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

Autor: Arnolfo Petruzziello, Rocco Sabatino, Livia Anna Catapane, Carmela De Falco, Antonella Petti, Elena Tripaldelli, Giovanna Loquercio, Angela Annecchiarico, Angela Salzillo, Eugenio Caradonna, Paolo Maggi
Přispěvatelé: Petruzziello, Arnolfo, Sabatino, Rocco, Catapane, Livia Anna, De Falco, Carmela, Petti, Antonella, Tripaldelli, Elena, Loquercio, Giovanna, Annecchiarico, Angela, Salzillo, Angela, Caradonna, Eugenio, Maggi, Paolo
Rok vydání: 2023
Předmět:
Zdroj: Journal of Clinical Laboratory Analysis. 37
ISSN: 1098-2825
0887-8013
DOI: 10.1002/jcla.24867
Popis: 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 (Ct )-value reaching 100% and 86% with 15
Databáze: OpenAIRE
Externí odkaz: