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At-home COVID-19 testing kits blocked by the FDA

Some startup health companies raced to release COVID-19 testing kits you can take yourself at home. They have not been approved by the FDA.

With a spike in positive coronavirus cases nationwide, many people are calling for an increase in testing availability. Health officials are warning consumers about at-home COVID-19 testing kits being sold online. These tests are not approved by the U. S. Food and Drug Administration (FDA) and health officials warn they are not reliable.

“If they produce false negatives and false positives, they’re going to give you inaccurate information, which could be dangerous,” explained Dr. Rachel Levine, Pennsylvania’s Secretary of Health.

Some startup health companies, like Everlywell and Nurx, raced to release at-home COVID-19 testing kits to the public. Consumers would need to be approved to receive a test. Once it is delivered, they would ship their samples to a lab certified under the FDA Emergency Use Authorization.

Companies halted distribution of these tests after the FDA announced it had not authorized at-home testing for COVID-19.

RELATED: WellSpan Health York Hospital worker tests positive for COVID-19

However, the FDA has issued an Emergency Use Authorization for a transformative new test by a company called Cepheid. The company said its machines can be based near an emergency room or operating room and deliver test results within 45 minutes.

“The results are available much more quickly and that means those results will play into how those patients are managed,” stated Dr. David Persing, Chief Medical and Technology Officer at Cepheid. “Who gets respiratory isolation, who needs antibiotics, who doesn’t need antibiotics—those kinds of decisions can be made in real time.”

RELATED: FDA approves coronavirus test that produces results in 45 minutes

According to the FDA, Cepheid is rolling-out these rapid tests by March 30th. Testing will be limited to healthcare workers or those in severe condition, and we may see these rapid tests soon in Pennsylvania hospitals.

“That would be a very important development,” said Dr. Levine. “We’ll be looking to check in on the availability of that test. But again, that would be for healthcare providers.”

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