Evaluation of a point-of-care blood test for identification of Ebola virus disease at Ebola holding units, Western Area, Sierra Leone, January to February 2015

Evaluation of a point-of-care blood test for identification of Ebola virus disease at Ebola holding units, Western Area, Sierra Leone, January to February 2015
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DOI:
10.2807/1560-7917.es2015.20.12.21073
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发表时间:
2015-03-26
期刊:
影响因子:
19
通讯作者:
Brooks, T.
Brooks, T.
中科院分区:
医学2区
文献类型:
--
作者:
Walker, N. F.;Brown, C. S.;Brooks, T.

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目前埃博拉病毒病(EVD)的诊断依赖于逆转录-聚合酶链式反应(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,导致目前西非2014和2015年埃博拉病毒病暴发的诊断出现延误,影响了疫情控制。我们评估了英国国防科学和技术实验室开发的埃博拉病毒床边快速诊断抗原检测(RDT)的诊断准确性,并与埃博拉病毒RT-PCR进行了比较,以对塞拉利昂西部地区埃博拉病毒收治病房收治的疑似病例进行埃博拉病毒诊断。从2015年1月22日至2月16日,共有138人参加。EVD患病率为11.5%。所有EVD病例均以RDT阳性为标准,测线评分在6分或以上,敏感性为100%(95%可信区间:78.2~100)。相应的特异度高(96.6%,95%CI:91.3~99.1)。对人群患病率的阳性预测值为79.0%(95%CI:54.4~93.8),阴性预测值为100%(95%CI:96.7~100)。这些结果如果在更大的研究中得到证实,表明这种RDT可以用作埃博拉病毒病的“排除”筛查试验,以改进快速病例识别和资源分配。
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.