and that additional safety procedures may be required.
The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.
Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.
- Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
- Testing donors and/or donor stool for SARS-CoV-2, as feasible.
- Development of criteria for exclusion of donors and donor stool based on screening and testing.
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.
“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.
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