The Panel’s recommendations come as health authorities warn the virus that causes COVID-19 may be transmitted through FMT's.
Writing in The Lancet, the Panel advise that if either checks test positive, the donor should be rejected or tested with the Reverse transcription polymerase chain reaction (RT-PCR) assay for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
“In endemic countries, the RT-PCR assay should be considered in all donors, even if they are asymptomatic or do not have a history of high-risk travel or contact,” the Panel says.
“Alternatively, donor stools should be stored and quarantined for 30 days before use and released only if the donor has not developed symptoms.”
FDA Safety Alert
The Panel also recommends that stool banks should retrospectively check the donor’s health status before using frozen faeces, to avoid further potential spreading of SARS-CoV-2.
In a safety alert issued this week, the Food and Drug Administration (FDA) points to evidence that document the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals.
In line with the Panel’s recommendations, the FDA also advises donor screening, testing and development of criteria for exclusion of donors and donor stool based on the results.
At the time of writing the European Commission or the European Centre for Disease Control (ECDC) have not issued any advice or recommendations as such.
FMT has rapidly earned a major role in the management of recurrent Clostridioides difficile infection due to its clear advantages over antibiotics, namely a lack of significant side effects.
However, evidence shows the virus can be found in faeces and stool samples can remain positive for the virus even when undetectable in the respiratory tract, suggesting a faecal–oral route of transmission.
Another issue concerns classification of FMT with countries regulating these transplants as a drug (UK, France and the USA), as a tissue (Italy), and others that do not provide specific regulation (Australia).
“This discrepancy results in a confusing scenario, in which some countries will apply rules for human cells, tissues, or cellular or tissue-based products, and others will not, potentially contributing to the spread of the infection,” says the Panel consisting of researchers from Italy, UK, France and the Netherlands.
“Given the global COVID-19 outbreak, we, as an international group of experts in faecal microbiota transplantation and stool banking, believe that recommendations to update (at least temporarily) the screening of stool donors are urgently needed.
“The risk of transmitting SARS-CoV-2 by faecal microbiota transplantation might be higher than that in other tissue transplants.”
Source: The Lancet - Gastroenerology & Hepatology.
Published online ahead of print: doi.org/10.1016/S2468-1253(20)30082-0
“Screening of faecal microbiota transplant donors during the COVID-19 outbreak: suggestions for urgent updates from an international expert panel.”
Authors: Gianluca Ianiro et al.