Performance of a SARS-CoV-2 antigen rapid immunoassay in patients admitted to the emergency department

Abstract

Objectives: Given 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. Methods: Nasopharyngeal swabs collected in patients with suspected COVID-19 and in patients with no symptoms suggesting COVID-19, but requiring hospitalization, were obtained. Results: 792 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). Conclusions: The 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.

Keywords

• Diagnostic techniques and procedures
• COVID-19
• SARS-CoV-2
• Microfluidic analytical techniques
• Reverse transcriptase polymerase chain reaction
• Emergency department