journal: Clinical Chemistry and Laboratory Medicine (CCLM)

Impact Factor: 8.490

Published since January 1, 1963

Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

ISSN: 1437-4331

Editor-in-chief: Mario Plebani

Edited by: Philippe Gillery, Ronda Greaves, Karl J. Lackner, Giuseppe Lippi, Bohuslav Melichar, Deborah A. Payne, Peter Schlattmann

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About this journal

Objective
Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. It is focused on basic and applied research and cutting-edge clinical laboratory medicine. CCLM is one of the leading journals in the field, with an impact factor over 3.5. All contributions submitted for publication in CCLM are single-blind peer reviewed by at least two experts in the field. CCLM is led by a multi-institutional editorial board. It is issued monthly, both in print and electronically. Letters to the Editor and Congress Abstracts are published online only.

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Topics

clinical biochemistry
clinical genomics and molecular biology
clinical haematology and coagulation
clinical immunology and autoimmunity
clinical microbiology
drug monitoring and analysis
evaluation of diagnostic biomarkers
disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes)
new reagents, instrumentation and technologies
new methodologies
reference materials and methods
reference values and decision limits
quality and safety in laboratory medicine
translational laboratory medicine
clinical metrology

Article formats
Research Articles, Reviews, Mini Reviews and Opinion Papers on all aspects of clinical chemistry and laboratory medicine, Guidelines and Recommendations, Point/Counterpoint Articles, Letters to the Editor, Editorials

For EFLM Academy Members

To take advantage of all the opportunities offered to members of the EFLM Academy, please access your personal area in the EFLM Academy at the link https://academy.eflm.eu/secretariat/login (if you do not remember your login details, you can use the option FORGOT PASSWORD). Click on the section “International Journals” on the left-hand side where you find CCLM as the first listed journal.

Your Benefits

Latest developments in the clinical laboratory sciences
Fundamental and applied approach
Novel teaching and training methods
High quality peer-review
Follow @cclm_degruyter on Twitter!

CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and affiliated to the National Societies that are members of the EFLM Academy. It publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); Slovenia (SZKK); and Spain (SEQC-ML) and it is affiliated to AACB (Australia).

Previous Titles

Vol. 1 - Vol. 4, 1963-1966
Zeitschrift für Klinische Chemie
Vol. 5 - Vol. 9, 1967-1971
Zeitschrift für Klinische Chemie und Klinische Biochemie
Vol. 10 - Vol. 13, 1972-1975
Zeitschrift für Klinische Chemie und Klinische Biochemie Journal of Clinical Chemistry and Clinical Biochemistry
Vol. 14 - Vol. 26, 1976-1988
Journal of Clinical Chemistry and Clinical Biochemistry Zeitschrift für Klinische Chemie und Klinische Biochemie
Vol. 27 - Vol. 28, 1989-1990
Journal of Clinical Chemistry and Clinical Biochemistry
Vol. 29 - Vol. 35, 1991-1997
European Journal of Clinical Chemistry and Clinical Biochemistry

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Volume 61 Issue 4

March 2023

Publicly Available February 27, 2023

Frontmatter

Page range: i-iv

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Editorial

Publicly Available February 8, 2023

SMART and GREEN LABORATORIES. How to implement IVDR, emerging technologies and sustainable practices in medical laboratories?

Tomris Ozben

Page range: 531-534

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Articles

Publicly Available November 3, 2022

Where is laboratory medicine headed in the next decade? Partnership model for efficient integration and adoption of artificial intelligence into medical laboratories

Anna Carobene, Federico Cabitza, Sergio Bernardini, Raj Gopalan, Jochen K. Lennerz, Clare Weir, Janne Cadamuro

Page range: 535-543

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Abstract

Objectives 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. Methods 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. Results 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. Conclusions 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.

Publicly Available January 25, 2023

Diagnostic quality model (DQM): an integrated framework for the assessment of diagnostic quality when using AI/ML

Jochen K. Lennerz, Roberto Salgado, Grace E. Kim, Sahussapont Joseph Sirintrapun, Julia C. Thierauf, Ankit Singh, Iciar Indave, Adam Bard, Stephanie E. Weissinger, Yael K. Heher, Monica E. de Baca, Ian A. Cree, Shannon Bennett, Anna Carobene, Tomris Ozben, Lauren L. Ritterhouse

Page range: 544-557

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Abstract

Background 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. Methods 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. Results 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. Conclusions 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.

