Snibe Diagnostic’s Maglumi SARS-CoV-2 S-RBD IgG Test Receives CE Mark

Snibe Diagnostic (Shenzhen, China) 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 test, called Maglumi SARS-CoV-2 S-RBD IgG, is designed for the quantitative detection of antibodies to the receptor-binding domain of the S protein, which are believed to neutralize the coronavirus and are an effective measure of immunity as compared to antibodies that target other SARS-CoV-2 proteins. According to Snibe, the test has 99.6% specificity and 100% sensitivity at 15 days following the onset of symptoms for COVID-19, thus providing more accurate results. A strong correlation to neutralizing antibodies ensures better clinical management.

The test can be run on the company’s Maglumi CLIA systems, including the Maglumi X8 immunoassay analyzer which can run up to 600 tests per hour. More than 13,000 Maglumi CLIA system installations across the world pave the way for wide availability of the test. Snibe has confirmed that it is ready to ship the Maglumi SARS-CoV-2 S-RBD IgG test worldwide.

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