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Worldwide, there is a rising demand for thoroughly screened, high-quality fecal microbiota transplantation (FMT) products that can be obtained at a reasonable cost. In the light of this evolving therapeutic area of the intestinal microbiota, both private and public stool banks have emerged. However, some of the larger difficulties when establishing stool banks are caused by the absence of or international disagreement on regulation and legislative formalities. In this context, the establishment of a stool bank within a nonprofit blood and tissue transplant service has several advantages. Especially, this setting can ensure that every step of the donation process, laboratory handling, and donor-traceability is in agreement with the current expert guidelines and meets the requirements of the European Union's regulative directives on human cells and tissues. Although safety and documentation are the top priority of the stool bank setup presented here, cost-effectiveness of the production is possible due to a high donor screening success rate and the knowhow, infrastructure, facilities, personnel, and laboratory- and quality-management systems that were already in place. Overall, our experience is that a centralized, nonprofit, blood and tissue transplant service is an ideal and safe facility to run a stool bank of high quality FMT products that are based on stool donations from volunteer, unpaid, healthy, blood donors., (© 2020 AABB.)

Background: The increasing incidence of reported hepatitis E cases in Europe has focused attention on hepatitis E virus (HEV) and the risk of transfusion-transmitted hepatitis E. The aim of this study was to investigate the prevalence of antibodies to HEV (anti-HEV) among Danish blood donors in 2013 and to compare it to previous studies in Denmark. In addition we wanted to compare the relative reactivity of two different assays., Study Design and Methods: Samples from 504 blood donors were collected and analyzed for anti-HEV with an in-house assay developed at the National Institutes of Health (NIH). In addition the samples were analyzed with the Wantai anti-HEV assay. Demographic information and possible HEV exposure was collected by self-administered questionnaire., Results: Using the NIH assay the prevalence of anti-HEV among Danish blood donors was 10.7% and with the Wantai assay the prevalence of anti-HEV was 19.8% (p < 0.001). In both cases the presence of anti-HEV was significantly correlated with increasing age. In addition, anti-HEV as measured by the Wantai test was significantly associated with contact with children (p = 0.01), but in multivariate analysis only age was associated with anti-HEV in both assays. By the NIH assay, the prevalence had declined from 20.6% in 2003 to 10.7% in 2013., Conclusions: Anti-HEV prevalence had decreased by half among Danish blood donors over 10 years, but was still highly prevalent. The difference in reactivity of the two assays demonstrates the importance of using the same assay when comparing the anti-HEV prevalence in populations over time., (© 2015 AABB.)

Background: In 1996, a national lookback study was performed in Denmark identifying 1018 patients exposed to hepatitis C virus (HCV) by transfusion before 1991. The objective of this study was to describe morbidity and mortality during extended follow-up among patients in the Danish HCV lookback cohort alive in 1996., Study Design and Methods: In a retrospective cohort study of 230 patients exposed to HCV by blood transfusion and alive in 1996 we extracted data from national registers and compared these with a matched group of unexposed transfusion recipients., Results: Among 230 HCV-exposed recipients alive in 1996, 124 (53.9%) had chronic hepatitis C, 43 (18.7%) were not infected, and 63 (27.4%) had incomplete HCV data. In 2009, 121 (52.6%) were still alive a median of 21.8 years after transfusion. The mortality rate among the HCV-exposed recipients followed from 1996 was 4.9 per 100 person-years (PY). The incidence of liver cirrhosis and decompensated cirrhosis was 1.0 per 100 PY and 0.4 per 100 PY, respectively; 16.5% had cirrhosis at death. Among HCV-exposed recipients, no difference in all-cause or liver-related mortality was observed between HCV-infected and HCV-uninfected recipients. Further, there was no difference in mortality between HCV-exposed and -unexposed transfusion recipients (mortality rate ratio [MRR], 1.06; 95% confidence interval [CI], 0.96-1.17; p = 0.47), but liver-related mortality was significantly higher among HCV-exposed patients (MRR, 10.0; 95% CI, 7.20-17.7; p < 0.001)., Conclusion: Two decades after exposure to blood products from HCV-infected donors, only 121(11.8%) of 1018 recipients remained alive. For HCV-exposed recipients no excess all-cause mortality was observed, but liver-related mortality was significantly increased., (© 2011 American Association of Blood Banks.)

Background: Hemovigilance has shown that bacteria cause more fatalities than other infections together. Surveillance for detection of bacteria in platelets (PLTs) was initiated. Concomitantly, the storage period for PLTs was extended from 5 to 7 days to reduce cost., Study Design and Methods: Analysis was performed of all cases of a positive signal in a screening procedure for contaminated PLTs taking into account results of confirmative cultures and results of culture from blood components including bacteria strains. Records were assessed from patients transfused with blood components issued before the screening culture became positive., Results: Samples were collected from 22,057 PLT units. An initial reaction was seen in 84 (0.38%). Growth was confirmed in 70 of these. Of the associated PLT units, 26 had been issued or outdated at the time when the culture was found to be reactive, in 27 bacteria were found, and in 17 cultures were negative. The bacteria found were mainly from normal skin flora. Sixty-six patients received 75 blood components issued before the screening system alarmed. None of these patients had a transfusion reaction reported. The outdating fell to less than 5 percent., Conclusion: A screening system for detection of bacterial contamination was implemented without increase in cost owing to extension of storage time to 7 days. Transfusion of several contaminated blood components was prevented.