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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.

Aim: The aim of this study was to develop machine learning (ML) models to mitigate the inappropriate request of Procalcitonin (PCT) in clinical wards. Material and methods: We built six different ML models based on both demographical data, i.e., sex and age, and laboratory parameters, i.e., cell blood count (CBC) parameters, inclusive of monocyte distribution width (MDW), and C-reactive protein (CRP). The dataset included 1667 PCT measurements of different patients. Based on a PCT cut-off of 0.50 ng/mL, we found 1090 negative (65.4%) and 577 positive (34.6%) results. We performed a 70:15:15 train:validation:test splitting based on the outcome. Results: Random Forest, Support Vector Machine and eXtreme Gradient Boosting showed optimal performances for predicting PCT positivity, with an area under the curve ranging from 0.88 to 0.89. Conclusions: The ML models developed could represent a useful tool to predict PCT positivity, avoiding unusefulness PCT requests. ML models are based on laboratory tests commonly ordered together with PCT but have the great advantage to be easy to measure and low-cost.

Abstract Background and Aims Artificial intelligence (AI) has emerged as a transformative force in laboratory medicine, promising significant advancements in healthcare delivery. This study explores the potential impact of AI on diagnostics and patient management within the context of laboratory medicine, with a particular focus on low‐ and middle‐income countries (LMICs). Methods In writing this article, we conducted a thorough search of databases such as PubMed, ResearchGate, Web of Science, Scopus, and Google Scholar within 20 years. The study examines AI's capabilities, including learning, reasoning, and decision‐making, mirroring human cognitive processes. It highlights AI's adeptness at processing vast data sets, identifying patterns, and expediting the extraction of actionable insights, particularly in medical imaging interpretation and laboratory test data analysis. The research emphasizes the potential benefits of AI in early disease detection, therapeutic interventions, and personalized treatment strategies. Results In the realm of laboratory medicine, AI demonstrates remarkable precision in interpreting medical images such as radiography, computed tomography, and magnetic resonance imaging. Its predictive analytical capabilities extend to forecasting patient trajectories and informing personalized treatment strategies using comprehensive data sets comprising clinical outcomes, patient records, and laboratory results. The study underscores the significance of AI in addressing healthcare challenges, especially in resource‐constrained LMICs. Conclusion While acknowledging the profound impact of AI on laboratory medicine in LMICs, the study recognizes challenges such as inadequate data availability, digital infrastructure deficiencies, and ethical considerations. Successful implementation necessitates substantial investments in digital infrastructure, the establishment of data‐sharing networks, and the formulation of regulatory frameworks. The study concludes that collaborative efforts among stakeholders, including international organizations, governments, and nongovernmental entities, are crucial for overcoming obstacles and responsibly integrating AI into laboratory medicine in LMICs. A comprehensive, coordinated approach is essential for realizing AI's transformative potential and advancing health care in LMICs.

In 2023, the World Health Organization estimates that 1 in every 10 patients experiences harm from unsafe care, with 3 million deaths occurring yearly from the same. Over half the cases of patient harm are preventable and resultant from errors. As 70% of medical decision making involves the laboratory, laboratory medicine is looked upon to improve patient safety. However, laboratory errors are not isolated and unpredictable entities, but rather reflective of the overall healthcare system. Laboratory errors often occur outside the laboratory, as medical testing and procedures are performed by individuals with various levels of quality control training. We describe a case of a specimen labeling error which prolonged a patient’s hospitalization, hindered the medical team’s clinical decision making and increased healthcare cost utilization. We review categories of laboratory errors, outline steps to prevent pre-analytical laboratory errors (defined as those that occur before, during or after specimen collection) and describe metrics to measure quality improvement.

Objectives: The routine teaching mode of diabetes mellitus (DM) is divided into various sub-majors of medical laboratory, which is not conducive to clinical laboratory physicians quickly mastering relevant knowledge. A novel DM laboratory testing pathway is established to improve teaching efficiency and enhance the effects of talent cultivation in laboratory medicine. Methods: The guidelines and expert consensuses of DM were gathered from professional websites and databases. The clinical laboratory diagnostic pathway was formulated, and the questionnaire and mutual evaluation were used to evaluate the teaching effectiveness of 8-year undergraduate students enrolled in 2018 and enrolled in 2019, respectively. Results: Clinical laboratory physicians developed and approved the DM clinical laboratory diagnostic pathway, which included the entire process of DM diagnosis and differential diagnosis, drug selection, treatment impact monitoring, prognosis evaluation, etc. The results of the questionnaires showed that, in comparison to the teaching mode used with the students enrolled in 2018 and enrolled in 2019, the percentages of more improvement and significant improvement were significantly increased (P < 0.01) and the percentages of no improvement and slight improvement were significantly decreased (P < 0.01). Following the instruction of the DM clinical laboratory diagnostic route, the results were greatly improved, including points emphasized and the accuracy of responding to questions, among other things, according to the teachers' and students' mutual evaluation (P < 0.05). Conclusions: To enhance the teaching quality in laboratory medicine, it is required to build the disease clinical laboratory diagnostic pathway for a novel teaching method. This may boost teachers' and students' confidence and broaden their knowledge. [ABSTRACT FROM AUTHOR]

