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

IntroductionSevere 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 (R) 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 MethodsA 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 (R) SARS-CoV-2 antigen compared to qualitative real-time RT-PCR in asymptomatic patients. ResultsLumipulse (R) 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. ConclusionOur data showed that Lumipulse (R) SARS-CoV-2 antigen assay might be an efficient tool in the identification and limitation of SARS-CoV-2 transmission in large asymptomatic populations.