Clinical Assessment of the DiaSorin LIAISON SARS-CoV-2 Ag Chemiluminescence Immunoassay

Abstract

Background. Due to the large volume of tests needed in a relatively short time for screening and diagnosing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, antigen immunoassays may provide a potential supplement to molecular testing. This study was aimed to assess the clinical preference of DiaSorin LIAISON SARS-CoV-2 Ag chemiluminescence immunoassay.Methods. An upper respiratory specimen was collected in a series of patients referred to the Laboratory Medicine service of Pederzoli Hospital (Peschiera del Garda, Verona, Italy) for screening or diagnosis of SARS-CoV-2 infection. Nasopharyngeal samples were assayed with DiaSorin LIAISON SARS-CoV-2 Ag test and Altona Diagnostics RealStar® SARSCoV-2 RT-PCR Kit.Results. The final study population consisted of 421 patients (median age, 48 years; 227 women), 301 (71.5%) with positive result of molecular testing, and 126 (29.9%) with cycle threshold (Ct) values of both E and S genes Conclusion. The performance of this chemiluminescence immunoassay would not permit it to replace molecular testing for diagnosing SARS-CoV-2, but may enable rapid and efficient detection of subjects with high SARS-CoV-2 viral load, who are responsible for the largest proportion of infectious clusters.