Performance of focus ELISA tests for herpes simplex virus type 1 (HSV-1) and HSV-2 antibodies among women in ten diverse geographical locations
Performance of focus ELISA tests for herpes simplex virus type 1 (HSV-1) and HSV-2 antibodies among women in ten diverse geographical locations
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DOI：
10.1111/j.1469-0691.2004.00836.x
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发表时间：
2004-06-01
影响因子：
14.2
通讯作者：
Smith, J
中科院分区：
文献类型：
--
作者：
Ashley-Morrow, R;Nollkamper, J;Smith, J
为了确定Focus HerpeSelect ELISA的灵敏度和特异性，在8个国家的10个城市收集了18-55岁女性的血清或血浆样本，并通过HerpeSelect HSV-1 ELISA（Focus-HSV-1）和HerpeSelect HSV-2 ELISA（Focus-HSV-2）进行检测。对具有Focus-HSV-2阳性结果的血清进行复检; 3617份复检样本中94%为阳性。然后基于HSV-2结果选择来自每个位点的血清子集，并通过蛋白质印迹（WB）进行检测。用来自10个研究中心（n = 967）的Focus-HSV-1样本和来自7个研究中心（n = 675）的Focus-HSV-2样本测定灵敏度和特异性。对于97%的样本，Focus-HSV-1和WB结果一致（均为阴性或均为阳性），灵敏度为99%，特异性为77%。来自泰国Songkla的标本与HSV-1的WB结果具有84%的一致性，而其他三个地点具有100%的一致性。Focus-HSV-2和WB的一致性为92%，敏感性为97%，特异性为89%。尼日利亚伊巴丹的一致性为78%。在伊巴丹以外的其他部位，Focus-HSV-2的敏感性和特异性分别为97%和93%。将HSV-2的阳性临界指数值从1.1提高到3.5，敏感性为90%，特异性为96%。对于除尼日利亚以外的具有较高临界值的研究中心，灵敏度为90%，特异性为98%。总之，Focus-HSV-1和Focus-HSV-2检测的灵敏度和特异性因研究中心而异。在一个地区产生的业绩数据可能不适用于其他人群。
To determine the sensitivity and specificity of Focus HerpeSelect ELISAs, sera or plasma samples from women aged 18-55 years were collected in ten cities from eight countries and tested by HerpeSelect HSV-1 ELISA (Focus-HSV-1) and by HerpeSelect HSV-2 ELISA (Focus-HSV-2). Sera with Focus-HSV-2-positive results were retested; 94% of the 3617 samples retested were positive. A subset of sera from each site was then selected, based on the HSV-2 results, and tested by Western blot (WB). The sensitivity and specificity were determined with samples from ten sites (n = 967) for Focus-HSV-1 and from seven sites (n = 675) for Focus-HSV-2. Focus-HSV-1 and WB results were concordant (both negative or both positive) for 97% of samples, with 99% sensitivity and 77% specificity. Specimens from Songkla, Thailand had 84% concordance with WB results for HSV-1, while three other sites had 100% concordance. Concordance of Focus-HSV-2 and WB was 92%, with 97% sensitivity and 89% specificity. Ibadan, Nigeria had 78% concordance. Focus-HSV-2 sensitivity and specificity in sites other than Ibadan were 97% and 93%, respectively. Raising the positive cut-off index value for HSV-2 from 1.1 to 3.5 yielded a sensitivity of 90% and a specificity of 96%. A sensitivity of 90% and a specificity of 98% were achieved for sites other than Nigeria with the higher cut-off. In summary, the sensitivity and specificity of the Focus-HSV-1 and Focus-HSV-2 tests varied by site. Performance data generated in one area may not be applicable to other populations.