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FDA Clarifies that Less Penetrating Self-Swab Test Update at Collection Sites Doesn’t Mean Individuals Can Use At-Home Test Kits for Coronavirus COVID-19

Tue March 24 2020 1:02 pm
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The FDA has clarified that less penetrating Self-Swabs to be implemented at Collection Sites does not mean that individuals can use At-Home Kits to test for Coronavirus COVID-19.

Vice President Mike Pence recently spoke about the good news of approval of a self-administered Coronavirus COVID-19 test that swabs from the front of the nose instead of deep into the nose, but this update is not the equivalent of a self-administered at-home test. President Donald J. Trump also spoke early Tuesday afternoon March 24, 2020 on a Fox News interview, saying that this new swab test will be available very, very soon.

The FDA, in its daily round up, updated information on Diagnostic Testing for SARS-CoV-2 regarding specimen collection for COVID-19 testing. Based on available data, the FDA said it believes that, for symptomatic patients, nasal swabs could be used that access just the front of the nose rather than the depth of the nasal cavity. This would provide COVID-19 testing that is more comfortable for patients, allows self-collection of specimens at collection sites, and that can be performed with a simpler and more readily available swab.

The self-swab update does not mean that people can take the test at home by themselves. People with symptoms will still have to go to an authorized clinical or drive-through testing site, and will still have to meet the screening requirement of the Centers for Disease Control and Prevention (CDC) in order to get approval to be tested.

Vice President Mike Pence lauded the upcoming swab update this week, saying that testing conditions will become safer for frontline medical personnel at the drive-thru testing sites, and reduce consumption of personal protection equipment (PPE) because personnel will not have to change some of their PPE gear because they won’t be contaminated because personnel won’t be conducting the actual swab procedure at the collection site.

The FDA also said, in certain emergencies, the FDA can often quickly issue an emergency use authorization for diagnostic tests based on FDA’s rolling review of data and where the request meets certain criteria. In the COVID-19 pandemic, the FDA has worked with more than 160 test developers who have said they will be submitting applications to make tests that detect the virus. To date, 15 emergency use authorizations have been issued for nation-wide use, including two today. Under the FDA laboratory developed test policy during COVID-19 [PDF], the FDA has been notified by more than 65 laboratories.


At-Home Testing Disallowed

The swab update does not mean that at-home sample collection is permitted. At-home kits are specifically disallowed by the FDA. Any at-home test collection kits being distributed by diagnostic startups are unauthorized.

On Friday, March 20, 2020, the FDA warned consumers about unauthorized, fraudulent COVID-19 test kits. The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.

The FDA stated on Friday March 20, 2020 that it wants to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA added that it sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and that the FDA is actively working with test developers in this space.

Fraudulent health claims, tests, and products can pose serious health risks, according to the FDA. The fraudulent claims, tests, and products may keep some patients from seeking care, or may delay necessary medical treatment. The FDA reminds consumers to follow the U.S. Centers for Disease Control and Prevention’s guidelines and speak to a medical provider when symptoms of COVID-19 are experienced. The FDA said medical providers will advise whether individuals should get tested, and how to proceed to be tested with an appropriate test, if the test is recommended.

The FDA stated it will take appropriate action to protect consumers from bad actors who take advantage of a crisis to deceive the public by marketing tests that pose risks to patient health. The FDA may seek enforcement, including issuing warning letters, seizures or injunctions. The FDA has already identified and issued warning letters to companies found selling and promoting fraudulent items, and expects additional such actions will be forthcoming. Additionally, the FDA stated it is stepping up enforcement at ports of entry, including International Mail Facilities, to ensure these fraudulent products that originate outside the country do not enter through United States borders.

The FDA urges that if any citizens are aware of fraudulent test kits for COVID-19, the should report the fraudulent test kits to the FDA [CONTACT FDA]. The FDA will continue to aggressively pursue those who place the public health at risk and hold bad actors accountable.

As a reminder, the President’s Coronavirus Guidelines for America details simple actions we can take as individuals and families to #SlowTheSpread of coronavirus.


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