PDF(Pubmed)
Abstract：
The Advisory Committee on Immunization Practices (ACIP) recommended that dengue pre-vaccination screening tests for Dengvaxia administration have at least 98% specificity and 75% sensitivity. This study evaluates the performance of commercial anti-DENV IgG tests to identify tests that could be used for pre-vaccination screening. First, for 7 tests, we evaluated sensitivity and specificity in early convalescent dengue virus (DENV) infection, using 44 samples collected 7-30 days after symptom onset and confirmed by RT-PCR. Next, for the 5 best performing tests and two additional tests (with and without an external test reader) that became available later, we evaluated performance to detect past dengue infection among a panel of 44 specimens collected in 2018-2019 from healthy 9-16-year-old children from Puerto Rico. Finally, a full-scale evaluation was done with the 4 best performing tests using 400 specimens from the same population. We used virus focus reduction neutralization test and an in-house DENV IgG ELISA as reference standards. Of seven tests, five showed ≥75% sensitivity detecting anti-DENV IgG in early convalescent specimens with low cross-reactivity to Zika virus. For the detection of previous DENV infections the tests with the highest performance were the Euroimmun NS1 IgG ELISA (sensitivity 84.5%, specificity 97.1%) and CTK Dengue IgG rapid test R0065C with the test reader (sensitivity 76.2% specificity 98.1%). There are IgG tests available that can be used to accurately classify individuals with previous DENV infection as eligible for dengue vaccination to support safe vaccine implementation.
摘要：
免疫实践咨询委员会（ACIP）建议登革热疫苗接种前筛查试验对登革热的给药具有至少98％的特异性和75％的敏感性。这项研究评估了商业抗DENVIgG测试的性能，以鉴定可用于疫苗接种前筛查的测试。首先,对于7个测试，我们评估了早期恢复期登革病毒（DENV）感染的敏感性和特异性，使用在症状发作后7-30天收集并通过RT-PCR确认的44个样本。接下来,对于后来可用的5个性能最佳的测试和两个额外的测试（有和没有外部测试读取器），我们评估了2018-2019年从波多黎各9-16岁健康儿童收集的44份样本中检测过去登革热感染的性能.最后,使用来自同一人群的400个样本,对4个表现最好的测试进行全面评估.我们使用病毒焦点减少中和测试和内部DENVIgGELISA作为参考标准。在七个测试中，5例患者在对寨卡病毒具有低交叉反应性的恢复期早期标本中检测抗DENVIgG的灵敏度≥75%。对于以前的DENV感染的检测，性能最高的测试是EuroimmunNS1IgGELISA（灵敏度84.5％，特异性97.1％）和CTK登革热IgG快速测试R0065C与测试读数（灵敏度76.2％特异性98.1％）。有可用的IgG测试，可用于准确地将先前的DENV感染的个体分类为有资格进行登革热疫苗接种，以支持安全的疫苗实施。
