NEW YORK — Snibe Diagnostic said this week that it has received CE marking for its Maglumi SARS-CoV-2 Neutralizing Antibody Assay.
According to Snibe, the fully automated test can detect neutralizing antibodies against SARS-CoV-2 within 20 minutes when used with its Maglumi analyzers. It can be used to determine the immune status of COVID-19 patients and individuals who have been vaccinated against the virus, the Shenzhen, China-based firm said.
In September, Snibe received Emergency Use Authorization from the US Food and Drug Administration for its CE-marked Maglumi 2019-nCoV IgM/IgG capture chemiluminescence immunoassay.