Assure Antibody Test for COVID-19 Distributed by MEDformance is First in the U.S. to Receive Point-of-Care Authorization

Actualizado el 7 de octubre, 2020 - 21.20hs.

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Assure Antibody Test for COVID-19 Distributed by MEDformance is First in the U.S. to Receive Point-of-Care Authorization

Expanded Availability of Antibody Testing for "Waiver" Status Labs

PR Newswire

MCMINNVILLE, Tenn., Oct. 7, 2020

MCMINNVILLE, Tenn., Oct. 7, 2020 /PRNewswire/ -- On September 23rd, 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.

Point-of-Care Delivers More Timely and Convenient Results
"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."

The expanded authorization also makes it possible for more smaller pharmacies and clinics (CLIA Waived status facilities) to administer and bill for the test.

Highly Accurate, Meaningful Data
The tests, which are in stock in the U.S., passed quality control and received their initial EUA designation in July. Quality control testing from NCI labs confirmed combined estimated performance for sensitivity of 100%, and 98.8% for specificity. According to Dr. Ramsey Kilani, Chief Medical Officer for GSIS (a MEDformance alliance partner), "These tests may provide useful information about antibody-mediated immunity, and are currently important pieces of the diagnostic puzzle."

The tests start at $15.50 each or less based on volume to providers.

Founded in 2018, MEDformance delivers critical to care solutions for healthcare providers, businesses, schools, colleges, and local, state, and federal entities. Products and services include PPE (Personal Protective Equipment), Testing and Diagnostics, Infection Control & Prevention, Healthcare Supply Chain Management, and innovative Medical Devices.

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