DiaSorin, Saluggia, Italy, has completed studies to support the launch of a new high-throughput serological test to detect the presence of antibodies in patients infected with the SARS-CoV-2, which causes covid-19. The company is working to obtain the CE mark and FDA emergency use authorization (EUA) by the end of April 2020.
The new serological test is designed to recognize IgG antibodies directed against the S1 and S2 domains of the SARS-CoV-2 virus spike protein, selected for its ability to provide specificity for SARS-CoV-2 compared to other coronaviruses. The product has been designed to respond to the need to identify people in the population who have already been infected with the virus, where diagnosis has not been performed with a swab and a molecular diagnostic test.
The test can be performed on the company’s Liaison XL platform, which enables fully automated management of the diagnostic process, allowing laboratories to process up to 170 patient sera samples per hour, with a minimum level of intervention required by laboratory operators. Approximately 5,000 Liaison XL instruments have been installed worldwide.
“The alarm generated by the coronavirus pandemic prompted us initially to work on a molecular diagnostic solution that we were able to offer to hospital laboratories very quickly,” says Fabrizio Bonelli, chief scientific officer at DiaSorin. “At the same time, we started to work on an immunodiagnostic test to respond to the increasing need to conduct epidemiological investigations to establish the percentage of the population exposed to the virus in the absence of a diagnosis performed with molecular tests on a swab.”
For more information, visit DiaSorin.
Featured image: Transmission electron micrograph of SARS-CoV-2 virus particles isolated from a patient. Image captured and color-enhanced at the NIAID Integrated Research Facility in Fort Detrick, Md. Photo courtesy NIAID.