Immunodiagnostics Receives European CE marking approvals for three diagnostic products to detect SARS-CoV-2 (COVID-19)
March 28, 2020
The three highly-specific and sensitive immunoassays developed by Immunodiagnostics for serological detection of antibodies against the major nucleocaspid protein (NP) of SARS-CoV-2, including SARS-COV-2 NP Ab ELISA (Cat No:41A225); SARS-COV-2 NP IgG ELISA (Cat No: 41A222); SARS-COV-2 NP IgM ELISA (Cat No: 41A224) have been granted with CE marking certification from European Union (CE marking: NL-CA002-2020-49738; NL-CA002-2020-49739; NL-CA002-2020-49737). These products were fully validated in patients diagnosed with COVID-19 in different centers . The detection rate of anti-NP total Ab and anti-NP IgG is approximately 90% in serum of >74 COVID-19-patients tested. These serological tests can be used to detect individuals with ongoing or previous infection with SARS-CoV-2, and to monitor the disease progression. Besides, the Free Sale Certificate (FSC) will further enable these products to be used for diagnostic applications in Iran, South Korea, Turkey, Malaysia and Thailand (in application). These CE-marked products are manufactured by Uniten Biotech Limited , the industrial partner of Immunodiagnostics.
GBA injects new impetus to biotech start-ups
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“Our assay detects biomarker in circulation. Some biomarkers reflect a certain disease condition, and some can detect diseases at a very early stage, even before any clinical symptoms,” said Dr Kelsey Zhongling, deputy executive director of ImmunoDiagnostics.
Research team of Professor Aimin Xu, the founder of ImmunoDiagnostics Limited, won a Gold Medal at the 47th International Exhibition of Inventions in Geneva.
April 14th, 2019
A novel method for risk predication and accurate diagnosis of autoimmune diabetes by measuring enzymatic activities and protein concentrations of neurophil elastase (NE) and proteinase 3 (PR3) in human plasma. It is developed by the research team of Professor XU Aimin, Department of Medicine, Li Ka Shing Faculty of Medicine, HKU.
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