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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.

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]

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.

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]

Copyright of Hamidiye Medical Journal is the property of Galenos Yayinevi Tic. LTD. STI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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]

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]

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]

• The next frontier of the clinical laboratory is the system biology approach. • Metabolomics represents the result of the interplay between the host and exposome. • ISO 23118:2021 contains specifications for standardizing the preanalytical phase. • A standard reference material is available to improve harmonization in metabolomics. [ABSTRACT FROM AUTHOR]

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]

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]

The term "emerging technology" (ET) is used extensively, and there are numerous definitions offered, but to our knowledge, none specifically encompass the field of laboratory medicine. An ET definition that incorporates the overarching IFCC aim of "Advancing excellence in laboratory medicine to support healthcare worldwide" would clarify discussions. We discuss key aspects of the term "emerging technology(ies)" as it applies to laboratory medicine with a view to laying the foundations for a practical definition for the profession and propose the definition of an ET as "An analytical method or device that by virtue of its stage of development, translation into broad routine clinical practice, or geographical adoption and implementation has the potential to add value to clinical diagnostics". [ABSTRACT FROM AUTHOR]

Allergic bronchopulmonary aspergillosis (ABPA), a severe inflammatory respiratory disease, is caused by a hypersensitivity reaction to the colonization of the airways with Aspergillus fumigatus. It is most often described in patients with asthma or cystic fibrosis. The diagnosis of ABPA is based on a combination of clinical, radiological, and immunological findings that have been included in different diagnostic criteria over the years. In this paper, we review the biomarkers included in these diagnostic criteria and novel research biomarkers that may be used in the diagnosis and treatment follow-up of ABPA in cystic fibrosis. [ABSTRACT FROM AUTHOR]

Clinical chemistry plays an important role in medical practice. Approximately 60% to 70% of medical decisions rely on laboratory test results, justifying the need for physicians to have sufficient knowledge of clinical chemistry. However, recent studies have shown that medical students’ knowledge of clinical chemistry is inadequate, and many are unable to interpret the meaning of laboratory parameter results. This implies that the study of clinical chemistry in the curriculum is currently insufficient. There are several related problems, namely a lack of a formal or structured clinical chemistry curriculum, limited time allocated for these studies, a lack of teaching experts and the failure of stakeholders to acknowledge the importance of clinical chemistry. This review discusses problems in the current clinical chemistry education of medical students and provides solutions. A structured search strategy in PubMed and Google Scholar for publications in English was applied using the search terms “clinical chemistry”, “clinical pathology”, “laboratory” and “laboratory medicine” in combination with one of the following keywords: “education”, “medical student”, “curriculum”, “guideline”, “undergraduate”, “medical school” and “training”. The extracted literature focused on research studies, review articles and meta-analyses. Background information and details about the current status of clinical chemistry/ laboratory medicine education were extracted from review articles, while research articles were used to analyse and evaluate the current conditions in the medical schools regarding clinical chemistry/ laboratory medicine education. [ABSTRACT FROM AUTHOR]

Background: Reference intervals (RIs) for patient test results are in standard use across many medical disciplines, allowing physicians to identify measurements indicating potentially pathological states with relative ease. The process of inferring cohort-specific RIs is, however, often ignored because of the high costs and cumbersome efforts associated with it. Sophisticated analysis tools are required to automatically infer relevant and locally specific RIs directly from routine laboratory data. These tools would effectively connect clinical laboratory databases to physicians and provide personalized target ranges for the respective cohort population. Objective: This study aims to describe the BioRef infrastructure, a multicentric governance and IT framework for the estimation and assessment of patient group–specific RIs from routine clinical laboratory data using an innovative decentralized data-sharing approach and a sophisticated, clinically oriented graphical user interface for data analysis. Methods: A common governance agreement and interoperability standards have been established, allowing the harmonization of multidimensional laboratory measurements from multiple clinical databases into a unified "big data" resource. International coding systems, such as the International Classification of Diseases, Tenth Revision (ICD-10); unique identifiers for medical devices from the Global Unique Device Identification Database; type identifiers from the Global Medical Device Nomenclature; and a universal transfer logic, such as the Resource Description Framework (RDF), are used to align the routine laboratory data of each data provider for use within the BioRef framework. With a decentralized data-sharing approach, the BioRef data can be evaluated by end users from each cohort site following a strict "no copy, no move" principle, that is, only data aggregates for the intercohort analysis of target ranges are exchanged. Results: The TI4Health distributed and secure analytics system was used to implement the proposed federated and privacy-preserving approach and comply with the limitations applied to sensitive patient data. Under the BioRef interoperability consensus, clinical partners enable the computation of RIs via the TI4Health graphical user interface for query without exposing the underlying raw data. The interface was developed for use by physicians and clinical laboratory specialists and allows intuitive and interactive data stratification by patient factors (age, sex, and personal medical history) as well as laboratory analysis determinants (device, analyzer, and test kit identifier). This consolidated effort enables the creation of extremely detailed and patient group–specific queries, allowing the generation of individualized, covariate-adjusted RIs on the fly. Conclusions: With the BioRef-TI4Health infrastructure, a framework for clinical physicians and researchers to define precise RIs immediately in a convenient, privacy-preserving, and reproducible manner has been implemented, promoting a vital part of practicing precision medicine while streamlining compliance and avoiding transfers of raw patient data. This new approach can provide a crucial update on RIs and improve patient care for personalized medicine. [ABSTRACT FROM AUTHOR]

