King s Sierra Leone Partnership, King's Centre for Global Health, King's College London, and King s Health Partners, London, United Kingdom.
Euro Surveill. 2015 Mar 26;20(12):21073. doi: 10.2807/1560-7917.es2015.20.12.21073.
Current Ebola virus disease (EVD) diagnosis relies on reverse transcription-PCR (RT-PCR) technology, requiring skilled laboratory personnel and technical infrastructure. Lack of laboratory diagnostic capacity has led to diagnostic delays in the current West African EVD outbreak of 2014 and 2015, compromising outbreak control. We evaluated the diagnostic accuracy of the EVD bedside rapid diagnostic antigen test (RDT) developed by the United Kingdom's Defence Science and Technology Laboratory, compared with Ebola virus RT-PCR, in an operational setting for EVD diagnosis of suspected cases admitted to Ebola holding units in the Western Area of Sierra Leone. From 22 January to 16 February 2015, 138 participants were enrolled. EVD prevalence was 11.5%. All EVD cases were identified by a positive RDT with a test line score of 6 or more, giving a sensitivity of 100% (95% confidence interval (CI): 78.2-100). The corresponding specificity was high (96.6%, 95% CI: 91.3-99.1). The positive and negative predictive values for the population prevalence were 79.0% (95% CI: 54.4-93.8) and 100% (95% CI: 96.7-100), respectively. These results, if confirmed in a larger study, suggest that this RDT could be used as a 'rule-out' screening test for EVD to improve rapid case identification and resource allocation.
目前的埃博拉病毒病(EVD)诊断依赖于反转录聚合酶链反应(RT-PCR)技术,需要熟练的实验室人员和技术基础设施。由于缺乏实验室诊断能力,导致 2014 年和 2015 年西非埃博拉疫情爆发时诊断出现延误,从而影响了疫情的控制。我们评估了英国国防科学技术实验室(Defence Science and Technology Laboratory)开发的 EVD 床边快速诊断抗原检测(RDT)在塞拉利昂西部埃博拉留观单位疑似病例 EVD 诊断中的临床应用效能,将其与 Ebola 病毒 RT-PCR 进行了比较。2015 年 1 月 22 日至 2 月 16 日,共纳入 138 名参与者。EVD 的患病率为 11.5%。所有 EVD 病例均通过 RDT 检测呈阳性(检测线评分≥6)而确定,其灵敏度为 100%(95%置信区间:78.2-100)。相应的特异性较高(96.6%,95%置信区间:91.3-99.1)。对于该人群的阳性和阴性预测值分别为 79.0%(95%置信区间:54.4-93.8)和 100%(95%置信区间:96.7-100)。如果在更大的研究中得到证实,这些结果表明,该 RDT 可作为 EVD 的“排除”筛查试验,以提高快速病例识别和资源分配的效率。