Analytical performance evaluation of Lumipulse® SARS‐CoV‐2 antigen assay in 392 asymptomatic patients

INTRODUCTION: Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection is one of the current public health care challenges. The main strategy adopted to prevent the spread of infection is the rapid identification of COVID‐19‐positive subjects. The aim of this study was to compare the performance of Lumipulse® antigen immunoassay with the real‐time RT‐PCR, the gold standard for the diagnosis of SARS‐CoV‐2 infection, in a strictly selected asymptomatic population. MATERIALS AND METHODS: A total of 392 consecutive oro‐nasopharyngeal swabs were collected from patients with no symptoms related to COVID‐19 at the Emergency Department of AORN Sant'Anna e San Sebastiano, Caserta, Italy to evaluate the analytical performance of Lumipulse® SARS‐CoV‐2 antigen compared to qualitative real‐time RT‐PCR in asymptomatic patients. RESULTS: Lumipulse® SARS‐CoV‐2 antigen assay shows an overall agreement rate of 97% with a sensitivity of 96% and a specificity of 98%, with a PPV and NPV of 97%. The sensitivity varies according to the cycle threshold (C (t))‐value reaching 100% and 86% with 15 < C (t) < 25 and C (t) ≥ 25, respectively. The ROC analysis yielded an AUC value of 0.98, suggesting that the antigen test may accurately detect SARS‐CoV‐2. CONCLUSION: Our data showed that Lumipulse® SARS‐CoV‐2 antigen assay might be an efficient tool in the identification and limitation of SARS‐CoV‐2 transmission in large asymptomatic populations.