Snibe received CE Mark for MAGLUMI® SARS-CoV-2 S-RBD IgG, a brand new solution for assessing the COVID-19 patients' immunity

Release Date:2020-07-16

Snibe announced on 16 July that it has received the CE mark for the fully automated quantitative serology test for detecting IgG antibodies against SARS-CoV-2 S-RBD (the receptor-binding domain of S protein). Now the new tests are ready to ship to worldwide and available to come into service.  
 

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 is believed to neutralize the coronavirus, indicating that they can be an effective measure to assess immunity when compared to antibodies targeting other SARS-CoV-2 proteins.
MAGLUMI® SARS-CoV-2 S-RBD IgG kits have 99.6% specificity and 100% sensitivity at 15 days post-onset of symptom for COVID-19, which can provide more accurate and reasonable results within 30 mins with ONLY 10uL sample volume. Due to the strong correlation to neutralizing antibodies, the S-RBD IgG concentration can be an effective assistance for clinicians to make a better clinical diagnosis and treatment.
The new MAGLUMI® SARS-CoV-2 S-RBD IgG tests can be run on a global installed base of 13000 MAGLUMI® CLIA systems, including MAGLUMI® X8 immunoassay analyzer, which can run up to 14400 tests per day. Multiple MAGLUMI® X8 could be connected to form a modular system to meet the high demands of large hospitals, especially during the COVID-19 pandemic period.
 
Snibe never stops pursuing high-quality solutions for human health. In these difficult times, Snibe stands together with governments and all those working people to overcome the pandemic.