Publicly Available August 29, 2022

Disruption vs. evolution in laboratory medicine. Current challenges and possible strategies, making laboratories and the laboratory specialist profession fit for the future

Janne Cadamuro

Page range: 558-566

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Abstract

Since beginning of medical diagnostics, laboratory specialists have done an amazing job, continuously improving quality, spectrum and speed of laboratory tests, currently contributing to the majority of medical decision making. These improvements are mostly of an incremental evolutionary fashion, meaning improvements of current processes. Sometimes these evolutionary innovations are of a radical fashion, such as the invention of automated analyzers replacing manual testing or the implementation of mass spectrometry, leading to one big performance leap instead of several small ones. In few cases innovations may be of disruptive nature. In laboratory medicine this would be applicable to digitalization of medicine or the decoding of the human genetic material. Currently, laboratory medicine is again facing disruptive innovations or technologies, which need to be adapted to as soon as possible. One of the major disruptive technologies is the increasing availability and medical use of artificial intelligence. It is necessary to rethink the position of the laboratory specialist within healthcare settings and the added value he or she can provide to patient care. The future of the laboratory specialist profession is bright, as it the only medical profession comprising such vast experience in patient diagnostics. However, laboratory specialists need to develop strategies to provide this expertise, by adopting to the quickly evolving technologies and demands. This opinion paper summarizes some of the disruptive technologies as well as strategies to secure and/or improve the quality of diagnostic patient care and the laboratory specialist profession.

Publicly Available January 11, 2023

Digital transformation towards the clinical laboratory of the future. Perspectives for the next decade

Snežana Ž. Jovičić, Dalius Vitkus

Page range: 567-569

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Abstract

The transformation of clinical laboratories towards digitalization requires processes that improve digital maturity. This requires establishing connectivity, end-to-end workflow, and advanced analytical technologies and techniques. Digital technologies have the key role here, directing laboratory personnel and scientists to move their focus from routine to more complex and meaningful work. This requires their empowerment in working with new instruments and software. Strategies leading clinical laboratories through this transformation are not without challenges, but different models are being developed to overcome them. The essential is the role of interoperability.

Publicly Available February 9, 2023

Crossing the chasm: strategies for digital transformation in clinical laboratories

Merve Sibel Gungoren

Page range: 570-575

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Abstract

Total testing process in a clinical laboratory is designed to produce useful information for patients and clinicians. The changing landscape of healthcare industry forces clinical laboratory leaders to meet the needs of their stakeholders, maximize operational efficiency and improve overall quality of patient care at the same time. The increasing number of data produced force healthcare services industry to digital transformation. Digital transformation is a process of change which includes finding solutions to novel and unmet requirements of an industry by integrating information, computing, communication and connectivity technologies to minimize the number of low-value tasks and focus on high-value tasks. As the process of digital transformation includes not only the modernization of IT infrastructure but also a paradigm shift in perception of value creation and delivery to improve the quality and cost-effectiveness of laboratory operations in the long run, financial, managerial, and educational issues have been blocking the widespread implementation. Clinical laboratories are at the crossroads on the road to the future. Laboratories that fail to align themselves with data-driven practices will risk losing a competitive advantage. In this review, strategies for a successful digital transformation will be overviewed in the context of clinical laboratory settings.

Publicly Available February 6, 2023

The laboratory journey to become a decision engine: a roadmap for diagnostic transformation

Florian Lange

Page range: 576-579

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Abstract

Laboratories and diagnostic departments are presiding over a massive amount of data they are failing to fully leverage it. Data is the new black gold of healthcare organizations and by extracting insights from it, laboratories could become true decision engines, able to drive action across healthcare. This opinion paper responds three fundamental questions: (1) Where are we (diagnostic parties)? Taking a look at the most significant trends and challenges in healthcare and shedding some light upon the status of diagnostics. (2) Where do we want to be? Reviewing the opportunities for digital health, its role in the healthcare of the future and providing inspiration about what success looks like. (3) What do we need to do? Explaining what Digital Health Solutions (DHS) from Abbott is doing in this regard. This will include information about how DHS can impact the Diagnosis Cycle and how to set a roadmap for laboratories and diagnostic organizations. Diagnosis Cycle means the different steps in the diagnosis process, from the beginning when a patient is seen by a clinician and some tests are ordered, until the results are reviewed by the clinician and the treatment, follow up or discharge is decided.

