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Int. J. Infect. Dis. · Sep 2021
Performance of a SARS-CoV-2 antigen rapid immunoassay in patients admitted to the emergency department.
- Christian Leli, Luigi Di Matteo, Franca Gotta, Elisa Cornaglia, Daria Vay, Iacopo Megna, Rosalia Emanuela Pensato, Riccardo Boverio, and Andrea Rocchetti.
- Microbiology Laboratory, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy, EU. Electronic address: christian.leli@ospedale.al.it.
- Int. J. Infect. Dis. 2021 Sep 1; 110: 135-140.
ObjectivesGiven the ongoing pandemic emergency, there is a need to identify SARS CoV-2 infection in various community settings. Rapid antigen testing is spreading worldwide, but diagnostic accuracy is extremely variable. Our study compared a microfluidic rapid antigen test with a reference molecular assay in patients admitted to the emergency department (ED) of a general hospital from October 2020 to January 2021.MethodsNasopharyngeal swabs collected in patients with suspected COVID-19 and in patients with no symptoms suggesting COVID-19, but requiring hospitalization, were obtained.Results792 patients of median age 71 years were included. With a prevalence of 21%, the results showed: 68.7% (95% confidence interval [CI]: 60.9-75.5) sensitivity; 95.2% (95% CI: 93.1-96.7) specificity; 79.2% (95% CI: 71.4-85.3) positive predictive value (PPV); 91.9% (95% CI: 89.5-93.9) negative predictive value; 3.8 (95% CI: 2.7-5.3) positive likelihood ratio (LR+); and 0.09 (95% CI: 0.07-0.1) negative likelihood ratio (LR-). In the symptomatic subgroup, sensitivity increased to 81% (95% CI: 70.3-88.6) and PPV to 96.9% (95% CI: 88.5-99.5), along with an LR+ of 32 (95% CI: 8.2-125.4).ConclusionsThe new rapid antigen test showed an overall excellent diagnostic performance in a challenging situation, such as that of an ED during the COVID-19 emergency.Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.
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