ABSTRACT
BACKGROUND: Prematurity is a significant health issue due to its incidence and associated complications. Anemia is common in extremely preterm infants (EPI) and often requires transfusions. Red blood cells (RBC) from adult blood (AB) donors have been linked to oxygen-related complications in EPI, leading to the exploration of cord blood (CB) as an alternative source. However, standardization of CB-RBC manufacturing and comparison with AB-RBC characteristics are necessary before clinical studies can be conducted. MATERIALS AND METHODS: This study investigated the quality and characteristics of leukoreduced, gamma-irradiated CB-RBC obtained using a commercial closed system from CB donations not meeting hematopoietic transplantation criteria. CB-RBC units were compared with AB-RBC units, both stored in saline-adenine-glucose-mannitol (SAGM). Various parameters, including hematological and biochemical characteristics, pH, 2,3-DPG levels, blood gases and potential toxicants, were evaluated during storage. RESULTS: CB-RBC units had acceptable initial quality parameters and a hematocrit (55±2%) comparable to AB-RBC. The main finding during storage was a faster rise in hemolysis compared to AB-RBC. Potassium (K+) significantly increased during storage in both sources. As expected, glucose levels decreased, and conversely, lactate levels increased, indicating similar patterns of anaerobic glycolysis during storage. pH decreased, affecting the oxygen dissociation curve due to reduced 2,3-DPG levels. After irradiation at 14 days of storage, CB-RBC were less stable as hemolysis and K+ significantly increased compared to AB-RBC at 24 hours. Phthalate concentrations, indicative of plasticizers, increased during storage, but significantly less in CB compared to AB-RBC. Most metals measured were within acceptable ranges. DISCUSSION: The quality of CB-RBC during storage is primarily influenced by levels of hemolysis and extracellular K+ content. Based on the analyzed parameters, we suggest that the expiration date for CB-RBC stored with SAGM should be set at 14 days, with transfusion occurring within <24 hours after irradiation.
ABSTRACT
Testing is crucial in controlling COVID-19. The Procleix® SARS-CoV-2 assay, a transcription-mediated amplification nucleic acid test that runs on an automated system, was evaluated using inactivated virus and clinical samples. The sensitivity of the assay was assessed using heat-inactivated SARS-CoV-2 and compared to 3 other tests. Clinical validation utilized 2 sets of samples: (1) Nasal, nasopharyngeal and oropharyngeal samples (n = 963) from asymptomatic individuals, and (2) nasopharyngeal samples from symptomatic patients: 100 positive and 100 negative by RT-PCR. The Procleix assay had greater sensitivity (3-fold to 100-fold) than the comparators and had high specificity (100%) in asymptomatic subjects. In symptomatic patients, the Procleix assay detected 100% of PCR-positives and found 24 positives in the initial PCR-negatives. Eighteen of these were confirmed positive and 6 were inconclusive. These studies showed that the Procleix SARS-CoV-2 assay was a sensitive and specific tool for detecting COVID-19.
Subject(s)
Automation , COVID-19 Testing/methods , COVID-19/diagnosis , COVID-19/virology , SARS-CoV-2/isolation & purification , High-Throughput Screening Assays , Humans , Molecular Diagnostic Techniques , Nucleic Acid Amplification Techniques , Retrospective Studies , Sensitivity and SpecificityABSTRACT
BACKGROUND: The COVID-19 pandemic is placing blood and tissue establishments under unprecedented stress, putting its capacity to provide the adequate care needed at risk. Here we reflect on how our integrated organisational model has faced the first impact of the pandemic and describe what challenges, opportunities and lessons have emerged. MATERIALS AND METHODS: The organisational model of the Catalan Blood and Tissue Bank (Banc de Sang i Teixits, BST) is described. The new scenario was managed by following international recommendations and considering the pandemic in a context of volatility, uncertainty, complexity, and ambiguity (VUCA), allowing rapid measures to be taken. These aimed to: ensure donor safety, promote proper responses to patients' needs, ensure the health and well-being of personnel, and prepare for future scenarios. RESULTS: The BST has adapted its activities to the changes in demand. No shortage of any product or service occurred. Donor acceptance, safety and wellbeing were maintained except for tissue donation, which almost completely stopped. To support the health system, several activities have been promoted: large-scale convalescent plasma (CP) production, clinical trials with CP and mesenchymal stromal cells, massive COVID-19 diagnoses, and participation in co-operative research and publications. Haemovigilance is running smoothly and no adverse effects have been detected among donors or patients. DISCUSSION: Several elements have proven to be critical when addressing the pandemic scenario: a) the early creation of a crisis committee in combination with technical recommendations and the recognition of a VUCA scenario; b) identification of the strategies described; c) the integrated donor-to-patient organisational model; d) active Research and Development (R&D); and e) the flexibility of the staff. It is essential to underline the importance of the need for centralised management, effective contingency strategies, and early collaboration with peers.
