The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc.), the first antibody test approved for the use of collected antibodies. sample of dry blood area.
The Symbiotica COVID-19 Self-Collected Antibody Test System is intended for use as an aid in the identification of individuals with an adaptive immune response to SARS-CoV-2, indicating current or previous infection. The EUA allows finger -dried blood samples to be collected in -house by an individual 18 years of age and older or collected by an adult from an individual 5 years of age and older. The collected samples were then sent to a Symbiotica, Inc. laboratory for analysis. The test is only available by prescription.
“Allowing the first use of the prescription, home collection testing plays an important role in helping health care professionals identify individuals who have developed an appropriate resistance response from the bag. -or or previously infected with COVID-19, ”said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
The Agency warns that the Symbiotica COVID-19 Self-Collected Antibody Test System should not be used to diagnose or exclude severe SARS-CoV-2 infection. It is not known at this time whether the presence of antibodies confer immunity and how long the antibodies will persist after infection.
Coronavirus Update (COVID-19): FDA Grants Emergency Use Authorization for Symbiotica COVID-19 Self-Collected Antibody Test System. [press release]. Silver Spring, MD: Food and Drug Management in the United States; April 6, 2021.
This article originally appeared The MPR