Novel recombinant-antigen enzyme immunoassay for serological diagnosis of syphilis
Novel recombinant-antigen enzyme immunoassay for serological diagnosis of syphilis
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DOI：
10.1128/jcm.36.4.913-917.1998
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发表时间：
1998-04-01
影响因子：
9.4
通讯作者：
McMillan, A
中科院分区：
文献类型：
--
作者：
Young, H;Moyes, A;McMillan, A
酶免疫分析法是一种理想的梅毒筛查方法。我们评估了一种新的免疫捕获EIA（ICE Sylidae; Murex Diagnostics），该EIA使用三种重组梅毒螺旋体抗原（TpN 15、TpN 17和TpN 47），并将结果与天然T.梅毒抗原EIA（Captia SelectSyph-G; Centocor），我们目前用于梅毒的血清学诊断。通过ICE Syphony和SelectSyph-G检测平行筛选1，184份梅毒血清标本来评价特异性，同时用来自不同感染阶段患者的101份含有抗密螺旋体抗体（治疗和未治疗）的血清标本测试灵敏度。ICESyph-G EIA的特异性（99.8%）显著高于SelectSyph-G EIA（99.2%）（P < 0.02）。在初始（99%对91.3%）和重复（100%对92.4%）检测中，ICE Syphine EIA的灵敏度显著高于SelectSyph-G EIA（P < 0.01）。ICE梅毒螺旋体EIA的敏感性也显著高于荧光抗体（92.4%）（P < 0.01），而T.苍白球血凝试验（97.1%）。含有抗密螺旋体抗体的血清通过ICE SyphilEIA比通过SelectSyph-G EIA给出高得多的抗体指数（测试血清/试剂盒截止值的吸光度）。Tl;与整体高灵敏度相结合，使ICE梅毒EIA成为排除或检测人类免疫缺陷病毒（HIV）感染患者梅毒螺旋体感染的理想检测方法。在研究中，来自所有15名HIV感染患者的血清的ICE SyphidEIA均为阳性，而来自3名HIV感染患者的血清的SelectSyph-G EIA为阴性。我们的结论是，高灵敏度和特异性的ICE Syphilis EIA和其适用于自动化使其成为一个理想的筛选试验。
Enzyme immunoassay (EIA) is an ideal method for screening large numbers of patients for syphilis. We evaluated a novel immune-capture EIA (ICE Syphilis; Murex Diagnostics) that uses three recombinant Treponema pallidum antigens (TpN15, TpN17, and TpN47) and compared the results with those obtained by the native T. pallidum antigen EIA (Captia SelectSyph-G; Centocor) that we currently use for the serodiagnosis of syphilis. Specificity was evaluated by screening 1,184 unselected serum specimens in parallel by the ICE Syphilis and SelectSyph-G assays, while sensitivity was tested with a panel of 101 serum specimens containing antitreponemal antibodies (treated and untreated) from patients with various' stages of infection. The specificity of the ICE Syphilis EIA (99.8%) on screening was significantly higher (P < 0.02) than that pf the SelectSyph-G EIA (99.2%). The sensitivity of the ICE Syphilis EIA was significantly higher (P < 0.01) than that of the SelectSyph-G EIA on both initial (99 versus 91.3%) and repeat (100 versus 92.4%) testing. The ICE Syphilis EIA was also significantly more sensitive (P < 0.01) than the fluorescent treponemal antibody-abs (92.4%) but not the T. pallidum hemagglutination assay (97.1%). Sera containing antitreponemal antibodies gave a much higher antibody index (absorbance of test serum/kit cutoff) by the ICE Syphilis EIA than by the SelectSyph-G EIA. Tl;is combined with the overall high sensitivity makes the ICE Syphilis EIA an ideal test for excluding or detecting treponemal infection In human immunodeficiency virus (HIV)-infected patients. The ICE Syphilis EIA was positive with sera from all 15 HIV-infected patients in the study, whereas sera from 3 HIV-infected patients were negative by the SelectSyph-G EIA. We conclude that the high sensitivity and specificity of the ICE Syphilis EIA and its suitability for automation make it an ideal screening test.