Context: Clarification of the association among phenotypes, genetic, and environmental factors with clinical laboratory traits can reveal the cause of diseases and assist in developing methods for the prediction and prevention of diseases. It is difficult to investigate the environmental effect on phenotypes using individual samples because their genetic and environmental factors differ, but we can easily investigate the influence of environmental factors using monozygotic (MZ) twins because they have the same genetic factors. Objective: We aimed to examine the methylation level of CpG sites as an environmental factor affecting adiponectin levels on the basis of the same genetic background using MZ twins and to identify the epigenetic factors related to adiponectin levels and the genetic factors associated with sensitivity to acquired changes in adiponectin. Methods: Using 2 groups built from each twin of 232 MZ twin pairs, we performed a replicated epigenome-wide association study to clarify the epigenetic factors affecting adiponectin levels adjusted by genetic risk score. Moreover, we divided twin pairs into concordant and discordant for adiponectin levels. We conducted a genome-wide association study to identify a genetic background specific for discordance. Results: Methylation levels at 38 CpG sites were reproducibly associated with adjusted adiponectin levels, and some of these CpG sites were in genes related to adiponectin, including CDH13. Some genes related to adiponectin or insulin resistance were found to be genetic factors specific for discordance. Conclusion: We clarified specific epigenetic factors affecting adiponectin levels and genetic factors associated with sensitivity to acquired changes in adiponectin. [ABSTRACT FROM AUTHOR]

Copyright of Acibadem Saglik Bilimleri Dergisi is the property of Acibadem University Medical School and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This article primarily concentrates on the theoretical and intellectual dimensions of nature cure, particularly efforts to revive it during the second half of the nineteenth century. Little is known about specific medical professionals or theories concerning the Victorian philosophy of nature cure, although this philosophy is mentioned in general terms in studies on alternative medicine and hygiene. This article illuminates a Victorian nature cure philosophy through the works of Edward W. Lane (1823-1889). As a physician and hydropathist, Lane aspired to create a new form of medical system, 'hygienic medicine', seeking answers to the questions 'What is disease?' and 'What is medicine?' throughout his career. Lane was among many physicians interested in nature's healing power during his time. However, few undertook as thorough a theorisation of nature cure philosophy as Lane did in the latter half of the nineteenth century, a period that presented unprecedented challenges in reconciling medicine with nature. This study explores the subtle nuances of the concepts that Lane actively used in his theoretical explanations, including 'nature', 'laws of health' and 'vital force', interpreting his efforts as a reconciliation between Romantic naturalism and laboratory medicine. The aim of this study is not to re-evaluate the significance of Lane's medical theory itself. It rather uses Lane as a lens to reveal the intricacies of Victorian nature cure philosophy.

