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FDA Warns Against At-Home COVID-19 Testing Kits

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Update: On April 21, the Food and Drug Administration (FDA) approved the first (and so far only) at-home diagnostic test for COVID-19. Make by Laboratory Corporation of America, the Pixel by LabCorp COVID-19 Test allows patients to collect their own swab sample using the collection kit at home. The collection kit is then mailed back to LabCorp for COVID-19 analysis. According to the FDA, LabCorp will make its at-home test kits available in most states with a doctor’s order starting in the next few weeks.

As three private companies prepare to roll out at-home COVID-19 test kits in the United States, the U.S. Food and Drug Administration (FDA) issued a response clearly stating no at-home COVID-19 test is currently approved for use.

COVID-19 testing has been slow to roll out in the United States, which has posed a major hurdle in trying to understand and respond to the scope of the virus’ spread. The new-to-humans respiratory illness causes symptoms such as fever, cough and shortness of breath and can lead to serious lung complications in severe cases. As the U.S. races to catch up with testing, a number of public and private companies have jumped into the ring with testing kits.

This week, three private companies — Everlywell, Carbon Health and Nurx — announced they have developed at-home test kits that will be on the market in the coming week. Each company’s process works similarly. Those who want a test do an initial assessment with a medical professional (typically through telehealth) who will then evaluate your symptoms. If you qualify for a test, the test kit is shipped to your house for collection. Once you’ve collected your samples, they’re sent back via overnight mail where they’re tested in an FDA-approved lab.

The key language here is that the testing materials themselves haven’t been authorized by the FDA’s emergency use authorization, only the labs the samples are sent to. This means the testing kits themselves haven’t been scrutinized for their validity or the ability of non-medical professionals to correctly collect viable samples at home.

When reached for comment on at-home COVID-19 testing, an FDA spokesperson directed The Mighty to an FDA press release issued on Friday that states no at-home COVID-19 test kit has been approved for use, citing “unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.” The FDA did not call out any specific company by name.

“We want 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 wrote in the press release. “The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”

At-home testing has faced criticism in the past for the validity of the tests it markets to consumers. In 2018, for example, allergen experts told STAT that the immunoglobulin G at-home finger-prick blood test Everlywell marketed to test for food sensitivities had little scientific value. On its home testing guidance webpage, the FDA recommends at-home testing should only be used in conjunction with regular visits to your doctor.

The shortage of adequate COVID-19 testing has been a major challenge in the United States. Though any new test option might be welcome, if test collection kits aren’t made or used properly, there’s a risk of inaccurate results, which could lead to delayed or improper care. At-home testing will also likely run into the same shortages of the specialized collection swabs currently faced by health care providers in the field.

In some hard-hit areas, including Los Angeles and New York, health officials have turned to rationing tests for use only if the outcome would drastically change a patient’s course of treatment. Because the virus has spread beyond containment, experts are making this shift to preserve supplies and focus on mitigation by encouraging social distancing to flatten the curve and reduce the burden on the health care system.

In response to the FDA’s statement on at-home COVID-19 testing, Carbon Health released a statement on its website clearly outlining it was selling an at-home collection kit as opposed to an at-home test. An Everlywell media relations representative said the company is “working directly with the FDA to ensure our kits meet the regulatory requirements that apply to at-home collection kits,” and added:

Everlywell provides at-home sample collection kits for testing to be completed by our laboratory partners. Every lab that we are working with to provide COVID-19 testing has had their validation data and reports reviewed by the FDA under the Emergency Use Authorization (EUA) framework. These labs already offer other infectious disease assays, including tests for other respiratory viruses.

The at-home SARS-CoV-2 tests kits are not currently covered under the government mandate that testing be provided at no-cost to patients. Everlywell’s test will cost patients $135, and according to TechCrunch, Carbon Health’s test costs $167.50 and Nurx’s test costs $181, which includes the online physician assessment and shipping. The companies indicate the cost of the tests may be covered by your health savings account. And like other COVID-19 tests, availability will be limited initially as they ramp up production.

On Saturday, the FDA did approve a new rapid COVID-19 test that delivers patient results in about 45 minutes at their point of care. The approved Cepheid Xpert Xpress SARS-CoV-2 test will be available starting March 30 at health care offices that have a GeneXpert testing machine. There are approximately 5,000 of the testing machines in the United States.

“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” said FDA Commissioner Stephen Hahn, M.D., in a press release, adding:

Today marks an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.

The Mighty also reached out to Nurx for comment and has yet to hear back.

Update: On March 22, Carbon Health informed The Mighty it has discontinued its at-home collection kits based on clarification from the FDA. Based on the FDA’s update, Everlywell and Nurx will also need to discontinue their at-home kits as well. 

“Carbon Health was notified by our lab partner, Curative Inc, that the 3/21/2020 FDA update for COVID 19 testing clarified that at-home sample collection is not covered under the emergency use authorization (EUA),” Eren Bali, CEO and cofounder of Carbon Health, said in a statement. “Carbon Health is discontinuing distribution of the at-home sample collection kits effective immediately. We are also contacting our 50 initial patients to schedule expedited testing in our clinics. No patients had received results yet.”

Header image via Carbon Health’s Instagram page

Originally published: March 22, 2020
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