DiaSorin Launches New LIAISON SARS-CoV-2 Ag High-Throughput Antigen Test in Markets Accepting CE Mark

The new high-throughput antigen test uses chemiluminescence immunoassay (CLIA) technology to determine the presence of SARS-CoV-2 Nucleocapsid protein antigen in nasal dry swabs and nasopharyngeal swabs eluted in Universal Transport Media for Virus (UTM/VTM), quantifying the viral load of the infection directly from individuals suspected of COVID-19 by their healthcare provider. The new test is designed for use on the over 8,000 CLIA high-throughput analyzers (LIAISON XL, LIAISON XS and LIAISON) installed in laboratories worldwide, delivering up to 140 results per hour and providing full traceability of collected samples. The test is the first in the market to be run on high-throughput analyzers for COVID-19 detection on symptomatic patients.

In clinical studies, LIAISON SARS-CoV-2 Ag showed, within 10days post onset of symptoms, a 97.1% sensitivity and a 100.0% specificity on nasal swabs and a 94.6% sensitivity and a 99.5% specificity on nasopharyngeal swabs. The LIAISON SARS-CoV-2 Ag is intended as an aid in diagnosing acute COVID-19 infection and will be offered as an alternative solution in cases where molecular PCR testing availability is lacking, in geographies where PCR technology is too expensive and in those cases where traceability of clinical samples needs to be improved. DiaSorin’s manufacturing capacity for LIAISON SARS-CoV-2 Ag is estimated to be up to 10 million tests per month shortly after its launch. The test will be soon available in the US market, following notification to the US Food and Drug Administration. This is the fifth test to be launched by DiaSorin to support laboratories and healthcare systems in containing the spread of SARS-CoV-2 since the beginning of the COVID-19 pandemic worldwide.

“The availability of molecular tests is limited and the need for additional reliable diagnostic tools is on the rise, said Chen Even, Chief Commercial Officer of DiaSorin Group. “This is why we expanded our existing offer for SARS-CoV-2 detection with our new antigen test, allowing safe decentralized sample collection procedure, while maintaining patient sample traceability.”

“The increasing circulation of SARS-CoV-2 is a challenge to healthcare systems and it is driving us to provide innovative solutions to support physicians and laboratories in managing the growing demand in testing volumes,” added Carlo Rosa, CEO of DiaSorin Group. “Our new antigen test is an innovative solution that allows patients to get a quick and reliable response on their infection status, thus supporting the containment of the virus among the population. We are already working on the expansion of the use of our new antigen test to saliva specimens, allowing an even easier, safer and non-invasive sample collection process to be used on a larger amount of individuals.”