FDA Authorized Only Handful of Antibody Tests

According to an FDA database, only nine tests so far have been authorized under Emergency Use Authorization.

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Many of the coronavirus antibody tests advertised in South Florida might not be what you thought they were, according to the U.S. Food and Drug Administration. 

There are more than 150 products marketing themselves as antibody tests. They were allowed to go out with the understanding that they had to tell customers they were not FDA approved.

According to an FDA database, only nine so far have been authorized under Emergency Use Authorization. None have been approved - a process that will take months. 

When your body fights off a virus, it creates antibodies in your blood. Detecting those antibodies could be a way to determine if someone already had the virus and beat it.

But, it is in no way cut and dry. Much of our knowledge about the coronavirus and any possible testing changes along with the pandemic. There are no easy answers. 

It’s important to know some are good, some are bad. Some are good and not yet authorized - even that process can take weeks. Some are simply junk science. Being authorized is a less rigorous standard than products that will be eventually approved. 

The crux is - before this latest pandemic - there were four coronaviruses: KU1, NL63, OC43, or 229E. Those just led to the common cold. Your body creates antibodies for all of them. 

Then came a fifth and new coronavirus: SARS-CoV-2. That’s the virus causing thousands of deaths and stay-at-home orders across Florida. 

“Many of the antibody tests do not distinguish between COVID-19 versus the other four coronaviruses that cause the common cold. If you are going to use the test on a mass scale for population-based screening, you need test that is essentially 99.99999% sensitive. Meaning, you’re going to pick up every single infection that occurred,” said Dr. Carla McWilliams, MD, the Chief of Infectious Disease at the Cleveland Clinic Florida.

“A lot of places are making these antibody tests and doing everything they can to get them up and running, but right now at this time, we have not implemented antibody tests for that reason," she added.

It’s also a reason why the state of Florida waited to purchase antibody tests in bulk. 

“There’s a coronavirus that causes the common cold, for example. That does not give us that much predictive ability or data that’s useful if you’re getting effectively what’s a false positive,” said Florida Gov. Ron DeSantis at a news conference on Saturday.

There’s really two issues with the antibody tests en masse. The FDA reports only a few tests successfully screen the other four coronaviruses out and only deliver results from antibodies specifically for SARS-CoV-2. 

Even if the FDA authorizes a test, several of them only detect one of the two antibodies your virus creates to fight off the virus: IgM and IgG. 

The University of Miami and Miami-Dade County random testing study from early April estimated 165,000 people might have had the virus in tech country and used North Carolina-based BioMedomics tests. Those tests have not been authorized or approved by the FDA. Does that mean they are junk science? No. It means they haven’t been authorized or approved - yet. 

But it does mean they can’t be relied upon for certain accuracy. Researchers say they expect them to be about 90% accurate. But at the end of the day, it’s only an estimate. 

Jackie Llama was one of thousands of people in South Florida wanting to know if they had the new coronavirus, SARS-CoV-2. 

“I just miss my mom and my family. I wanted to see if I had had it and then it might be a little safer for us to go out,” said Llama.

She went to Biotech in Doral to get the antibody test they sell for almost $90. The results came back negative. She knew it was going to be hit or miss going in. 

“It was a chance my husband and I were willing to take at this point. You know, we wanted peace of mind and if there was a chance we could get it. We were willing to do it. Overall, I just want to get back to some sort of normal again,” said Llama. 

We don’t know what brand of test Jackie took. We reached out to Biotech to find out. They haven’t returned our call or email.

Antibody tests are known as “serological” tests because they use blood samples. 

The FDA has a database of which tests have been authorized.

As of Wednesday, the below tests have been authorized to detect at least one of two antibodies created by SARS-CoV-2. But these are only the companies, not the specific tests themselves. Look to the database above for the specific products from the specific companies. 

  • Bio-Rad Laboratories – total antibody
  • Abbott Labs - IgG only
  • DiaSorin Inc -IgG only 
  • OrthoClinical Diagnostics, Inc. - IgG only 
  • AutobioDiagnostics Co. - IgG and IgM
  • Mount Saini Lab - IgG
  • Chembio Diagnostic System - IgM and IgG
  • Ortho Clinical Diagnostic - “serological total antibody” 
  • Cellex Inc. - IgM and IgG
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