FDA Stops Two COVID-19 Rapid Diagnostics Tests

The coronavirus (COVID-19) pandemic has been around for more than two years. While in many ways the world is returning to normal, the wave of Omicron and continued cases of COVID-19 still need to be addressed. As more people return to in-person activities, there is a high need for quick and accurate tests, which can protect vulnerable people and prevent the contagion from going further.

There are different types of rapid diagnostic tests for COVID-19  have been developed since early 2020, but not all tests are created equal. Unreliable results can lead to people not knowing their accurate diagnosis and complicate treatment, if there are any symptoms, and without symptoms, can put the person at risk of transmitting or getting the disease. This is why it’s important to be aware of new developments in the world of COVID-19 testing, in particular, the recent news about the U.S. Food and Drug Administration (FDA)  pulling Empowered Diagnostics and ImmunoPass COVID-19 tests off the market. (1)

January 28, 2022, the FDA was warning people to stop using Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test because these tests might lead to a higher risk of false results, despite labeling that indicated otherwise.

The same day, Empowered Diagnostics started the recall, pulling back at least 284 thousand antigen tests in the United States and around 2,000 antibodies tests, however, their tests have been authorized in Canada and the E.U.   according to the website of the company (https://empdx.net). (2) 

Why are the tests being recalled in the U.S.? According to the FDA, the main reason is that they are not authorized for use in the United States and have not been cleared by this organization. This means that there is a risk that the tests might not yield reliable results, as their effectiveness has not been confirmed officially. Both antigen and antibodies tests are being withdrawn at the moment due to FDA Class I recall, the more serious type of recall in existence. (1) (3)

The FDA said it is concerned about a “potentially higher risk of false positives and false negatives. What does this mean? For an antigen test, a false negative means that the person is told that they do not have COVID-19, but that they actually do have it. A false positive is that the person is told by the test that they have the disease when they do not actually have it. (3)

What happens with the antibody test? A false negative involves a result that implies that the person is told they don’t have antibodies when they do. A false positive on an antibody test means that they have antibodies when they actually don’t. Any of these scenarios can lead to negative consequences for the individual, as they might make specific choices, like going to crowded places or interacting with vulnerable family members. (3)

The implications of these false results are significant. A test that is unreliable can lead to a variety of negative situations. People might get exposed to the virus and catch it without being aware of its vulnerabilities. People might go to work when they are actually sick and should stay home. Furthermore, false result increases the chance of spreading the infection and also can lead to decisions made on false information, something that can be dangerous for the individual and those around them as well. A person with another illness might assume their symptoms are caused by COVID-19 and not pursue medical attention, putting their well-being and health on the line. The FDA takes steps to announce test recalls, so people who have acquired these tests should not trust them and should use other, certified, and approved brands instead.

Additionally, the recalls extend beyond this one brand. Previously, the FDA announced the recall of the COVID-19 tests from the brand Ellume. (4)

This happened in November of 2021 and was also occurring due to the chance for false positives and false negatives that made the tests unreliable.

It seems that the FDA is cracking down on tests with potentially unreliable effects and for good reason. It is likely that these recalls might negatively impact brands like Emergent Diagnostics, however, due to their effects on the perceived trustworthiness and the financial impact brand recall might have. This debacle might lead to consumers being less willing to trust the company or purchase medical and diagnostic products from it. Of course, in the case of these types of products, confidence is especially significant. Recalls usually lead to drops in stock prices and also have an impact on the brand’s finances, as the company is responsible for withdrawing their products. (5) 

On the other hand, the unreliability of a specific brand of tests does not need to alarm consumers in general. There are many alternatives that can be employed instead, and it’s a good idea to get re-tested if there is any doubt in the validity of the results. While there have been few recalls so far, it is better to use tests that have better reliability and look at whether the FDA has recommended pulling a certain brand off the market. National institutions like the FDA often report the important news and try to make the public aware of any unreliable products as soon as possible. Healthcare providers and medical supplies suppliers also should check which brands they are using as well to avoid any unreliable outcomes.

Currently, the FDA is working with Empowered Diagnostics to resolve these issues. The FDA will continue to keep the public informed of significant new information. Consumers should rely on brands that are FDA-approved and check for this information on the packaging. It is useful to see whether the FDA has cautioned against specific brands. Using trustworthy care providers to run the tests and getting two tests from two different brands, if there is any doubt, can be good strategies to reduce the likelihood of unreliable results. The FDA recommended if you have these COVID tests at home, stop using them. If you think you had a problem with a COVID-19 test, you can report it through the FDA’s website. (6)

References

1. FDA (2022) https://www.fda.gov/medical-devices/safety-communications/stop-using-empowered-diagnostics-covid-19-tests-fda-safety-communication?utm_medium=email&utm_source=govdelivery

2. https://empdx.net

3. Leo, B. (2022) https://timesnewsexpress.com/news/newsusa/dallas/fda-stop-using-this-brand-of-rapid-covid-tests

4. FDA. (2021) https://www.fda.gov/medical-devices/medical-device-recalls/ellume-recalls-covid-19-home-test-potential-false-positive-sars-cov-2-test-results

5. Neith, T. (2021). https://www.investopedia.com/articles/investing/010815/how-do-recalls-affect-company.asp

6. FDA https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

About the Author:

Lin Zhang, M.D., senior director of a health care industry company in the United States. With the experience in clinical medicine, biotechnology, health industry and other fields, he is responsible for the research and development of plant medicine, functional food and health products. He was a clinician and worked for the National Cancer Institute, FDA and the National Cancer Center of Japan for many years.