Background: Early posttransplant cytomegalovirus (CMV) infections in CMV seronegative solid organ transplant recipients (SOTR) with CMV seronegative donors (D-/R-) are often attributed transfusion-transmitted CMV. The prevalence of false-negative donor CMV serology in D-/R- SOTR with early CMV infections has not been explored., Methods: We determined the frequency and characteristics of CMV DNAemia that occurred within 90 days of transplant among adult SOTR classified as D-/R- who underwent a first SOT at a single center between February 25, 2014 and February 25, 2024. Repeat donor CMV antibody testing was performed on stored donor sera if possible., Results: Thirteen of 737 (1.8%) D-/R- SOTR from 12 donors developed CMV DNAemia within 90 days of transplant (median time to DNAemia: 28 days, interquartile range 23-42 days). Five (38%) recipients experienced CMV disease either before (n = 2) or after (n = 3) CMV DNAemia was identified, and five (38%) developed CMV antiviral resistance mutations during their course. Repeat CMV antibody testing was performed on sera from four donors to five recipients and was positive in three (75%) tested donors., Conclusions: Early CMV infections in D-/R- SOTR are uncommon but associated with high morbidity. CMV transmission from organ donors with false negative CMV serology is an important source of early CMV infections in D-/R- SOTR. Clinicians should suspect and promptly report early CMV infections in D-/R- SOTR as potential donor-derived processes, regardless of donor and/or recipient transfusion histories. Reporting such cases is essential to promote broader investigations that may identify suboptimal donor CMV screening assays., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

With Industry 4.0, big data and artificial intelligence have become paramount in the field of medicine. Electronic health records, the primary source of medical data, are not collected for research purposes but represent real-world data; therefore, they have various constraints. Although structured, laboratory data often contain unstandardized terminology or missing information. The major challenge lies in the lack of standardization of test results in terms of metrology, which complicates comparisons across laboratories. In this review, we delve into the essential components necessary for integrating real-world laboratory data into high-quality big data, including the standardization of terminology, data formats, equations, and the harmonization and standardization of results. Moreover, we address the transference and adjustment of laboratory results, along with the certification for quality of laboratory data. By discussing these critical aspects, we seek to shed light on the challenges and opportunities inherent to utilizing real-world laboratory data within the framework of healthcare big data and artificial intelligence.

Machine learning (ML) is currently being widely studied and applied in data analysis and prediction in various fields, including laboratory medicine. To comprehensively evaluate the application of ML in laboratory medicine, we reviewed the literature on ML applications in laboratory medicine published between February 2014 and March 2024. A PubMed search using a search string yielded 779 articles on the topic, among which 144 articles were selected for this review. These articles were analyzed to extract and categorize related fields within laboratory medicine, research objectives, specimen types, data types, ML models, evaluation metrics, and sample sizes. Sankey diagrams and pie charts were used to illustrate the relationships between categories and the proportions within each category. We found that most studies involving the application of ML in laboratory medicine were designed to improve efficiency through automation or expand the roles of clinical laboratories. The most common ML models used are convolutional neural networks, multilayer perceptrons, and tree-based models, which are primarily selected based on the type of input data. Our findings suggest that, as the technology evolves, ML will rise in prominence in laboratory medicine as a tool for expanding research activities. Nonetheless, expertise in ML applications should be improved to effectively utilize this technology.

Abstract Opportunity is the essence of a career in science or medicine and this continues to be a major source of satisfaction for the many scientists and health care providers worldwide. Having trained as a PhD scientist, the world of clinical medicine seemed to be a galaxy away. I could not have been more wrong in that assumption. Here, I tell the story of my career trajectory so that those new to the sciences understand the potential and the opportunities afforded by a career in clinical laboratory medicine.

Background: Rapid SARS-CoV-2 antigen tests are potentially useful tools for screening carriers with high viral load. This study was aimed to assess the potential association between viral load and positivization time of a manual SARS-CoV-2 commercial antigen test in routine nasopharyngeal specimens. Methods: In a sample of subjects undergoing routine diagnostic testing, SARS-CoV-2 positivity of nasopharyngeal samples was assayed with both molecular (Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit) and antigenic (Roche SARS-CoV-2 Rapid Antigen Test) tests. Positivization time of rapid antigen test was correlated and compared with viral load expressed as mean of SARS-CoV2 E/S genes cycle threshold (Ct) values. Results: The study sample consisted of 106 patients (median age 48 years, 55 women) with positive results of rapid SARS-CoV-2 antigen testing. A highly significant Spearman's correlation was found between mean SARSCoV-2 E/S genes Ct values and positivization time of manual antigen test (r= 0.70; p

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]

