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Introduction: Alzheimers disease (AD) and aging are associated with platelet hyperactivity. However, the mechanisms underlying abnormal platelet function in AD and aging are yet poorly understood. Methods: To explore the molecular profile of AD and aged platelets, we investigated platelet activation (i.e., CD62P expression), proteome and transcriptome in AD patients, non-demented elderly, and young individuals as controls. Results: AD, aged and young individuals showed similar levels of platelet activation based on CD62P expression. However, AD and aged individuals had a proteomic signature suggestive of increased platelet activation compared with young controls. Transcriptomic profiling suggested the dysregulation of proteolytic machinery involved in regulating platelet function, particularly the ubiquitin-proteasome system in AD and autophagy in aging. The functional implication of these transcriptomic alterations remains unclear and requires further investigation. Discussion: Our data strengthen the evidence of enhanced platelet activation in aging and provide a first glimpse of the platelet transcriptomic changes occurring in AD.

Acest document oferă o recomandare comună a Federației Europene de Chimie Clinică și Medicină de Laborator (EFLM), Grupului de lucru pentru faza preanalitică (WG-PRE) și Grupului de lucru din America Latină pentru Faza preanalitică (WG-PRE-LATAM) al Confederației Americii Latine de Biochimie Clinică (COLABIOCLI) pentru recoltarea sângelui venos. Documentul oferă îndrumări asupra cerințelor pentru asigurarea faptului că procedura de recoltare a sângelui este una sigură, centrată pe pacient și oferă îndrumări practice despre cum să fie depășite cu succes potențiale bariere și obstacole în calea difuzării și implementării ei. Publicul țintă pentru această recomandare este personalul medical implicat direct în procesul de recoltare a sângelui. Această recomandare se aplică în cazul utilizării unui sistem închis de recoltare a sângelui și nu oferă recomandări pentru recoltarea sângelui cu seringi și catetere în sistem deschis. Mai mult, acest document nu abordează obținerea consimțământului pacientului, solicitarea testelor, manipularea și transportul probelor și nici recoltarea de la copii și pacienții inconștienți. Procedura recomandată se bazează pe cele mai bune dovezi disponibile. Fiecare pas a fost evaluat folosind un sistem care punctează calitatea dovezilor și puterea recomandării. Procesul de evaluare a fost realizat la mai multe întâlniri față în față implicând aceleași părți interesate menționate anterior. Principalele părți ale acestei recomandări sunt: 1) Proceduri de pre-recoltare, 2) Procedura de recoltare, 3) Proceduri de post-recoltare şi 4) Implementarea. O primă schiță a recomandării a fost transmisă membrilor EFLM pentru consultare publică. A fost invitat și WG-PRE-LATAM pentru a comenta documentul. O versiune revizuită a fost trimisă spre vot tuturor membrilor EFLM și COLABIOCLI și a fost aprobată oficial de 33 dintre cei 40 de membri EFLM și toți membri COLABIOCLI. Încurajăm profesioniștii din toată Europa şi America Latină să adopte şi să implementeze această recomandare pentru a îmbunătăți calitatea practicilor de recoltare a sângelui și creșterea siguranței pacientului și personalului medical.

The amount of data generated in the field of laboratory medicine has grown to an extent that conventional laboratory information systems (LISs) are struggling to manage and analyze this complex, entangled information (“Big Data”). Statistical learning, a generalized framework from machine learning (ML) and artificial intelligence (AI) is predestined for processing “Big Data” and holds the potential to revolutionize the field of laboratory medicine. Personalized medicine may in particular benefit from AI-based systems, especially when coupled with readily available wearables and smartphones which can collect health data from individual patients and offer new, cost-effective access routes to healthcare for patients worldwide. The amount of personal data collected, however, also raises concerns about patient-privacy and calls for clear ethical guidelines for “Big Data” research, including rigorous quality checks of data and algorithms to eliminate underlying bias and enable transparency. Likewise, novel federated privacy-preserving data processing approaches may reduce the need for centralized data storage. Generative AI-systems including large language models such as ChatGPT currently enter the stage to reshape clinical research, clinical decision-support systems, and healthcare delivery. In our opinion, AI-based systems have a tremendous potential to transform laboratory medicine, however, their opportunities should be weighed against the risks carefully. Despite all enthusiasm, we advocate for stringent added-value assessments, just as for any new drug or treatment. Human experts should carefully validate AI-based systems, including patient-privacy protection, to ensure quality, transparency, and public acceptance. In this opinion paper, data prerequisites, recent developments, chances, and limitations of statistical learning approaches are highlighted.

