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!
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
- FDA Approves First Rapid COVID-19 Test
- Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test
- New blood tests for antibodies could show true scale of coronavirus pandemic
- CDC – Evaluating and Reporting Persons Under Investigation (PUI)
- CDC – Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19)
- CDC – Should I be tested for COVID-19?
- CDC – Serology Test for COVID-19
- CDC – COVID-19 Frequently Asked Questions and Answers
- FDA – Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics
- FDA – Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency
- WHO – Coronavirus disease (COVID-19) technical guidance: Laboratory testing for 2019-nCoV in humans
- COVID-19 Lab Guidance & Diagnostics
- ECDC – Laboratory support (for primary/and or confirmatory testing) by Coronavirus specialised laboratories in the EU
- FDA – Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
- COVID-19 Testing Kits Arrive at State Public Health Laboratories
- As Coronavirus Spreads, Experts Explain When to Call a Doctor, How Testing Works and More
- States start testing for COVID-19, screening more broadly
- Quest Diagnostics to Launch Coronavirus Disease 2019 (COVID-19) Test
- LabCorp Launches Test for Coronavirus Disease 2019 (COVID-19)
- Share Facts About COVID-19
- Coronavirus tests are hard to get — unless you have money, fame and the right doctor
- At-Home COVID-19 Tests Are a Scam, City Attorney Mike Feuer Warns
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