Snibe Diagnostic’s Maglumi 2019-nCoV IgM/IgG Test Granted FDA Emergency Use Authorization

Snibe Diagnostic (Shenzhen, China) has received Emergency Use Authorization from the US Food and Drug Administration for its SARS-CoV-2 antibody test.

Snibe’s Maglumi 2019-nCoV IgM/IgG test comprises a capture chemiluminescence immunoassay for immunoglobulin M antibodies against SARS-CoV-2 and an indirect chemiluminescence immunoassay for immunoglobulin G antibodies against the virus. The test uses human serum and serum in separating gel tube samples and runs on the company's Maglumi 2000 series fully automated chemiluminescence immunoassay analyzer. The test can be used by any lab certified to perform moderate- or high-complexity tests, according to the FDA.

Snibe had received CE marking for the Maglumi 2019-nCoV IgM/IgG test in February. In August, the company also received CE marking for its fully automated quantitative serology test for detecting IgG antibodies against SARS-CoV-2S-RBD, the receptor-binding domain of the S protein.

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