A non-parametric framework for evaluating total analytical error in in vitro diagnostic medical devices in transfusion medicine.

The performance assessment of quantitative measurements is predominantly based on evaluating Total Analytical Error (TAE). This evaluation encompasses several key objectives critical to ensuring accurate, reliable, and clinically relevant test results. Traditional parametric methods often fall short due to data normality assumptions in the performance assessment of in vitro diagnostic medical devices (IVD-MDs).

A targeted survey on teachers' perception of training/education for blood donation in high school students: An invited case report for enhancing and retention of dedicated donors in Portugal.

Promoting blood donation requires understanding and identifying the factors that motivate donations so that strategies for retaining and increasing loyalty can be developed. Transfusion literacy can be improved through school-based teaching and information about giving and solidarity to promote the development of future donors. For the purpose of aligning any strategies and motivational dynamics that promote adherence to informed donation and loyalty among students in the municipality of Coimbra.

Spotlights on the trends in performance assessment of qualitative in vitro diagnostic medical devices in transfusion medicine.

For reliable clinical decisions in transfusion medicine, assessing the performance of qualitative tests performed in medical laboratories is critical. When false results are reported, these can lead to an adverse reaction to blood components. Good performance assessment practices are essential for this kind of scenario, and they still remain as one of the many unmet high-priority challenges in this area.

Current principles for the establishment of the virological "cutoff points" in transfusion science and medicine: A short concise overview.

Establishing the virological cutoff point, during epidemics, such as the COVID-19 Pandemic, is crucially important as inadequate standardization and the false qualitative results, have enormous clinical and economic consequences when screening for SARS-CoV-2. Moreover, a cutoff point is a crucial step in ensuring a minimal risk of clinical misclassification. Therefore complying with such statutory requirements is an essential part of obligatory good laboratory and clinical practices.

Insights on trends in the management of metrological analysis of devices in blood and transfusion medicine services: Verification based on their fitness for purpose and suitability for their respective applications.

In the field of blood and transfusion medicine, European Directorate for the Quality of Medicines & HealthCare recommends practices for metrological devices. Monitoring and measurement resources, as well as their permitted metrological limits, must be considered in this regard. We must understand variables such as metrological domains, the International System of Units, metrological traceability, and metrological requirements and controls in the field of transfusions in order to understand these metrological devices.

Challenges in the Management of the Patient with a Failing Kidney Graft: A Narrative Review.

Patients with a failed kidney allograft have steadily increase in recent years and returning to dialysis after graft loss is one of the most difficult transitions for chronic kidney disease patients and their assistant physicians. The management of these patients is complex and encompasses the treatment of chronic kidney disease complications, dialysis restart and access planning, immunosuppression withdrawal, graft nephrectomy, and evaluation for a potential retransplant. In recent years, several groups have focused on the management of the patient with a failing renal graft and expert recommendations are arising.

Strategies to Overcome HLA Sensitization and Improve Access to Retransplantation after Kidney Graft Loss.

An increasing number of patients waitlisted for kidney transplantation have a previously failed graft. Retransplantation provides a significant improvement in morbidity, mortality, and quality of life when compared to dialysis. However, HLA sensitization is a major barrier to kidney retransplantation and the majority of the highly sensitized patients are waiting for a subsequent kidney transplant.

Spotlights on the latest opinions on identification, prevention, and management of newer CoV-2 variants: A roundup appraisal on innovative ideas and designer vaccines for Omicron.

Although mass vaccination combined with some other preventative strategies and lockdown was associated with some early signs that COVID-19 infection might be fading away, the over 35 sites mutated new South African variant, "Omicron", emerged almost globally. Certain predisposed hosts may develop severe inflammatory thrombotic or mild long-Covid conditions due to this variant, which depletes T-cells, neutralizes antibodies circulating in the body, and coincidentally induces hypercoagulability. The surge of Omicron combined with Delta variants may confer unresponsiveness to the currently available vaccines even when the second dose is given up to 90 days.

Process capability indexes: Trends and developments in the manufacturing of blood components.

The production of blood components takes place in a workflow where conditions should be controlled and stabilized. The quality control claims and the principles of statistical process control should be understood to apply a control policy properly. Control typically employs charts complemented by a set of rules that allow taking well-supported actions.

Differences for T-Cell Subtypes in Aspiration Biopsies of Patients With Kidney Transplant Under Polyclonal and Monoclonal Immunosuppressive Treatments.

Thymoglobulin, or antithymocyte globulin (ATG), and anti-interleukin 2α (IL-2α) chain receptor antibody (IL-2αRAb) achieve comparable good results in kidney transplantation notwithstanding different actions on immune cells. Previously, we reported the usefulness of flow cytometry (FC) analysis of lymphocyte subsets present in peripheral blood sample (PBL) and fine-needle aspiration biopsies (FNABs) for clinical surveillance, as, FC reaches very high predictive positive values for acute rejection diagnosis. Now we report an FC study on 2 kidney transplantation (KT) groups under ATG (n = 19) and IL-2αRAb (n = 24) treatment.

Subcutaneous immunotherapy induces alterations in monocytes and dendritic cells homeostasis in allergic rhinitis patients.

Background: Specific subcutaneous immunotherapy (SCIT) can achieve long-term remission in patients with allergic rhinitis (AR) through complex and still unknown mechanisms. The aim of this study is to evaluate the effect of SCIT over CD16 and CD16 monocytes, myeloid (mDCs) and plasmacytoid dendritic cells (pDCs) in patients with AR, comparatively to pharmacological standard treatment (non-SIT).

