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首页> 外文期刊>The Lancet Global Health >Determining dengue virus serostatus by indirect IgG ELISA compared with focus reduction neutralisation test in children in Cebu, Philippines: a prospective population-based study
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Determining dengue virus serostatus by indirect IgG ELISA compared with focus reduction neutralisation test in children in Cebu, Philippines: a prospective population-based study

机译：通过间接IgG ELISA测定登革热病毒Serostatus与菲律宾宿务儿童的焦点减少中和试验相比：一项潜在人口的研究

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Background Detection of dengue virus antibodies is important for understanding future dengue virus risk and for prevaccination screening. We aimed to evaluate the performance of a dengue IgG indirect ELISA in determining dengue seroprevalence in a cohort of children in the Philippines, using a focus reduction neutralisation test (FRNT) as the reference test. Methods In this prospective population-based cohort study, we enrolled healthy children residing in Bogo or Balamban, Cebu, Philippines, who were to be aged 9–14 years at the time of a mass dengue vaccination campaign. Sera were collected from participants and batch tested by indirect IgG ELISA and FRNT. The primary endpoint was dengue seroprevalence in the cohort, detected by ELISA, and validated by that detected by reference FRNT. This study is registered with ClinicalTrials.gov , NCT03465254 . Findings We collected 2996 serum samples between May 2, and June 2, 2017, and we tested each sample with IgG ELISA. Using 1961 samples (65·5%) that were tested with FRNT, and 1035 samples (34·5%) with imputed results, we found that 320 (10·7%) of 2996 children were dengue naive and 2676 (89·3%) were seropositive for previous dengue virus infection. Based on the 1961 non-imputed FRNT results classified as dengue seronegative or seropositive, the ELISA (with a 0·9 index value cutoff) showed 95·2% sensitivity, 93·4% specificity, 6·6% false positivity, and 4·8% false negativity. However, sensitivity of the ELISA was poor (77·1%) among children with immunity to just one dengue virus serotype. Of the 11 sera that were false positive with ELISA, seven samples (63·6%) were seropositive for Zika virus or Japanese encephalitis virus with FRNT. Interpretation Most children (89·3%) assessed in our study and eligible to participate in the mass dengue vaccination campaign were seropositive for previous dengue virus infection. Compared with FRNT, ELISA had high sensitivity and specificity (90%), but the false-negative and false-positive rates makes the test suboptimal for prevaccination screening. Individuals who are falsely identified as seropositive by dengue IgG ELISA and then vaccinated might be at risk of developing severe disease during a subsequent exposure to wild-type dengue virus. Those with a monotypic profile would benefit the most from vaccination, but the sensitivity of the IgG ELISA was much lower in this group than in those with a multitypic profile. Funding Philippine Department of Health, Hanako Foundation, WHO, Swedish International Development Cooperation Agency through the International Vaccine Institute, and University of North Carolina, Chapel Hill, NC, USA.
机译：登革热病毒抗体的背景检测对于了解未来登革热病毒和预留筛查是重要的。我们旨在评估登革船IGG间接ELISA在菲律宾儿童队列中的登革热Seroprevalys的表现，使用聚焦还原试验（FRNT）作为参考测试。方法在本潜在人口的队列队列研究中，我们注册了居住在菲律宾宿务宿务宿务驻培斯巴或巴勒布兰的健康儿童，他在大规模登革热疫苗接种活动时期为9-14岁。从参与者和间接IgG ELISA和FRNT测试的分批收集血清。主要终点是由ELISA检测到的群组中的登革热血管升压，并通过参考FRNT检测到的核对。本研究以ClinicalTrials.gov，NCT03465254注册。调查结果我们在2017年5月2日和2017年6月2日之间收集了2996个血清样本，我们用IgG Elisa测试了每个样品。使用FRNT测试的1961个样品（65·5％），以及1035个样品（34·5％），结果，我们发现320（10·7％）的2996名儿童是登革热天真，2676（89·3 ％）为先前登革病毒感染是血清阳性。基于1961年的非算术FRNT结果分类为登革热血清基，ELISA（具有0·9指数截止值）显示95·2％敏感性，93·4％特异性，6·6％的假阳性，4 ·8％的错误消极性。然而，ELISA的敏感性差（77·1％），只有一个登革热病毒血清型。在患有ELISA的错误阳性的11个血清中，七个样本（63·6％）是ZIKA病毒或日本脑炎病毒的血清阳性，与FRNT。在我们的研究中评估的大​​多数儿童（89·3％）并有资格参加大众登革热疫苗疫苗系列对先前登革热病毒感染的血清阳性。与FRNT相比，ELISA具有高敏感性和特异性（> 90％），但假阴性和假阳性率使得测试次优为预处理筛查。被证明IgG ELISA被错误地识别为血清阳性的个体，然后接种疫苗的疫苗可能存在在随后暴露于野生型登革病毒期间发育严重疾病的风险。那些有单型剖面的人将受益于疫苗接种中最多的，但IgG ELISA的敏感性在该组中比具有多重性概况的敏感性远低得多。资助菲律宾卫生部，汉高基金会，瑞典国际发展合作机构通过国际疫苗研究所，美国北卡罗来纳大学，美国北部教堂山。

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