Local doctor frustrated over FDA limits on COVID-19 immunity test


Dr. Regina Velarde, Newton Medical Urgent Care

ALBANY, N.Y. (NEWS10)- One local doctor is perplexed after being told her practice would be unable to perform coronavirus immunity testing for their patients. Dr. Regina Velarde said her practice had several boxes on order when they were told they would not be able to administer the test.

“Immunity testing of those with mild or moderate COVID-19 symptoms is paramount in detecting what percentage of the Capital District population has already had the virus,” said Dr. Velarde from Newton Medical Urgent Care.

Velarde said many of her patients have had a cough and fever but with a lack of available tests and hospitals instructing physicians to have those with mild symptoms self-quarantine, there is no accurate way to know how many people are still at risk. She also suspects the number of total cases in N.Y. is much higher than what’s being reported due to the lack of testing.

Not knowing what percentage of the population has already had the coronavirus Velarde said, could lead to a longer shutdown across the state and have devastating economic repercussions throughout the country. She was hopeful that the coronavirus antibody testing would be able to be done in her offices in Latham and Albany but Velarde and her partner, Dr. Piotr Biegun, will not be able to offer the test to patients.

Velarde said the test has been labeled by the Federal Drug Administration (FDA) as “complex” even though it requires a droplet of blood similar to that of a diabetes test, which can be done in the office or even at home.

Despite the antibody test not technically falling under the category of “complex”, the FDA said the test can only be done by CLIA (Clinical Laboratory Improvement Amendments) approved facilities, or in most cases, hospitals only.

“It was ready to go out into the market where doctor’s offices could perform the test. Now they cannot do this. In order for our community to function again, this test has to be widely available. The hospitals alone are not equipped to handle such a large volume of people. The FDA must be held accountable for this sudden change which can have devastating impacts on our already flagging economy,” Velarde said in a letter to President Donald Trump.

In a statement on Tuesday the FDA stressed the importance of testing the coronavirus immunity of Americans, “Serological tests can play a critical role in the fight against COVID-19 by helping healthcare professionals to identify individuals who have overcome an infection in the past and have developed an immune response. In the future, this may potentially be used to help determine, together with other clinical data, that such individuals are no longer susceptible to infection and can return to work.” In addition, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19.

That’s why Velarde doesn’t understand why the FDA won’t allow doctor’s offices to perform the test. “We can do this test, it’s easy. It would be lifesaving for this country,” she said.

News10 ABC reached out to the FDA for comment and was referred to its website.


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