Brendish Nathan J, Tanner Alex R, Poole Stephen, Beard Kate R, Naidu Vasanth V, Mansbridge Christopher T, Norton Nicholas J, Wheeler Helen, Presland Laura, Clark Tristan W
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.
Infect Dis Ther. 2022 Jun;11(3):1267-1280. doi: 10.1007/s40121-022-00646-4. Epub 2022 May 9.
RT-PCR has suboptimal sensitivity for the diagnosis of COVID-19. A composite reference standard comprising RT-PCR plus radiological and clinical features has been recommended for diagnostic accuracy studies. The FebriDx finger prick point-of-care test detects an antiviral host response protein (MxA) in 10 min. We evaluated the diagnostic accuracy of FebriDx and RT-PCR compared to a composite reference standard.
Adults presenting to hospital with suspected COVID-19 were tested by FebriDx and RT-PCR. A composite reference standard was used to classify patients as having COVID-19 based on RT-PCR positivity, or RT-PCR negativity with COVID-19 radiological findings or other clinical criteria. Measures of accuracy were calculated for MxA alone, RT-PCR alone, and both combined. This study is registered with the ISRCTN (ISRCTN14966673) and has completed.
A total of 478 patients were tested, with valid results in 475. Of these 475 patients, 222 (46.7%) were classified as having COVID-19; 192 (40.4%) were RT-PCR positive, and 30 (6.3%) were RT-PCR negative and diagnosed on radiological/clinical criteria. Sensitivity of FebriDx MxA vs the composite reference standard was 186/222 (83.8%, 95% CI 78.3-88.4) and was similar to the sensitivity of RT-PCR (192/222 (86.5%, 95% CI 81.3-90.7), (difference of 2.7%, 95% CI - 3.9 to 9.3, p = 0.42). The sensitivity of combined FebriDx and RT-PCR was 208/222 (93.7%) which was superior to both RT-PCR alone (difference of 9.9, 95% CI 4.1-15.9; p = 0.001) and FebriDx MxA alone (difference of 7.2, 95% CI 1.6-12.9; p = 0.011).
Sensitivity of combined FebriDx and RT-PCR testing was superior to each alone for the detection of COVID-19 in hospital and may improve infection control and treatment decisions.
逆转录聚合酶链反应（RT-PCR）在2019冠状病毒病（COVID-19）诊断中的敏感性欠佳。对于诊断准确性研究，已推荐采用包含RT-PCR以及影像学和临床特征的综合参考标准。FebriDx指尖即时检测可在10分钟内检测到一种抗病毒宿主反应蛋白（Mx蛋白A）。我们将FebriDx和RT-PCR与综合参考标准进行比较，评估了它们的诊断准确性。
对因疑似COVID-19到医院就诊的成人进行FebriDx和RT-PCR检测。采用综合参考标准，根据RT-PCR阳性，或RT-PCR阴性但有COVID-19影像学表现或其他临床标准，将患者分类为患有COVID-19。分别计算单独检测Mx蛋白A、单独检测RT-PCR以及两者联合检测的准确性指标。本研究已在国际标准随机对照试验编号注册库（ISRCTN，编号：ISRCTN14966673）注册并已完成。
共检测了478例患者，475例结果有效。在这475例患者中，222例（46.7%）被分类为患有COVID-19；192例（40.4%）RT-PCR呈阳性，30例（6.3%）RT-PCR呈阴性但根据影像学/临床标准被诊断为COVID-19。FebriDx Mx蛋白A检测相对于综合参考标准的敏感性为186/222（83.8%，95%置信区间78.3 - 88.4），与RT-PCR的敏感性相似（192/222，86.5%，95%置信区间81.3 - 90.7），差异为2.7%（95%置信区间 - 3.9至9.3，p = 0.42）。FebriDx和RT-PCR联合检测的敏感性为208/222（93.7%），优于单独的RT-PCR检测（差异为9.9，95%置信区间4.1 - 15.9；p = 0.001）和单独的FebriDx Mx蛋白A检测（差异为7.2，95%置信区间1.6 - 12.9；p = 0.011）。
在医院中，FebriDx和RT-PCR联合检测对COVID-19的检测敏感性优于单独检测，可能有助于改善感染控制和治疗决策。
