Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Infectious and Tropical Diseases Unit, Careggi University Hospital, Florence, Italy.
Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Int J Infect Dis. 2021 Jul;108:231-236. doi: 10.1016/j.ijid.2021.04.065. Epub 2021 Apr 24.
Evaluate the real-world accuracy of Myxovirus resistance protein A (MxA) detected by the rapid, point-of-care FebriDx test during the second-wave pandemic in Italy in patients with acute respiratory infection (ARI) and a clinical suspicion of COVID-19.
Prospective, observational, diagnostic accuracy study whereby hospitalized patients with ARI were consecutively enrolled in a single tertiary care center in Italy from August 1, 2020 to January 31, 2021.
COVID-19 was diagnosed in 136/200 (68.0%) patients and Non-COVID-19 was diagnosed in 64/200 (32.0%) patients. COVID-19 patients were younger and had a lower Charlson comorbidity index compared to Non-COVID-19 patients (p < 0.001). Concordance between FebriDx, MxA and rt-PCR for SARS-CoV-2 (gold standard) was good (k 0.93, 95% CI 0.87-0.99). Overall sensitivity and specificity were 97.8% [95% CI 93.7-99.5] and 95.3% [95% CI 86.9%-99.0%], respectively. FebriDx demonstrated a negative predictive value of 95.3% (95% CI 86.9-99.0) for an observed disease prevalence of 68%.
FebriDx MxA showed high diagnostic accuracy to identify COVID-19 and could be considered as a real-time triage tool to streamline the management of suspected COVID-19 patients. FebriDx also detected bacterial etiology in Non-COVID-19 patients suggesting good performance to distinguish bacterial from viral respiratory infection.
评估快速、即时的呼吸道感染（ARI）患者中甲型流感病毒（MxA）检测试剂盒（FebriDx）在意大利第二波大流行期间用于临床疑似 COVID-19 患者的真实世界准确性。
前瞻性、观察性、诊断准确性研究，研究对象为 2020 年 8 月 1 日至 2021 年 1 月 31 日期间意大利一家三级保健中心连续收治的 ARI 住院患者。
136/200（68.0%）例患者诊断为 COVID-19，64/200（32.0%）例患者诊断为非 COVID-19。COVID-19 患者较非 COVID-19 患者年龄更小，Charlson 合并症指数更低（p < 0.001）。FebriDx、MxA 和用于 SARS-CoV-2（金标准）的逆转录聚合酶链反应（rt-PCR）之间的一致性较好（κ 0.93，95%置信区间 0.87-0.99）。总体灵敏度和特异性分别为 97.8%[95%置信区间 93.7%-99.5%]和 95.3%[95%置信区间 86.9%-99.0%]。FebriDx 的阴性预测值为 95.3%（95%置信区间 86.9%-99.0%），观察到的疾病流行率为 68%。
FebriDx MxA 对识别 COVID-19 具有较高的诊断准确性，可作为实时分诊工具，用于简化疑似 COVID-19 患者的管理。FebriDx 还可检测非 COVID-19 患者的细菌病因，表明其在区分细菌性和病毒性呼吸道感染方面具有良好的性能。
