Abstract
Objective: 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.
Design and methods: 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.
Results: 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%.
Conclusions: 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.
Keywords: Accuracy; COVID-19; FebriDx; Italy; Point-of-care.
【저자키워드】 COVID-19, Italy, point-of-care, Accuracy, FebriDx, 【초록키워드】 SARS-CoV-2, pandemic, diagnostic, Comorbidity, Italy, RT-PCR, Predictive value, point-of-care, Diagnostic accuracy, respiratory infection, ARI, Concordance, Disease prevalence, Sensitivity and specificity, management, Prospective, Patient, gold, Acute respiratory infection, etiology, Care, patients, COVID-19 patients, Bacterial, Streamline, COVID-19 patient, Negative predictive value, Non-COVID-19 patients, 95% CI, gold standard, clinical suspicion, viral respiratory infection, enrolled, identify, diagnosed, hospitalized patient, demonstrated, protein A, Myxovirus, 【제목키워드】 SARS-CoV-2, Diagnosis, exclusion,