Publicly Available December 22, 2022

From big data to better patient outcomes

Tim Hulsen, David Friedecký, Harald Renz, Els Melis, Pieter Vermeersch, Pilar Fernandez-Calle

Page range: 580-586

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Abstract

Among medical specialties, laboratory medicine is the largest producer of structured data and must play a crucial role for the efficient and safe implementation of big data and artificial intelligence in healthcare. The area of personalized therapies and precision medicine has now arrived, with huge data sets not only used for experimental and research approaches, but also in the “ real world ”. Analysis of real world data requires development of legal, procedural and technical infrastructure. The integration of all clinical data sets for any given patient is important and necessary in order to develop a patient-centered treatment approach. Data-driven research comes with its own challenges and solutions. The Findability, Accessibility, Interoperability, and Reusability (FAIR) Guiding Principles provide guidelines to make data findable, accessible, interoperable and reusable to the research community. Federated learning, standards and ontologies are useful to improve robustness of artificial intelligence algorithms working on big data and to increase trust in these algorithms. When dealing with big data, the univariate statistical approach changes to multivariate statistical methods significantly shifting the potential of big data. Combining multiple omics gives previously unsuspected information and provides understanding of scientific questions, an approach which is also called the systems biology approach. Big data and artificial intelligence also offer opportunities for laboratories and the In Vitro Diagnostic industry to optimize the productivity of the laboratory, the quality of laboratory results and ultimately patient outcomes, through tools such as predictive maintenance and “moving average” based on the aggregate of patient results.

Publicly Available January 4, 2023

Clinical lipidomics in the era of the big data

Aleš Kvasnička, Lukáš Najdekr, Dana Dobešová, Barbora Piskláková, Eliška Ivanovová, David Friedecký

Page range: 587-598

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Abstract

Lipidomics as a branch of metabolomics provides unique information on the complex lipid profile in biological materials. In clinically focused studies, hundreds of lipids together with available clinical information proved to be an effective tool in the discovery of biomarkers and understanding of pathobiochemistry. However, despite the introduction of lipidomics nearly twenty years ago, only dozens of big data studies using clinical lipidomics have been published to date. In this review, we discuss the lipidomics workflow, statistical tools, and the challenges of standartisation. The consequent summary divided into major clinical areas of cardiovascular disease, cancer, diabetes mellitus, neurodegenerative and liver diseases is demonstrating the importance of clinical lipidomics. In these publications, the potential of lipidomics for prediction, diagnosis or finding new targets for the treatment of selected diseases can be seen. The first of these results have already been implemented in clinical practice in the field of cardiovascular diseases, while in other areas we can expect the application of the results summarized in this review in the near future.

Publicly Available December 22, 2022

Principles of ideal diagnostic regulation and the IVDR

Anna Margareta Hallersten, Nicholas Michael Decker, Yasha Huang

Page range: 599-607

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Abstract

This article discusses principles and concepts for ideal regulatory frameworks for diagnostics, and the expression of those principles in the EU IVDR. The authors present the benefits of regulatory frameworks and implementation approaches for diagnostics that are risk-based, globally convergent, connected, nimble and efficient, under the IVDR and with a future outlook. While many expressions of these principles can already be found in the EU IVDR text, and in its implementation approaches, their further embrace is needed in future EU diagnostic regulation. In the long term outlook, risk-based approaches can be extended to comprise entity-based excellence appraisals. Globally convergent approaches can be more explicit in e.g. qualification and classification of products. This will also help further reliance models. Better connections and cooperation between regulators across the healthcare spectrum including pharmaceuticals should be fostered. Nimble approaches such as Emergency Use Authorisations for pandemics are essential in highly regulated schemes like the IVDR and beyond. Finally, regulatory efficiency as in timely availability of IT infrastructure and oversight mechanisms is a distinguishing attribute of globally competitive diagnostic regulatory schemes. All the above needs consideration in the long term efforts to modernize the EU regulatory system, so that diagnostics can play their important role in clinical research as well as along the entire care continuum in the EU.

