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July 31, 2020
Right now, the U.S. Meals and Drug Administration licensed the primary two COVID-19 serology exams that show an estimated amount of antibodies current within the particular person’s blood. Each exams from Siemens, the ADVIA Centaur COV2G and Attelica COV2G, are what are often called “semi-quantitative” exams, which means that they don’t show a exact measurement, however estimate the amount of a affected person’s antibodies produced towards an infection with the virus that causes COVID-19.
“Having the ability to measure a affected person’s relative degree of antibodies in response to a earlier SARS-CoV-2 an infection could also be helpful as we proceed to be taught extra in regards to the virus and what the existence of antibodies might imply,” stated Tim Stenzel, M.D., Ph.D., director of the Workplace of In Vitro Diagnostics and Radiological Well being within the FDA’s Heart for Gadgets and Radiological Well being. “There are nonetheless many unknowns about what the presence of SARS-CoV-2 antibodies might inform us about potential immunity, however in the present day’s authorizations give us further instruments to judge these antibodies as we proceed to analysis and research this virus. Sufferers mustn’t interpret outcomes as telling them they’re immune, or have any degree of immunity, from the virus.”
On account of these unknowns, the FDA cautions sufferers towards utilizing the outcomes from these exams, or any serology check, as a sign that they will cease taking steps to guard themselves and others, corresponding to stopping social distancing, discontinuing sporting masks or returning to work. The FDA additionally desires to remind sufferers that serology exams shouldn’t be used to diagnose an lively an infection, as they solely detect antibodies the immune system develops in response to the virus – not the virus itself.
The FDA, an company inside the U.S. Division of Well being and Human Companies, protects the general public well being by assuring the security, effectiveness, and safety of human and veterinary medication, vaccines and different organic merchandise for human use, and medical gadgets. The company is also liable for the security and safety of our nation’s meals provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.
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