We evaluated the performance of a candidate assay, the DENV1-4 nonstructural protein 1 (NS1) IgG enzyme-linked immunosorbent assay (ELISA), developed by the University of Hawaii (UH), using well-documented serum/plasma samples including those >20 years post-DENV infection, and tested samples from 199 study participants including 100 Dengvaxia recipients from the fever surveillance programs in the Philippines.
The sensitivity and specificity of the assay were 96.6% and 99.4%, respectively, which are higher than those reported for pre-vaccination screening. A significantly higher rate of symptomatic breakthrough DENV infection was found among children that were DENV-naïve (10/23) than among those that were DENV-immune (7/53) when vaccinated with Dengvaxia (p=0.004, Fisher\'s exact test), demonstrating the feasibility of the assay and algorithms in clinical practice.
The UH DENV1-4 NS1 IgG ELISA can determine baseline DENV serostatus among Dengvaxia recipients not only during non-acute dengue but also during breakthrough DENV infection, and has implications for assessing the long-term safety and effectiveness of Dengvaxia in the post-licensure period.
■我们评估了候选测定的性能,DENV1-4非结构蛋白1(NS1)IgG酶联免疫吸附试验(ELISA),由夏威夷大学(UH)开发,使用有据可查的血清/血浆样本,包括DENV感染后20年以上的样本,并测试了199名研究参与者的样本,其中包括100名来自菲律宾发烧监测计划的登瓦夏接受者。
■检测的灵敏度和特异度分别为96.6%和99.4%,分别,高于疫苗接种前筛查报告的水平。在未接触DENV(10/23)的儿童中,发现有症状的突发性DENV感染率明显高于接种Dengvaxia疫苗的DENV免疫儿童(7/53)(p=0.004,Fisher精确检验),证明分析和算法在临床实践中的可行性。
■UHDENV1-4NS1IgGELISA不仅可以在非急性登革热期间,而且可以在突发性DENV感染期间确定登革热受者的基线DENV血清状态,并对评估登瓦夏在许可后期间的长期安全性和有效性具有影响。