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首页> 外文期刊>Journal of Clinical Microbiology >Evaluation of a visual, rapid, membrane enzyme immunoassay for the detection of herpes simplex virus antigen.
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Evaluation of a visual, rapid, membrane enzyme immunoassay for the detection of herpes simplex virus antigen.

机译：评估视觉，快速，膜酶免疫测定法，以检测单纯疱疹病毒抗原。

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We evaluated a 12-min, direct, monoclonal antibody-based enzyme immunoassay (EIA) (SureCell; Kodak, Rochester, N.Y.) which aids in the detection of herpes simplex virus infection; the assay system is also approved for culture confirmation. The test was evaluated from direct clinical samples and compared with conventional culture methodology by using a single swab. A total of 265 specimens from 180 female cervical-urogenital sites, 62 male urogenital sites, 4 rectal sites, 3 skin sites, 6 oral sites, and 10 colposcopy sites were collected on Dacron or cotton swabs and placed in viral transport medium (VTM). Within 6 h of receipt, 0.2 ml of the vortexed VTM was inoculated into each of two replicate cell cultures. Cell monolayers were observed daily for ten days, and cytopathic effect was confirmed by using an indirect immunoperoxidase reagent. The procedure for the SureCell assay conformed to the manufacturer's recommendations. When conventional culture was compared with EIA results, the overall sensitivity, specificity, positive predictive value, negative predictive value, and agreement were 64.4, 98.9, 96.7, 84.4, and 87.2%, respectively. Variables affecting the EIA sensitivity are the stage of the lesion and conventional culture methodologies. A review of culture results for 32 EIA false-negative tests indicated that 15 were detected after 48 h of incubation. Cytopathic effect observed at 48-, 72-, and 96-h cutoffs altered the sensitivity for the EIA. To ensure detection of SureCell herpes simplex virus-negative specimens, it is recommended that an unused aliquot of VTM be tested in cell culture.
机译：我们评估了一种12分钟的，直接的，基于单克隆抗体的酶免疫测定（EIA）（SureCell;柯达，罗彻斯特，纽约州），它有助于检测单纯疱疹病毒感染;该测定系统也被批准用于培养确认。从直接的临床样本中评估该测试，并使用单个拭子与常规培养方法进行比较。在涤纶或棉签上收集了总共265个标本，分别来自180个女性宫颈泌尿生殖器部位，62个男性泌尿生殖器部位，4个直肠部位，3个皮肤部位，6个口腔部位和10个阴道镜检查部位，并将其放置在病毒运输培养基（VTM）中。收到后6小时内，将0.2 ml涡旋VTM接种到两个重复细胞培养物中。每天观察细胞单层，持续十天，并通过使用间接免疫过氧化物酶试剂确认了细胞病变作用。 SureCell分析的程序符合制造商的建议。将常规培养与EIA结果进行比较时，总体敏感性，特异性，阳性预测值，阴性预测值和一致性分别为64.4％，98.9、96.7、84.4和87.2％。影响EIA敏感性的变量是病变的阶段和常规培养方法。对32个EIA假阴性试验的培养结果进行的审查表明，孵育48小时后检测到15个。在48、72和96小时截止时观察到的细胞病变效应改变了对EIA的敏感性。为确保检测到SureCell单纯疱疹病毒阴性标本，建议在细胞培养中测试未使用的VTM等分试样。

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