"Having done an extensive evaluation on Truvian's device, I firmly believe that Easy Check delivers the accuracy and clinical performance as stipulated by the FDA, and sets the tone for what the medical community needs in terms of a highly reliable antibody test."
Jerry Yeo, PhD, DABCC, FAACC
Professor of Pathology
University of Chicago
About Easy Check
Truvian's U.S.-manufactured Easy Check COVID-19 IgM/IgGTM antibody test offers a low-cost, rapid first-line detection of COVID-19 antibodies. Authorized by the FDA under EUA and validated by industry leaders, Easy Check identifies the presence of IgM and IgG antibodies against SARS-CoV-2 in 10 minutes with a high level of sensitivity and specificity.
Easy Check exceeds the FDA's standards and requirements, with testing sponsored by the National Cancer Institute (NCI).
Objectives: To evaluate the analytical and clinical performance of the Truvian Easy Check COVID-19 IgM/IgG™ anti-SARS CoV- 2 antibody test.
Background: While serological assays have become increasingly available for surveillance through the 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.
Methods: The Easy Check device was analytically evaluated and its performance was compared with the Roche Elecsys® anti-SARS-CoV-2 antibody assay. The test was further characterized for cross-reactivity using sera obtained from patients infected by other viruses. Serial time-courses were also obtained with confirmed SARS-CoV-2-positive patient samples. Clinical performance was analyzed with PCR-confirmed samples and a 2015 pre-pandemic reference sample set.
Results: The Easy Check device showed excellent analytical performance and compares well with the Roche Elecsys antibody assay, with an overall concordance of 98.6%. Clinical performance showed a sensitivity of 96.6%, a specificity of 98.2%, and an overall accuracy of 98.1%.
Conclusions: The Easy Check device is a simple, reliable, and rapid test for detection of SARS-CoV-2 seropositivity and its performance compares favorably against the well-established, automated Roche Elecsys antibody assay.
Making routine health testing convenient, affordable, and actionable for today's connected consumers.
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