Truvian Sciences receives FDA Emergency Use Authorization for Easy Check COVID-19 IgM/IgG Test: Rigorously and independently tested and validated, Easy Check exceeds current testing requirements for the detection of IgM/IgG antibodies to SARS-CoV-2.
Truvian Sciences (Truvian), a healthcare company at the intersection of diagnostics and consumer technology, announced that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company’s Easy Check COVID-19 IgM/IgG™ antibody test. Truvian’s Easy Check test is being produced at mass scale at a US based manufacturing facility and will be available to healthcare practitioners immediately.
The test, which has been rigorously tested and validated by leading healthcare professionals and scientific experts at University of California San Diego (UCSD) and the University of Chicago, exceeds the current EUA requirements for current COVID-19 antibody tests by delivering a sensitivity rate of 98.44 percent and a specificity of 98.9 percent. Additionally, the cross-reactivity evaluation determined no cross-reactivity (0 percent) with HIV, Influenza A and B and several coronavirus strains.
“Truvian’s Easy Check performed exceptionally well, with a robust sample set, in both our own studies, as well as the studies conducted by independent laboratories,” said Jeff Hawkins, President and Chief Executive Officer, Truvian Sciences. “With its consistent reproducibility, we are confident our testing solution, backed by the FDA’s EUA, will set a higher bar for COVID-19 antibody testing.”
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