CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
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.
Pages: 1 2