The antibody test is authorised for use with home collected dried blood spot samples
Symbiotica has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 self-collected antibody test system.
It is said to be the first antibody test authorised for use with home collected dried blood spot samples. Symbiotica’s laboratory will analyse the samples that are collected at home.
The test system is provided EUA for prescription use with a fingerstick dried blood sample, which is self-collected by an individual age 18 years or older or collected by an adult from an individual five years of age and older.
Symbiotica’s test will help detect individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
The FDA’s Center for Devices and Radiological Health director Dr Jeff Shuren said: “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.
“The FDA will continue to authorize Covid-19 tests that will give more Americans access to greater testing flexibility and options.”
According to the FDA, the Covid-19 self-collected antibody test system in not intended to be used to diagnose or exclude acute SARS-CoV-2 infection.
Antibody tests, which are also called as serology tests, will enable to identify antibodies present in the blood when the body is responding to a specific infection.
The new antibody test has the potential to predict whether a patient will experience mild versus more severe symptoms of the virus.