We founded Truvian with intent to have profound impact on human health through transformative blood diagnostics. With that, not only is our core rapid blood testing platform being designed to disrupt the market, but we have also expanded our focus to help tackle the COVID-19 pandemic and have recently announced our efforts on a SARS-CoV-2 antibody test.
Due to concerns regarding the accuracy of antibody tests, and in keeping in line with our own high standards, Truvian has taken the time to ensure performance criteria is met, and exceeded, by working with established leaders in the scientific and medical communities. In times of crisis, collaboration is key.
Sensitivity and specificity of antibody testing have come under great scrutiny and for great reason. Healthcare professionals, scientists and patients all need information that is both accurate and reliable. Critical decisions are being made from the population level, down to the individual level, and in the absence of sound data, those decisions can lead to life-altering, and society-altering unintended consequences.
Our COVID-19 antibody test importantly includes a mixture of both nucleocapsid and spike receptor binding domain antigens to enable better sensitivity without sacrificing specificity. Through our external studies, we have demonstrated 98% sensitivity and 99% specificity which rivals lab based serology tests.
In working with Dr. Davey Smith and Dr. Stephen Rawlings at UCSD, we were able to establish the sensitivity of our Easy Check COVID-19 IgM/IgG antibody test by looking at patients with PCR-confirmed cases of COVID-19 to determine if Easy Check could identify those same individuals as antibody positive. We also looked at over 150 normal donors, who gave blood samples over 2 years, prior to September 1, 2019, to determine specificity. Access to this robust sample set was key to validating our product through a rigorous testing process.
But there is more to accuracy than the standard sensitivity and specificity, to ensure a more reliable test. For Emergency Use Authorization (EUA), the FDA recommends you complete cross-reactivity testing with other viruses and in particular include evaluation of non SARS-CoV-2 coronaviruses, but it’s often challenging to get access to these types of samples.
In partnering with Dr. Jerry Yeo at the University of Chicago, we had access to 40+ samples of patients that have been diagnosed with other infectious diseases to look at cross–reactivity, to ensure our test is specific to SARS–CoV-2 including other coronavirus confirmed samples. As of the date this blog post has been published, Easy Check has a greater sample set for cross-reactivity testing than any COVID-19 antibody lateral flow test currently under EUA and all of the samples are indeed negative, confirming the specificity of our test to SARS-CoV-2.
At Truvian we are staying the course to deliver on a promise to have an impact on healthcare. Easy Check isn’t the first to market, but it offers the reliability that most other lateral flow COVID-19 serology tests can’t, with accuracy that rivals lab-based tests. We look forward to expanding our collaborations to generate more data to understand sero-conversion, antibody kinetics, and more. If you may be interested in a study with us, feel free to reach out. I would love to hear from you!