Background: Medical educators seek innovative ways to engage learners efficiently and effectively. Gamification has been explored as one way to accomplish this feat; however, questions remain about which contexts gamification would be most useful. Time constraints and student interest present major barriers for teaching laboratory medicine to students. This study aims to compare two versions of an interactive online module, one gamified and one not, for teaching laboratory medicine concepts to pre-clinical medical students. Methods: First-year medical students reviewed either a gamified or non-gamified version of an interactive online module in preparation for an in-person flipped classroom session on Laboratory Medicine. Learning theory guided the design of the modules and both contained identical content, objectives, and structure. The "gamified" module included the additional elements of personalization, progress meters, points, badges, and story/role play. After reviewing the module, students completed an anonymous knowledge check and optional survey. Results: One hundred seventy-one students completed the post module knowledge check as assigned (82 gamified, 89 non-gamified). Knowledge check scores were higher for the students who reviewed the gamified module (p < 0.02), corresponding to an effect size of 0.4 for the gamified module. Eighty-one students completed optional post-module surveys (46 gamified, 35 non-gamified). Instructional efficiency was calculated using task difficulty questions and knowledge check scores, and the resulting instructional efficiency was higher for the gamified module. There was no significant difference in the student-reported time required to complete the modules. Additionally, both versions of the module were well received and led to positive ratings related to motivation and confidence. Finally, examination of open-ended survey results suggested that the addition of game elements added value to the gamified module and enhanced engagement and enjoyment. Conclusions: In this setting, the addition of gamification to an interactive online module enhanced learning outcome, instructional efficiency, student engagement and enjoyment. These results should inspire further exploration of gamification for teaching Laboratory Medicine concepts to pre-clinical medical students. [ABSTRACT FROM AUTHOR]

Keywords: COVID-19; laboratory medicine; pandemic; SARS-CoV-2 EN COVID-19 laboratory medicine pandemic SARS-CoV-2 e235 e238 4 10/30/23 20231101 NES 231101 To the Editor, According to the World Health Organization (WHO), the European region is in a "polycrisis" and "permacrisis" that goes far beyond pandemic, climate change, and war [[1]]. Most of these laboratories performed <1 million tests per year (42.0 %), followed by laboratories performing between 1 and 4 million tests per year (32.0 %), while 15.5 % of all respondents worked in large laboratories performing more than 8 million tests per year. COVID-19, laboratory medicine, pandemic, SARS-CoV-2. [Extracted from the article]

An emerging technology (ET) for laboratory medicine can be defined as an analytical method (including biomarkers) or device (software, applications, and algorithms) that by its stage of development, translation into broad routine clinical practice, or geographical adoption and implementation has the potential to add value to clinical diagnostics. Considering the laboratory medicine-specific definition, this document examines eight key tools, encompassing clinical, analytical, operational, and financial aspects, used throughout the life cycle of ET implementation. The tools provide a systematic approach starting with identifying the unmet need or identifying opportunities for improvement (Tool 1), forecasting (Tool 2), technology readiness assessment (Tool 3), health technology assessment (Tool 4), organizational impact map (Tool 5), change management (Tool 6), total pathway to method evaluation checklist (Tool 7), and green procurement (Tool 8). Whilst there are differences in clinical priorities between different settings, the use of this set of tools will help support the overall quality and sustainability of the emerging technology implementation. [ABSTRACT FROM AUTHOR]

Background: Matrix-assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS) is one of the preferred detection techniques for identification of clinical microorganisms and it has the characteristics of rapid identification, simple operation, low cost, and updatable databases. For laboratory medicine undergraduates, clinical internship is an important stage for the connection of basic theoretical knowledge and clinical practice. Internship teaching choosing MALDI-TOF MS as the content will greatly increase the popularity and applicability of the new technology in the clinical microbiology laboratory. Methods: With the help of electronic databases on the network, we conducted a systematic review. According to the purpose of research, we singled out forty papers. Latest studies on history, basic principles, clinical features, and applications of MALDI-TOF MS and the internship teaching contents introducing new technologies are summarized and focused on. In internship teaching, firstly we explain the historical development, basic principle and widespread applications of MALDI-TOF MS in the identification of clinical pathogenic microorganisms and the detection of antibiotic resistance. Subsequently, we instruct the students to perform the experimental operations, analyze the common problems, and find solutions. Finally, we highlight quality control and laboratory biosafety. Results: Most of the reviews published previously report the clinical features and applications of MALDI-TOF MS and the internship teaching contents choosing other new technologies. It is the first study selecting MALDI-TOF MS technology as an internship teaching content creatively. Primary outcome is that the students understand the theoretical knowledge in detail, master the operation skills of MALDI-TOF MS quickly, and obtain excellent internship performances in the clinical internship through the internship teaching. Secondary outcome is that it is a help to cultivate medical students' train of thought for scientific research and to understand the application of the new technology in clinical testing and scientific research. Conclusions: Laboratory medicine undergraduates should cherish the opportunity to learn the new technology during the internship period and should master basic principle and operation. As internship teachers, it is necessary to introduce the new technology to students during the internship and encourage undergraduates to cultivate creative and innovative thinking of scientific research. [ABSTRACT FROM AUTHOR]

For almost 2 decades, equations that use serum creatinine, age, sex, and race to estimate glomerular filtration rate (GFR) have included "race" as Black or non-Black. Given considerable evidence of disparities in health and health care delivery in African American communities, some regard keeping a race term in GFR equations as a practice that differentially influences access to care and kidney transplantation. Others assert that race captures important non-GFR determinants of serum creatinine and its removal from the calculation may perpetuate other disparities. The National Kidney Foundation (NKF) and American Society of Nephrology (ASN) established a task force in 2020 to reassess the inclusion of race in the estimation of GFR in the United States and its implications for diagnosis and subsequent management of patients with, or at risk for, kidney diseases. This interim report details the process, initial assessment of evidence, and values defined regarding the use of race to estimate GFR. We organized activities in phases: (1) clarify the problem and examine evidence, (2) evaluate different approaches to address use of race in GFR estimation, and (3) make recommendations. In phase 1, we constructed statements about the evidence and defined values regarding equity and disparities; race and racism; GFR measurement, estimation, and equation performance; laboratory standardization; and patient perspectives. We also identified several approaches to estimate GFR and a set of attributes to evaluate these approaches. Building on evidence and values, the attributes of alternative approaches to estimate GFR will be evaluated in the next phases and recommendations will be made.

