About Those Rapid COVID-19 Tests

A company is selling rapid COVID-19 tests that promise quick results in 10 minutes. The only problem? They are not approved by the FDA…

While everyone has been talking about tests for SARS-CoV-2 infections, it is mostly the PCR tests from nasopharyngeal swabs that take a few days to get results.

The PCR tests that nobody can really get their hands on…

About Those Rapid COVID-19 Tests

Now, in addition to more and more of those tests becoming available every day, many folks are excited about rapid tests.

How rapid?

“The Food and Drug Administration has approved the first rapid point-of-care COVID-19 test, that can deliver results in less than an hour.”

FDA Approves First Rapid COVID-19 Test

The new COVID-19 test, from Cepheid, provides results, also from a nasal swab, in about 45 minutes.

Most importantly, like strep and flu tests, this new COVID-19 rapid test doesn’t have to be sent anywhere. That doesn’t mean that your pediatrician will be able to see you and run a rapid COVID-19 test anytime soon though.

“The test has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, with a detection time of approximately 45 minutes.”

Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test

It needs the specialized, and expensive, GeneXpert System to run.

Who has these systems?

Mostly hospital labs.

And that’s great news!

Even if the test could be run in your pediatrician’s office, a lack of personal protective equipment would still limit how much testing they could do.

On the other hand, a fast test that could be run in big hospitals will help them set up centralized, mobile testing centers.

Unfortunately, in addition to the very real rapid COVID-19 test from Cepheid, we are seeing many other rapid tests pop up that are not FDA approved!

COVID-19 test results in 10 minutes? From a blood sample?
COVID-19 test results in 10 minutes? From a blood sample?

Among the tests that you should be especially wary of are those that say they give quick results from a blood sample – a serology test.

“Initial work to develop a serology test for SARS-CoV-2 is underway at CDC. In order to develop the test, CDC needs blood samples from people who had COVID-19 at least 21 days after their symptoms first started. Researchers are currently working to develop the basic parameters for the test, which will be refined as more samples become available. Once the test is developed, CDC will need additional samples to evaluate whether the test works as intended.”

Serology Test for COVID-19

Unfortunately, these types of serology tests which look at antibody levels are not yet available – at least they aren’t available in the United States.

Several companies have begun the application process with the FDA under the COVID-19 Emergency Use Authorization (EUA) though.

We will have to see if they really work and how long it takes for them to get approved.

What else isn’t available yet? There are no FDA approved home COVID-19 test kits, even though many companies and some physicians are selling them…

More on Rapid COVID-19 Tests

Author: Vincent Iannelli, MD

Vincent Iannelli, MD

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