答的个体（经Bethesda测定法验证）的共246份血浆样本和来自50名对照受试者的样本中是否存在FVIII特异性IgG。还通过ELISA检测了来自18名患者的配对血清。在通过Bethesda试验检测为FVIII抑制剂阳性的246份样本中，235份（95.5%）通过ELISA检测也为阳性。使用Log BU的回归系数为r = 0.82。 当27个抑制剂样品进一步稀释时，相关数据得到加强。18对血清和血浆样本的ELISA结果之间存在强相关性（r= 0.99）。 ELISA和Bethesda方法在检测对FVIII的免疫应答方面具有很强的相关性。ELISA提供了快速筛查，可以在Bethesda检测确认之前很好地进行。
Inhibitors of FVIII are usually IgG polyclonal antibodies that develop as alloimmune responses in patients with congenital haemophilia A or as autoimmune responses resulting in acquired haemophilia. Their recognition can be difficult, especially when the titre is low. Furthermore, results from a Bethesda assay often require several days as samples are referred to a specialty laboratory. The aim of this study is to assess the utility of an ELISA system for detecting immune responses to FVIII. A total of 246 plasma samples submitted from 176 individuals with immune responses to FVIII, as verified with the Bethesda assay, and samples from 50 control subjects were tested for the presence of FVIII‐specific IgG using an ELISA‐based assay. Paired sera from 18 of the patients were also tested by the ELISA. Of the 246 samples that were positive for a FVIII inhibitor by the Bethesda assay, 235 (95.5%) were also positive by ELISA. The regression coefficient, using Log BU wasr= 0.82. The correlation data were strengthened when 27 inhibitor samples were diluted further. There was a strong correlation between ELISA results for the 18‐paired serum and plasma samples (r= 0.99). There is a strong correlation between the ELISA and Bethesda methods in detecting immune responses to FVIII. The ELISA provides rapid screening that could be available well in advance of confirmation by the Bethesda assay.