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用于诊断阿根廷出血热的酶免疫吸附测定法的评估

Evaluation of an enzyme immunosorbent assay for the diagnosis of Argentine haemorrhagic fever.

作者信息

Riera L M, Feuillade M R, Saavedra M C, Ambrosio A M

机构信息

Instituto Nacional de Enfermedades Virales Humanas Dr. Julio I. Maiztegui, Pergamino, Argentina.

出版信息

Acta Virol. 1997 Dec;41(6):305-10.

PMID:9607087
Abstract

To elaborate a set of serological tests for the diagnosis of Argentine haemorrhagic fever (AHF), an enzyme-linked immunosorbent assay (ELISA) for detection of specific anti-Junin virus (JV) IgG is described, and its performance is compared with that of the plaque reduction neutralization test (PRNT). The reproducibility, sensitivity, specificity, and confidence limits for positive and negative results for ELISA were statistically analysed. The value of 800 was demonstrated as the lowest positive titer. Titers > or = 800 varied within one (two-fold) dilution in 95.6% of the tests, while the sensitivity and specificity were 99.2% and 98.8%, respectively. The assay yielded 1% of false positives and 0.05% of false negatives. A comparison of ELISA to PRNT in detecting the seroconversion for JV was studied by the chi square test (comparison of proportions in paired samples) and the K parameter for agreement proportion. Comparison of ELISA to PRNT showed no significant difference in the proportions of positive and negative results of these assays (P < 0.01), demonstrating an equivalent performance (K = 0.98) in the diagnosis of AHF. In addition, the simplicity and safety of the procedures involved make this ELISA the most suitable test to detect natural human JV infections.

摘要

为了精心设计一套用于诊断阿根廷出血热(AHF)的血清学检测方法,本文描述了一种用于检测特异性抗胡宁病毒(JV)IgG的酶联免疫吸附测定(ELISA),并将其性能与蚀斑减少中和试验(PRNT)进行比较。对ELISA阳性和阴性结果的重复性、敏感性、特异性及置信限进行了统计学分析。确定800为最低阳性滴度值。在95.6%的检测中,滴度≥800在一个(两倍)稀释度范围内变化,而敏感性和特异性分别为99.2%和98.8%。该检测产生1%的假阳性和0.05%的假阴性。通过卡方检验(配对样本比例比较)和一致性比例的K参数研究了ELISA与PRNT在检测JV血清转化方面的比较。ELISA与PRNT的比较显示,这些检测的阳性和阴性结果比例无显著差异(P<0.01),表明在AHF诊断中具有同等性能(K=0.98)。此外,所涉及程序的简单性和安全性使这种ELISA成为检测人类自然JV感染的最合适检测方法。

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