Truvian's COVID-19 antibody test cleared by FDA

2020 06 17 20 35 0417 Covid 19 Antibody 400

Truvian Sciences has received an emergency use authorization from the U.S. Food and Drug Administration for its Easy Check COVID-19 immunoglobulin M (IgM)/immunoglobulin G (IgG) antibody test.

The antibody test offers 98.4% sensitivity and 98.9% specificity, and has been tested and validated by healthcare professionals and scientists at the University of California, San Diego (UCSD) and the University of Chicago, according to the company. Furthermore, company evaluation suggests no cross-reactivity with HIV, influenza A and B, and several coronavirus strains, Truvian said.

The test is being produced at mass scale at a U.S.-based manufacturing facility and will be available immediately to healthcare practitioners, according to the vendor.

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