|EpiGentek’s SeroFlash™ SARS-CoV-2 Rapid Antibody Test Undergoing IRB/IBC-Approved Fingertip Validation Study at Oakland University for Point-of-Care
Aug. 3, 2020 - FARMINGDALE, NY – EpiGentek, renowned for its high-quality antibody-based products for epigenetic and genetic research, has joined the global fight against SARS-CoV-2 with several COVID-19 assay kits, antibodies, and proteins. The first one of these developed, the SeroFlash™ SARS-CoV-2 IgM/IgG Antibody Detection Kit, is now being used in a study at the Oakland University William Beaumont School of Medicine that has been approved by the university’s Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC).
The study, co-authored by fourth-year medical student Nahrain Putris and Dr. Kenneth Mitton, is intended to focus on fingertip blood kits that can be effectively used to determine if individuals have COVID-19 antibodies at the point-of-care. The goal is to find reliable testing alternatives to the standard blood draw-based tests, which can be time-consuming and have struggles in scaling in order to be available to millions of people.
Although there are a growing number of fingertip blood antibody test kits on the market, EpiGentek’s SeroFlash kit was chosen as the subject of the study as past experiences with other reagents from the company were described as “reliable and specific as promised” by Mitton. Reagents, being the main ingredient of chemical-based tests, are a crucially important element to these tests and therefore need to come from a trustworthy, proven source.
Individuals can participate in the study if they’ve had a confirmed case of COVID-19, had since recovered and tested negative, or had been clinically assessed and cleared by qualified medical staff. What this does is help the researchers confirm testing correlation and that SeroFlash is free of the false positive problem that have been common in other poorly validated antibody tests on the market.
“So far,” Mitton comments, “we have not seen any false positive tests from persons who also have no antibodies based on the clinical arm draw test.”
While the study is still ongoing, there is promise in these preliminary results that the study could show that a robust point-of-care antibody test can be an effective tool to track and contain the virus at scale while understanding population-wide immune response to SARS-CoV-2.
If you would like to learn more information about the kit, see the SeroFlash™ SARS-CoV-2 IgM/IgG Antibody Detection Kit product page for clinical performance data, instructions/user guide, lot certificate of analysis and more.
Original Story: Oakland University William Beaumont School of Medicine Newsroom
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