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Snibe Diagnostic Gets CE Mark for SARS-CoV-2 Antigen Assay

NEW YORK — Snibe Diagnostic said this month that it has received CE-IVD marking for its Maglumi SARS-CoV-2 Ag antigen test and has launched the test in countries accepting the designation.

According to the Shenzhen, China-based company, the chemiluminescence assay detects SARS-CoV-2 nucleocapsid antigens in nasopharyngeal and oropharyngeal swab samples and has demonstrated 97.7 percent sensitivity and 99.6 percent specificity.

In January, Snibe received the CE mark for its Maglumi SARS-CoV-2 Neutralizing Antibody Assay. The company also received Emergency Use Authorization from the US Food and Drug Administration for its CE-marked Maglumi 2019-nCoV IgM/IgG capture chemiluminescence immunoassay in late 2020.