New Research Study Validates Performance and Accuracy of Truvian Sciences' Easy Check COVID-19 IgM/IgG™ Test
SAN DIEGO, Nov. 3, 2020 /PRNewswire/ -- Truvian Sciences ("Truvian"), a healthcare company at the intersection of diagnostics and consumer technology, today unveiled the results of a first-of-its- kind research study validating the performance and accuracy of the Easy Check COVID-19 IgM/IgG™ antibody test. The clinical study, led by Jerry Yeo, PhD, DABCC, FAACC, Professor of Pathology at the University of Chicago, was published today in The American Journal of Clinical Pathology, revealing one of the highest overall accuracy rates for SARS-CoV-2 antibody detection via lateral flow technology.
While serological assays have become increasingly available for surveillance via the Food and Drug Administrations' (FDA) Emergency Use Authorization (EUA), reports of faulty or inaccurate tests underscore the need for rapid COVID-19 antibody tests to be thoroughly validated prior to their implementation. Truvian is leading this charge to ensure its diagnostic devices are validated by rigorous testing and sound science, including this independent analytical and clinical validation of Easy Check by Dr. Yeo.
During the study, Easy Check, which received EUA by the FDA in late July, showed excellent clinical performance with a sensitivity of 96.6%, specificity of 98.2% and an overall accuracy of 98.1%. The study also demonstrated that the Easy Check device is a simple, fast, and reliable platform for detection of seropositivity of SARS-CoV-2 at ten minutes after test initiation for either plasma, serum, or whole blood samples.
Easy Check performance was tested against Roche's Elecsys® anti-SARS-CoV-2 antibody assay and showed an overall concordance of 98.6% – demonstrating it compares very well with large lab-based serology analyzers. Using sera obtained from patients infected with other infectious diseases, including other coronaviruses, the test showed no cross reactivity – providing evidence the test is specific for SARS-CoV-2.
"Progress in the fight against the COVID-19 pandemic has been stunted by the presence of faulty or inaccurate testing solutions – primarily due to lack of third-party validation and rigorous testing," said Dena Marrinucci, PhD, Co-Founder and Chief Operating Officer of Truvian. "Our goal with Easy Check is to deliver a SARS-CoV-2 antibody assay that is, most importantly, reliable and accurate, while simultaneously delivering timely results. The device, which is manufactured in the U.S., can be produced at mass scale in order to meet the urgent needs of our healthcare workers on the front lines of this pandemic. Dr. Yeo's independent study validates that Easy Check has the potential to set the new gold standard for SARS-CoV-2 antibody testing."
Easy Check will help address current testing gaps by providing ongoing and real-time information regarding the seroconversion status of individuals who have been infected by SARS-CoV-2. It will also allow for frequent, low-cost testing and provide key data that will enable the medical community to better estimate the number of people previously infected to inform public health measures and infection fatality rate, which is critical to vaccination development.
"Sound and thorough science is part of Truvian's DNA," said Jeff Hawkins, President and Chief Executive Officer of Truvian. "We pride ourselves on ensuring that all of our testing and diagnostic platforms, including Easy Check, are thoroughly vetted and validated by credible third-party scientists. Dr. Yeo's study provides critical corroboration that Easy Check does what we intended for it to do – allow for reliable, quick and cost-efficient diagnostic information in the fight against COVID-19."
Truvian's Easy Check test is available for order now by emailing email@example.com. To read Dr. Yeo's full paper regarding the clinical study, research methodology and results, as well as other critical details about Easy Check, please visit Truvian's website.
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