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

COVID-19 Hype or Hazard

Hopefully you are concerned, but aren’t panicking about the new coronavirus that is all over the news right now.

Breaking News: we have seen community spread in the US, at least nine 41 deaths, and more cases in more states. (see below)

What do you think of the news of the 2019 novel coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)?

Experts say don't panic about the 2019 novel coronavirus.

Are you ready to put on a mask, never leave your home, or just wait and see what happens?

COVID-19 Hype or Hazard

Hopefully you are concerned, but aren’t panicking and want to wait and see what happens over the next few days, weeks, and months.

So what’s going on?

A new coronavirus, 2019-nCoV SARS-CoV-2 has been detected in Wuhan, China and it is spreading, killing some people.

Why is this a concern?

While there are coronaviruses that are very common, even causing many cases of the common cold, there are others that are much more serious.

Seasonal coronavirus are very common during cold and flu season.
Seasonal coronavirus are very common during cold and flu season.

These include the coronaviruses that cause SARS and MERS.

A worldwide outbreak of severe acute respiratory syndrome caused by SARS-CoV caused 8,098 cases and 774 deaths in 2002-03. It also started in China.

MERS-CoV, which causes Middle East Respiratory Syndrome, has been causing cases and deaths since 2012.

What’s Next With COVID-19?

Why are experts concerned about SARS-CoV-2?

Check for Travel Alerts and Warnings before your next trip.
Check for Travel Alerts and Warnings before your next trip.

Mostly because of past experiences with SARS and MERS.

There is also the fact that there is no treatment or vaccine for 2019-nCoV.

Coronavirus that shows up on those large respiratory panels that some health providers do is seasonal coronavirus = the common cold.
Coronavirus that shows up on those large respiratory panels that some health providers do is seasonal coronavirus = the common cold.

And no, your doctor won’t be able to routinely test you for SARS-CoV-2. Testing can be done for those who are high risk, but it still involves sending the specimens to a lab at your local or state health department or the CDC.

That shouldn’t put you into panic mode though…

“Two cases of 2019-nCoV have been reported in the United States. Both patients had recently returned from Wuhan, China. More cases are likely to be identified in the coming days, including more cases in the United States.”

COVID-19 Frequently Asked Questions

Unless you have recently traveled to Wuhan, China an area where there is a COVID-19 outbreak or have had close contract with someone who traveled to an area with a lot of cases while they were sick, then you likely aren’t at much risk to get sick with this virus.

“For the general American public, who are unlikely to be exposed to this virus at this time, the immediate health risk from COVID-19 is considered low.”

Coronavirus Disease 2019 (COVID-19) Situation Summary

It is certainly not something to ignore though.

Since first being detected in Wuhan, China on December 29, 2019, cases have spread to 28 41 46 64 72 134 other countries.

“More cases are likely to be identified in the coming days, including more cases in the United States. It’s also likely that person-to-person spread will continue to occur, including in the United States.”

Coronavirus Disease 2019 (COVID-19) Situation Summary

Most experts expect SARS-CoV-2 to become a pandemic, but that still shouldn’t put you into panic mode…

Experts are also working to learn more so that we know:

  • the original source of the virus – is it the animal markets in Wuhan, China?
  • the incubation period – it seems to be 1 to 14 days
  • how contagious the virus can be and how it spreads – close contact
  • how serious are the complications of infection or how deadly is this virus – so far, “reported illnesses have ranged from mild to severe, including illness resulting in death,” but the latest worldwide mortality rate of 1.4 to 3.4% is much higher than seasonal flu
  • can the virus be contained – this seems unlikely…

We got one answer recently, as it seems that people with the virus are contagious before they have symptoms.

What’s next?

Don’t panic. Plan ahead.

Stay up to date on SARS-CoV-2 information and call your health care provider if you have flu-like symptoms and recently traveled to Wuhan, China or had contact with someone who is under investigation for COVID-19.

“Limited reports of children with COVID-19 in China have described cold-like symptoms, such as fever, runny nose, and cough. Gastrointestinal symptoms (vomiting and diarrhea) have been reported in at least one child with COVID-19. These limited reports suggest that children with confirmed COVID-19 have generally presented with mild symptoms, and though severe complications (e.g., acute respiratory distress syndrome, septic shock) have been reported, they appear to be uncommon.”

CDC on Frequently Asked Questions and Answers: Coronavirus Disease-2019 (COVID-19) and Children

And even if you are starting to get nervous, at least you don’t have to worry too much about your kids. So far, there is no evidence that children are more susceptible to COVID-19 and there are reports that they actually get milder symptoms!

Lastly, if you haven’t yet, be sure to get a flu vaccine.

Affected geographic areas include China, Italy, South Korea, Iran, and Japan.
As we see community spread in more areas, the criteria to guide evaluation of PUI for COVID-19 continues to loosen up.

If you are going to develop a fever and symptoms of lower respiratory illness during cold and flu season in the United States, especially if you haven’t traveled to a high risk area, then it is probably the flu, not the new coronavirus…

More on COVID-19 Hype or Hazard