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以免疫荧光法为参考方法对四种市售爱泼斯坦-巴尔病毒酶免疫测定法进行评估。

Evaluation of four commercially available Epstein-Barr virus enzyme immunoassays with an immunofluorescence assay as the reference method.

作者信息

Gärtner Barbara C, Hess Ralf D, Bandt Dirk, Kruse Alexander, Rethwilm Axel, Roemer Klaus, Mueller-Lantzsch Nikolaus

机构信息

Department of Virology, EBV Reference Center, University Homburg/Saar, Homburg/Saar, Germany.

出版信息

Clin Diagn Lab Immunol. 2003 Jan;10(1):78-82. doi: 10.1128/cdli.10.1.78-82.2003.

Abstract

Four commercially available enzyme immunoassays (EIAs) (Novitec, Biotest, Virotech, and DiaSorin) were evaluated, with an indirect immunofluorescence assay as the reference method, for Epstein-Barr virus (EBV) VCA (viral capsid antigen) immunoglobulin G (IgG), VCA IgM, or EBNA (EBV nuclear antigen) IgG at three different locations (Homburg, Stuttgart, and Dresden). Serum samples from 66 immunocompetent patients with infectious mononucleosis, 73 patients without prior EBV infection, and 96 patients with past EBV infections and 29 serum samples with possible cross-reactions to other herpesviruses were included. In addition, 25 samples from an extensively pretested panel that is commercially available (Boston Biomedica) were tested. Each sample was tested at only one location. The four EIAs varied considerably in performance. When analyzing for EBV diagnosis, the Novitec assay performed the best, with 4.9% discrepant diagnoses, followed by the Biotest, Virotech, and DiaSorin assays, with 6.8, 11.7, and 14.0% discrepant diagnoses, respectively. On the basis of single-parameter analysis, the Novitec assay also showed the lowest number of discrepant results, with 3.5%, compared with the Virotech, Biotest, and DiaSorin assays, which produced 5.4, 6.4, and 8.6% discrepant results, respectively. VCA assays using affinity-purified native antigens performed better than assays with recombinant or synthetic antigens. The synthetic EBNA-1s showed the lowest concordance with the reference compared to recombinant p72. Commercially available EBV EIAs differed considerably in performance; however, some proved to be reliable and convenient alternatives to the indirect immunofluorescence assay for routine diagnostics. Native antigens, rather than synthetic peptides, are favored for EBV serology testing.

摘要

采用间接免疫荧光法作为参考方法,在三个不同地点(洪堡、斯图加特和德累斯顿)对四种市售酶免疫测定法(EIA)(诺维泰克、比奥泰、维罗泰克和迪亚索林)检测爱泼斯坦 - 巴尔病毒(EBV)的病毒衣壳抗原(VCA)免疫球蛋白G(IgG)、VCA IgM或EBV核抗原(EBNA)IgG的情况进行了评估。纳入了66例免疫功能正常的传染性单核细胞增多症患者、73例既往无EBV感染的患者、96例既往有EBV感染的患者的血清样本,以及29份可能与其他疱疹病毒发生交叉反应的血清样本。此外,还检测了来自一个经过广泛预测试的市售检测组(波士顿生物医学公司)的25份样本。每个样本仅在一个地点进行检测。这四种EIA的性能差异很大。在分析EBV诊断时,诺维泰克测定法表现最佳,诊断差异率为4.9%,其次是比奥泰、维罗泰克和迪亚索林测定法,诊断差异率分别为6.8%、11.7%和14.0%。基于单参数分析,诺维泰克测定法的差异结果数量也最低,为3.5%,相比之下,维罗泰克、比奥泰、迪亚索林测定法的差异结果分别为5.4%、6.4%和8.6%。使用亲和纯化天然抗原的VCA测定法比使用重组或合成抗原的测定法表现更好。与重组p72相比,合成的EBNA - 1与参考结果的一致性最低。市售的EBV EIA性能差异很大;然而,一些被证明是常规诊断中可靠且方便的间接免疫荧光法替代方法。EBV血清学检测更倾向于使用天然抗原而非合成肽。

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