FDA Develops Fecal Test for COVID-19

The FDA said Thursday that it has developed a test for COVID-19 in fecal matter, in an attempt to prevent the disease from being inadvertently transmitted during fecal transplantation.

Fecal microbiota transplantation (FMT) is a relatively new technique in which microbes normally found in the human gut and that are part of a healthy body are transplanted into patients suffering from conditions such as clostridium difficile infection, a pathogen that is often transmitted in healthcare settings.

Unsupervised use of this technique by people without medical training can lead to transmission of pathogens, according to Paul Carlson, principal investigator in the Laboratory of Mucosal Pathogens and Cellular Immunology at FDA’s Office of Vaccines Research and Review. He spoke during a webinar Thursday that was organized by the agency’s Office of Scientific Professional Development.

There are also concerns about pathogens being transmitted in medical settings, and earlier this year as the COVID-19 pandemic spread, reports began to reach the agency of the coronavirus being found in patients’ stool. Therefore, 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,” he said. “We know now that the viral RNA is found in stool and infectious virus as well. Infection in the GI tract is likely.” Carlson’s office became concerned about asymptomatic individuals infected with COVID-19 unknowingly becoming FMT donors.

While there is still no validated stool test, Carlson said his office has developed a “working assay for detection” of the coronavirus responsible for COVID-19 in stool in results independently confirmed by a laboratory at Stanford University. A scientific paper on the test is now in pre-publication, he said. The method could have other research uses, he said. — Martin Berman-Gorvine