TCT Services LLC, located in Bismarck, North Dakota, is excited to announce our primary Covid-19 IgM/IgG antibodies test kit, the Assure Tec, is not only FDA-approved for Emergency Use Authorization (EUA), but it is now the only Covid-19 IgM/IgG antibodies FDA-approved to be used in point of care settings. Please call Pat Testa with any question, comments, or to place an order at 701-516-3850. Please read the FDA announcement below:
On September 23rd.2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. Today, that EUA is being reissued to authorize the test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing. “Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D. “Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.” Nearly 50 serology tests have been granted an EUA since the start of the pandemic. The Assure test is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood. This serology POC test, unlike POC COVID-19 diagnostic tests, uses a blood sample from the fingertip to run the test. Again, as of this date, the Assure Tec covid-19 IgM/IgG antibodies testing device is currently the only FDA authorized COVID-19 POC serology test.
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