Swiss Red Cross

PURPOSE: Autologous serum eye drops (ASED) are classified as non-standardisable medicine by Swissmedic. Future approval is dependent on whether manufacturing meets the requirements of the European Pharmacopoeia (Ph. Eur.). Currently there is an effort to harmonise the manufacturing process for ASED in Switzerland, in order to facilitate approval. This includes standardisation of sterility assessment. This study evaluates the relevant sterility testing methods as described in the Ph. Eur. and includes the verification of possible antimicrobial activity of serum and the suitability test of the selected membrane filtration method for serum concentrations of 100%, 50% and 20%. METHODS: For sterility testing of medicinal products, Ph. Eur. specifies membrane filtration (MF) and direct inoculation (DI). Alternative methods such as automated blood culture (ABC) systems may be considered. The methods were systematically evaluated for a Switzerland-wide standard for assessing the sterility of ASED. MF was subjected to a suitability test according to Ph. Eur. RESULTS: Although inexpensive and fast, ABC, widely used internationally for sterility assessment of ASED, had to be rejected, as none of the laboratories with a Swissmedic licence for sterility testing of finished medicinal products offer an ABC system. In addition, as an alternative method according to Ph. Eur. it would have required complex and expensive validation of the method with proof of accuracy, specificity, limit of detection, robustness, suitability and equivalence to the pharmacopoeia method. As part of the suitability assessment of the DI, serum was found to inhibit the growth of Pseudomonas aeruginosa. DI requires appropriate neutralisation of the antimicrobial activity of the serum prior to sterility testing, which is not possible and therefore DI was not considered suitable. The most expensive and time-consuming method, MF, was selected. Suitability tests were performed in triplicate for Bacillus subtilis, Staphylococcus aureus, Pseudomonas aeruginosa, Clostridium sporogenes, Candida albicans and Aspergillus brasiliensis. MF was deemed suitable for the detection of bacterial and fungal strains, with antimicrobial activity of the product eliminated under the test conditions.

Preoperative anemia and non-anemic iron deficiency are common in cardiac surgery patients. Both are frequently caused by absolute iron deficiency or are associated with chronic diseases and inflammation. Multiple studies have shown an association between preoperative anemia and increased RBC transfusion, prolonged intensive care unit and hospital length of stay, and higher postoperative morbidity and mortality. The impact of preoperative non-anemic iron deficiency on postoperative adverse outcome is less clear, but worsened postoperative outcomes have been suggested. Accordingly, treatment for anemia and iron deficiency is a primary goal in preoperative optimization in cardiac surgery patients. Several guidelines recommend timely supplementation with modern oral iron formulation as first-line intervention, followed by intravenous iron administration in case of patient intolerance or time restriction. In patients with non-pure iron deficiency or in ultra-short treatment strategies, the combined therapy of intravenous iron and erythropoiesis-stimulating agents seems safe and most efficacious to increase red blood mass before surgery. However, the positive effects of preoperative interventions in anemic or iron-deficient patients were mostly limited to reduced transfusion of red blood cells, whereas lower morbidity and mortality were shown in limited studies only. It is also important to note that allogeneic blood products are a limited resource, and preoperative oral iron supplementation showed the best cost-effectiveness.

The blood donor population has great potential to serve as a sentinel system for the general population. The data presented in this study of a survey of the seroprevalence of Anti-SARS-CoV-2 antibodies in Switzerland are an illustrative example of this possibility. From March 2020 to January 2021, the increase in antibody seroprevalence for both Anti-NCP and Anti-S was only very moderate, up to ~17%. In May/June 2021, the Anti-NCP seroprevalence was 21.6% and the S-seroprevalence 59.4%, respectively, indicating only a moderate natural infection rate. The Anti-seroprevalence rate was in good agreement with the first vaccination campaign launched in winter 2020/21. The dramatic increase in the antibodies against the NCP protein (74.6%) since November/December 2021 to June–August 2022 was simultaneous with the appearance and rapid spread of the Omicron SARS-CoV-2 variant in Switzerland and the abolition of compulsory mask wearing in public spaces. At the end of 2022, 99.0% of the blood donor population already developed antibodies against the S protein and 83.9% against the NCP. One year later, after the official termination of the pandemic, these seroprevalences were even higher, 99.8% for the Anti-S and 95.0% for Anti-NCP. This increase for both of them was in accordance with the vaccination campaigns, the abolition of mask wearing, and the spread of the Omicron variant. These data show how the blood donor population can be used to represent the infection surveillance of the general population of a region or country.

