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DiaSorin High-Throughput, Rapid Antigen SARS-CoV-2 Test Gets CE Mark

NEW YORK – DiaSorin said on Monday that it has received the CE mark for a high-throughput rapid antigen test for the quantitative detection of SARS-CoV-2.

The Liaison SARS-CoV-2 Ag test is a chemiluminescence immunoassay that detects the coronavirus nucleocapsid protein antigen in nasal dry swabs and nasopharyngeal swabs eluted in universal transport media for virus. Clinical studies have demonstrated that when used within 10 days after the onset of COVID-19 symptoms, the test demonstrated 97.1 percent sensitivity and 100 percent specificity on nasal swabs and 94.6 percent sensitivity and 99.5 percent specificity on nasopharyngeal swabs, DiaSorin said.

According to the Saluggia, Italy-based company, the test is the first for SARS-CoV-2 that runs on high-throughput analyzers to detect the coronavirus on symptomatic patients. It can be used with the Liaison XL, Liaison XS, and Liaison analyzers, DiaSorin said, noting there are more than 8,000 such systems installed in laboratories worldwide.

The firm said the test will be offered as an alternative test when PCR-based testing is not available. It will be offered in the US market after the Food and Drug Administration has been notified. DiaSorin will have a manufacturing capacity of up to 10 million Liaison SARS-CoV-2 Ag tests per month shortly after its launch.

DiaSorin CEO Carlo Rosa said in a statement that the firm is working on expanding the test for use with saliva samples "allowing an even easier, safer and non-invasive sample collection process to be used on a larger amount of individuals."