Establishment of VCA and EBNA1 IgA-based combination by enzyme-linked immunosorbent assay as preferred screening method for nasopharyngeal carcinoma: a two-stage design with a preliminary performance study and a mass screening in southern China
Establishment of VCA and EBNA1 IgA-based combination by enzyme-linked immunosorbent assay as preferred screening method for nasopharyngeal carcinoma: a two-stage design with a preliminary performance study and a mass screening in southern China
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DOI：
10.1002/ijc.26380
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发表时间：
2012-07-15
影响因子：
6.4
通讯作者：
Hong, Minghuang
中科院分区：
文献类型：
--
作者：
Liu, Yue;Huang, Qihong;Hong, Minghuang
在中国南方进行了一项两阶段研究，以确定和验证EB病毒（EBV）相关血清标志物用于鼻咽癌（NPC）筛查的最佳组合。第一阶段采用酶联免疫吸附试验（ELISA）和免疫荧光试验（IFA）分别检测191例鼻咽癌患者和337例正常人血清中的VCA-IgA、EA-IgA、EB病毒核抗原1（EBNA 1-伊加）、EBNA 1-IgG、Zta-IgA和Rta-IgG;应用Logistic回归模型筛选出鼻咽癌诊断的最佳血清标志物组合。结果表明，ELISA法检测VCA-IgA和EA-IgA的诊断性能优于IFA法检测的同类血清标志物的上级性能。VCA-IgA与EBNA 1-伊加联合ELISA检测NPC的ROC曲线下面积（AUC）达0.97，敏感性为95.3%，特异性为94.1%。在第二阶段，从2008年5月至2009年2月，在中国四会市招募了5，481名年龄为30 - 59岁且没有NPC临床证据的参与者参加以人群为基础的NPC筛查项目。同时用新的和传统的筛查方案对他们的血清进行检测，8名早期NPC患者随后被组织病理学证实。传统筛查方案与新筛查方案的特异性相当（估计为98.5%），但新筛查方案的敏感性（75.0%）显著高于传统筛查方案（25.0%）。ELISA联合检测VCA-IgA和EBNA 1-伊加的效果优于传统的鼻咽癌筛查方案，有望成为鼻咽癌高发区鼻咽癌筛查的首选血清学诊断策略。
A two-stage study was conducted in southern China to determine and validate an optimal combination of Epstein-Barr virus (EBV)-related seromarkers for nasopharyngeal carcinoma (NPC) screening. In the first stage, six seromarkers [VCA-IgA, EA-IgA, Epstein-Barr virus nuclear antigen 1 (EBNA1-IgA), EBNA1-IgG, Zta-IgA and Rta-IgG] were detected by enzyme-linked immunosorbent assay (ELISA) and two traditional NPC screening seromarkers (VCA-IgA and EA-IgA) were detected by immunofluorescence assay (IFA) in serum samples from 191 NPC patients and 337 controls. An optimal combination of seromarkers for NPC diagnosis was selected using logistic regression models. Results showed that the diagnostic performances of VCA-IgA and EA-IgA tested by ELISA were superior to the performances of the same seromarkers by IFA. VCA-IgA combined with EBNA1-IgA by ELISA was identified as the optimal combination, with an area under the receiver operating characteristic (ROC) curve (AUC) up to 0.97, a sensitivity of 95.3% and a specificity of 94.1% for classification of NPCs vs. controls. In the second stage, 5,481 participants aged 3059 years and without clinical evidence of NPC were recruited into a population-based NPC screening program from May 2008 to February 2009 in Sihui City, China. Their sera were tested simultaneously by both the new and the traditional screening schemes and eight early stage NPC patients were subsequently histopathologically confirmed. The traditional and the new screening schemes had comparable specificity (estimated as 98.5%), but the sensitivity of the new scheme (75.0%) was significantly higher than that of the traditional one (25.0%). The combination of VCA-IgA and EBNA1-IgA by ELISA outperforms the traditional NPC screening scheme and could become the preferred serodiagnostic strategy for NPC screening in high-incidence areas.