The article discusses the impact of unintended shortages in technical resources on the quality of endpoint clinical laboratory diagnosis. It emphasizes the importance of laboratory services in diagnosing and treating diseases and highlights the need for high-quality laboratory services to ensure accurate and reliable results. The research conducted in Iran shows that private laboratories perform better than government ones, indicating the need for more supervision in government laboratories. The article also addresses concerns about the provision of kits, equipment, and spare parts for laboratory devices, which can affect the quality of laboratory services. It suggests that addressing these issues is crucial to maintain the quality of clinical lab services and avoid harm to patients. [Extracted from the article]

Graduate-level pathology education is under-resourced in low/middle-income countries (LMIC) and provides a unique opportunity for building sustainable collaborations. By focusing on a bi-directional educational exchange through graduate medical training in Pathology and Laboratory Medicine (PALM), global collaborations can extend to research and scholarship efforts. There are few PALM-based graduate medical programs in high-income countries (HIC) that offer this type of global educational exchange, and the few that exist have been mitigated by pandemic-related travel restrictions. Nonetheless, re-investing in these types of exchanges will allow for new opportunity in global pathology education and research for the next generation of trainees. Drawing on the author’s own experience in South Africa and Guatemala, five essential elements to establish a sustainable educational collaboration will be discussed: sustained effort and communication between partners of HIC and LMIC, involvement of key stakeholders, educational curriculum involving community engagement and cultural competency, bi-directional exchange between partners, and dedicated time and funding.

No abstract available.

Medical language is in a constant state of evolution. Its grammar and vocabulary are not fixed by rigid rules. The interdisciplinary field of sepsis has become a meeting point for new insights arising from advances in systems biology, epidemiology, mechanistic understandings of disease process and antimicrobial interventions. This convergence has gained from our recent experience of SARS-CoV-2 infection and COVID-19 and possibilities inferred from emerging information technology. Biomedical descriptors have diverged along disciplinary lines creating an unfortunate disconnect between clinical and laboratory-based terminology. The resulting confusion between clinically determined sepsis and laboratory verified bloodstream infection raises practical questions that affect daily operational processes in the ward, clinic and laboratory. There is an urgent need to understand how the clinical sepsis pathway and corresponding clinical laboratory workflow can be better aligned as a single coherent entity. There is also an implicit need to understand how this process should produce actionable information in a timely and orderly manner, and identify residual obselete terminology that has crept into common usage. A widely accepted sepsis epistemology, ontology and heuristic will help us improve our clinical management of sepsis.

MS-based analytical methods now play an important role in medical laboratory analysis. Predominantly triple-stage mass spectrometry is used for the quantification of small molecule biomarkers and xenobiotics in blood and urine. The spectrum of applications ranges from completely in-house developed analytical methods, to industrially manufactured kit solutions used on generic equipment, to the first closed MS-based analysis systems. It is to be expected that the weights will shift in the coming years. Thus, operation and evaluation for most applications will remain very challenging and very different from the far more user-friendly and fully automated systems — mainly photometry-based — which are commonly used in clinical laboratories. General regulatory requirements for medical analysis differ significantly between countries globally. General requirements for in-house developed assay methods are valid in some countries, but concrete and methodology-specific rules for operation and quantification when using MS methods in the medical diagnostic laboratory are not applied. This differs significantly from other bio-analytical areas such as food monitoring, pharmaceutical research, or forensics, where legally binding, detailed rules exist in some cases, e.g., for substance identification. Internationally used relevant and helpful general standards with regard to mass spectrometric examination procedures in the clinical laboratory are in particular CLSI 62A and ISO 15189, while the IVDR in the EU primarily regulates the manufacture of diagnostic articles and not their application. In addition, from many years of application experience, some general advice can be recommended as rules that can contribute to robustness and patient safety in the clinical application of MS procedures; with emphasis on: reasonable method description, batch release, competence management, maintenance, and continuity management. This article also proposes some procedural basic requirements for the application of MS procedures in the clinical laboratory. [ABSTRACT FROM AUTHOR]

Clinical laboratory test results alone are of little value in diagnosing, treating, and monitoring health conditions; as such, a clinically actionable cutoff or reference interval is required to provide context for result interpretation. Healthcare practitioners base their diagnoses, follow-up treatments, and subsequent testing on these reference points. However, they may not be aware of inherent limitations related to the definition and derivation of reference intervals. Laboratorians are responsible for providing the reference intervals they report with results. Yet, the establishment and verification of reference intervals using conventional direct methods are complicated by resource constraints or unique patient demographics. To facilitate standardized reference interval best practices, multiple global scientific societies are actively drafting guidelines and seeking funding to promote these initiatives. Numerous national and international multicenter collaborations demonstrate the ability to leverage combined resources to conduct large reference interval studies by direct methods. However, not all demographics are equally accessible. Novel indirect methods are attractive solutions that utilize computational methods to define reference distributions and reference intervals from mixed data sets of pathologic and non-pathologic patient test results. In an effort to make reference intervals more accurate and personalized, individual-based reference intervals are shown to be more useful than population-based reference intervals in detecting clinically significant analyte changes in a patient that might otherwise go unrecognized when using wider, population-based reference intervals. Additionally, continuous reference intervals can provide more accurate ranges as compared to age-based partitions for individuals that are near the ends of the age partition. The advantages and disadvantages of different reference interval approaches as well as the advancement of non-conventional reference interval studies are discussed in this review. [ABSTRACT FROM AUTHOR]

The definition of the specific role of the laboratory medicine professionals (conventionally known as "laboratorists"), their specific areas of activity, and their relationships with all the potential stakeholders, are aspects that are still largely debated in the context of the modern healthcare. To this end, in recent years we have attempted to respond to various unresolved issues (through a "Manifesto of Laboratory Medicine"), by defining a precise identity of the laboratorist, and elaborating a set of ten themes (the content of the "Manifesto") focused on specific areas for improvement. Almost five years after its publication, some aspects highlighted in the Manifesto have benefited from a significant evolution, while others remain partially or largely unanswered, as will be analyzed and discussed in detail in this article. [ABSTRACT FROM AUTHOR]

