Update March 28, 2020 – the FDA posted more detailed information on March 24, 2020, clarifying that they will not be authorizing any home testing under the emergency use authorization, but they are still exploring home testing once it has been fully reviewed as accurate.
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The FDA issued a warning letter about fraudulent COVID-19 test kits on March 20, 2020. I read the letter and unfortunately it is not clear to me. There has been too much poor communication from our own government over the past month, and I’ll do my best to keep my information clear.
From the FDA statement linked to above:
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.
I am wondering if there is a different between a test that is not “authorized” and a test that is “fraudulent”.
There was this letter from the FDA on February 29, 2020, which seems to allow labs to offer testing before officially approved by the FDA. My interpretation from the letter is that if a lab is CLIA certified (Clinical Laboratory Improvement Amendments), and that lab submits an Emergency Use Authorization (EUA), then that lab can start using the test immediately. From that letter:
The immediately in effect guidance issued today describes the circumstances where the FDA does not intend to object to the use of these tests for clinical testing while the laboratories are pursuing an EUA with the FDA. Importantly, this policy only applies to laboratories that are certified to perform high-complexity testing consistent with requirements under Clinical Laboratory Improvement Amendments.
So, is the FDA objecting to companies who are making their tests immediately available, or are they referring to other “fraudulent” tests? I have seen some tests being sold online which are clearly not developed by a CLIA lab and I would 100% agree those are fraudulent. However, there are also many companies offering at-home test kits over the next week which were developed by CLIA certified labs. While the FDA is correct in that they did not “authorize” those test kits yet, based on the February 29, 2020 letter, it appears to me the FDA said they would not object to those tests being made available. I hope I am just over-interpreting what the FDA is saying, but the language is not clear to me. The March 20, 2020 letter appears to be trying to discourage people from using home test kits, even if they are offered through CLIA certified labs.
If I get clarification somehow, I’ll post an update.