School of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; NIHR Post Doctoral Fellowship Programme, UK.
School of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
J Infect. 2020 Oct;81(4):607-613. doi: 10.1016/j.jinf.2020.06.051. Epub 2020 Jun 21.
Management of the COVID-19 pandemic is hampered by long delays associated with centralised laboratory PCR testing. In hospitals this leads to poor patient flow and nosocomial transmission and so rapid, accurate diagnostic tests are urgently required. The FebriDx is a point-of-care test that detects an antiviral host response protein in finger prick blood within 10 min, but its accuracy for the identification of COVID-19 is unknown.
We performed a real-world diagnostic accuracy study of FebriDx in hospitalised patients during the first wave of the pandemic. Measures of diagnostic accuracy were calculated based on FebriDx results compared to the reference standard of SARS-CoV-2 PCR on combined nose and throat swabs. A multivariable predictive model including FebriDx, age, sex, and clinical characteristics was developed and underwent internal validation.
FebriDx was performed on 251 patients and gave a valid result in 248. 118 of 248 (48%) were PCR positive for COVID-19. FebriDx results were available after 10 min compared with 1.7 (1.6 to 2.1) hours with point-of-care PCR testing and 23.4 (17.2 to 31.1) hours with laboratory PCR testing. Sensitivity of FebriDx for the identification of COVID-19 was 93% (110/118; 95% CI 87 to 97%) and specificity was 86% (112/130; 95%CI 79 to 92%). Positive and negative likelihood ratios were 6.73 (95%CI 4.37 to 10.37) and 0.08 (95%CI 0.04 to 0.15) respectively. In the multivariate model age, sex and other clinical features did not contribute significantly to the effect of the FebriDx result in distinguishing patients with and without COVID-19.
During the first wave of the pandemic, FebriDx had high accuracy for the identification of COVID-19 in hospitalised adults and could be deployed as a front door triage tool.
ISRCTN14966673.
由于中央实验室聚合酶链反应（PCR）检测的长时间延迟，对 COVID-19 大流行的管理受到阻碍。在医院中，这会导致患者的流动不畅以及院内传播，因此迫切需要快速、准确的诊断检测方法。FebriDx 是一种即时检测方法，可在 10 分钟内通过指尖采血检测到抗病毒宿主反应蛋白，但它对 COVID-19 的检测准确性尚不清楚。
我们在大流行的第一波期间对住院患者进行了 FebriDx 的真实世界诊断准确性研究。根据 FebriDx 结果与 SARS-CoV-2 聚合酶链反应（PCR）检测联合鼻拭子和咽拭子的参考标准进行了诊断准确性的评估。建立了包含 FebriDx、年龄、性别和临床特征的多变量预测模型，并进行了内部验证。
对 251 名患者进行了 FebriDx 检测，其中 248 名患者获得了有效的结果。248 名患者中有 118 名（48%）的 COVID-19 聚合酶链反应（PCR）检测结果为阳性。与即时检测 PCR 相比，FebriDx 可在 10 分钟内获得检测结果，而即时检测 PCR 需 1.7（1.6 至 2.1）小时，实验室 PCR 检测需 23.4（17.2 至 31.1）小时。FebriDx 对 COVID-19 的识别敏感度为 93%（110/118；95%CI 87%至 97%），特异性为 86%（112/130；95%CI 79%至 92%）。阳性似然比为 6.73（95%CI 4.37 至 10.37），阴性似然比为 0.08（95%CI 0.04 至 0.15）。在多变量模型中，年龄、性别和其他临床特征对 FebriDx 检测结果区分 COVID-19 患者与非 COVID-19 患者的影响无显著意义。
在大流行的第一波期间，FebriDx 对识别住院成年人的 COVID-19 具有较高的准确性，可作为分诊的第一道工具。
ISRCTN82660355。
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