The test has been widely tested and validated by healthcare professionals and scientific experts at University of California San Diego (UCSD) and the University of Chicago
Truvian Sciences has secured FDA EUA status for Easy Check Covid-19 IgM/IgGTM antibody test. (Credit: Truvian Sciences / PRNewswire)
Truvian Sciences has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Easy Check Covid-19 IgM/IgGTM antibody test.
The Easy Check Covid-19 IgM/IgGTM antibody test, which is being produced at a mass scale at a US-based manufacturing facility, will be available to healthcare practitioners immediately.
The test has been widely tested and validated by healthcare professionals and scientific experts at the University of California San Diego (UCSD) and the University of Chicago. It is said to exceed the current EUA requirements for current Covid-19 antibody tests by delivering a sensitivity rate of 98.44% and a specificity of 98.9%.
University of Chicago pathology professor Dr Jerry Yeo said: “The FDA’s EUA validates the extensive testing our team at the University of Chicago has conducted on Truvian’s Easy Check solution.”
The cross-reactivity evaluation confirmed no cross-reactivity with HIV, Influenza A and B and several coronavirus strains
According to the company, the cross-reactivity assessment confirmed no cross-reactivity with HIV, Influenza A and B and several coronavirus strains.
In addition, further validation by the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National Cancer Institute (NCI) showed the combined sensitivity of 100% and a combined specificity of 97.5%.
Truvian Sciences president and CEO Jeff Hawkins said: “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.
“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.”
In June this year, diagnostic blood testing company Babson Diagnostics has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG antibody test.