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Snibe Diagnostic SARS-CoV-2 Antigen Assay Secures CE Mark

By LabMedica International staff writers
Posted on 17 Mar 2021

Image: Maglumi SARS-CoV-2 Ag (CLIA) Kit (Photo courtesy of Snibe Diagnostic)

Image: Maglumi SARS-CoV-2 Ag (CLIA) Kit (Photo courtesy of Snibe Diagnostic)

Snibe Diagnostic (Shenzhen, China) has received CE-IVD marking for its Maglumi SARS-CoV-2 Ag antigen test and has launched the test in countries accepting the designation.

The MAGLUMI SARS-CoV-2 Ag with CE mark is a chemiluminescence immunoassay solution for the quantitative detection of nucleocapsid antigens of SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples taken from suspected COVID-19 patients. The assay has demonstrated 97.7% sensitivity and 99.6% specificity, and could aid in the early detection of SARS-CoV-2 virus from suspected COVID-19 cases.

The MAGLUMI SARS-CoV-2 Ag assay runs on all MAGLUMI fully-auto chemiluminescence immunoassay analyzers which are widely available around the world. The SARS-CoV-2 antigen assay can shorten the TAT and simplify operation procedure to improve the efficiency of clinical diagnosis when compared with RT-PCR molecular testing, making it more applicable for large-scale testing.

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