* Context.--Underuse of laboratory testing has been previously investigated in preselected populations, such as documented malpractice claims. However, these numbers might not reflect real-life situations. Objective.--To evaluate the underuse and misuse of laboratory follow-up testing in a real-life hospital patient population with microcytic anemia, using laboratory results ordered during routine patient care. Design.--From all patients in whom a microcytic anemia was detected during routine diagnostics in 2018, all available laboratory data were collected and screened for appropriateness of diagnostic workup of iron deficiency and thalassemia. Subgroup analysis was performed for patient groups with mean corpuscular volume values 75 to 79 [micro][m.sup.3] (group 1), 65 to 74 [micro][m.sup.3] (group 2), and Results.--A total of 2244 patients with microcytic anemia were identified. Follow-up testing for iron deficiency was not performed in 761 cases (34%). For inconclusive ferritin levels due to elevated C-reactive protein results (n = 336), reticulocyte hemoglobin content or soluble transferrin receptor levels were missing in 86 cases (26%). In patients with suspected thalassemia (n = 127), follow-up testing for hemoglobin variants was not performed in 70 cases (55%). Subgroup analysis showed that the frequency of underuse of iron status as well as thalassemia/hemoglobinopathy testing decreased from group 1 to group 3. When considering relevant preexisting anemia diagnoses, laboratory tests were underused in 904 cases (40.3%). Conclusions.--Because 40% (n = 904) of the patients with microcytic anemia were potentially not followed up correctly, laboratory specialists are advised to act by implementing demand management strategies in collaboration with clinicians to overcome underuse of laboratory tests and to improve patient safety., During the last few decades, the number and availability of high-quality laboratory tests have gradually increased. Alongside this evolution some rather unthoughtful and inappropriate use of these tests developed. Ordering [...]

As the healthcare sector evolves, Artificial Intelligence’s (AI’s) potential to enhance laboratory medicine is increasingly recognized. However, the adoption rates and attitudes towards AI across European laboratories have not been comprehensively analyzed. This study aims to fill this gap by surveying European laboratory professionals to assess their current use of AI, the digital infrastructure available, and their attitudes towards future implementations.We conducted a methodical survey during October 2023, distributed via EFLM mailing lists. The survey explored six key areas: general characteristics, digital equipment, access to health data, data management, AI advancements, and personal perspectives. We analyzed responses to quantify AI integration and identify barriers to its adoption.From 426 initial responses, 195 were considered after excluding incomplete and non-European entries. The findings revealed limited AI engagement, with significant gaps in necessary digital infrastructure and training. Only 25.6 % of laboratories reported ongoing AI projects. Major barriers included inadequate digital tools, restricted access to comprehensive data, and a lack of AI-related skills among personnel. Notably, a substantial interest in AI training was expressed, indicating a demand for educational initiatives.Despite the recognized potential of AI to revolutionize laboratory medicine by enhancing diagnostic accuracy and efficiency, European laboratories face substantial challenges. This survey highlights a critical need for strategic investments in educational programs and infrastructure improvements to support AI integration in laboratory medicine across Europe. Future efforts should focus on enhancing data accessibility, upgrading technological tools, and expanding AI training and literacy among professionals. In response, our working group plans to develop and make available online training materials to meet this growing educational demand. [ABSTRACT FROM AUTHOR]

In the last decades, clinical laboratories have significantly advanced their technological capabilities, through the use of interconnected systems and advanced software. Laboratory Information Systems (LIS), introduced in the 1970s, have transformed into sophisticated information technology (IT) components that integrate with various digital tools, enhancing data retrieval and exchange. However, the current capabilities of LIS are not sufficient to rapidly save the extensive data, generated during the total testing process (TTP), beyond just test results. This opinion paper discusses qualitative types of TTP data, proposing how to divide laboratory-generated information into two categories, namely metadata and peridata. Being both metadata and peridata information derived from the testing process, it is proposed that the first is useful to describe the characteristics of data, while the second is for interpretation of test results. Together with standardizing preanalytical coding, the subdivision of laboratory-generated information into metadata or peridata might enhance ML studies, also by facilitating the adherence of laboratory-derived data to the Findability, Accessibility, Interoperability, and Reusability (FAIR) principles. Finally, integrating metadata and peridata into LIS can improve data usability, support clinical utility, and advance AI model development in healthcare, emphasizing the need for standardized data management practices. [ABSTRACT FROM AUTHOR]

Objectives: Despite the currently prevailing, milder Omicron variant, coronary artery disease (CAD) patients constitute a major risk group in COVID-19, exhibiting 2.6 times the mortality risk of non-CAD patients and representing over 22% of non-survivors. No data are currently available on the efficacy of antibody levels in CAD patients, nor on the relevance of vaccination status versus antibody levels for predicting severe courses and COVID-19 mortality. Nor are there definitive indicators to assess if individual CAD patients are sufficiently protected from adverse outcomes or to determine the necessity of booster vaccinations. Methods: A prospective, propensity-score-matched, multicenter cohort study comprising 249 CAD patients and 903 controls was conducted. Anti-SARS-CoV-2-spike antibodies were measured on hospital admission. Prespecified endpoints were in-hospital mortality, intensive care, and oxygen administration. Results: After adjustment for potential confounders, CAD patients exhibited 4.6 and 6.1-times higher mortality risks if antibody levels were <1200 BAU/mL and <182 BAU/mL, respectively, compared to CAD patients above these thresholds (aOR 4.598, 95%CI 2.426–8.714, p < 0.001; 6.147, 95%CI 2.529–14.941, p < 0.001). Risk of intensive care was 3.7 and 4.0 (p = 0.003; p < 0.001), and risk of oxygen administration 2.6 and 2.4 times higher below these thresholds (p = 0.004; p = 0.010). Vaccination status was a weaker predictor of all three outcomes than both antibody thresholds. Conclusion: Antibody levels are a stronger predictor of outcome in CAD patients with COVID-19 than vaccination status, with 1200 BAU/mL being the more conservative threshold. Measuring anti-SARS-CoV-2 antibodies in CAD patients may ensure enhanced protection by providing timely booster vaccinations and identifying high-risk CAD patients at hospital admission. [ABSTRACT FROM AUTHOR]