Recent progress in diagnostic testing has the potential to enable more accurate diagnosis and improved clinical outcomes. However, diagnostic data are fragmented, being produced and delivered within the "silo" of each diagnostic discipline, and the electronic health record does little to synthesize existing data to be translated in actionable information. Therefore, despite great promise, diagnoses may still be incorrect, delayed, or never made. Integrated diagnostics (ID) represents a vision for the future, wherein laboratory, pathology and imaging data, together with clinical information, are aggregated to support through expert systems, algorithms based on machine learning and artificial intelligence, the provision to clinicians of a more actionable diagnostic information. Advanced information technology is needed for implementing ID and improving diagnostics. Innovative training models, new cultural and professional knowledge and skills are fundamental requisites for future laboratory professionals. [ABSTRACT FROM AUTHOR]

Laboratory medicine and health care systems are changing rapidly due to increasing demands from the public regarding availability, quality and equity and these changes are significantly affecting the role of laboratory professionals. New competencies should be defined to be in alignment with the mission and vision of both clinical laboratories and health care systems, and, first and foremost to meet patients' and clinicians' needs. Aim of this paper is to review the content of already published Manifesto(s) and to move the discussion towards a new Manifesto for the future of laboratory professional. [ABSTRACT FROM AUTHOR]

Background: The quality of laboratory test results is crucial for accurate clinical diagnosis and treatment. Pre-analytical errors account for approximately 60%–70% of all laboratory test errors. Laboratory test results may be largely impacted by pre-analytical phase management. However, primary care clinics currently do not have pre-analytical quality management audit systems. We aimed to understand the current status of pre-analytical quality management in laboratory medicine in Korean primary care clinics. Methods: Questionnaires were designed to focus on essential components of the pre-analytical process of primary care clinics. An online survey platform was used to administer the survey to internal medicine or family medicine physicians in primary care clinics. Results: A total of 141 physicians provided a complete response to the questionnaire. In 65.2% of the clinics, patient information was hand-labeled rather than barcoded on the specimen bottles; 14.2% of clinics displayed only one piece of patient information (name or identification number), and 19.9% of clinics displayed two pieces of information. Centrifuges were not available in 29.1% of the clinics. Institutions carrying out the National Health Screening Program (NHSP) used more barcode system and had more centrifuges than institutions that did not carrying out the NHSP. Conclusions: Pre-analytical quality management is inadequate in many primary clinics. We suggest implementation of a mandatory management system, allowing for a pre-analytical quality management to be carried out in primary care clinics. [ABSTRACT FROM AUTHOR]

Objectives Developing an expanded representation of the total testing process that includes contemporary elements of laboratory practice can be useful to understanding and optimizing testing workflows across clinical laboratory and patient care settings. Methods Published literature and meeting reports were used by the coauthors to inform the development of the expanded representation of the total testing process and relevant examples describing its uses. Results A visual representation of the total testing process was developed and contextualized to patient care scenarios using a number of examples covering the detection of blood culture contamination, use of next-generation sequencing, and pharmacogenetic testing. Conclusions The expanded representation of the total testing process can serve as a model and framework to document and improve the use of clinical testing within the broader context of health care delivery. This representation recognizes increased engagement among clinical laboratory professionals with patients and other health care providers as essential to making informed decisions. The increasing use of data is highlighted as important to ensuring quality, appropriate test utilization, and sustaining an efficient workflow across clinical laboratory and patient care settings. Maintaining a properly resourced and competent workforce is also featured as an essential component to the testing process. [ABSTRACT FROM AUTHOR]

Acute or intense exercise can result in metabolic imbalances, muscle injuries, or reveal hidden disorders. Laboratory medicine in sports is playing an increasingly crucial role in monitoring athletes' health conditions. In this study, we designed an integrated approach to explore the causes of a deep venous thrombosis event in an elite basketball player. Since the complete blood count revealed a marked platelet count (838 × 103 µL), and thrombophilia screening tests did not reveal any significant alteration, we evaluated the thrombin generation, which highlights a state of hypercoagulability. First-level haemostasis exams showed only a slight prolongation of the activated Partial Thromboplastin Time (aPTT). Thus, screening tests for von Willebrand Disease showed a reduction in vWF parameters. Therefore, we directed our hypothesis towards a diagnosis of acquired von Willebrand disease secondary to Essential Thrombocythemia (ET). To confirm this hypothesis and highlight the molecular mechanism underlying the observed phenotype, molecular tests were performed to evaluate the presence of the most common mutations associated with ET, revealing a 52-bp deletion in the coding region of CALR exon 9. This case report highlights the importance of an integrated approach to monitoring the athletes' health status to personalise training and treatments, thus avoiding the appearance of diseases and injuries that, if underestimated, can undermine the athlete's life. [ABSTRACT FROM AUTHOR]

Objectives Peripheral blood smear (PBS) interpretation represents a cornerstone of pathology practice and resident training but has remained largely static for decades. Here, we describe a novel PBS interpretation support tool. Methods In a mixed-methods quality improvement study, a web-based clinical decision support (CDS) tool to assist pathologists in PBS interpretation, PROSER, was deployed in an academic hospital over a 2-month period in 2022. PROSER interfaced with the hospital system's electronic health record and data warehouse to obtain and display relevant demographic, laboratory, and medication information for patients with pending PBS consults. PROSER used these data along with morphologic findings entered by the pathologist to draft a PBS interpretation using rule-based logic. We evaluated users' perceptions of PROSER with a Likert-type survey. Results PROSER displayed 46 laboratory values with corresponding reference ranges and abnormal flags, allowed for entry of 14 microscopy findings, and computed 2 calculations based on laboratory values; it composed automated PBS reports using a library of 92 prewritten phrases. Overall, PROSER was well received by residents. Conclusions In this quality improvement study, we successfully deployed a web-based CDS tool for PBS interpretation. Future work is needed to quantitatively evaluate this intervention's effects on clinical outcomes and resident training. [ABSTRACT FROM AUTHOR]

