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.

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.

Lorenzo Menicacci, Alessandro Morettini, Filippo Lagi, Sasha Trevisan, Matteo Piccica, Lucia Graziani, Gregorio Basile, Jessica Mencarini, Beatrice Borchi, Micol Vaudo, Valentina Scotti, Alessia Fabbri, Giulia Bandini, Camilla Tozzetti, Andrea Berni, Noemi Aiezza, Giulia Pestelli, Valerio Turchi, Alberto Moggi Pignone, Loredana Poggesi, Carlo Nozzoli, Gian Maria Rossolini, Alessandro Bartoloni

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 in64/200 (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.

2021

covid-19, Italy, Accuracy, point-of-care, FebriDx

10.1016/j.ijid.2021.04.065

International Journal of Infectious Diseases

Elsevier