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FDA Develops Fecal Test for COVID-19

By LabMedica International staff writers
Posted on 14 Dec 2020
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The US Food and Drug Administration (FDA Silver Spring, MD, USA) has developed a test for COVID-19 in fecal matter that aims to prevent the disease from being inadvertently transmitted during fecal transplantation.

Fecal microbiota transplantation (FMT) is a modern method in which microbes usually found in the human gut and are part of a healthy body are transplanted into patients who are suffering from conditions such as clostridium difficile infection, a pathogen that is generally transmitted in healthcare settings. The unsupervised use of FMT by people lacking medical training can lead to the transmission of pathogens. Additionally, there are concerns about pathogens transmitted in medical settings and the FDA has received reports of the novel coronavirus found in the stool of patients.

There is no validated stool test as of now, although Paul Carlson, principal investigator in the Laboratory of Mucosal Pathogens and Cellular Immunology at FDA’s Office of Vaccines Research and Review said that his office has developed a “working assay for detection” of the coronavirus responsible for COVID-19 in stool in results confirmed independently by a laboratory at Stanford University. Carlson’s office was concerned that asymptomatic individuals infected with COVID-19 would unknowingly becoming FMT donors.

Speaking during a webinar that was organized by the agency’s Office of Scientific Professional Development, Carlson said, “we advised no use of fecal donations from after Dec. 1, 2019, until effective screening methods are implemented. There were no methods for testing for COVID in stool. We know now that the viral RNA is found in stool and infectious virus as well. Infection in the GI tract is likely.”

A scientific paper on the test is now in pre-publication and the method could have other research uses, according to Carlson.

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