key: cord-0882446-65mvfw8m authors: Quraishi, Mohammed Nabil; Shabir, Sahida; Manzoor, Susan E; Green, Christopher A; Sharma, Naveen; Beggs, Andrew D; Iqbal, Tariq H title: The journey towards safely restarting faecal microbiota transplantation services in the UK during the COVID-19 era date: 2021-02-19 journal: Lancet Microbe DOI: 10.1016/s2666-5247(21)00036-7 sha: a8c731f64bf48c38ee7eeb778481f923229806c0 doc_id: 882446 cord_uid: 65mvfw8m nan The journey towards safely restarting faecal microbiota transplantation services in the UK during the COVID-19 era Faecal , was the first to mandate SARSCoV2 testing of stool as part of donor screening and called for a halt of FMT production globally until a validated stool assay was available 5 with an evidencebased international consensus on guidance for donor screening being published. 6 FMT production at UoBMTC was paused in March, 2020 and FMT that was already manufactured from February, 2020, was quarantined. Following consensus agreements with FMT providers globally and a review of updated evidence on safety and efficacy, the shelf life of FMT collected before December, 2019, was extended from 6 months to 12 months. This allowed our centre to treat a further 68 patients with recurrent C difficile infection until the stocks were exhausted by August, 2020. In conjunction with FMT providers globally, we established new donor screening protocols that now include multiple levels of questionnairebased and molecular screening for SARSCoV2 infection or enteric carriage at several timepoints of the donor and FMT production pathway (appendix). However, restarting FMT manufacture principally relied on a validated assay for detection of SARSCoV2 in stool, which is not commercially available. Our centre worked towards validating a sensitive and specific assay that uses multiple technologies in parallel for the detection of SARSCoV2 in stool. 7 A combination that includes realtime PCR, digital droplet PCR, and nanopore sequencing technology was validated with stool viral spiking experiments and testing of stool samples from more than 100 COVID19 positive and COVID19 negative hospitalised patients (on the basis of nasopharyngeal PCR). The assay was approved by the Medicine and Healthcare Regulatory Agency in January, 2021, and has enabled the resumption of donor screening and FMT services in the COVID19 era. We have now released quarantined FMT aliquots from those manufactured in February, 2020, and have treated several patients successfully. Although FMT is a safe and a highly effective treatment for recurrent C difficile infection, FDA safety alerts in the USA, following serious adverse events as a result of transmission of enteric pathogens, emphasise that there can be no room for complacency. 8 Although our revised protocols are highly robust in screening asymptomatic carriers of SARSCoV2, both FMT providers and users need to remain vigilant for new threats during the changing viral pandemic and beyond. We declare no competing interests. Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Reorganisation of faecal microbiota transplant services during the COVID19 pandemic Multimodality detection of SARSCoV2 in faecal donor samples for transplantation and in asymptomatic emergency surgical admissions Important safety alert regarding use of fecal microbiota for transplantation and risk of serious adverse reactions due to transmission of multidrug resistant organisms