Rotavirus, vaccine failure or diagnostic error?
Rotavirus, vaccine failure or diagnostic error?
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DOI：
10.1016/j.vaccine.2016.10.032
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发表时间：
2016-11-21
期刊：
影响因子：
5.5
通讯作者：
Diez-Domingo, Javier
中科院分区：
文献类型：
--
作者：
Lopez-Lacort, Monica;Collado, Susana;Diez-Domingo, Javier
免疫层析 (ICG) 在临床环境中广泛用于轮状病毒 (RV) 诊断。测试的特异性因品牌类型而异，并非 100%，因此在疾病流行率较低时（即接种疫苗的儿童）使用该测试可能会导致一定比例的假阳性诊断。在某些地区，疫苗有效性研究或监测是使用 ICG 进行的。我们的目的是评估 ICG 测试在已接种疫苗的儿童中的有效性，并估计西班牙巴伦西亚地区假阳性结果的数量，该地区所有 RV 感染均使用 ICG 诊断，而不是通过 PCR 确诊。基于人群的登记用于识别 2008 年 1 月至 2012 年 6 月期间对 37 个月以下儿童进行的 RV 抗原测试的所有结果。通过唯一的识别号链接不同的数据库来获取患者的住院和疫苗接种状况。 ICG 测试的阳性预测值取决于儿童的疫苗接种状况、住院情况和轮状病毒季节，通过潜伏类别的贝叶斯模型进行估计。 在具有有效结果的 48,833 项测试中，9429 项是在已接种疫苗的儿童中进行的，其中 3963 项（42%）是在轮状病毒季节期间进行的。根据住院情况和季节性，疫苗接种阳性结果的发生率从 2.9% 到 21.4% 不等。当按这两个参数分层时，估计的 PPV 也从 27.1% 变化到 84.6%。据计算，全球范围内，接种疫苗的儿童中 520 例阳性中，约有 267 例 (51.3%) 为假阳性检测。由于接种疫苗期间和房车季节之外的检测次数过多，导致假阳性的比例很高，如果将其解释为疫苗失败，可能会导致对疫苗失去信心并降低对疫苗有效性的估计。 (C) 2016 Elsevier Ltd. 保留所有权利。
Immunochromatography (ICG) is highly used in clinical settings for rotavirus (RV) diagnosis. The specificity of the tests differs by brand type and is not 100%, therefore its use when the prevalence of the disease is low (i.e. in vaccinated children) may result in a proportion of false positive diagnoses.In some areas, vaccine effectiveness studies or surveillance is done using ICG. Our objective was to estimate the validity of ICG test in vaccinated children, and estimate the number of false positive results in the Valencian Region of Spain, where all RV infections are diagnosed using ICG and are not confirmed by PCR.Population based registries were used to identify all results from the RV antigen tests performed between January 2008 and June 2012 in children under 37 months. Hospitalization and vaccination status of the patients were obtained by linking different databases through a unique identification number. The Positive Predictive Value of the ICG test depending on the vaccination status of the child, hospitalization and the rotavirus season was estimated by a Bayesian model of latent classes.Of the 48,833 tests with valid results, 9429 were done in vaccinated children, and of those 3963 (42%) during the rotavirus season. The prevalence of positive results in vaccinated varied from 2.9 to 21.4% of the tests depending on the hospitalization and seasonality. The estimated PPV also varied from 27.1 to 84.6% when stratified by these two parameters. Globally it is calculated that approximately 267 out of the 520 (51.3%) positives in vaccinated children were false positive tests.The large percentage of false positives, due to an excessive number of tests in vaccinated and out of the RV season, if interpreted as vaccine failures, can cause a loss of confidence in the vaccine and lower the estimates of vaccine effectiveness. (C) 2016 Elsevier Ltd. All rights reserved.