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The adherence to accreditation programs proves the institutions' voluntary effort to pursue the quality and safety of their products and services by meeting internationally accepted standards audited by experts in the field, external to the service. Meeting such standards often exceeds domestic legal requirements. However, service providers are not released from complying with the legal requirements, both local and international, pertinent to the field. Accreditation programs use the precepts of the quality management system to validate and standardize processes, monitor results through quality control, proficiency testing, and indicators, and perform risk management. For cellular therapy services, the assessing agencies available in our field are the AABB/ABHH (American Association of Blood Banks/Brazilian Association of Hematology, Hemotherapy and Cellular Therapy) and FACT-JACIE (Foundation for the Accreditation of Cellular Therapy-Joint Accreditation Committee, ISCT/EBMT). Both agencies require that the accredited organization meets all the standards defined in each program. Applying services also have to establish and comply with a quality management standard that demonstrates procedural interrelationship to ensure product and service quality. This paper aims to concisely outline the essential features of those two accreditation programs, along with a brief overview of the accreditation process under each of them., Competing Interests: Conflicts of interest The authors declare no conflicts of interest., (Copyright © 2021 Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier España, S.L.U. All rights reserved.)

Most dengue virus (DENV) infections remain asymptomatic. This increases the risk of DENV transfusion transmission (TT-DENV) during outbreaks. We evaluated DENV viremia in 8475 blood donations assembled in minipools for the presence of DENV RNA. The tested samples were obtained between February and May, 2016, during a large DENV outbreak in Ribeirão Preto city, northeast region of the São Paulo State, Brazil. The DENV RNA + samples were serotyped and screened for DENV NS1. We also tested a significant number of plasma samples (n = 372) to estimate the DENV seroprevalence among blood donors in the region. We detected three DENV RNA + samples in the tested blood donations (n = 3/8475, 0.04%). From these, two samples were further serotyped as DENV-1 and one sample as DENV-2. All DENV RNA positive samples were negative for anti-DENV IgG, indicating the presence of primary acute infection. Moreover, two of the DENV RNA + samples were also NS1 antigen positive (antigenemia). The anti-DENV IgG seroprevalence among blood donor population was 50.8% (n = 189/372). Our results are in accordance with the presence of DENV primary infection in blood donors which can lead to transfusion transmission of the infection to recipients. Measures to exclude such donors should be adopted to prevent TT-DENV., (© 2020 Wiley Periodicals LLC.)

Case Report: A 26-year-old woman with sickle cell disease (SCD) on chronic transfusion therapy complained of severe arthralgia, myalgia, abdominal pain, headache, and fever 24 hours after transfusion of a red blood cells (RBCs). Dengue virus (DENV) infection was suspected and the patient was hospitalized for clinical support and RBC transfusion, to lower the hemoglobin S to less than 30%. The patient's clinical condition improved approximately 8 days after the onset of symptoms., Results: DENV type 2 (DENV-2) TaqMan real-time polymerase chain reaction was negative in the patient's pretransfusion sample while the posttransfusion sample was positive (Ct, 27.8), suggesting a high viral load and an acute infection. To investigate DENV transfusion transmission (TT-DENV) the stored donor serum was tested and was also positive (Ct, 25.8). Molecular typing confirmed the presence of DENV-2. The phylogenetic analysis of the DENV-2 strains obtained from both donor and patient samples were classified as the Southeast Asia-American genotype (Genotype III) and demonstrated 100% genomic identity, indicating TT-DENV., Conclusion: This is the first description of TT-DENV in a SCD patient. A presumed high viral load in the transfused RBC unit probably determined the early clinical manifestation. In endemic regions dengue fever should be considered as differential diagnosis in SCD patients with fever and acute pain crisis, mainly during DENV outbreaks., (© 2020 AABB.)

Influenza A virus infection has rarely been documented to cause viremia. In 28 blood donations in Brazil that were deferred because of postdonation information, we identified influenza A(H3N2) virus RNA in 1 donation using metagenomic analysis. Our finding implies theoretical risk for viremia and transfusion transmission.

Background and Objectives: The rare S-s- phenotype has two main molecular backgrounds. GYPB deletions give rise to the S-s-U- phenotype, which loses the expression of the U antigen, while variant GYPB alleles usually lead to the S-s-U +var phenotype, which express a variant U antigen. The S-s- phenotype is typically found in people of African origin and represents a challenge in transfusion sets, especially when S-s- patients develop anti-U. Molecular analysis is the most reliable method for determining U antigen status. We studied the molecular basis of the S-s- phenotype in donors and patients at Regional Blood Center of Ribeirão Preto., Material and Methods: Five patients and 25 donors with the S-s- phenotype were investigated through real-time PCR for the GYPB*S/s polymorphism, followed by an allele-specific/RFLP-PCR for GYPB deletion (GYPB*Null) and for its main variants: GYPB*P2 and GYPB*NY. DNA sequencing was conducted in one sample., Results: Two samples were heterozygous GYPB*P2/GYPB*NY, eight were homozygous/hemizygous for GYPB*P2 and 19 samples were homozygous for GYPB*Null. A hybrid gene (GYPB-E-B.Ros) was found in one sample after discrepant results in the initial tests., Conclusion: GYPB deletion is the main mechanism responsible for the S-s- phenotype in our donors and patients. It is essential to evaluate the main GYPB variant alleles when genotyping in order to obtain the correct prediction of the phenotype. Hybrid genes lead to discrepancies between genotype and phenotype and may not be detected by conventional molecular assays., (© 2019 International Society of Blood Transfusion.)

Background: In 2015, there was a large Zika virus (ZIKV) outbreak in Brazil. The proportion of asymptomatic infections is very high, and it is possible for transfusion-transmitted ZIKV (TT-ZIKV) infection to occur. The prevalence of asymptomatic ZIKV infection among Brazilian blood donors during this epidemic outbreak is unknown., Study Design and Methods: Plasma samples obtained between October 2015 and May 2016 from 1393 volunteer blood donors were tested for ZIKV RNA. The viral load was quantified using an in-house standard curve. Additionally, positive ZIKV RNA samples were tested for anti-ZIKV immunoglobulin (Ig)M and anti-ZIKV IgG., Results: Of the 1393 blood samples, ZIKV RNA was detected in 37 (n = 37/1393; 2.7%). The median infection viral load detected was 7714 copies/mL (ranging from 135-124,220 copies/mL). The majority of the positive samples (70.3%) exhibited a viral load of approximately 10 3 copies/mL. Six samples that were positive for ZIKV RNA were also positive for anti-ZIKV IgM and IgG (n = 6/37; 13.5%)., Conclusion: This is the first study evaluating the prevalence of ZIKV RNA among Brazilian blood donors, which was relatively high and might lead to TT-ZIKV infection. It is unclear whether the simultaneous presence of anti-ZIKV IgM and IgG in RNA-positive donations or the viral load influences transfusion transmission of the infection. This study also adds to the global understanding of ZIKV prevalence in blood donors during outbreaks and the transfusion impact of the infection., (© 2017 AABB.)