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.

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.

Procalcitonin Kinetics in the First 72 Hours Predicts 30-Day Mortality in Severely Ill Septic Patients Admitted to an Intermediate Care Unit.

BACKGROUND: Severe sepsis and septic shock are leading causes of morbidity and mortality among critically ill patients, thus the identification of prognostic factors is crucial to determine their outcome. In this study, we explored the value of procalcitonin (PCT) variation in predicting 30-day mortality in patients with sepsis admitted to an intermediate care unit. METHODS: This prospective observational study enrolled 789 consecutive patients with severe sepsis and septic shock admitted to a medical intermediate care unit between November 2012 and February 2014. Kinetics of PCT expressed as percentage were defined by the variation between admission and 72 hours, and 24 and 72 hours; they were defined as Δ-PCT0-72h and Δ-PCT24-72h, respectively. RESULTS: The final study group of 144 patients featured a mean age of 73 ± 14 years, with a high prevalence of comorbidities (Charlson index greater than 6 in 39%). Overall, 30-day mortality was 28.5% (41/144 patients). A receiver-operating-characteristic (ROC) analysis identified a decrease of Δ-PCT0-72h less than 15% (area under the curve: 0.75; 95% confidence interval (CI): 0.67 - 0.82) and a decrease of Δ-PCT24-72h less than 20% (area under the curve: 0.83; 95% CI: 0.74 - 0.92) as the most accurate cut-offs in predicting mortality. Decreases of Δ-PCT0-72h less than 15% (HR: 3.9, 95% CI: 1.6 - 9.5; P < 0.0001) and Δ-PCT24-72h less than 20% (HR: 3.1, 95% CI: 1.2 - 7.9; P < 0.001) were independent predictors of 30-day mortality. CONCLUSIONS: Evaluation of PCT kinetics over the first 72 hours is a useful tool for predicting 30-day mortality in patients with severe sepsis and septic shock admitted to an intermediate care unit.