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.

Use of the FebriDx point-of-care test for the exclusion of SARS-CoV-2 diagnosis in a population with acute respiratory infection during the second (COVID-19) wave in Italy / Lagi F.; Trevisan S.; Piccica M.; Graziani L.; Basile G.; Mencarini J.; Borchi B.; Menicacci L.; Vaudo M.; Scotti V.; Fabbri A.; Bandini G.; Tozzetti C.; Berni A.; Aiezza N.; Pestelli G.; Turchi V.; Pignone A.M.; Poggesi L.; Nozzoli C.; Morettini A.; Rossolini G.M.; Bartoloni A.. - In: INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES. - ISSN 1201-9712. - ELETTRONICO. - 108:(2021), pp. 231-236. [10.1016/j.ijid.2021.04.065]

Use of the FebriDx point-of-care test for the exclusion of SARS-CoV-2 diagnosis in a population with acute respiratory infection during the second (COVID-19) wave in Italy

Lagi F.;Trevisan S.;Piccica M.;Graziani L.;Basile G.;Mencarini J.;Menicacci L.;Vaudo M.;Scotti V.;Fabbri A.;Bandini G.;Tozzetti C.;Berni A.;Aiezza N.;Pestelli G.;Pignone A. M.;Poggesi L.;Nozzoli C.;Morettini A.;Rossolini G. M.;Bartoloni A.
2021

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.
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231
236
Lagi F.; Trevisan S.; Piccica M.; Graziani L.; Basile G.; Mencarini J.; Borchi B.; Menicacci L.; Vaudo M.; Scotti V.; Fabbri A.; Bandini G.; Tozzetti C.; Berni A.; Aiezza N.; Pestelli G.; Turchi V.; Pignone A.M.; Poggesi L.; Nozzoli C.; Morettini A.; Rossolini G.M.; Bartoloni A.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2158/1238601
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