The US Food and Drug Administration said it has issued emergency use authorization for the Symbiotica Covid-19 Self-Collected Antibody Test System.
The test system lets people know if they have been infected in the past with coronavirus.
It is the first to use home collected dried blood spot samples, which are then sent to a Symbiotica, Inc. laboratory to be analyzed.
“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,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement Tuesday.
The test should not be used to diagnose or exclude acute SARS-CoV-2 infection, the FDA said.
The Covid-19 Self-Collected Antibody Test System has been authorized for prescription use with a fingerstick dried blood sample, either self-collected by people age 18 and up or collected by an adult for children ages 5 and up.
The performance of the test has not been established in people who have received a Covid-19 vaccine, the EUA says.
“The clinical significance of a positive or negative antibody result following Covid-19 vaccination has not been established, and the results from this assay should not be interpreted as an indication or degree of protection from infection after vaccination,” it says.