Toolkit for emerging technologies in laboratory medicine.

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

Creating a Blueprint for the Future: Lessons Learned From Public Health Laboratories in the COVID-19 Response.

Public health laboratories have played a central role in the US response to COVID-19. Since the earliest days, myriad issues have impeded the laboratory community's ability to keep pace with the overwhelming demand for effective tests. In this article, the Association of Public Health Laboratories and a subset of its members examine the response to date and evaluate lessons learned from 4 main categories: testing surges, supplies, staffing, and regulations and policy. Within these categories, the authors offer recommendations intended both to improve the ongoing COVID-19 response and to strengthen planning for future outbreaks.

Strategies for Sustainability of University-Based Medical Laboratory Sciences Programs.

The COVID-19 pandemic has taken a major toll on the economy and funding for public education. For that reason, the pandemic has a worrisome effect on the sustainability of university/college based Medical Laboratory Sciences MLS training programs. Stakeholders of university-based MLS programs include university administrators, students, clinical affiliates and faculty. Each group has specific goals and challenges that affect the sustainability of the program. This report details strategies that can be used to satisfy the goals specific to key stakeholders that lead to sustainability. These strategies apply in pandemic times and in the back-to-normal future.

Covid-19 Pandemic: Through the Lens of Science, a Painstaking Review.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has imperiled human lives and global infrastructure since the emergence of SARS-CoV-2 in China. The current review meticulously summarizes the COVID-19 pandemic situation through the lens of science from the inception of the outbreak to the current progression, which is valuable to mitigate the current pandemic situation. METHODS: We reviewed all the relevant literature available on PubMed, Web of Sciences, Google Scholar, and World Health Organization (WHO) website related to COVID-19 from the inception of the outbreak to 18 June 2020. We selected ninety different scientific studies and reports to compile the current review. RESULTS: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a betacoronavirus with four major structural proteins encoded by S, M, E, and N genes and distinct in morphology. The potential provenance of SARS-Cov-2 is zoonotic, and it binds to the host cell receptors by spike protein. The SARS-CoV-2 infectious cycle carries on through direct contact, air, inanimate objects, and contaminated surfaces. The reproductive number (R0) of SARS-CoV-2 is 2 to 3.5, representing that one infected patient can spread this virus to two to three people. An expeditious laboratory diagnosis has a pivotal role in patient management and prevention. Due to the lack of definitive treatment, symptomatic medication regimen and supportive organ therapies are adapted for debilitated patients. CONCLUSIONS: Nucleoside analogs and protease-inhibitors have approved to attenuate the viral infection until the discovery of a specific drug. The other treatment strategies comprise antimalarial drugs, monoclonal antibodies, and glucocorticoids. The use of alcoholic scrubs, sodium hypochlorite, masks, social distancing, and quarantine the affected individual is inevitable to eradicate the infection vector and to break the transmission path.

Inflammatory Bowel Disease Through the Lens of Single-cell RNA-seq Technologies.

The intestinal mucosa represents a unique environment where the coordinated function of diverse epithelial, mesenchymal, and immune cells maintains a physiologically balanced environment in the presence of gut microbiota. The intestinal mucosa plays a central role in the pathogenesis of inflammatory bowel disease (IBD), yet the molecular and cellular composition of this diverse environment is poorly understood. However, the recent advent of multimodal single-cell technologies, including single-cell RNA sequencing (scRNA-seq), now provides an opportunity to accurately map the tissue architecture, characterize rare cell types that were previously overlooked, and define function at a single-cell level. In this review, we summarize key advances in single-cell technology and provide an overview of important aspects of computational analysis. We describe emerging data in the field of IBD and discuss how the characterization of novel intestinal mucosa cell populations is reshaping our understanding of this complex disease. We conclude by considering the potential clinical applications, including the definition of novel drug targets and the opportunity for personalization of care in this exciting new era of precision medicine.

[Emergence of 3D human fatty liver models engineered in the laboratory]. / L'émergence des modèles miniatures de foie gras humain en 3D générés en laboratoire.