Abstract BackgroundCOVID-19 convalescent plasma (CCP) is obtained from people recently recovered from COVID-19 and contains viral-neutralizing antibodies. Because such treatment is safe and effective against SARS-CoV-2, the US Food and Drug Administration (FDA) has recently authorized the use of CCP for COVID-19 patients with immunodeficiencies. Currently available CCP is a “hybrid” product with antibodies from individuals who had both infection and vaccination (vaccine-boosted CCP). In this context, there is growing interest in CCP treatment outcomes in specific groups of immunocompromised patients. Specifically, B-cell depleted patients are at risk of not producing antibodies after either infection or vaccination. Hence, B-cell depleted patients are conceivably among those who would benefit the most from CCP. We thus conducted a systematic review and individual patient data meta-analysis to assess characteristics associated with 60-day survival in B-cell depleted patients transfused with CCP.MethodsThe last search was April 2nd, 2024, and included all studies using CCP in B-cell depleted patients. Whenever not available in the publication, we requested individual participant data from corresponding authors of eligible studies. Risk of bias was assessed using Joanna Briggs Institute Critical Appraisal Tools. Data were analyzed using conditional logistic regression.ResultsWe describe individual patient data extracted from 85 studies and synthesized into a cohort of 570 patients. The overall 60-day survival rate was 86.5%. Of patients with information available, 70.1% achieved SARS-CoV-2 clearance, and 64.3% had clinical improvement within 5 days of CCP transfusion. After controlling for age, sex, calendar year of infection and World Health Organization (WHO) disease severity, we found a significant association between 60-day survival and days since last anti-CD20 dose (OR=1.16 per 10-day increase; 95% CI 1.04 to 1.29; p=0.007) and transfusion of vaccine-boosted CCP (OR=9.49; 95% CI 2.01 to 44.82; p=0.005), but not with concomitant remdesivir treatment (OR=1.31; 95% CI 0.66 to 2.61; p=0.440).DiscussionOur study is limited to individual participant data analysis, with a majority of the studies included being case series and case reports. Overall survival in our cohort of B-cell depleted patients was consistent with prior meta-analysis of randomized controlled trials on survival of immunocompromised patient transfused with CCP (∼84%). A novel finding from this analysis is that vaccine-boosted CCP with a presumably higher content of neutralizing antibodies is associated with a high survival benefit.RegistrationThe protocol for this systematic review and individual participant data meta-analysis was registered with PROSPERO (CRD42024516513) on March 1st, 2024.

In the United States and other high-income countries, blood donation primarily relies on anonymous, voluntary donors. However, directed blood donation-where people donate for a specific recipient-has resurged, particularly due to misinformation surrounding COVID-19 vaccination. Requests for "nonvaccinated" blood, driven by misconceptions about vaccine safety, have led to legislative attempts to mandate compliance. Historically, directed donation was used to mitigate the risk for transfusion-related infections before modern screening techniques rendered it largely unnecessary. Today, it presents important patient safety risks, including increased infectious disease transmission, immunologic complications, and logistic burdens. Directed donations also introduce inefficiencies, diverting resources from the community blood supply and exacerbating shortages. Moreover, directed donation for nonmedical indications lacks scientific justification. Blood safety is ensured through rigorous donor screening, pathogen testing, and processing measures. There is no evidence that blood from vaccinated donors poses risk. Requests for nonvaccinated blood, as well as other directed donation preferences based on personal beliefs, introduce biases that are not grounded in medical necessity. Accommodating such requests undermines public trust in blood safety protocols and legitimizes unfounded fears. Ethical concerns arise as non-medically justified requests reinforce discriminatory practices, such as selecting donors based on race or gender. Allowing such preferences risks politicizing blood donation, spreading misinformation, and straining health care systems. Although autonomy is a core ethical principle in medicine, it does not justify non-evidence-based interventions. Given the potential harm and societal impact, directed blood donations should be limited to rare, medically necessary cases. Ongoing legislative efforts to mandate these requests require unified opposition from the medical and scientific community to uphold ethical, evidence-based, blood allocation practices.