Subject(s)
Blood Banks/organization & administration , COVID-19/epidemiology , Pandemics , SARS-CoV-2 , Tissue Banks/organization & administration , Blood Banks/supply & distribution , Blood Component Transfusion/statistics & numerical data , Blood Donors , Bone Marrow Transplantation , COVID-19/prevention & control , COVID-19/therapy , Humans , Immunization, Passive , Models, Organizational , Occupational Diseases/prevention & control , Safety , Spain , Tissue and Organ Procurement , COVID-19 SerotherapyABSTRACT
Introduction. The selection and definition of quality indicators is essential for proper control of processes. This is not always easy, particularly with extra-analytical indicators, due to the complexity and degree of comparison of processes between laboratories, and the fact that data collection is not always automated. For this reason, the indicators and specifications need to be dynamic and re-designed in accordance with changes in the system. The aim of this paper is to describe the methodology used in the selection and definition of quality indicators, and their specifications for extra-analytical processes in public laboratories in Catalonia. Material and methods. During the study period (2004-2013), the members of the working group reported the mean annual value for each indicator, and the overall yearly mean of all participants was calculated. These results were compared and analyzed during periodic meetings, with regards to the pre-established specifications of the different laboratories. Results. Quality indicators and their specifications are presented. The evaluation of the validity of each quality indicator was made taking into account aspects including usefulness of the indicator in process monitoring, a clear definition, and a precise and reliable quantification. This methodology has made it possible to contrast the validity of the indicators or to reconsider the specification. Conclusions. The last 10 years experience of the Catalonian Health Institute Working Group on Quality Indicators in designing indicators and establishing quality specifications has proved very useful for improving the monitoring of processes in clinical laboratories included in the group (AU)
Introducción. La selección y definición de los indicadores de la calidad es imprescindible para controlar adecuadamente un proceso. Ello no siempre es fácil, sobre todo en el caso de los indicadores extraanalíticos, dada la complejidad y grado de comparabilidad de los procesos entre laboratorios y la necesaria recogida de datos que en muchas ocasiones no está automatizada. Asimismo, los indicadores y especificaciones deben ser dinámicos y rediseñarse en función de los cambios del sistema. El objetivo de este trabajo es describir la metodología utilizada en la selección y definición de indicadores de calidad y especificaciones para los procesos extraanalíticos en los laboratorios públicos de Cataluña. Material y métodos. Durante el período de estudio (2004-2013), los miembros del grupo han informado del valor medio anual para cada indicador, y se ha calculado la media anual de todos los participantes para cada uno de ellos. Estos resultados se han comparado y analizado a través de reuniones periódicas, con respecto a las especificaciones preestablecidas de los diferentes laboratorios. Resultados. Se presentan los indicadores de calidad y sus especificaciones. La evaluación de la validez de cada indicador de calidad se llevó a cabo teniendo en cuenta los aspectos incluyendo la utilidad del indicador en la supervisión de procesos, una definición clara y una cuantificación precisa y fiable. Esta metodología ha permitido contrastar la validez de los indicadores o reconsiderar la especificación. Conclusiones. Los últimos 10 años de experiencia del Grupo de Trabajo del Instituto Catalán de la Salud de Indicadores de Calidad en el diseño de indicadores y en establecer especificaciones de calidad ha demostrado ser muy útil para mejorar el seguimiento de los procesos en los laboratorios clínicos integrados en el grupo (AU)