Case series summary: A total of 1692 medical records from a primary care feline practice and a veterinary referral hospital were evaluated retrospectively to assess discordant feline leukemia virus (FeLV) test results. In total, 73 cats were positive for FeLV using serum in a lateral flow immunoassay (LFI) or laboratory-based ELISA. Of these cats, 21 subsequently tested negative for FeLV proviral DNA by non-quantitative PCR on EDTA whole blood (16/21, 76.2%), bone marrow (4/21, 19%) or both (1/21, 4.7%). The proportional morbidity (an estimate of prevalence in a sample of the total population) for FeLV by LFI/ELISA and PCR assays was 3.1%, consistent with that reported in previous studies for cats in North America. Cats with discordant LFI/ELISA and PCR results had either primary bone marrow disease (18 autoimmune, one neoplastic), a bone marrow insult (hemotrophic mycoplasmosis) or systemic inflammation (pyothorax with a marked neutrophilic leukocytosis). The percentage of cats with a positive LFA/ELISA result and negative PCR assay surviving to discharge was 85.7% (18/21). Of these, 88.9% (16/18) survived 4 months to 6 years. Seven cats (33.3%) were re-tested with LFI or ELISA once primary disease was controlled, and all tested negative. Relevance and novel information: These findings indicate that in cats with bone marrow disease that shares features of progressive FeLV infection, positive LFI and ELISA FeLV test results should be followed up with FeLV proviral DNA PCR testing, particularly in populations where disease prevalence is low. [ABSTRACT FROM AUTHOR]

The UCLA Immunogenetics Center is an Immunogenetics and Histocompatibility laboratory that performs testing for multiple transplant programmes within and outside of UCLA. The single antigen bead (SAB) test is a high complexity luminex bead test used to assess pretransplant and post-transplant patients for the presence of pathogenic human leucocyte antigen donor-specific antibody associated with allograft rejection. Efficient reporting of the SAB test has been difficult as data analysis and reports are generated in the laboratory information system (LIS) and uploaded to the electronic medical record (EMR) as PDFs. To solve this, we recently developed a state of the art reporting workflow allowing discrete reporting of SAB data (antibody specificity, mean fluorescent intensity and interpretative comments) from the LIS HistoTrac to UCLA Health System's EMR EPIC:CareConnect. However, a proportion of tests did not report to the EMR appropriately. Baseline system performance data evaluated over a 10-week period showed that ~4.5/100 tests resulted in EPIC as 'preliminary result' or 'in process' instead of 'final result' with only common cause variation. Quality improvement methods were employed to improve the process with the SMART Aim of reporting 100% of tests as 'final result'. Pareto analysis identified two errors accounting for 79% of common system-level failures-status errors and interface errors. We hypothesised that addressing the status error would reduce or eliminate the interface errors. We used the Model For Improvement to test a reprogramming intervention. Status and interface errors were completely resolved through the process improvement. Continuous monitoring revealed a system-level shift with only ~1.9/100 tests resulting inappropriately. Through the audit process, the remaining common system-level failures were identified and resolved. Therefore, 100% of tests result to EPIC as 'final result'. The study demonstrates that high complexity SAB bead data can be efficiently reported EPIC:CareConnect from HistoTrac as discrete data.

Laboratory Medicine is a crucial discipline that contributes to the diagnosis, management and monitoring of patients. This branch of medicine faces two major challenges: New technologies and increased demand. There is limited information available of the state of affairs in Laboratory Medicine in Spain. This study provides a picture of clinical laboratories and clinical laboratory professionals.

The document discusses the increasing prevalence of cyber-attacks in healthcare, posing risks to patient safety, data privacy, and healthcare system functionality. Clinical laboratories are particularly vulnerable to cyber-attacks due to high digitalization levels. A survey conducted by the EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) in Europe revealed that many respondents lacked familiarity with cyber threats, highlighting the need for increased cybersecurity training and incident response planning in hospitals and laboratories. The survey results suggest a global need for improved cybersecurity measures in healthcare facilities. [Extracted from the article]

We have known for years that laboratory medicine would not have enough employees at all levels to effectively support the growing needs of medical doctors. According to the US Bureau of Labor Statistics prediction "MLS/ MLT will increase by 11% by 2030" and we will need "almost 26,000 openings each year through 2030." Our colleges and universities only produce "5,000 graduates per year." This commentary article will provide specific context for the current workforce situation in laboratory medicine in the United States and then discuss solutions at progressive levels of commitment. Level one can be quickly implemented by laboratories in their local area by reaching out to their local high school or middle schools. Level two will create advocates in the community with highly effective career exploration tools. Level three will require a change in paradigm about entry level staff in a medical laboratory along with significant infrastructure building through development of high school medical laboratory assisting and/or phlebotomy training programs. These programs will have the greatest effect on the employment outlook as they will produce highly skilled and engaged graduates who are ready for medical laboratory entry level employment and medical laboratory college programs. To fill the employment gap in laboratory medicine we must stop accepting that they are the "hidden profession" and move to actively engaging with every young person in the country before they go off to college. The industry from the phlebotomists and laboratorians to the C-suites of medical laboratories must be part of the solution. [ABSTRACT FROM AUTHOR]

Objective: Interpreting laboratory results for transgender individuals who started hormone therapy requires careful consideration, specifically for analytes that have sex-specific reference intervals. In literature, conflicting data exist on the effect of hormone therapy on laboratory parameters. By studying a large cohort, we aim to define what reference category (male or female) is most appropriate to use for the transgender population over the course of gender-affirming therapy. Methods: A total of 2201 people (1178 transgender women and 1023 transgender men) were included in this study. We analyzed hemoglobin (Hb), hematocrit (Ht), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT), creatinine, and prolactin, at 3 different time points: pretreatment, during hormone therapy, and after gonadectomy. Results: For transgender women, Hb and Ht levels decrease after initiation of hormone therapy. The concentration of liver enzymes ALT, AST, and ALP decreases whereas the levels of GGT do not change statistically significantly. Creatinine levels decrease whereas prolactin levels rise in transgender women during gender-affirming therapy. For transgender men, Hb and Ht values increase after starting hormone therapy. Liver enzymes and creatinine levels increase statistically significantly as well upon hormone therapy while prolactin concentrations decrease. Overall, reference intervals in transgender people after 1 year on hormone therapy resembled those of their affirmed gender. Conclusions: Generating transgender-specific reference intervals is not essential to correctly interpret laboratory results. As a practical approach, we recommend to use the reference intervals of the affirmed gender from 1 year onwards after starting hormone therapy. [ABSTRACT FROM AUTHOR]

