The U.S. Food and Drug Administration took action just ten days after learning about new direct-to-consumer (DTC) testing schemes. Lab companies were selling COVID-19 tests straight to consumers who were promised that the samples they collected themselves would be tested at Clinical Laboratory Improvement Amendments (CLIA)-certified labs.
Although the at-home tests for COVID-19 would seem to be a good option to increase nation-wide testing, the problem lies with the collection of the sample by the consumer. Specimen quality concerns are the main problem with DTC testing of the virus. A large source of errors, even within a professional setting, are due to mistakes made during specimen collection, transportation, and preparation for analysis – there is a lot of room for error. The viability of non-professional consumers collecting samples for themselves and receiving accurate results drops considerably.
In a statement, the FDA stated: “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.”
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