Publicly Available January 31, 2023

ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation

Joint opinion of task force on European regulatory affairs and working group accreditation and ISO/CEN standards of the European Federation of Clinical Chemistry and Laboratory Medicine

Florent J.L.A. Vanstapel, Matthias Orth, Thomas Streichert, Ettore D. Capoluongo, Wytze P. Oosterhuis, Hikmet Can Çubukçu, Francisco A. Bernabeu-Andreu, Marc Thelen, Leo H.J. Jacobs, Solveig Linko, Harjit Pal Bhattoa, Patrick M.M. Bossuyt, Pika Meško Brguljan, Guilaine Boursier, Christa M. Cobbaert, Michael Neumaier

Page range: 608-626

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Abstract

The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified devices, and post-market surveillance. The IVDR regulates design, manufacture and putting into use of devices, but not medical services using these devices. In the absence of suitable commercial devices, the laboratory can resort to laboratory-developed tests (LDT) for in-house use. Documentary obligations (IVDR Art 5.5), the performance and safety specifications of ANNEX I, and development and manufacture under an ISO 15189-equivalent quality system apply. LDTs serve specific clinical needs, often for low volume niche applications, or correspond to the translational phase of new tests and treatments, often extremely relevant for patient care. As some commercial tests may disappear with the IVDR roll-out, many will require urgent LDT replacement. The workload will also depend on which modifications to commercial tests turns them into an LDT, and on how national legislators and competent authorities (CA) will handle new competences and responsibilities. We discuss appropriate interpretation of ISO 15189 to cover IVDR requirements. Selected cases illustrate LDT implementation covering medical needs with commensurate management of risk emanating from intended use and/or design of devices. Unintended collateral damage of the IVDR comprises loss of non-profitable niche applications, increases of costs and wasted resources, and migration of innovative research to more cost-efficient environments. Taking into account local specifics, the legislative framework should reduce the burden on and associated opportunity costs for the health care system, by making diligent use of existing frameworks.

Publicly Available December 6, 2022

Digital transformation and sustainability in healthcare and clinical laboratories

Mariana Fragão-Marques, Tomris Ozben

Page range: 627-633

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Abstract

Healthcare, and in particular, clinical laboratories, are major contributors to carbon emissions and waste. Sustainability in healthcare has shifted from an environmental concern towards a holistic definition that includes balancing socio-ecological and socio-technical systems, including health services effectiveness and cost efficiency. Digital transformation can reduce waste and the cost of services by enhancing effectiveness while maintaining quality. Digital health interventions can provide personalized patient-centered care on a global scale and include decision support systems that have the potential to improve the performance and quality of healthcare. The right interfaces must be used so that the advantages of going digital are felt throughout the health system: a successful and sustainable implementation of digital innovation depends on its integration into a functional health ecosystem. Telehealth has the potential to reduce carbon emissions due to the reduced daily commute of health professionals, although research is limited. Recently, economic models have changed from the linear “take-make-dispose” to circular models based on recycling and upcycling that have the goal of keeping products, components, and materials at their highest utility and value. The previous linear models threaten human health and well-being and harm natural ecosystems.

Publicly Available November 8, 2022

Imperative: reducing the environmental impact of clinical laboratories

Alistair J. Gammie, Joseph B. Lopez, Sheri Scott

Page range: 634-637

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Abstract

Clinical laboratories are significant contributors to the environmental burden of the planet. They have been slow to address the issues with a few exceptions, but it is highly encouraging to see the current impetus and ambition in this direction. This paper describes some of these initiatives and provides the rationale as to why clinical laboratories should become sustainable. It also describes the economic and intangible benefits that labs will accrue in achieving sustainability.

Publicly Available December 20, 2022

Embedding education into clinical laboratory professional training to foster sustainable development and greener practice

Sheri Scott

Page range: 638-641

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Abstract

It has become apparent that the climate crisis is reaching critical levels and Governments and key organisations are recognising the need for change. A review of current literature reveals very little published research concerning the impact of clinical laboratory practice on the carbon footprint of healthcare. For a clinical laboratory to become more environmentally sound, key target areas of focus are required. With sustainability becoming a key consideration for course development, employing educational principles such as Education for Sustainable Development (ESD) in the form of Sustainability in Quality Improvement (SusQI), Quality Improvement objectives can be met, while benefitting the patient and the environmental impact of organisation.

