{"title":"Quality control perspectives: Weak signal detection to prevent clinical sensitivity failures in donors' screening","authors":"Paulo Pereira","doi":"10.1016/j.transci.2025.104152","DOIUrl":"10.1016/j.transci.2025.104152","url":null,"abstract":"<div><div>Ensuring the accuracy of donor screening examinations is critical to minimizing the risk of transfusion-transmissible infections. Weak signals, which refer to low-intensity examination responses near the detection threshold, pose a challenge in distinguishing true positive results from background noise, which leads to the increasing likelihood of misclassification. Screening immunoassays are more susceptible to weak signal issues than nucleic acid tests (NAT) due to the inherent amplification step in NAT, which enhances sensitivity. This article explores the risks associated with weak signal detection failures, the necessity of cutoff protection, and the role of verification and validation targeted samples. Additionally, it discusses the importance of internal quality control and external quality assessment strategies to mitigate the limitations of using high-signal samples in donor screening.</div></div>","PeriodicalId":49422,"journal":{"name":"Transfusion and Apheresis Science","volume":"64 3","pages":"Article 104152"},"PeriodicalIF":1.4,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143917355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The role of red cell exchange in the management of malaria in 2024","authors":"Tanya Glatt , Hans Vrielink","doi":"10.1016/j.transci.2025.104146","DOIUrl":"10.1016/j.transci.2025.104146","url":null,"abstract":"","PeriodicalId":49422,"journal":{"name":"Transfusion and Apheresis Science","volume":"64 3","pages":"Article 104146"},"PeriodicalIF":1.4,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143917359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"18th International Congress of World Apheresis Association 2024","authors":"Hans Vrielink , Teguh Triyono","doi":"10.1016/j.transci.2025.104135","DOIUrl":"10.1016/j.transci.2025.104135","url":null,"abstract":"","PeriodicalId":49422,"journal":{"name":"Transfusion and Apheresis Science","volume":"64 3","pages":"Article 104135"},"PeriodicalIF":1.4,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143927714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The impact of leukapheresis and chemotherapy on early mortality in adult acute myeloid leukemia with hyperleukocytosis: Single center experience in Indonesia","authors":"Jaka Susila , Ibnu Purwanto , Teguh Triyono , Hans Vrielink , Johan Kurnianda , Kartika Widayati Taroeno-Hariadi , Mardiah Suci Hardianti , Susanna Hilda Hutajulu","doi":"10.1016/j.transci.2025.104145","DOIUrl":"10.1016/j.transci.2025.104145","url":null,"abstract":"<div><h3>Background</h3><div>Hyperleukocytosis (HL) is associated with high rates of morbidity and early mortality of up to 29 % due to the development of leukostasis, tumor lysis syndrome (TLS), and disseminated intravascular coagulopathy (DIC) in adult acute myeloid leukemia (AML). The treatment options include chemotherapy, steroids, and leukapheresis. Leukapheresis has a beneficial effect on chemotherapy, but clinical trials showed controversy. We aimed to evaluate the effect of adding leukapheresis to chemotherapy on 30-day survival in AML patients with HL.</div></div><div><h3>Methods</h3><div>The study design was as a retrospective cohort study using secondary data from medical records collected between July and August 2024. Inclusion criteria were ages of 18 years and older, diagnosed with AML with a leukocyte count greater than 100,000/mm<sup>3</sup> admitted to our hospital between January 2019 and July 2024, and received chemotherapy with and without leukapheresis. The primary endpoint is a 30-day survival rate since admission to the hospital. The Kaplan–Meier (log-rank) curve method was used for mortality between leukapheresis concomitant with chemotherapy (Group A) and chemotherapy only (Group B). Bivariate analysis is used to analyze correlations between mortality and clinical parameters.</div></div><div><h3>Results</h3><div>We identified 50 patients with 25 patients in each group. Group A showed a significantly higher leukocyte count (222 vs. 172.000/mm<sup>3</sup> p = 0.031) and a larger proportion of leukostasis (80 % vs. 37.5 %, p = 0.002). The median overall survival in group A was 20 days (95 % confidence interval/CI: 17.178–22.822), while in group B 19 days (95 % CI: 8.394–29.606). By day 30, 72 % of patients in group A had died, compared to 84 % in group B. Kaplan-Meier analysis with log-rank test for 30 days of mortality showed an insignificant difference between the two groups with p log-rank: 0.352. In the bivariate analysis, age showed a significant negative correlation with the survival (r: −0.462, p = 0.001).</div></div><div><h3>Conclusion</h3><div>In our study, we showed a comparable 30-day survival of AML patients with HL receiving leukapheresis and chemotherapy and those treated with chemotherapy only. It indicated that leukapheresis reversed the poorer survival of group A to a similar level as group B. Older age was the only prognostic factor for unfavorable 30-day survival.