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Method evaluation is one of the critical components of the quality system that ensures the ongoing quality of a clinical laboratory. As part of implementing new methods or reviewing best practices, the peer-reviewed published literature is often searched for guidance. From the outset, Clinical Chemistry and Laboratory Medicine (CCLM) has a rich history of publishing methods relevant to clinical laboratory medicine. An insight into submissions, from editors' and reviewers' experiences, shows that authors still struggle with method evaluation, particularly the appropriate requirements for validation in clinical laboratory medicine. Here, we consider through a series of discussion points an overview of the status, challenges, and needs of method evaluation from the perspective of clinical laboratory medicine. We identify six key high-level aspects of clinical laboratory method evaluation that potentially lead to inconsistency. 1. Standardisation of terminology, 2. Selection of analytical performance specifications, 3. Experimental design of method evaluation, 4. Sample requirements of method evaluation, 5. Statistical assessment and interpretation of method evaluation data, and 6. Reporting of method evaluation data. Each of these areas requires considerable work to harmonise the practice of method evaluation in laboratory medicine, including more empirical studies to be incorporated into guidance documents that are relevant to clinical laboratories and are freely and widely available. To further close the loop, educational activities and fostering professional collaborations are essential to promote and improve the practice of method evaluation procedures. [ABSTRACT FROM AUTHOR]

Quality in laboratory medicine is defined as "an unfinished journey", as the more essential the laboratory information provided, the more assured its quality should be. In the past decades, the Journal Clinical Chemistry and Laboratory Medicine has provided a valuable forum for garnering new insights into the analytical and extra-analytical phases of the testing cycle, and for debating crucial aspects of quality in clinical laboratories. The impressive number of papers published in the Journal is testimony to the efforts made by laboratory professionals, national and international scientific societies and federations in the quest to continuously improve upon the pre-, intra- and post-analytical steps of the testing cycle, thus enhancing the quality of laboratory information. The paper appearing in this special issue summarizes the most important and interesting contributions published in the Journal, thus updating our knowledge on quality in laboratory medicine and offering further stimuli to identify the most valuable measures of quality in clinical laboratories. [ABSTRACT FROM AUTHOR]

Food poisoning can be caused by the potato alkaloids α-solanine (SO) and α-chaconine (CHA). Therefore, this study aimed to establish new enzyme-linked immunosorbent assays (ELISAs) for detecting these two toxins in biological samples and potato extracts. Two antibodies that bind to solanidine, a chemical compound found in both SO and CHA, were newly developed, and two types of ELISAs (Sold1 ELISA and Sold2 ELISA) were constructed. We measured SO and CHA diluted in phosphate-buffered saline (PBS), serum, and urine. The detection performance of the two ELISAs for SO and CHA in PBS was higher than in serum and urine, and the sensitivity of Sold2 ELISA was lower than that of Sold1 ELISA. Thus, we used these ELISAs to measure SO and CHA in potato part extracts and found that potato sprouts contained approximately 80-fold more SO and CHA than tubers and 8-fold more SO and CHA than peels. Although the detection sensitivity of SO and CHA depends on the sample types, these ELISAs may be effective as future clinical and food testing methods after further improvements. [ABSTRACT FROM AUTHOR]

In vitro diagnostics (IVD) testing is a powerful tool for medical diagnosis, and patients' safety is guaranteed by a complex system of personnel qualification of the specialist in laboratory medicine, of process control, and legal restrictions in healthcare, most of them under national regulation. Direct-to-consumer laboratory testing (DTCT) is testing ordered by the consumer and performed either by the consumer at home or analysis of self-collected samples in a laboratory. However, since DTCT are not always subject to effective competent authority oversight, DTCT may pose risks to lay persons using and relying on it for healthcare decision-making. Laboratory medicine specialists should be very cautious when new DTCTs are introduced. As qualified professionals, they should feel obliged to warn and educate patients and the public about the risks of inappropriate and harmful DTCT. [ABSTRACT FROM AUTHOR]

Laboratory medicine has reached the era where promises of artificial intelligence and machine learning (AI/ML) seem palpable. Currently, the primary responsibility for risk-benefit assessment in clinical practice resides with the medical director. Unfortunately, there is no tool or concept that enables diagnostic quality assessment for the various potential AI/ML applications. Specifically, we noted that an operational definition of laboratory diagnostic quality – for the specific purpose of assessing AI/ML improvements – is currently missing. A session at the 3rd Strategic Conference of the European Federation of Laboratory Medicine in 2022 on "AI in the Laboratory of the Future" prompted an expert roundtable discussion. Here we present a conceptual diagnostic quality framework for the specific purpose of assessing AI/ML implementations. The presented framework is termed diagnostic quality model (DQM) and distinguishes AI/ML improvements at the test, procedure, laboratory, or healthcare ecosystem level. The operational definition illustrates the nested relationship among these levels. The model can help to define relevant objectives for implementation and how levels come together to form coherent diagnostics. The affected levels are referred to as scope and we provide a rubric to quantify AI/ML improvements while complying with existing, mandated regulatory standards. We present 4 relevant clinical scenarios including multi-modal diagnostics and compare the model to existing quality management systems. A diagnostic quality model is essential to navigate the complexities of clinical AI/ML implementations. The presented diagnostic quality framework can help to specify and communicate the key implications of AI/ML solutions in laboratory diagnostics. [ABSTRACT FROM AUTHOR]

The field of artificial intelligence (AI) has grown in the past 10 years. Despite the crucial role of laboratory diagnostics in clinical decision-making, we found that the majority of AI studies focus on surgery, radiology, and oncology, and there is little attention given to AI integration into laboratory medicine. We dedicated a session at the 3rd annual European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) strategic conference in 2022 to the topic of AI in the laboratory of the future. The speakers collaborated on generating a concise summary of the content that is presented in this paper. The five key messages are (1) Laboratory specialists and technicians will continue to improve the analytical portfolio, diagnostic quality and laboratory turnaround times; (2) The modularized nature of laboratory processes is amenable to AI solutions; (3) Laboratory sub-specialization continues and from test selection to interpretation, tasks increase in complexity; (4) Expertise in AI implementation and partnerships with industry will emerge as a professional competency and require novel educational strategies for broad implementation; and (5) regulatory frameworks and guidances have to be adopted to new computational paradigms. In summary, the speakers opine that the ability to convert the value-proposition of AI in the laboratory will rely heavily on hands-on expertise and well designed quality improvement initiative from within laboratory for improved patient care. [ABSTRACT FROM AUTHOR]