Publicly Available December 22, 2022

Chemical strategies for sustainable medical laboratories

Tomris Ozben, Mariana Fragão-Marques

Page range: 642-650

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Abstract

Chemicals are essential components of our daily lives, for the well-being, high living standards and comfort of modern society. They are used in many sectors, including health. However, some chemicals have hazardous properties which can harm the environment and human health. Chemical pollution is significantly contributing to the current global problem of climate change and loss of biodiversity There is an increase in health problems that can be partially explained by the use of chemicals. Some man-made chemicals are found in the most remote places in the environment, but also in our bodies. Chemicals are everywhere. Chemicals strategy for sustainability towards a toxic-free environment will ensure better protection of human health and the environment from hazardous chemicals, boost innovation for safe and sustainable chemicals and enable the transition to chemicals that are safe and sustainable by design. It is a first step towards the Zero pollution ambition for a toxic-free environment announced in the European Green Deal. The strategy proposes comprehensive chemical legislations for the transformation of industry with the aim of attracting investment into safe and sustainable products and production methods. Clinical laboratories must choose safer, more sustainable alternatives to hazardous chemicals, address sustainability issues, and implement official guidelines on how to reduce their carbon footprint.

Publicly Available February 1, 2023

The EU Green Deal: the challenge of greening medical technologies

Valérie Rampi, Oliver Bisazza

Page range: 651-653

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Abstract

As sustainability has been a growing priority of the European Union (EU) in the last decade, especially since the establishment of the EU Green Deal, the medical technology sector – including the in vitro diagnostics (IVD) sector – must comply with European legislation in this field, like all other sectors. However, this sector faces particular challenges as the health and safety of human lives are at stake. Chemicals, in particular, can comprise a politically sensitive issue, as they can pose risks to the environment that need to be managed. At the same time, the same chemicals can be considered essential to safeguard continuity of diagnostic services to health systems, who rely on laboratory medicines for the treatment of patients. An important task for the EU Green Deal to succeed, from an IVD sector perspective, is therefore to find the right balance between serving patients on the one hand and protecting the planet on the other.

Publicly Available December 6, 2022

Greater expectations: meeting clinical needs through broad and rapid genomic testing

Corey Poveda-Rogers, Jennifer J.D. Morrissette

Page range: 654-661

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Abstract

Cancer describes a group of diseases driven by genetic and genomic changes that can occur across hundreds of different genes. Knowledge of the specific variants present in a patient’s cancer can help to predict response to different treatment options, confirm disease diagnosis, and understand a patient’s prognosis and risks, which ultimately leads to improved survival outcomes. The advent of next-generation sequencing (NGS) technology has allowed pathologists to simultaneously profile the sequences of many genes in a single reaction, but not all NGS assays are built the same. While those used for broad genomic profiling are useful to probe large regions of the genome and gather more information about a patient’s tumor, it comes at the cost of relatively long turnaround times (TAT), which may be detrimental to patient care. Conversely, NGS assays used for rapid genomic profiling provide faster results, but may miss detection of variants that are clinically informative. Determining which type of genomic profiling to order depends on a number of factors including the severity of a patient’s illness, standard of care paradigms, and success or failure of previous therapies. Ultimately, the ideal clinical diagnostic laboratory will be able to offer both options to best meet the clinical needs of its patients.

Publicly Available January 19, 2023

Opinion paper on the systematic application of integrated bioinformatic tools to actuate routine precision medicine in poly-treated patients

Marina Borro, Gerardo Salerno, Giovanna Gentile, Maurizio Simmaco

Page range: 662-665

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Abstract

Precision Medicine is a reality in selected medical areas, as oncology, or in excellent healthcare structures, but it is still far to reach million patients who could benefit from this medical concept. Here, we sought to highlight how the time is ripe to achieve horizontal delivery to a significant larger audience of patients, represented by the poly-treated patients. Combination therapies are frequent (especially in the elderly, to treat comorbidities) and are related to decreased drug safety and efficacy, disease’s exacerbation, additional treatments, hospitalization. But the recent development and validation of bioinformatic tools, aimed to automatic evaluation and optimization of poly-therapies, according to the unique individual characteristics (including genotype), is ready to change the daily approach to pharmacological prescription.