</div></div>","PeriodicalId":49422,"journal":{"name":"Transfusion and Apheresis Science","volume":"64 3","pages":"Article 104145"},"PeriodicalIF":1.4,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143917357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Considerations on the number of plasma donations per donor per year: Pro","authors":"Rainer Moog","doi":"10.1016/j.transci.2025.104143","DOIUrl":"10.1016/j.transci.2025.104143","url":null,"abstract":"<div><h3>Background and objectives</h3><div>Although plasmapheresis is generally well tolerated, there is a matter of debate about the number of yearly plasma donations. While some countries follow a very conservative approach with a low number of yearly donations others allow for up to 104 plasma donations per year. This article summarises side effects and possible long-term effects of frequent plasmapheresis analysing the current literature data.</div></div><div><h3>Study design and methods</h3><div>Donor-related and machine-related adverse events were identified. Donor-related adverse events were subdivided into actual and possible long-term health effects.</div></div><div><h3>Results</h3><div>Vasovagal reactions and venepuncture-related problems were the most often actual side effects. Reported issues of long-term adverse events were iron deficiency, loss of protein/immunoglobulin G (IgG), and the occurrence of malignancies. There are contradictory reports in the literature for the occurrence of iron deficiency and malignancies as well as the impact of immunoglobulin loss with respect to infections.</div></div><div><h3>Conclusions</h3><div>Evidence-based data about the impact of frequent plasmapheresis on donor health are poor. High-quality studies on risks and outcome of frequent plasmaphereses are needed to ensure donor health.</div></div>","PeriodicalId":49422,"journal":{"name":"Transfusion and Apheresis Science","volume":"64 3","pages":"Article 104143"},"PeriodicalIF":1.4,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143906356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"18th International Congress of World Apheresis Association 2024, Yogyakarta, Indonesia","authors":"Soumya Das , Arwa Z. Al-Riyami , Hans Vrielink","doi":"10.1016/j.transci.2025.104136","DOIUrl":"10.1016/j.transci.2025.104136","url":null,"abstract":"","PeriodicalId":49422,"journal":{"name":"Transfusion and Apheresis Science","volume":"64 3","pages":"Article 104136"},"PeriodicalIF":1.4,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143924627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Paulo Pereira , Alan Carvalho Dias , Filipe Luig , Rute Marcelino , Inês Moranguinho , Mário Cunha , Susana Ribeiro , Paulo Nogueira
{"title":"Revisiting reference intervals in transfusion medicine: Innovations and challenges in current practice","authors":"Paulo Pereira , Alan Carvalho Dias , Filipe Luig , Rute Marcelino , Inês Moranguinho , Mário Cunha , Susana Ribeiro , Paulo Nogueira","doi":"10.1016/j.transci.2025.104154","DOIUrl":"10.1016/j.transci.2025.104154","url":null,"abstract":"<div><div>Reference intervals (RIs) are essential for donor selection, blood component quality, and post-transfusion safety in transfusion medicine. The CLSI EP28 non-parametric method, based on the Harris-Boyd framework, is widely used but has limitations in handling outliers and skewed distributions. Emerging computational approaches, including Expectation-Maximization (EM), reflimR, and refineR, offer improved RI estimation. This study evaluates the limitations of CLSI EP28 in transfusion medicine and compares EM, reflimR, and refineR to assess their effectiveness in refining RI estimation.A simulated blood donor dataset (<em>n</em> = 500) was generated, modelling hemoglobin (Hb), hematocrit (Hct), and platelet count (PLT). Four RI estimation methods were compared: (1) CLSI EP28 (Non-Parametric Percentile Method), (2) Expectation-Maximization (EM) Algorithm, (3) reflimR (Robust Regression Method) and, (4) refineR (Advanced Statistical Modeling Method).The dataset had mean values of 15 g/dL (Hb), 44 % (Hct), and 250 × 10⁹/L (PLT). CLSI EP28 and EM yielded similar RIs, relying on empirical percentiles. ReflimR and refineR produced wider RIs, improving outlier resistance and distributional accuracy.While CLSI EP28 remains the regulatory standard, computational RI estimation methods improve accuracy, robustness, and regulatory compliance (IVDR, FDA 510(k), ISO 15189). Implementing EM, reflimR, and refineR can enhance donor screening and transfusion safety.</div></div>","PeriodicalId":49422,"journal":{"name":"Transfusion and Apheresis Science","volume":"64 3","pages":"Article 104154"},"PeriodicalIF":1.4,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143917361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A stepwise approach to JACIE accreditation in a middle income country - the South African experience","authors":"Tanya Glatt , Hans Vrielink","doi":"10.1016/j.transci.2025.104150","DOIUrl":"10.1016/j.transci.2025.104150","url":null,"abstract":"","PeriodicalId":49422,"journal":{"name":"Transfusion and Apheresis Science","volume":"64 3","pages":"Article 104150"},"PeriodicalIF":1.4,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143917358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Considerations on the number of plasma donations per donor per year: Con","authors":"Hans Vrielink","doi":"10.1016/j.transci.2025.104142","DOIUrl":"10.1016/j.transci.2025.104142","url":null,"abstract":"","PeriodicalId":49422,"journal":{"name":"Transfusion and Apheresis Science","volume":"64 3","pages":"Article 104142"},"PeriodicalIF":1.4,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143906487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}