Clinical laboratories play a vital role in the healthcare system. Objective medical data provided by clinical laboratories supports approximately 60–70% of clinical decisions, however, evidence supporting this claim is poorly documented and laboratories still lack visibility, despite their indisputable impact on patient care and public health. The International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Outcome Studies in Laboratory Medicine (TF-OSLM) was recently developed to support directed research evaluating the role of laboratory medicine on clinical outcomes. Establishing and documenting this evidence is key to enhance visibility of the field in the eye of the public and other healthcare professionals together with optimizing patient outcomes and health care system operations. In this review, we discuss four areas that exemplify the contribution of laboratory medicine directly to patient care. This includes high-sensitivity cardiac troponin (hs-cTn) and N-terminal pro-B-type natriuretic peptide/B-type natriuretic peptides (NT-proBNP/BNP) for the diagnosis and prognosis of myocardial infarction and heart failure, respectively, and procalcitonin for the management of sepsis and antibiotic stewardship. Emerging markers of traumatic brain injury and the role of laboratory medicine in the fight against the COVID-19 pandemic are discussed along with an introduction to plans of IFCC TF-OSLM. [ABSTRACT FROM AUTHOR]

Abstract Extracellular vesicles (EVs) and their clinical applications have been recognized as one of the most fast‐growing and promising fields. Numerous groups including us have expressed their concerns on the idea of isolating “pure” EVs for different purposes, as there are no specific markers to date that can examine the exact EV purity. Typically, major instrument need and EV yielding loss are primary compensations of getting EVs with higher purity. As such, especially in biomarker‐based clinical tests, ceaseless efforts for obtaining more pure EV are worth of discussion. We here propose alternative philosophy to tone down the importance of purity, but to emphasize the significance in clinical laboratory medicine to measure EVs obtained by well‐controlled isolation methods. As a result, EVs are enriched to the adequate degree to meet certain clinical applications such as disease diagnosis and/or prognosis. In this review, we will justify the adequate enrichment rationale with advances of EV definitions, markers and contaminants, EV isolation methods, as well as the conclusions acquired from clinical research using less pure but ease‐to‐operate EV isolation methods.

Benign paroxysmal positional vertigo (BPPV) represents the most frequent cause of peripheral vertigo. In most cases, it is successfully treated using the canalith repositioning procedure, but it is often followed by continuous lightheadedness in the absence of vertigo or nystagmus (residual dizziness, RD). Our aim is to describe the clinical effectiveness and the urine metabolomics profile of treating these patients with polyphenol compound supplementation. We enrolled 30 patients reporting RD after BPPV of the posterior semicircular canal (PSC) successfully treated using the Semont maneuver. Supplementation with a polyphenol compound was administered for 60 days, and patients were evaluated after 30 and 60 days of treatment using self-administered questionnaires (Visual Analog Scales for Dizziness and Nausea, Dizziness Handicap Inventory, DHI) and urine metabolomics analysis performed using 1H-NMR spectroscopy and multivariate followed by univariate analysis. Most patients reported excellent or good efficacy in the treatment of RD with a significant decrease in VAS and DHI values. The metabolomics analysis identified six significant metabolites related to the treatment, namely 1-methylnicotinamide, anserine, hippurate, lysine, methyl succinate and urea, indicating the inflammatory activities and antioxidant properties of the polyphenol compound. These preliminary data suggest that supplementation with a polyphenol compound could induce some metabolic changes that can help in recovery from RD. However, future steps will require confirmation with a more significant cohort of patients and an extension of the metabolomics evaluation to other problems concerning the different clinical aspects of BPPV, such as the high rate of relapse.

Keywords: JCTLM; laboratory medicine; reference measurement procedure; standardisation; traceability EN JCTLM laboratory medicine reference measurement procedure standardisation traceability 1887 1889 3 10/03/23 20231001 NES 231001 Standardisation is the pinnacle of analytical measurement in laboratory medicine, facilitating comparability of patient results over time. An isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) for the quantification of aldosterone in human serum and plasma. An isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) for the quantification of methotrexate in human serum and plasma. [Extracted from the article]

The article discusses the impact of the COVID-19 pandemic on scientific publishing, specifically in the field of clinical chemistry and laboratory medicine. The number of articles related to COVID-19 increased significantly in 2020 and 2021, but has since declined as attention has shifted back to traditional research topics. The impact factor (IF) of many scientific medical journals, including Clinical Chemistry and Laboratory Medicine (CCLM), reached an all-time high in 2021 but has since decreased. Despite this, CCLM remains a leading journal in the field and maintains a high rejection rate, indicating the continued publication of high-quality articles. [Extracted from the article]

Male infertility has been recognized as a global health problem. Semen analysis, although considered the golden standard, may not provide a confident male infertility diagnosis alone. Hence, there is the urgent request for an innovative and reliable platform to detect biomarkers of infertility. The rapid expansion of mass spectrometry (MS) technology in the field of the 'omics' disciplines, has incredibly proved the great potential of MS-based diagnostic tests to revolutionize the future of pathology, microbiology and laboratory medicine. Despite the increasing success in the microbiology area, MS-biomarkers of male infertility currently remain a proteomic challenge. In order to address this issue, this review encompasses proteomics investigations by untargeted approaches with a special focus on experimental designs and strategies (bottom-up and top-down) for seminal fluid proteome profiling. The studies reported here witness the efforts of the scientific community to address these investigations aimed at the discovery of MS-biomarkers of male infertility. Proteomics untargeted approaches, depending on the study design, might provide a great plethora of biomarkers not only for a male infertility diagnosis, but also to address a new MS-biomarkers classification of infertility subtypes. From the early detection to the evaluation of infertility grade, new MS-derived biomarkers might also predict long-term outcomes and clinical management of infertility. [ABSTRACT FROM AUTHOR]

