NEW YORK – Snibe Diagnostics said recently that it has received the CE mark for its fully automated quantitative serology test for detecting IgG antibodies against SARS-CoV-2S-RBD, the receptor-binding domain of S protein.
The Shenzhen, China-based company said it is ready to ship the test worldwide.
The test, called Maglumi SARS-CoV-2 S-RBD IgG, was designed to detect antibodies to the receptor-binding domain of the S protein, which are believed to neutralize the coronavirus and are an effective measure of immunity compared to antibodies that target other SARS-CoV-2 proteins. According to Snibe, the test has 99.6 specificity and 100 percent sensitivity at 15 days following the onset of symptoms for COVID-19, the disease caused by the coronavirus.
The test can be run on the Maglumi CLIA systems, including the Maglumi X8 immunoassay analyzer.