Legal regulations and guidelines such as the Guidelines of the German Medical Association for the Quality Assurance of Laboratory Medical Examinations (Rili-BAEK) and ISO 15189 apply to electronic laboratory reports. However, many laboratories struggle with practical implementation of these regulations and guidelines.

The ultimate goal of value-based laboratory medicine is maximizing the effectiveness of laboratory tests in improving patient outcomes, optimizing resources and minimizing unnecessary costs. This approach abandons the oversimplified notion of test volume and cost, in favor of emphasizing the clinical utility and quality of diagnostic tests in the clinical decision-making. Several key elements characterize value-based laboratory medicine, which can be summarized in some basic concepts, such as organization of in vitro diagnostics (including appropriateness, integrated diagnostics, networking, remote patient monitoring, disruptive innovations), translation of laboratory data into clinical information and measurable outcomes, sustainability, reimbursement, ethics (e.g., patient empowerment and safety, data protection, analysis of big data, scientific publishing). Education and training are also crucial, along with considerations for the future of the profession, which will be largely influenced by advances in automation, information technology, artificial intelligence, and regulations concerning in vitro diagnostics. This collective opinion paper, composed of summaries from presentations given at the two-day European Federation of Laboratory Medicine (EFLM) Strategic Conference "A vision to the future: value-based laboratory medicine" (Padova, Italy; September 23–24, 2024), aims to provide a comprehensive overview of value-based laboratory medicine, projecting the profession into a more clinically effective and sustainable future. [ABSTRACT FROM AUTHOR]

Background: Fasting levels of glucagon are known to be elevated in youth and adults with type 2 diabetes mellitus (T2D). Children and adolescents with obesity were previously reported to show increasing fasting and post-glucose-challenge hyperglucagonemia across the spectrum of glucose tolerance, while no data are available in those with impaired fasting glucose (IFG). Materials and methods: Individuals from the Beta-JUDO study population (Uppsala and Salzburg 2010-2016) (n=101, age 13.3 ± 2.8, m/f=50/51) were included (90 with overweight or obesity, 11 with normal weight). Standardized OGTT were performed and plasma glucose, glucagon and insulin concentrations assessed at baseline, 5, 10, 15, 30, 60, 90 and 120 minutes. Patients were grouped according to their glycemic state in six groups with normal glucose metabolism (NGM) and normal weight (NG-NW), NGM with obesity or overweight (NG-O), impaired glucose tolerance (IGT), impaired fasting glucose (IFG), IGT+IFG and T2D, and in two groups with NGM and impaired glucose metabolism (IGM), for statistical analysis. Results and conclusion: Glucagon concentrations were elevated in young normoglycemic individuals with overweight or obesity (NG-O) compared to normoglycemic individuals with normal weight. Glucagon levels, fasting and dynamic, increased with progressing glycemic deterioration, except in IFG, where levels were comparable to those in NG-O. All glycemic groups showed an overall suppression of glucagon during OGTT. An initial increase of glucagon could be observed in T2D. In T2D, glucagon showed a strong direct linear correlation with plasma glucose levels during OGTT. Glucagon in adolescents, as in adults, may play a role in the disease progression of T2D. [ABSTRACT FROM AUTHOR]

Quality assurance (QA) in point-of-care testing (POCT) is an important issue for organizing POCT structures within the healthcare sector. In Germany, only one device needs to participate in an external QA program, if the responsible core laboratory is supervising internal quality controls of all other identical POCT devices. This flexible definition of quality control (QC) testing is in line with the fundamentals of ISO 22870 and the ISO 15189, but can only be regarded as a minimum requirement.

The preanalytical phase is crucial for assuring the quality of in vitro diagnostics. The leading aspects which contribute to enhance the vulnerability of this part of the total testing process include the lack of standardization of different practices for collecting, managing, transporting and processing biological specimens, the insufficient compliance with available guidelines and the still considerable number of preventable human errors. As in heavy industry, road traffic and aeronautics, technological advancement holds great promise for decreasing the risk of medical and diagnostic errors, thus including those occurring in the extra-analytical phases of the total testing process. The aim of this article is to discuss some potentially useful technological advances, which are not yet routine practice, but may be especially suited for improving the quality of the preanalytical phase in the future. These are mainly represented by introduction of needle-wielding robotic phlebotomy devices, active blood tubes, drones for biological samples transportation, innovative approaches for detecting spurious hemolysis and preanalytical errors recording software products.