Publicly Available November 28, 2022

Central role of laboratory medicine in public health and patient care

Pyper Olver, Mary Kathryn Bohn, Khosrow Adeli

Page range: 666-673

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Abstract

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.

Publicly Available January 9, 2023

Improved implementation of medical tests – barriers and opportunities

Andrew St John, Maurice O’Kane, Paul Jülicher, Christopher P. Price

Page range: 674-678

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Abstract

Applying the concept of a value proposition to medical testing is just one of the many ways to identify and monitor the value of tests. A key part of this concept focusses on processes that should take place after a test is introduced into routine local practice, namely test implementation. This process requires identification of the clinical pathway, the stakeholders and the benefits or disbenefits that accrue to those stakeholders. There are various barriers and challenges to test implementation. Implementation requires the process of clinical audit which involves measurement of outcomes external to the laboratory but this is not widely performed in laboratory medicine. A second key challenge is that implementation requires liaison with stakeholders outside of the laboratory including clinicians and other healthcare professional such as finance managers. Many laboratories are remote from clinical care and other stakeholders making such liaison difficult. The implementation process is based on data which again will be primarily on processes outside of the laboratory. However the recent enthusiasm for so-called real world data and new data mining techniques may represent opportunities that will facilitate better test implementation. A final barrier is that a range of new tools not currently in the education curriculum of the laboratory professional is required for implementation such as those of preparing a business case to support the introduction of a test and health economic analysis. The professional bodies in laboratory medicine could assist with education in these areas.

Publicly Available January 9, 2023

Precision quality control: a dynamic model for risk-based analysis of analytical quality

Robert L. Schmidt, Ryleigh A. Moore, Brandon S. Walker, Joseph W. Rudolf

Page range: 679-687

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Abstract

Objectives There is continuing pressure to improve the cost effectiveness of quality control (QC) for clinical laboratory testing. Risk-based approaches are promising but recent research has uncovered problems in some common methods. There is a need for improvements in risk-based methods for quality control. Methods We provide an overview of a dynamic model for assay behavior. We demonstrate the practical application of the model using simulation and compare the performance of simple Shewhart QC monitoring against Westgard rules. We also demonstrate the utility of trade-off curves for analysis of QC performance. Results Westgard rules outperform simple Shewhart control over a narrow range of the trade-off curve of false-positive and false negative risk. The risk trade-off can be visualized in terms of risk, risk vs. cost, or in terms of cost. Risk trade-off curves can be “smoothed” by log transformation. Conclusions Dynamic risk-models may provide advantages relative to static models for risk-based QC analysis.

Publicly Available January 23, 2023

Quality indicators in laboratory medicine: state-of-the-art, quality specifications and future strategies

Laura Sciacovelli, Andrea Padoan, Ada Aita, Daniela Basso, Mario Plebani

Page range: 688-695

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Abstract

In the last few decades, quality in laboratory medicine has evolved in concert with the transformation and the changes (technological, scientific and organizational) in this sector. Laboratory professionals have faced great challenges, at times being overwhelmed, yet also involved in this progress. Worldwide, laboratory professionals and scientific societies involved in laboratory medicine have raised awareness concerning the need to identify new quality assurance tools that are effective in reducing the error rate and enhancing patient safety, in addition to Internal Quality Control (IQC) procedures and the participation in the External Quality Assessment Schemes (EQAS). The use of Quality Indicators (QIs), specifically designed for laboratory medicine are effective in assessing and monitoring all critical events occurring in the different phases of Total Testing Process (TTP), in particular, in the extra-analytical phases. The Model of Quality Indicators (MQI), proposed by the Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and validated by experts in consensus conferences, is an important window of opportunity for the medical laboratory to demonstrate the use of an effective quality assurance tool fit for this purpose. Aim of this paper is to provide an update of the state-of-the-art concerning the most used QIs data collected in 2021 and the Quality Specifications (QSs) proposed for their evaluation. Moreover, a strategy for the future is proposed in order to improve the MQI and encourage its use in medical laboratories throughout the world.

Publicly Available December 26, 2022

Direct-to-consumer laboratory testing (DTCT): challenges and implications for specialists in laboratory medicine

Matthias Orth, Erik Vollebregt, Tomaso Trenti, Patti Shih, Mette Tollanes, Sverre Sandberg

Page range: 696-702

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Abstract

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.

