LIAISON SARS-CoV-2 IgG kit : DiaSorin said that it has completed studies at the Policlinico San Matteo in Pavia, Italy to support the roll out of a new serological and high-processing volume test to detect the presence of antibodies in people infected with the SARS-CoV-2 virus associated with COVID-19.

The Italian diagnostic company is working to secure the CE mark and the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) by the end of this month.

According to DiaSorin, the new serological test is designed to identify the IgG antibodies directed against the S1 and S2 domains of the SARS-CoV-2 virus spike protein, and has been chosen for its ability to deliver specificity for SARS-CoV-2 compared to other coronaviruses.

Furthermore, the LIAISON SARS-CoV-2 IgG kit has been designed to address the need to identify people in the population who have already been infected with the novel coronavirus, where diagnosis has not been carried out with a swab and a coronavirus molecular diagnostic test.

The serological test can be carried out on the LIAISON XL platform, which is said to enable fully automated management of the diagnostic process, helping laboratories to process up to 170 patient sera samples per hour, with a minimum level of intervention needed by laboratory operators.

DiaSorin said that the present install base of LIAISON XL platforms is about 5,000 units across the world, of which over 500 are in Italy and a similar number is available in the US. The platforms are said to have a widespread geographical footprint in primary hospital institutions and commercial laboratories.

The Italian diagnostic company will launch LIAISON SARS-CoV-2 IgG kit in the coming few days for clinical research and evaluation and will be initiated in Europe CE marked and submitted to the FDA under the Emergency Use Authorization process in the following weeks.

Carlo Rosa – DiaSorin CEO, commenting on the LIAISON SARS-CoV-2 IgG kit, said: “The pandemic generated by the spread of coronavirus is urging us to give quick and effective responses to the different laboratories and hospitals’ needs. Our molecular diagnostic test is speeding up the diagnosis process of swabs within hospitals, allowing rapid and effective patient triage and reducing the high pressure to which laboratories are subjected to identify the virus. The new test for the detection of IgG antibodies will help identify those who have developed an immune response to the virus as they are already infected”.

  Carlo Rosa, Coronavirus, COVID-19, DiaSorin, LIAISON SARS-CoV-2 IgG kit, Novel Coronavirus, US Food and Drug Administration