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NEW YORK – The US Food and Drug Administration has granted emergency use authorization for Quanterix's Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody test.

According to the FDA, the immunoassay is intended for qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and dipotassium EDTA plasma. The test runs on the Quanterix HD-X immunoassay analyzer and can be performed by labs certified under CLIA to run moderate- or high-complexity tests.

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