Publicly Available February 3, 2023

Direct-to-consumer testing – benefits for consumers, people with disease and public health

Rolf Hinzmann

Page range: 703-708

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Abstract

Direct-to-consumer (DTC) tests can be defined as any in-vitro diagnostic (IVD) test or, more broadly, any medical test using an IVD or medical device, that is marketed directly to consumers without involvement of a health care provider (HCP). Examples are pregnancy tests, alcohol breath tests, blood pressure measurements (medical device), coagulation tests (INR), self-monitoring of blood glucose, continuous glucose monitoring (medical device), HIV tests, HPV tests, SARS-CoV-2 antigen tests, or genetic tests. DTC tests fulfil various customer needs such as making rapid decisions (e.g. glucose monitoring for insulin dosing, SARS-CoV-2 antigen test, hormone test identifying fertile days, alcohol test), monitoring chronic conditions between consultations (e.g. diabetes, lipidaemia, hypertension), saving time and reducing consultations (e.g. INR, SARS-CoV-2 antigen test, blood pressure monitoring), screening for disease when no symptoms are present (e.g. occult blood, cholesterol, triglycerides, SARS-CoV2 antigen test), or maintaining privacy (e.g. pregnancy test, HIV test, HPV test, certain genetic tests). Further, DTC tests can reduce cost and expand access to care in countries with limited resources and can support healthcare systems in extraordinary circumstances such as a pandemic. Valid concerns about DTC testing need to be described, addressed and resolved with the help of authorities and regulators in collaboration with HCP and should not detract from the advantages DTC tests can provide. HCP should play a more prominent role in educating the public through mass media and social media on the proper use of DTC tests and help to pinpoint problem areas.

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5-year Impact Factor	5.681
Cite Score	8.9
Impact Factor	8.490
Journal Citation Indicator	1.82
SCImago Journal Rank	1.295
Source Normalized Impact per Paper	1.665

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Editor-in-Chief
Mario Plebani, Padova, Italy

Associate Editors
Philippe Gillery, Reims, France
Ronda Greaves, Bundoora, VIC, Australia
Karl Lackner, Mainz, Germany
Giuseppe Lippi, Verona, Italy (Reviews Editor)
Bohuslav Melichar, Olomouc, Czech Republic
Deborah A. Payne, Denver, CO, USA
Peter Schlattmann, Jena, Germany

Editorial Board
Ivan Brandslund, Odense, Denmark
Janne Cadamuro, Salzburg, Austria
Etienne Cavalier, Liège, Belgium
Sail Chun, Seoul, Republic of Korea
Vincent De Guire, Montreal, Canada
Vincent Delatour, Paris, France
Eleftherios P. Diamandis, Toronto, Canada
Pilar Fernandez-Calle, Madrid, Spain
Rajiv T. Erasmus, Stellenbosch, South Africa
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Julien Favresse, Brussels, Belgium
Joao Tiago Guimaraes, Porto, Portugal
Liam Heaney, Loughborough, UK
Brandon M. Henry, Cincinnati, OH, USA
Markus Herrmann, Graz, Austria
Martin Hersberger, Zurich, Switzerland
Johannes J.M.L. Hoffmann, Nuenen, Netherlands
Evgenija Homšak, Lenart, Slovenia
Zhi-De Hu, Hohhot, P.R. China
Berend Isermann, Magdeburg, Germany
Joannes F.M. Jacobs, Nijmegen, The Netherlands
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Graham Jones, Darlinghurst, NSW, Australia
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Tze Ping Loh, Singapore
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Tomris Özben, Antalya, Turkey
Vladimir Palicka, Hradec Králové, Czech Republic
Mauro Panteghini, Milan, Italy
Geraldo Picheth, Curitiba, Brazil
Ted E. Schutzbank, San Diego, CA, USA
Grazyna Sypniewska, Bydgoszcz, Poland
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Maria Alice V. Willrich, Rochester, MN, USA

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Heike Jahnke
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(Deutsch)

Online ISSN: 1437-4331
Print ISSN: 1434-6621
Type: Journal
Language: English
Publisher: De Gruyter
First published: January 1, 1963
Publication Frequency: 12 Issues per Year
Audience: basic scientists, translational researchers, clinical researchers, industry scientists and professionals in the field of laboratory medicine