Steroid analysis in clinical laboratories is dominated by immunoassays (IAs) that have a high sample turnover but are inherently limited in trueness, precision, and sensitivity. Liquid chromatography coupled to mass spectrometry (LC-MS/MS) has proved to be a far more capable tool, delivering better sensitivity, specificity, and the possibility of parallel analysis of multiple steroids and metabolites, providing the endocrinologist with more reliable and comprehensive diagnostic information. An LC-MS/MS assay with gradient elution over less than eight minutes and a one-step sample preparation combining protein precipitation with phospholipid removal of off-line solid-phase extraction was developed and validated. It allowed the quantification of 11-deoxycorticosterone (11-DOC), 11-deoxycortisol (11-DF), 17-OH-progesterone (17P), 21-deoxycortisol (21-DF), androstenedione (ANDRO), aldosterone (ALDO), corticosterone (CC), cortisol (CL), cortisone (CN), dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), dihydrotestosterone (DHT), estradiol (E2), progesterone (PROG), and testosterone (TES) in human serum. Interday imprecision was generally better than 15%, trueness was proven by recovery experiments with ISO 17034-certified reference materials, proficiency testing (UK NEQAS), and measuring serum reference standards. In-house comparison against IVD-CE-certified immunoassays (IA) for 17P, ANDRO, CL, DHEAS, E2, PROG, and TES was conducted by assessing leftover routine patient samples and purpose-built patient serum pools. None of the compared routine IAs were meeting the standards of the LC-MS/MS. Insufficient overall comparability was found for ANDRO and 17P (mean bias > +65%). Accuracy limitations at lower concentrations were present in IAs for PROG, E2, and TES. [ABSTRACT FROM AUTHOR]

Mainstays of current treatment for acute respiratory distress syndrome (ARDS) focus on supportive care and rely on intrinsic organ recovery. Animal models of ARDS are often limited by systemic injury. We hypothesize that superimposing gastric aspiration and ventilator-induced injury will induce a lung-specific injury model of severe ARDS. Adult swine (n = 8) were subject to a 12 h injury development period followed by 24 h of post-injury monitoring. Lung injury was induced with gastric secretions (3 cc/kg body weight/lung, pH 1-2) instilled to bilateral mainstem bronchi under direct bronchoscopic vision. Ventilator settings within the injury period contradicted baseline settings using high tidal volumes and low positive end-expiratory pressure. Baseline settings were restored following the injury period. Arterial oxygenation and lung compliance were monitored. At 12 h, PaO 2 /FiO 2 ratio and static and dynamic compliance were significantly reduced from baseline (P < 0.05). During the postinjury period, animals showed no signs of recovery in PaO 2 /FiO 2 ratio and lung compliance. Lung edema (wet/dry weight ratio) of injured lungs was significantly elevated versus noninjured lungs (8.5 ± 1.7 versus 5.6 ± 0.3, P = 0.009). Expression of proinflammatory cytokines IL-6 and IL-8 were significantly elevated in injured lungs (P < 0.05). Twelve hours of high tidal volume and low positive end-expiratory pressure in conjunction with low-pH gastric content instillation produces significant acute lung injury in swine. This large animal model may be useful for testing severe ARDS treatment strategies. [ABSTRACT FROM AUTHOR]

The Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) Big Data and Artificial Intelligence (BAI) Working Group promoted a survey to frame the knowledge, skills and technological predisposition in clinical laboratories. A questionnaire, focussing on digitization, information technology (IT) infrastructures, data accessibility, and BAI projects underway was sent to 1,351 SIBioC participants. The responses were evaluated using SurveyMonkey software and Google Sheets. The 227 respondents (17%) from all over Italy (47% of 484 labs), mainly biologists, laboratory physicians and managers, mostly from laboratories of public hospitals, revealed lack of hardware, software and corporate Wi-Fi, and dearth of PCs. Only 25% work daily on clouds, while 65%—including Laboratory Directors—cannot acquire health data from sources other than laboratories. Only 50% of those with access can review a clinical patient's health record, while the other access only to laboratory information. The integration of laboratory data with other health data is mostly incomplete, which limits BAI-type analysis. Many are unaware of integration platforms. Over 90% report pulling data from the Laboratory Information System, with varying degrees of autonomy. Very few have already undertaken BAI projects, frequently relying on IT partnerships. The majority consider BAI as crucial in helping professional judgements, indicating a growing interest. The questionnaire received relevant feedback from SIBioC participants. It highlighted the level of expertise and interest in BAI applications. None of the obstacles stands out more than the others, emphasising the need to all-around work: IT infrastructures, data warehouses, BAI analysis software acquisition, data accessibility and training. [ABSTRACT FROM AUTHOR]

