March 5, 2022 — Symbiotica, Inc. received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for its Self-Collected COVID-19 Antibody Test Kit System, the first antibody test authorized for use with simple home collected dried blood spot samples.

The COVID-19 Self-Collected Antibody Test System is intended for use as an aid to inform individuals over 5-years-old whether their body has made an adaptive immune response to SARS-CoV-2, the virus that causes COVID-19 disease. When someone is exposed to COVID-19 or vaccinated, their body usually produces antibodies as part of its immune reaction. This serology (antibody) test accurately tells the test taker whether they have antibodies to COVID-19. The test has a documented clinical sensitivity of 100% and a specificity of 98.04%.

The collection kit is not only accurate, but easy to use. The EUA allows for fingerstick dried blood samples to be self-collected at home by an individual over 18-years-old or collected by an adult from an individual over 5-years-old. The collected samples are then sent to California where a Symbiotica CLIA certified laboratory performs the analysis.

The test is available only by prescription and is offered online by 4UHealth.com.

“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,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. 

Some antibodies made for the virus that causes COVID-19 provide protection from getting infected. CDC is evaluating what degree of safety COVID antibodies provide and how long protection from antibodies might last. Although infection is possible after having produced antibodies from vaccination or prior infection, having antibodies plays an important role in helping prevent severe COVID-19 disease.

The COVID-19 antibody test is authorized for at-home collection in all states, except for MD, NY and PA.

Read More: https://4uhealth.com/natural-immunity-for-the-win-at-home-covid-antibody-test-gets-fda-eua/

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