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FDA Sends Warning Letters About Unauthorized SARS-CoV-2 Tests

NEW YORK – The US Food and Drug Administration sent three warning letters last month to two diagnostic companies offering unauthorized SARS-CoV-2 testing services.

All three letters were posted on the FDA website on Wednesday. 

One letter, dated July 23, was sent to Diagnostic Solutions Laboratory about the company's at-home stool sample collection kit for COVID-19 being sold on Amazon. The kit told customers to send the sample to Diagnostic Solutions Laboratory for SARS-CoV-2 PCR testing and was distributed in the US directly to consumers "without marketing approval, clearance, or authorization from FDA."

The agency noted it hasn't authorized any at-home stool sample collection kit for COVID-19 testing and added there are public health risks when collecting samples in the home. Those risks include whether a nonprofessional can properly collect a specimen, whether the specimen transport media components are safe to use in a home environment, and the impact of shipping conditions on the sample.

The letter was addressed to Alpharetta, Georgia-based Diagnostic Solutions Lab and Holistic Health International, which is headquartered in Bethel, Maine. The test is still listed on Diagnostic Solutions Lab's website though the company now says it is for investigational or research-use only. 

The other two warning letters, dated July 24, were sent to Lee's Summit, Missouri-based CoreMedica Laboratories for at-home SARS-CoV-2 antibody screening kits being sold on two separate websites. The company sold the COVID-19 (SARS-CoV-2) Antibody Screening Kit Specimen Self-Collection and Transport Kit without marketing approval or clearance from the FDA. According to the websites, users can collect a blood sample with a finger-stick and send the sample to the lab for serology testing. 

The FDA told both companies to "take immediate action" to end sales of these products.

CoreMedica's COVID-19 antibody test is still available on its website, though the company notes that it has not been approved by the FDA and the firm has submitted the test to the FDA for Emergency Use Authorization.