Amarillo area health officials warning public of rapid COVID-19 testing not approved by FDA

By Vanessa Garcia | April 21, 2020 at 10:14 AM CDT - Updated April 21 at 10:28 AM

AMARILLO, Texas (KFDA) - Amarillo area health officials are warning the public of rapid COVID-19 testing that aren’t FDA approved.





In a news release, BSA CareXpress said there are new antibody rapid tests for the coronavirus now offered in Amarillo and Canyon.

As quick as results are with these tests, health officials are questioning the accuracy.

“Most of these rapid antibody tests have not been approved by the Federal Drug Administration (FDA), and there are serious questions about their accuracy,” said Robert Gross, M.D. at CareXpress in Canyon.

Gross is certified in public health by the American Board of Preventive Medicine.

“There have been numerous reports of the tests flagging people as having the antibody when they do not, which can create a dangerous belief that people have immunity when they don’t," he said. “It’s also important to note that some of these tests are not designed to detect active infections."

Gross said this could lead to a false sense of security, meaning an asymptomatic person could expose the virus without being aware.

FDA Commissioner Stephen Hahn is also concerned of some of the antibody tests that are not FDA approved and their accuracies.

CareXpress offers tests that are FDA approved with results coming back within 24 hours.

“We want to be clear: we do have a test for COVID-19 which has been approved by the FDA, and we are able to get our patients the results within a day or so,” Gross said. “These are not antibody tests, but we feel confident in the results they provide, and they do it pretty quickly.”

Health officials are expecting an increase of tests not approved by the FDA, but they are urging residents in the Panhandle-region to make sure tests are FDA approved.

“The bottom line is that we just don’t know if the non-approved FDA tests are accurate, and there’s too much at risk to take chances with them,” Gross added. “I understand that we’re already to get back to a more normal life, but we must be smart about how we do that and do it in the safest manner possible."

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