emergency use authorization approved

Quanterix’s COVID-19 Antibody Test Earns FDA Emergency Use Authorization

January 4, 2021

The FDA has granted Emergency Use Authorization for Quanterix’s Simoa semi-quantitative SARS-CoV-2 antibody diagnostic.

The test numerically measures the level of IgG antibodies in the plasma or serum of patients suspected of prior or recent exposure to the coronavirus and may also be used to measure antibody response in vaccinated patients.

Quanterix’s test is run on the company’s Simoa HD-X Analyzer, a fully automated, high-throughput immunoassay device.

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