An 88-year old woman was admitted to the emergency room (ER) after a syncope and subsequent head trauma. A complete blood count and imaging studies showed cytopenia and bilateral cervical lymphadenopathy, respectively. After three months, the patient returned to ER with dyspnea and a large abdominal effusion. Cytopenia was progressed and protein electrophoresis revealed a monoclonal peak in the beta zone. Immunofixation showed the presence of gamma heavy-chains without associated light-chains. Capillary electrophoresis with immunosubtraction and immunophenotyping by flow cytometry returned the same results. Immunohistochemistry was apparently discordant, describing a monotypic kappa population. An important ascites with low total proteins in the ascitic fluid, a liver with lumpy margins and non-homogeneous structure, elevated GGT, and decreased albumin, suggested ascitogen liver cirrhosis in the context of a rare gamma heavy-chain disease. [ABSTRACT FROM AUTHOR]

Laboratory Medicine is a crucial discipline that contributes to the diagnosis, management and monitoring of patients. This branch of medicine faces two major challenges: New technologies and increased demand. There is limited information available of the state of affairs in Laboratory Medicine in Spain. This study provides a picture of clinical laboratories and clinical laboratory professionals. The Spanish Society of Laboratory Medicine distributed a questionnaire among the 250 most representative centers (the ones with the largest volume of determinations and training programs), of which 174 (69.6%) returned the questionnaire providing data for 2019. Laboratories were classified according to the number of determinations. In total, 37% identified themselves as small (<1 million determinations per year); 40% considered themselves medium-sized (1–5 million determinations per year) and 23% considered they were large laboratories (>5 million determinations). The level of specialization of laboratory physicians and laboratory performance were higher in large laboratories. Most requests (87%) and determinations (93%) corresponded to biochemistry and hematology. As many as 63% of physicians had an indefinite contract, and 23% were older than 60 years. Laboratory medicine is a consolidated discipline that is gaining relevance in Spain. It adds value to the diagnosis, prognosis and follow-up of diseases, and to treatment response monitoring. The results of this study will help us address challenges such as the need for specialized training for laboratory professionals; the emergence of technological innovations; exploitation of Big Data; optimization of quality management systems and patient safety. [ABSTRACT FROM AUTHOR]

This proof of concept study was aimed to validate the hypothesis that the time of positivization of SARS-CoV-2 self-performed rapid diagnostic tests (RDTs) may reflect the actual viral load in the specimen. A SARS-CoV-2 positive sample with high viral load was diluted and concomitantly assayed with molecular assay (Xpert Xpress SARS-CoV-2) and RDT (COVID-VIRO ALL IN RDT). The (mean cycle threshold; Ct) values and RDT positivization times of these dilutions were plotted and interpolated by calculating the best fit. The parameters of this equation were then used for converting the positivization times into RDT-estimated SARS-CoV-2 Ct values in routine patient samples. The best fit between measured and RDT-estimated Ct values could be achieved with a 2-degree polynomial curve. The RDT-estimated Ct values exhibited high correlation (r=0.996) and excellent Deming fit (y=1.01 × x − 0.18) with measured Ct values. In 30 consecutive patients with positive RDT test, the correlation between RDT positivization time and measured Ct value was r=0.522 (p=0.003). The correlation of RDT-estimated and measured Ct values slightly improved to 0.577 (Deming fit: y=0.44 × x + 11.08), displaying a negligible bias (1.0; 95% CI, −0.2 to 2.2; p=0.105). Concordance of RDT-estimated and measured Ct values at the <20 cut-off was 80%, with 0.84 sensitivity and 0.73 specificity. This proof of concept study demonstrates the potential feasibility of using RDTs for garnering information on viral load in patients with acute SARS-CoV-2 infection. [ABSTRACT FROM AUTHOR]

Medical science undergoes continuous development and improvement over the years - both the diagnosis and treatment of various diseases are changing, as well as the transition from the general solution for the treatment of the sick to the individual approach, which includes different ways tailored to the needs of each patient according to his needs. In this regard, the clinical laboratory as a medical specialty undergoes continuous development - new technologies are introduced, the spectrum of clinical-laboratory research is expanded, preserving the traditions of the founders of laboratory medicine. In modern medical practice, great importance is attached to laboratory tests, the results of which provide an objective assessment of the state of the body. The methods of laboratory diagnostics are used to confirm the clinical diagnosis, to specify the causes of the diseases, to characterize the severity of their course, to make a prognosis and to choose the appropriate etiological, pathogenetic and symptomatic therapy.The relevance and significance of the topic is determined by the fact that, on a global scale, the concept of laboratory medicine is used and considered as an integral part of the treatment of the patient. Without the data from the clinical and laboratory results, it is impossible to make the most accurate diagnosis, control the disease process and apply effective drug therapy. This gives reason to consider laboratory diagnostics as an irrevocable and significant part of all medico-biological disciplines. The aim of this article is to study and analyze the changes in the development of the clinical laboratory worldwide from the distant past to the present day, creation and development of the discipline in Bulgaria, as well as to reveal the opportunities and challenges faced by modern laboratory medicine. Materials and methods: The research includes a study of documents and sources regarding the development of laboratory medicine as a specialty, the challenges it faces and the prospects for its development. Methods of analysis and theoretical reasoning were used based on the available scientific literature. Conclusions: Based on the overview, it is proven that laboratory medicine around the world and the clinical laboratory in Bulgaria are constantly developing and improving, preserving the traditions created by the founders and leading to the creation of new highly qualified specialists, worthy successors of the doyens in the discipline that is entering in a new era of its development - introduction of innovative precision equipment, standardization, continuous communication between the clinician and the laboratory doctor, between the laboratory result and the correct and timely clinical decision. [ABSTRACT FROM AUTHOR]