COVID-19 Antibody Test Authorized for Point of Care Use by the FDA

The latest update from the FDA sees the very first COVID-19 antibody rapid test device authorized for CLIA waived usage, applicable to Point-of-Care (POC) settings. As the Emergency Use Authorization (EUA) had already been issued for the Assure Tech COVID-19 IgG/IgM Rapid Test Device, it has now been extended to include POC use. Please review the official letter from the FDA by clicking here.

Antibody testing may now conducted at the point-of-care in a hospital, doctor’s office or clinic.  Specifically, the test can now be used with finger-stick capillary blood specimens from POC collection settings that are operating under a CLIA Certificate of Waiver, Compliance or Accreditation. The rapid test device can still be used in laboratories meeting the requirements to perform moderate and high complexity tests.

The tests are used to detect the presence of the antibodies the human body produces as a response to a COVID-19 infection, indicating whether the person had been infected with the coronavirus in the past. With results taking as little as 15 minutes, this test will radically speed up testing, and will offer new insights into fighting the coronavirus spread. We have prepared an infographic summarising how different COVID-19 tests compare to each other, including the antibody tests:

https://verifydiagnostics.com/infographics/

Verify Diagnostics does have the Assure Tech COVID-19 IgG/IgM Rapid Test Device readily available and in stock. You may  call us at 866-446-2953 or contact us via our website with any enquiries:

https://verifydiagnostics.com/contact-us/

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