Field Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection
Field Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection
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DOI：
10.1093/infdis/jiw261
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发表时间：
2016-10-15
影响因子：
6.4
通讯作者：
Garry, Robert F.
中科院分区：
文献类型：
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作者：
Boisen, Matthew L.;Cross, Robert W.;Garry, Robert F.
背景。2013-2016年西非埃博拉病毒病（EVD）流行是有记录以来规模最大的一次。基于临床症状的分诊成功率有限，通过定量逆转录聚合酶链反应（qRT-PCR）进行诊断的时间可能超过5天。在这里，我们描述了ReEBOV抗原快速检测（ReEBOV RDT）的开发和现场验证，以帮助对疑似埃博拉病毒感染者进行分类。方法：2014年，将疑似埃博拉病毒患者的欧洲整体样本提交给塞拉利昂凯内马政府医院，用于拉沙热和埃博拉病毒病筛查。在2014年11月和2015年1月进行了一项盲法现场试验，以评估ReEBOV RDT的临床有效性，并与ebov特异性qrt - pcr进行了比较。euro积分初步ReEBOV RDT表现为91.1%（214个结果中的195个；95%置信区间[CI]， 86.5%-94.6%）的正百分比一致性（PPA）和90.2%（194个结果中的175个；95% CI, 85.1%-94.0%）的负百分比一致性（NPA）。在排除qRT-PCR参考方法阈值的情况下，美国食品和药物管理局用于确定是否批准该检测的紧急使用授权的最终估计结果是PPA为62.1%(116个结果中的72个；95% CI, 52.6%-70.9%)， NPA为96.7%(60个结果中的58个；95% CI, 88.5%-99.6%)，诊断可能性为18.6。世界卫生组织随后进行的独立评估得出的结果与初步性能估计一致。结论：欧洲一体化ReEBOV RDT显示了提供临床有效、快速和准确的即时检测结果的潜力，因此，它是提高分诊效率的有力工具。
Background. The 2013-2016 West African Ebola virus disease (EVD) epidemic is the largest recorded. Triage on the basis of clinical signs had limited success, and the time to diagnosis by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) could exceed 5 days. Here we describe the development and field validation of the ReEBOVAntigen Rapid Test (ReEBOV RDT) to aid triage of individuals with suspected EVD.Methods.aEuro integral Samples from patients with suspected EVD were submitted to Kenema Government Hospital, Sierra Leone, for Lassa fever and EVD screening throughout 2014. Banked residual clinical samples were tested in November 2014 and January 2015 in a blinded field trial to estimate the clinical effectiveness of the ReEBOV RDT, compared with EBOV-specific qRT-PCR.Results.aEuro integral Preliminary ReEBOV RDT performance demonstrated a positive percentage agreement (PPA) of 91.1% (195 of 214 results; 95% confidence interval [CI], 86.5%-94.6%) and a negative percentage agreement (NPA) of 90.2% (175 of 194; 95% CI, 85.1%-94.0%). The final estimates used by the Food and Drug Administration to determine whether to grant emergency use authorization for the test, which excluded a qRT-PCR reference method threshold cutoff, were a PPA of 62.1% (72 of 116 results; 95% CI, 52.6%-70.9%) and a NPA of 96.7% (58 of 60; 95% CI, 88.5%-99.6%), with a diagnostic likelihood of 18.6. A subsequent, independent evaluation by the World Health Organization generated results consistent with the preliminary performance estimates.Conclusions.aEuro integral The ReEBOV RDT demonstrated the potential to provide clinically effective rapid and accurate point-of-care test results and, thus, to be a powerful tool for increasing triage efficiency.