PHOENIX (3TV/CBS 5) -- A confusing part of the pandemic may have a simple explanation.

People who showed symptoms of COVID-19, but tested negative for the infection or antibodies, may have taken a bad test. False negatives and false positives are a problem with both diagnostic and antibody tests. Flu-like symptoms developed into severe breathing issues for Brian Corte, sending him to the hospital.

"I felt as though I could not get air into my lungs to the point I was frightened," recalls Brian.

A year and a half later, Brian says his lung capacity is still not back to where it was before getting sick. Brian's symptoms developed just before the pandemic. He tested negative for influenza. At that time, there were no tests to diagnose coronavirus. As the pandemic wore on, Brian realized he suffered the same symptoms as COVID-19 patients. To his surprise, an antibody test used to identify a previous COVID-19 infection came out negative.

"Seems like my experience mirrors many people who described their experience and been diagnosed with COVID," said Brian.

He still does not know if he ever had coronavirus. Brian's story may sound familiar to a lot of people. Under an accelerated process meant to help fight the pandemic, unreliable tests flooded the market. Nineteen tests to diagnose active covid infections and hundreds of antibodies tests have been placed on a "Should No Longer Be Used" list by the FDA.

Emergency Use Authorizations (EUAs) versus FDA Approval

At the beginning of the pandemic, there were no products approved to treat or diagnose COVID-19 due to the fact it is a new virus. To deal with the public health emergency, the FDA allowed products on the market to diagnose, treat or prevent COVID-19 under Emergency Use Authorizations (EUAs). EUAs are used when a product's 'benefits outweigh the risks.' A significantly lower standard than the FDA's 'approval' process. For example, in the case of a new drug, the FDA's approval process includes research, multiple studies, an application process, labeling approval, and inspections of manufacturing facilities.

Under the lower standards of the EUA, tests to diagnose active COVID-19 infections were allowed to go on the market without passing the FDA's standard approval process but had to submit a EUA application to the FDA within three weeks. This allowed tests to be put on the market faster but without prior review from the FDA. The FDA allowed antibody tests on the market with no requirements for EUAs. The result? Fake and unreliable antibody tests flooded the market, and the policy was revised to require EUA applications for antibody tests within two weeks. The FDA acknowledged their attempts to be flexible in dealing with the public health emergency led to unreliable tests:

"... flexibility never meant we would allow fraud. We, unfortunately, see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans' anxiety. Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing..." By: Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs, and Jeff Shuren, M.D., Director, Center for Devices and Radiological Health.

Dr. Diana Zuckerman is president of the National Center for Health Research in Washington, DC., a non-profit think tank focused on public health policy. Her article "Emergency Use Authorizations (EUAs) Versus FDA Approval: Implications for COVID-19 and Public Health" points out hundreds of medical products were rushed to market under EUAs, including COVID-19 vaccines, diagnostic and antibody tests, treatments, and personal protective equipment.

EUAs are supposed to expire when the public health emergency ends, but that is not always the case. There are still EUAs in place from years ago, including some used for Ebola, Zika, and Swine Flu.

Dr. Zuckerman is concerned that when it comes to COVID-19, standards for tests remain inconsistent and unproven products may remain on the market without meeting the standards to earn FDA approval.

"Going forward, we need to know which treatments are the best. Without FDA approval, the standards are just not high enough to be able to tell us that information," says Dr. Zuckerman. This investigation set out to answer several questions.

How common is the use of EUAs?

Before the COVID-19 pandemic, the FDA had issued a total of 62 EUAs in response to public health emergencies such as Swine Flu, Ebola, and Zika. During the COVID-19 pandemic, the FDA has issued 447 EUAs.

Were manufacturers always allowed to put COVID-19 tests on the market without first being review by the FDA? 

No. When the pandemic began, test developers were expected to have a EUA before the tests could be used:

  • February 2020- The FDA allowed certain labs to put diagnostic tests for COVID-19s on the market and apply for a EUA within three weeks.
  • March 2020 - The FDA allowed antibody tests on the market with no EUA requirements.
  • May 2020 - After a flood of unreliable tests, the FDA added the requirement that antibody test developers apply for a EUA within two weeks of going to market.

Has the FDA reviewed the research on all the tests that have been submitted for EUAs? 

No. As of June 2021, the FDA website lists about 360 tests that had been given EUAs. Another 300 tests have EUA applications the FDA has not yet review.

How many tests are on the FDA's "Should No Longer Be Used List"? 

At the time of this article, 19 diagnostic tests, and 267 antibody tests. Tests can be placed on this list for various reasons, including failure to apply for an EUA within the proper time frame or if a significant problem is identified. Some manufacturers voluntarily withdrew their notifications that they intended to manufacture a test. Those tests are also included in the list.

Are some tests with EUAs more accurate than others? 

Yes. Tests have different levels of both accuracy and sensitivity. We compared two tests used to diagnose an active COVID-19 infection and found one was 3,000 more sensitive in detecting COVID-19 than the other. Both tests have EUAs.

Are there any tests that have gone beyond the EUA requirements? 

Yes, but only one. The BioFire Respiratory Panel, which is used to diagnose COVID-19, has passed the review process that was standard before the pandemic. This will allow the test to continue to be marketed after the pandemic if the FDA pulls the EUAs for other tests.

Is there a way to find out if my COVID-19 diagnostic test is accurate? 

This is a tough one. According to Dr. Zuckerman, the best way to know if your test is accurate is to get a second test, especially if your first test was a rapid test. Antigen tests (rapid tests) can return results in as little as 15 minutes. PCR tests are more reliable, but the turnaround for results can take days.


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