Organoids offer an elegant approach to model human diseases and test new drugs. Nonalcoholic fatty liver disease (NAFLD) whose incidence has dramatically increased in recent years with the rise of obesity, is defined by triglyceride accumulation in hepatocytes, inflammation, liver injury, and progression to fibrosis. There is currently no approved therapy but many pathways are being explored. Two American teams have created mini-steatotic livers using different approaches, both using induced pluripotent stem cells (iPS), thus offering new tools to test developing drugs.

TITLE: L'émergence des modèles miniatures de foie gras humain en 3D générés en laboratoire. ABSTRACT: Les organoïdes constituent une approche de choix pour modéliser a minima une maladie humaine et tester l'efficacité thérapeutique de certaines drogues. La stéatopathie métabolique ou maladie du foie gras, dont l'incidence a considérablement augmenté avec l'accroissement de l'obésité dans les pays développés, se caractérise par l'accumulation de triglycerides dans l'hépatocyte et une atteinte hépatique pouvant évoluer vers la fibrose. Il n'existe pas de traitement efficace, mais de nombreuses pistes sont actuellement explorées. Deux équipes américaines ont récemment utilisé les cellules souches pluripotentes induites (iPS) et la culture muticellulaire pour modéliser un mini-foie stéatosique par deux approches différentes, offrant ainsi de nouveaux outils pour tester les drogues en cours de développement.

Philip T. Cagle, MD-Editor-in-Chief of the Archives of Pathology & Laboratory Medicine, 2005-2019.

• The Archives of Pathology & Laboratory Medicine was first published in 1926 as a specialty journal of the American Medical Association. It became the official journal of the College of American Pathologists in 1995. Under the dynamic leadership of its most recent editor-in-chief, Philip T. Cagle, MD, the Archives has dramatically increased its impact factor and become the most widely read general pathology journal. Dr. Cagle has consistently added leading pathologists to the editorial board, and the collective expertise of these individuals is clearly evident in new, cutting-edge journal masthead sections. The Archives has featured innovative content in the field of digital pathology, including articles on the utilization of smart phones in pathology and the incorporation of whole-slide images and videos into the content of articles. During the current editorial board's tenure, special sections were introduced and have proven immensely popular with the journal's readership. As the Archives celebrates its 94th anniversary, its editorial board remains committed to providing insightful and relevant medical knowledge. The journal's open access Web site ( www.archivesofpathology.org ) allows the dissemination of this information to every corner of the globe at no expense to those who wish to expand their knowledge or improve their medical practice. Dr. Cagle, with support from the editorial board and journal staff, has worked tirelessly during his tenure as Archives editor-in-chief to greatly enhance the content of the journal and its stature within pathology and laboratory medicine.

MR Imaging-Histology Correlation by Tailored 3D-Printed Slicer in Oncological Assessment.

3D printing and reverse engineering are innovative technologies that are revolutionizing scientific research in the health sciences and related clinical practice. Such technologies are able to improve the development of various custom-made medical devices while also lowering design and production costs. Recent advances allow the printing of particularly complex prototypes whose geometry is drawn from precise computer models designed on in vivo imaging data. This review summarizes a new method for histological sample processing (applicable to e.g., the brain, prostate, liver, and renal mass) which employs a personalized mold developed from diagnostic images through computer-aided design software and 3D printing. Through positioning the custom mold in a coherent manner with respect to the organ of interest (as delineated by in vivo imaging data), the cutting instrument can be precisely guided in order to obtain blocks of tissue which correspond with high accuracy to the slices imaged. This approach appeared crucial for validation of new quantitative imaging tools, for an accurate imaging-histopathological correlation and for the assessment of radiogenomic features extracted from oncological lesions. The aim of this review is to define and describe 3D printing technologies which are applicable to oncological assessment and slicer design, highlighting the radiological and pathological perspective as well as recent applications of this approach for the histological validation of and correlation with MR images.

Driving the route of laboratory medicine: a manifesto for the future.

