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Chembio Diagnostics Receives FDA EUA for Point-of-Care Serology SARS-CoV-2 Test

NEW YORK – Chembio Diagnostics announced Wednesday its DPP COVID-19 system has received Emergency Use Authorization from the US Food and Drug Administration. 

The serological point-of-care test and analyzer provides numerical readings for IgM and IgG antibody levels in 15 minutes from a finger stick drop of blood. The test works with Chembio's Micro Reader 1 and Micro Reader 2 analyzers. 

The Hauppauge, New York-based company said in a statement it has shipped the first lots of the COVID-19 system. Last month, Chembio announced a strategic partnership with LumiraDx to develop point-of-care diagnostic tests to detect SARS-CoV-2 and IgM and IgG antibodies.