During the last few years, clinical laboratories have faced a sea change, from facilities producing a high volume of low-cost test results, toward a more integrated and patient-centered service. Parallel to this paradigm change, the digitalization of healthcare data has made an enormous quantity of patients' data easily accessible, thus opening new scenarios for the utilization of artificial intelligence (AI) tools. Every day, clinical laboratories produce a huge amount of information, of which patients' results are only a part. The laboratory information system (LIS) may include other "relevant" compounding data, such as internal quality control or external quality assessment (EQA) results, as well as, for example, timing of test requests and of blood collection and exams transmission, these data having peculiar characteristics typical of big data, as volume, velocity, variety, and veracity, potentially being used to generate value in patients' care. Despite the increasing interest expressed in AI and big data in laboratory medicine, these topics are approaching the discipline slowly for several reasons, attributable to lack of knowledge and skills but also to poor or absent standardization, harmonization and problematic regulatory and ethical issues. Finally, it is important to bear in mind that the mathematical postulation of algorithms is not sufficient for obtaining useful clinical tools, especially when biological parameters are not evaluated in the appropriate context. It is therefore necessary to enhance cooperation between laboratory and AI experts, and to coordinate and govern processes, thus favoring the development of valuable clinical tools. [ABSTRACT FROM AUTHOR]

Appropriateness in Laboratory Medicine has been the object of various types of interventions. From published experiences, it is now clear that to effectively manage the laboratory test demand it is recommended to activate evidence-based preventative strategies stopping inappropriate requests before they can reach the laboratory. To guarantee appropriate laboratory test utilization, healthcare institutions should implement and optimize a computerized provider order entry (CPOE), exploiting the potential of electronic requesting as "enabling factor" for reinforcing appropriateness and sustaining its effects over time. In our academic institution, over the last 15 years, our medical laboratory has enforced various interventions to improve test appropriateness, all directly or indirectly based on CPOE use. The following types of intervention were implemented: (1) applying specific recommendations supported by monitoring by CPOE as well as a continuous consultation with clinicians (tumour markers); (2) removing outdated tests and avoiding redundant duplications (cardiac markers, pancreatic enzymes); (3) order restraints to selected wards and gating policy (procalcitonin, B-type natriuretic peptide, homocysteine); (4) reflex testing (bilirubin fractions, free prostate-specific antigen, aminotransferases, magnesium in hypocalcemia); and (5) minimum retesting interval (D-Dimer, vitamin B12, C-reactive protein, γ-glutamyltranspeptidase). In this paper, we reviewed these interventions and summarized their outcomes primarily related to the changes in total test volumes and cost savings, without neglecting patient safety. Our experience confirmed that laboratory professionals have an irreplaceable role as "stewards" in designing, implementing, evaluating, and maintaining interventions focused to improving test appropriateness. [ABSTRACT FROM AUTHOR]

This article discusses the issues on the veracity of measurement results in laboratory diagnostics, which are used as a basis in making medical decisions. For a correct diagnosis establishment, especially if the measurement results are close to the reference values of the parameters being determined, the accuracy and/or uncertainties of measurement results should be evaluated. The work considers the practical application of the document ISO/TS 20914:2019 "Medical laboratories ― Practical guidance for the estimation of measurement uncertainty," which uses the methodology of the Guide to the Expression of. Uncertainty in Measurement and outlines a practical approach to estimating uncertainties based on information available in a laboratory. This article presents an example of estimating measurement uncertainties performed in a medical laboratory. Particular attention was paid to the assessment of the measurement precision, i.e., type A uncertainty. The data available in the laboratory were analyzed, and the compliance of the obtained measurement results with current requirements was assessed. The implementation of ISO/TS 20914:2019 in activities of medical laboratories enables to evaluate the uncertainties of measurements conducted in the laboratory and the factors that make maximum contribution to measurement uncertainties. [ABSTRACT FROM AUTHOR]