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Two more companies recieve Emergency Use Authorization from FDA for antibody testing

The test measures the antibodies in your blood to help determine if you've ever been infected with COVID-19.

AUSTIN, Texas — Two more companies have recieved Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for serological tests, which are also known as antibody tests. 

The test measures the antibodies in your blood to help determine if you've ever been infected with COVID-19. 

Chembio Diagnostic Systems Inc. and Ortho Clinical Diagnostics each received the authorization. According to the FDA's website, it was issued on April 14. 

"Why you need antibody testing is you need to know – are you in the acute phase and have you developed your own antibodies?" said Gail Page, a member of the board of directors for Chembio Diagnostics. "The value of that test is it tells us our status of our antibodies."

Page, who lives in Austin, said the company has already started to distribute the test.

"What I can tell you that we, as a company, will have the capacity to produce millions of these a year," said Page. "What antibody tests have done for us as a society is it helps physicians manage the patient, but it also tells you that if whatever if you're taking – an antibiotic or whatever you're taking – you know it tells, are you in that recovery phase? It tells you, are you contagious or are you ready to go back to work?"

RELATED: State health official warns of COVID-19 antibody testing dangers

Page said the test is essentially taking a sample of blood from one's finger. 

"It's a finger stick and it can be analyzed in 15 minutes. The other value to that is that we do have two different sized readers. So it helps you to decentralize the testing depending on whether you're a physician's office or an emergency room, a clinic," said Page. "We can envision in the near future of being able to decentralize the testing for possible sporting events – so construction sites, other opportunities you wouldn’t ordinarily think that would need a health care test like this."

Credit: Chembio Diagnostics, Inc.
Chembio Diagnostics serological test.

According to a press release, Ortho Clinical Diagnostics has also started distributing its tests. 

“The COVID-19 pandemic continues to impact individuals, families and communities around the world,” said Chris Smith, the CEO of Ortho Clinical Diagnostics, in the release. “Ortho is proud to be working toward large-scale solutions that will help people return to work, reducing the strain on both employees and the economy as a whole. Our focus on improving patients’ lives through diagnostics led us to rapidly develop this test, providing one of the key resources needed for diagnosing and treating COVID-19. We remain committed to helping laboratories deliver fast, accurate, reliable results to health care professionals, patients and the researchers developing the long-term, sustainable management of this disease.” 

Credit: Ortho Clinical Diagnostics
Ortho Clinical Diagnostics' Serology Test

KVUE reached out to see if the City of Austin was actively pursuing supply for the tests. A spokesperson for the City of Austin told KVUE Austin Public Health (APH) is looking into antibody tests in general, but they are not being used by APH at this time and could not confirm about specific tests. 

KVUE also reached out to the Department of State Health Services and it said it's interested in adding serology (antibody) testing to its lab, but does not know yet which particular test that will be.

On Tuesday KVUE spoke with the Department of State Health Services on some of the things its said people should know about antibody testing. You can read that report here.  


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