Evaluation of rapid diagnostic tests and conventional enzyme-linked immunosorbent assays to determine prior dengue infection
Evaluation of rapid diagnostic tests and conventional enzyme-linked immunosorbent assays to determine prior dengue infection
复制标题
DOI：
10.1093/jtm/taz078
复制
发表时间：
2019-01-01
影响因子：
25.7
通讯作者：
Ataman-Onal, Yasemin
中科院分区：
文献类型：
--
作者：
Bonaparte, Matthew;Zheng, Lingyi;Ataman-Onal, Yasemin
背景资料：2018年9月，世界卫生组织建议对四价登革热疫苗（CYD-TDV）进行接种前筛查，以确保只有有登革热感染证据的个体才能接种疫苗。登革快速诊断试验（RDT）将提供一种潜在的解决方案，用于在护理点进行疫苗接种前筛查，但现有RDT用于识别PDI的性能数据有限。我们确定了四个登革RDTs和两个传统的酶联免疫吸附试验（ELISA），以确定PDI和评估与共循环flaviviruses.Methods的交叉反应的适用性：特异性进行了评估，使用534登革热阴性[确定50%空斑减少中和试验（PRNT 50）]从美国（n = 229）和登革热流行地区（n = 305）的血清样本。使用来自最近（n = 90）或远程（n = 90）病毒学确认的先前登革热病例的270个样本和登革热PRNT 50阳性样本（n = 90）评估灵敏度。在登革热血清阴性样本中评估交叉反应性，这些样本对黄热病（n = 57）、日本脑炎（n = 37）、西尼罗河病毒（n = 59）或寨卡病毒（n = 41）血清阳性。结果：登革热IgG RDTs和Panbio ELISA表现出良好的特异性（99-100%），高于Focus ELISA（95%）。RDT的灵敏度（40-70%）低于ELISA（>= 90%）。RDT与其他黄病毒的交叉反应性较低（
Background: In September 2018, the World Health Organization recommended that prevaccination screening be used with the tetravalent dengue vaccine (CYD-TDV), to ensure that only individuals with evidence of prior dengue infection (PDI) are vaccinated. Dengue rapid diagnostic tests (RDTs) would offer a potential solution for prevaccination screening at the point-of-care, but data on performance of available RDTs for identifying PDI are limited. We determined the suitability of four dengue RDTs and two conventional enzyme-linked immunosorbent assays (ELISAs) to identify PDI and evaluated cross-reactivity with co-circulating flaviviruses.Methods: Specificity was assessed using 534 dengue-negative [determined by 50% plaque reduction neutralization test (PRNT50)] serum samples from USA (n = 229) and dengue-endemic regions (n = 305). Sensitivity was assessed using 270 samples from recent (n = 90) or remote (n = 90) virologically confirmed prior dengue cases, and dengue PRNT50-positive samples (n = 90). Cross-reactivity was assessed in dengue-seronegative samples that were seropositive for yellow fever (n = 57), Japanese encephalitis (n = 37), West Nile (n = 59) or Zika (n = 41).Results: Dengue IgG RDTs and the Panbio ELISA exhibited favourable specificities (99-100%), higher than the Focus ELISA (95%). The RDTs had variable sensitivities (40-70%) that were lower than those of the ELISAs (>= 90%). Cross-reactivity to other flaviviruses was low with RDTs (