Truvian Sciences Introduces Easy Check COVID-19 IgM/IgG Test

Truvian Sciences has introduced Easy Check COVID-19 IgM/IgG, a rapid, highly accurate and scalable COVID-19 antibody test. Easy Check has been validated by leading healthcare professionals and scientific experts and is currently being evaluated by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization. Easy Check will be available to order upon FDA EUA approval.

Truvian's Easy Check antibody test requires a drop of whole blood, serum or plasma and delivers results at 10 minutes with a sensitivity and specificity that rivals lab-based COVID-19 antibody tests.

"Rapid, affordable and highly accurate COVID-19 antibody testing that can be delivered at scale will play a critical role in the fight against this global pandemic," said Jeff Hawkins, President and Chief Executive Officer of Truvian. "Unfortunately, many antibody tests have been rushed to market and have missed the mark in terms of performance and manufacturing capacity. Truvian is ensuring our serology test is validated by experts on the front lines of this global health crisis. Not only was Easy Check developed to meet the requirements of the FDA for EUA, we also conducted studies alongside the medical community to ensure the product is rigorously validated by independent experts."

"Serology testing is a valuable tool for understanding SARS-CoV-2 exposure and necessary from a public health response perspective to estimate the number of people who have been infected in various regions and settings," said Dr. Jerry Yeo, Professor of Pathology and Medical Director of Clinical Chemistry at the University of Chicago. "Our studies with Truvian's Easy Check COVID-19 IgM/IgG were designed to evaluate the performance, including clinical sensitivity, clinical specificity, and cross-reactivity of the test. Our results indicate Easy Check not only meets -- but surpasses -- performance criteria required by the FDA. In addition, we have found Easy Check demonstrates high concordance to laboratory-based serology tests which gives it great potential for use at the point of care setting."

Easy Check will endeavor to deliver testing results that will aid the public health response and planning efforts around COVID-19. This includes sero-epidemiologic surveillance to better estimate the number of people previously infected to inform public health measures and infection fatality rate. It will also provide an objective measure to define chains of transmission or connections to case clusters and better help with the management of exposed individuals, which is critical to help people and companies evaluate risk factors when making crucial decisions. Additionally, Easy Check test results may assist with monitoring essential health care workers through rapid testing availability and aid in vaccine development.