Telehealth and personalised medicine company InTelelabs Inc said on Tuesday that its elicity proprietary telehealth plaform is now offering the first COVID-19 antibody test that allows patients to collect dried blood spot samples at home.
elicity's first COVID-19 antibody test has received US FDA Emergency Use Authorization (EUA) for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorisation is revoked sooner.
Available through a collaboration with Symbiotica Inc, elicity's COVID-19 Self-Collected Antibody Test System is authorised for prescription use with a fingerstick dried blood sample that 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.
It is still unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The company's test aids in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
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