Centre for Emerging Zoonotic and Parasitic Diseases, National Institute for Communicable Diseases of the National Health Laboratory Service, Sandringham, Johannesburg 2131, South Africa.
Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2050, South Africa.
Viruses. 2019 Jul 24;11(8):678. doi: 10.3390/v11080678.
Filovirus serological diagnosis and epidemiological investigations are hampered due to the unavailability of validated immunoassays. Diagnostic performance of three indirect enzyme-linked immunosorbent assays (I-ELISA) was evaluated for the detection of IgG antibody to Ebola virus (EBOV) in human sera. One I-ELISA was based on a whole EBOV antigen (WAg) and two utilized recombinant nucleocapsid (NP) and glycoproteins (GP), respectively. Validation data sets derived from individual sera collected in South Africa (SA), representing an EBOV non-endemic country, and from sera collected during an Ebola disease (EBOD) outbreak in Sierra Leone (SL), were categorized according to the compounded results of the three I-ELISAs and real time reverse-transcription polymerase chain reaction (RT-PCR). At the cut-off values selected at 95% accuracy level by the two-graph receiver operating characteristic analysis, specificity in the SA EBOV negative serum panel ( = 273) ranged from 98.17% (GP ELISA) to 99.27% (WAg ELISA). Diagnostic specificity in the SL EBOV negative panel ( = 676) was 100% by the three ELISAs. The diagnostic sensitivity in 423 RT-PCR confirmed EBOD patients was dependent on the time when the serum was collected after onset of disease. It significantly increased 2 weeks post-onset, reaching 100% sensitivity by WAg and NP and 98.1% by GP I-ELISA.
由于缺乏经过验证的免疫检测方法，丝状病毒血清学诊断和流行病学调查受到阻碍。评估了三种间接酶联免疫吸附测定（I-ELISA）检测人类血清中埃博拉病毒（EBOV）IgG 抗体的诊断性能。一种 I-ELISA 基于整个 EBOV 抗原（WAg），两种分别利用重组核衣壳（NP）和糖蛋白（GP）。来自南非（SA）的个体血清中收集的验证数据集，代表埃博拉病毒非流行国家，以及来自塞拉利昂（SL）埃博拉疾病（EBOD）爆发期间收集的血清，根据三种 I-ELISA 和实时逆转录聚合酶链反应（RT-PCR）的综合结果进行分类。在通过双图接收器操作特性分析选择的 95%准确性水平的截止值处，在 SA EBOV 阴性血清组（=273）中，特异性范围为 98.17%（GP ELISA）至 99.27%（WAg ELISA）。在 SL EBOV 阴性组（=676）中，三种 ELISA 的诊断特异性均为 100%。在 423 例 RT-PCR 确诊的 EBOD 患者中，诊断敏感性取决于发病后采集血清的时间。在发病后 2 周显著增加，WAg 和 NP 的敏感性达到 100%，GP I-ELISA 的敏感性达到 98.1%。
