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首页> 外文期刊>Vaccine >Multicenter comparative study of a new ELISA, PLATELIA RABIES II, for the detection and titration of anti-rabies glycoprotein antibodies and comparison with the rapid fluorescent focus inhibition test (RFFIT) on human samples from vaccinated and non-
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Multicenter comparative study of a new ELISA, PLATELIA RABIES II, for the detection and titration of anti-rabies glycoprotein antibodies and comparison with the rapid fluorescent focus inhibition test (RFFIT) on human samples from vaccinated and non-

机译：新型ELISA PLATELIA RABIES II的多中心比较研究，用于检测和滴定抗狂犬病糖蛋白抗体，并与来自和未接种疫苗的人类样品的快速荧光聚焦抑制试验（RFFIT）进行比较

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The envelope glycoprotein G of rabies virus induces the production of neutralising antibodies, which are important in protection against rabies. Therefore, titration of anti-envelope glycoprotein antibodies is a good indicator of the degree of immunity in people during anti-rabies treatment or after vaccination. According to the World Health Organization (WHO) guidelines, a booster vaccine dose should be given if the rabies antibody titre falls below 0.5 IU/ml. Titration of anti-rabies antibodies is also useful for plasma centers in the preparation and standardization of human anti-rabies gamma-globulins for therapeutic use and to a lesser extent for the diagnosis of rabies in human sera and cerebrospinal fluid (CSF). This paper presents a new enzyme-linked immunosorbent assay (ELISA), PLATELIA RABIES II, developed for rabies envelope glycoprotein antibody detection or titration and its comparison to the current reference method (RFFIT). The data collected during validation of the test in a multicenter study are analysed to give a sound overall knowledge of the capabilities of the PLATELIA RABIES II, for instance specificity, linearity, accuracy, precision, detection limit and quantitation limit. To this aim, human serum samples from a total of 1348 vaccinated or non-vaccinated people were tested in parallel using the new ELISA and the RFFIT for the presence of anti-rabies antibodies. Data generated indicate a linear relationship across the range of titration between the two methods. The sensitivity reaches 98.6% and the specificity 99.4%. This study indicates that this new ELISA test is as sensitive and specific as the current standardized reference method. The method is simple, safe, rapid and can be considered as a useful alternative to the neutralisation test.
机译：狂犬病病毒的包膜糖蛋白G诱导中和抗体的产生，这在预防狂犬病中很重要。因此，抗信封糖蛋白抗体的滴定是抗狂犬病治疗期间或接种疫苗后人们免疫力的良好指标。根据世界卫生组织（WHO）指南，如果狂犬病抗体滴度低于0.5 IU / ml，则应给予加强疫苗剂量。抗狂犬病抗体的滴定也可用于血浆中心，用于制备和标准化用于治疗用途的人抗狂犬病γ-球蛋白，并在较小程度上用于诊断人血清和脑脊液（CSF）中的狂犬病。本文介绍了一种新的酶联免疫吸附测定法（ELISA），PLATELIA RABIES II，用于狂犬病毒包膜糖蛋白抗体的检测或滴定，并与当前的参考方法（RFFIT）进行了比较。分析在多中心研究中验证测试期间收集的数据，以全面了解PLATELIA RABIES II的功能，例如特异性，线性，准确性，精密度，检测限和定量限。为此，使用新的ELISA和RFFIT平行测试了来自1348名接种疫苗或未接种疫苗的人群的人血清样品中是否存在抗狂犬病抗体。生成的数据表明两种方法之间的滴定范围呈线性关系。灵敏度达到98.6％，特异性达到99.4％。这项研究表明，这种新的ELISA检测方法与当前的标准化参考方法一样灵敏，特异。该方法简单，安全，快速，可以认为是中和测试的有用替代方法。

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