Treatment with nonresorbable antibiotics is effective in diarrhea-predominant irritable bowel syndrome (IBS-D). Multimatrix (MMX) formulations ensure targeted drug delivery to the mid-distal small bowel and colon-traditionally considered the origin of IBS symptoms. To assess the efficacy of rifamycin SV-MMX for the treatment of IBS-D. Randomized controlled trial in patients with IBS-D (Rome IV). Patients received rifamycin SV-MMX 600 mg (b.i.d = 1200 mg/d or t.i.d = 1800 mg/d) or placebo for 2 weeks. Primary end point was responder rate in the first treatment week on the full analysis set (FAS). Response was defined as decrease in average abdominal pain ≥ 30% AND ≥50% reduction of days with stool type 6 or 7 based on daily reporting. A total of 279 patients were randomized (=ITT), and 264 of were included in the FAS. More patients with rifamycin SV-MMX b.i.d (22/88, 25.00%) met the primary end point than t.i.d (10/81, 12.35%) or placebo (9/95, 9.47%) in both FAS and ITT. Adjusted odds ratio (AOR) for b.i.d. vs placebo was 3.26 (95% confidence interval (CI): 1.39-7.67; P = 0.007) and for t.i.d. vs b.i.d. 0.40 (95% CI: 0.17-0.92; P = 0.031). After treatment, the percentage of monthly global responders was higher in the b.i.d. group vs placebo in the first month (64.2% vs 46.6%, adjusted odds ratio = 2.14 95% CI: 1.15; 4.00; P = 0.0173) and first 2 months. Rifamycin SV-MMX 600 mg b.i.d. was more effective than placebo and t.i.d. dosing in the first week of treatment. Two months after treatment, rifamycin SV-MMX 600 mg b.i.d. provided more global symptom relief than placebo.

No abstract available.

Introduction: Hepatitis E virus (HEV) genotype 3 is the major cause of acute viral hepatitis in several European countries. It is acquired mainly by ingesting contaminated pork, but has also been reported to be transmitted through blood transfusion. Although most HEV infections, including those via blood products, are usually self-limiting, they may become chronic in immunocompromised persons. It is thus essential to identify HEV-infected blood donations to prevent transmission to vulnerable recipients. Aims: Prior to the decision whether to introduce HEV RNA screening for all Swiss blood donations, a 2-year nationwide prevalence study was conducted. Methods: All blood donations were screened in pools of 12–24 samples at five regional blood donation services, and HEV RNA-positive pools were subsequently resolved to the individual donation index donation (X). The viral load, HEV IgG and IgM serology, and HEV genotype were determined. Follow-up investigations were conducted on future control donations (X + 1) and previous archived donations of the donor (X − 1) where available. Results: Between October 2018 and September 2020, 541,349 blood donations were screened and 125 confirmed positive donations were identified (prevalence 1:4331 donations). At the time of blood donation, the HEV RNA-positive individuals were symptom-free. The median viral load was 554 IU/mL (range: 2.01–2,500,000 IU/mL). Men (88; 70%) were more frequently infected than women (37; 30%), as compared with the sex distribution in the Swiss donor population (57% male/43% female, p < 0.01). Of the 106 genotyped cases (85%), all belonged to genotype 3. Two HEV sub-genotypes predominated; 3h3 (formerly 3s) and 3c. The remaining sub-genotypes are all known to circulate in Europe. Five 3ra genotypes were identified, this being a variant associated with rabbits. In total, 85 (68%) X donations were negative for HEV IgM and IgG. The remaining 40 (32%) were positive for HEV IgG and/or IgM, and consistent with an active infection. We found no markers of previous HEV in 87 of the 89 available and analyzed archive samples (X − 1). Two donors were HEV IgG-positive in the X − 1 donation suggesting insufficient immunity to prevent HEV reinfection. Time of collection of the 90 (72%) analyzed X + 1 donations varied between 2.9 and 101.9 weeks (median of 35 weeks) after X donation. As expected, none of those tested were positive for HEV RNA. Most donors (89; 99%) were positive for anti-HEV lgG/lgM (i.e., seroconversion). HEV lgM-positivity (23; 26%) indicates an often-long persistence of lgM antibodies post-HEV infection. Conclusion: The data collected during the first year of the study provided the basis for the decision to establish mandatory HEV RNA universal screening of all Swiss blood donations in minipools, a vital step in providing safer blood for all recipients, especially those who are immunosuppressed.