elicity® to Offer the First COVID-19 Antibody Test to Receive an EUA for Patients to Collect Dried Blood Spot Samples at Home
SAN DIEGO--(BUSINESS WIRE)--Apr 13, 2021--
elicity, a proprietary telehealth platform powered by InTeleLabs® Inc., is now offering the first COVID-19 Antibody test to receive an Emergency Use Authorization (EUA) that allows patients to collect dried blood spot samples at home. 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 5 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.
“This is another milestone in our response to COVID-19, as it provides greater access to testing, and the ability to get an answer from the safety and comfort of home. We are excited to leverage the elicity platform to improve access to home diagnostic testing,” said Erik Hennings, CEO of InTeleLabs.
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health noted in a April 6, 2021 press release, “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.”
Qualitative detection of IgG antibodies to SARS-CoV-2 in human fingerstick blood dried blood spot (DBS) specimens that are self-collected at home by an individual age 18 years or older or collected by an adult from an individual 5 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 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
InTelelabs, Inc. 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. For more information about this COVID-19 Self-Collected Antibody Test, or other available lab tests, visit elicity.health.
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CONTACT: Erik Hennings
KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: INFECTIOUS DISEASES GENERAL HEALTH HEALTH MEDICAL SUPPLIES
SOURCE: InTelelabs, Inc.
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PUB: 04/13/2021 08:30 AM/DISC: 04/13/2021 08:31 AM