14 April 2021 - - US-based telehealth platform elicity, powered by InTeleLabs Inc., is now offering the first COVID-19 Antibody test to receive an Emergency Use Authorization that allows patients to collect dried blood spot samples at home, the company said.

The COVID-19 Self-Collected Antibody Test System is available through a collaboration with Symbiotica, Inc., a CLIA-certified clinical laboratory.

The test is authorized 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.

The test is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The COVID-19 Self-Collected Antibody Test System should not be used to diagnose or exclude acute SARS-CoV-2 infection.

Qualitative detection of IgG antibodies to SARS-CoV-2 in human fingerstick blood dried blood spot specimens that are self-collected at home by an individual age 18 years or older or collected by an adult from an individual five years of age and older using the COVID-19 Self-Collected Antibody Test System Collection Kit when determined to be appropriate by a healthcare provider.

Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

Similar to other COVID-19 tests on the market, this test system has not been FDA cleared or approved but has been authorized for emergency use by the FDA under an Emergency Use Authorization by Symbiotica Inc., located at 1350 Burton Drive, Vacaville, CA 95687.

This test system has been authorized only for detecting IgG antibodies to SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this test system is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in-vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Federal Food, Drug and Cosmetic Act, 21 USC. § 360bbb-3(b) (1), unless the declaration is terminated or authorization is revoked sooner.

InTelelabs is a telehealth and personalized medicine company, leveraging its proprietary telehealth platform, elicity, to make clinical lab testing accessible and convenient.

elicity works by connecting patients with independent, board certified physicians to oversee the selection, ordering, and delivery of clinically actionable lab results, empowering patients to take control of their health from the safety and comfort of home.