The U.S. Food and Drug Administration (FDA) continues to step outside its traditional comfort zone in response to COVID-19 pandemic pressures. Among the most recent agency firsts is best seen as part of the current imperative to clear assays and collection kits for rapid and easy screening, including products that can be used in home settings. On April 6, the FDA crossed a new barrier by granting Emergency Use Authorization (EUA) for a SARS-CoV-2 antibody detection test used in dried blood spot samples collected at home. The Symbiotica System The product on the receiving end of the groundbreaking EUA was Symbiotica’s COVID-19 Self-Collected Antibody Test System, a prescription-only test designed to detect immunoglobulin G against SARS-CoV-2 in dried blood spots obtained via fingerstick. The kit includes lancets that individuals can use to collect the blood samples themselves and mail to Symbiotica’s California laboratory for analysis. “The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” noted Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. Molecular Test […]