FDA authorizes first two COVID-19 serology tests

Clinical Trials & Research, Research and Clinical Trials

At the moment, the U.S. Meals and Drug Administration approved the first two COVID-19 serology tests that show an estimated amount of antibodies current within the particular person’s blood. Each tests from Siemens, the ADVIA Centaur COV2G and Attelica COV2G are what are generally known as “semi-quantitative” tests, that means that they don’t show a exact measurement, however estimate the variety of a affected person’s antibodies produced towards an infection with the virus that causes COVID-19.

“Being able to measure a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection may be useful as we continue to learn more about the virus and what the existence of antibodies may mean,” stated Tim Stenzel, M.D., Ph.D., director of the Workplace of In Vitro Diagnostics and Radiological Well being within the FDA’s Middle for Gadgets and Radiological Well being. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorizations give us additional tools to evaluate those antibodies as we continue to research and study this virus. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”

As a result of these unknowns, the FDA cautions sufferers towards utilizing the outcomes from these tests, or any serology check, as a sign that they’ll cease taking steps to guard themselves and others, similar to stopping social distancing, discontinuing carrying masks or returning to work. The FDA additionally desires to remind sufferers that serology tests shouldn’t be used to diagnose an energetic an infection, as they solely detect antibodies the immune system develops in response to the virus – not the virus itself.

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