June 2021—DiaSorin received emergency use authorization from the FDA for its Liaison SARS-CoV-2 Ag.
The test uses chemiluminescence immunoassay technology to determine the presence of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal dry swabs and nasopharyngeal swabs, eluted in universal transport medium, and is used to assist in the diagnosis of acute COVID-19 infection through qualitative detection of the virus.
In clinical studies the test showed a 97 percent sensitivity within 10 days after the onset of symptoms and a 100 percent specificity on anterior nasal swabs. Nasopharyngeal swabs showed a 96.1 percent sensitivity and a 99.3 percent specificity.
DiaSorin received funding from the Biomedical Advanced Research and Development Authority for the development, validation, FDA emergency use authorization, and submission of 510(k) clearance of the test.
The Liaison SARS-CoV-2 Ag runs on the company’s Liaison XL platform.
DiaSorin, 562-240-6500