Methods: The relative frequency and absolute number of monocytes and DC subsets, the frequency of these cells producing TNFα after in vitro stimulation with (Dpt) extract, and the expression levels of receptor-bound IgE or IgG were assessed by flow cytometry, in peripheral blood samples from 23 healthy individuals (HG) and 43 participants with AR mono-sensitized to Dpt; 10 with non-SIT treatment and 33 under SCIT, just before (SCIT-T0) and 4 h after administration (SCIT-T4).

Statistical control of the production of blood components by control charts of attribute to improve quality characteristics and to comply with current specifications.

Statistical process control (SPC) is closely related to good quality control practices in the manufacturing process. One of the primary goals is to detect unnatural patterns, allowing the production service to control the conformity of the blood components produced. Despite being recommended by national and international standards, its exercise is not uniform, and sometimes the methodology used is misinterpreted as SPC.

Statistical methods to the control of the production of blood components: principles and control charts for variables.

General quality control good practices require the control of the production of blood components using statistical techniques, such as mandatory by the European Commission Directives and the American Association of Blood Banks standards. Sometimes, the control procedure is exclusively in favor of the compliance verification with specifications per individual component or to compute the number of defective parts usually on a monthly basis. However, this is a critical restriction to detect unnatural patterns such as to guarantee that the production has a non-significance chance to manufacturing nonconforming components.

Sampling methods to the statistical control of the production of blood components.

The control of blood components specifications is a requirement generalized in Europe by the European Commission Directives and in the US by the AABB standards. The use of a statistical process control methodology is recommended in the related literature, including the EDQM guideline. The control reliability is dependent of the sampling.

Increased frequencies of circulating CXCL10-, CXCL8- and CCL4-producing monocytes and Siglec-3-expressing myeloid dendritic cells in systemic sclerosis patients.

Objective: To investigate the ex vivo pro-inflammatory properties of classical and non-classical monocytes as well as myeloid dendritic cells (mDCs) in systemic sclerosis (SSc) patients.

Methods: Spontaneous production of CXCL10, CCL4, CXCL8 and IL-6 was intracellularly evaluated in classical, non-classical monocytes and Siglec-3-expressing mDCs from peripheral blood of SSc patients and healthy controls (HC) through flow cytometry. In addition, production of these cytokines was determined upon toll-like receptor (TLR) 4 plus Interferon-γ (IFN-γ) stimulation.

Bisoprolol-induced thrombocytopenia: A case report.

What Is Known And Objective: Thrombocytopenia, not associated with bone marrow primary disease, is a common clinical problem. The possibility of drug-induced thrombocytopenia must be considered, especially in hospitalized patients. Drugs can cause thrombocytopenia by several mechanisms including direct bone marrow or other organ toxicity, and immune reactions.

High Antimicrobial Activity and Low Human Cell Cytotoxicity of Core-Shell Magnetic Nanoparticles Functionalized with an Antimicrobial Peptide.

Superparamagnetic iron oxide nanoparticles (SPIONs) functionalized with antimicrobial agents are promising infection-targeted therapeutic platforms when coupled with external magnetic stimuli. These antimicrobial nanoparticles (NPs) may offer advantages in fighting intracellular pathogens as well as biomaterial-associated infections. This requires the development of NPs with high antimicrobial activity without interfering with the biology of mammalian cells.

Sera from patients with active systemic lupus erythematosus patients enhance the toll-like receptor 4 response in monocyte subsets.

Background: Systemic Lupus Erythematosus (SLE) is an auto-immune disease whose complex pathogenesis remains unraveled. Here we aim to explore the inflammatory ability of SLE patients' sera upon peripheral blood (PB) monocyte subsets and myeloid dendritic cells (mDCs) obtained from healthy donors.

Methods: In this study we included 11 SLE patients with active disease (ASLE), 11 with inactive disease (ISLE) and 10 healthy controls (HC).

CD38, CD81 and BAFFR combined expression by transitional B cells distinguishes active from inactive systemic lupus erythematosus.

In view of its heterogeneous presentation and unpredictable course, clinical management of systemic lupus erythematosus (SLE) is difficult. There is a need for biomarkers and diagnostic aids to monitor SLE disease activity and severity prior to, during and after treatment. We undertook this study to search for unique phenotypic patterns in each peripheral blood (PB) B cell subset, capable of distinguishing SLE patients with inactive disease versus SLE patients with active disease versus controls by using an automated population separator (APS) visualization strategy.

Quality management in European screening laboratories in blood establishments: A view of current approaches and trends.

The screening laboratory has a critical role in the post-transfusion safety. The success of its targets and efficiency depends on the management system used. Even though the European Union directive 2002/98/EC requires a quality management system in blood establishments, its requirements for screening laboratories are generic.

The role of uncertainty regarding the results of screening immunoassays in blood establishments.

The risk of uncertain results in infectious agents' tests is recognized in blood establishments, being particularly evident during the blood donor selection. The current risk-based approaches require risk assessment and "risk-based thinking". Accordingly, the blood establishment should consider the effect of uncertainty in all the technical decisions taken in a screening laboratory.

Alterations on peripheral blood B cell subsets induced by allergic rhinitis.

Objectives And Design: Here we evaluated whether allergic rhinitis to Dermatophagoides pteronyssinus induces alterations on circulating B cell subsets.

Materials And Methods: Circulating B cell subsets and isotype expression on antigen-experienced B cells from allergic patients under conventional pharmacological treatment (NO-SIT, n = 15) and under subcutaneous immunotherapy (SCIT, n = 33), and non-allergic subjects (NC, n = 25) were analyzed by flow cytometry.

Results: In allergic patients, we found a significant decrease in IgM(+) and IgG(+) memory B cells and an increase in IgA(+) memory B cells.