The role of laboratory medicine is essential in healthcare, since in vitro diagnostic testing represents now an unavoidable part of reasoning and clinical decision making. Laboratory tests are an essential part of most care pathways, aimed at optimizing resource utilization and improving patient outcome. The activity of laboratory professionals is interconnected with all medical disciplines, and provides a crucial support for ordering the right test, for the right patient and at the right time, but also helps interpreting and using laboratory data. Although recent advancement in laboratory medicine, catalyzed by technical innovations and development of innovative tests, have promoted a substantial revolution in the organization of clinical laboratories, the future of this profession seems still ambiguous. We have hence developed a "manifesto" of laboratory medicine, meant to promote an innovative prospect of our discipline and encouraging the establishment of a new generation of laboratory professionals and managers.

Adoption of Evidence-Based Medicine in Clinical Laboratory Science: A Survey of the Prevalence of Systematic and Narrative Reviews.

BACKGROUND: Systematic reviews (SRs) play a critical role in evidence-based medicine. OBJECTIVE: To determine the publication trends of SRs in clinical laboratory science (CLS). METHODS: We searched Scopus to identify all reviews published in the top 20 CLS journals during the past 10 years (2008-2017). We determined year of publication, review type (systematic vs narrative), citations, and whether the review was accompanied by a meta-analysis (MA). RESULTS: We identified 2934 reviews. Of these, 2833 (96.6%) were narrative reviews, and 98 (3.3%) were SRs. A total of 67 (66.3%) of the SRs were accompanied by a MA. Three journals accounted for 68 of 98 (69.4%) SRs. The percentage of SRs (relative to all reviews) has increased during the past decade (P = .01). SRs were more frequently published in high-impact journals (P <.001). CONCLUSION: The publication rate of SRs in CLS journals has increased during the past decade.

Clinical Laboratory Reference Intervals in Ethiopia: Current Status and Future Considerations: Review.

Background: Clinical laboratory reference intervals are derived from a sample of selected healthy population and they are used for disease diagnosis, management, and monitoring. International guidelines recommended that laboratories and manufacturers are supposed to establish their own RIs for a certain group of population. Therefore, the aim of this narrative review is to summarize the current status and to show future directions regarding reference intervals of clinical laboratory parameters among Ethiopian population. Methods: PubMed, Google Scholar, and Google databases were searched to access relevant reference interval studies in Ethiopia. Journal articles, guidelines, reports, and related documents published in English language were included without publication period restriction. Results: Fifteen studies were conducted to establish local reference intervals for hematology, immunology, and clinical chemistry parameters in Ethiopia from 1999 - 2018. The majority of those studies determined clinical laboratory reference intervals for adults only. Some other Ethiopian reference interval studies did not include the majority of routine hematology and clinical chemistry parameters. In addition, the studies we reviewed did not consider the cultural, ethnic, demographic, and geographical diversity of Ethiopian population. Conclusions: There is limited data regarding locally established reliable clinical laboratory reference intervals in Ethiopia though attempts are made. Therefore, further local reference interval studies should be undertaken considering the cultural, ethnic, demographical, and geographical diversity of the Ethiopian population.

El papel del laboratorio clínico en la medicina personalizada: situación actual y retos futuros / The role of the clinical laboratory in personalised medicine: Present situation and future challenges

La medicina personalizada, medicina de precisión o medicina individualizada ha sido definida como una manera de abordar el tratamiento y la prevención de las enfermedades en base a la variabilidad genética, ambiental y al estilo de vida de cada persona. Clasifica a los individuos en subpoblaciones que difieren en la susceptibilidad a desarrollar una enfermedad determinada o en la respuesta a un tratamiento específico, con el fin de aplicar el seguimiento y tratamiento más adecuado a cada paciente. La implementación de los procesos asociados a la Medicina Personalizada implica que los profesionales de laboratorio se enfrenten a una tecnología muy avanzada y poco conocida y a la dificultad de interpretación de los hallazgos, especialmente la valoración de su significación clínica. En este artículo se revisa la situación actual de la Medicina Personalizada, la función del laboratorio dentro de la misma y los retos que se deben afrontar

Personalised medicine, precision medicine, or individualised medicine has been defined as the way of preventing and treating diseases based on the genetic, environmental, and lifestyle variability for each individual. It classifies subjects into sub-populations that have different susceptibilities to develop a specific disease or to respond to a particular treatment. Its aim is to follow-up and treat each patient in the more suited to the patient. The establishment of the processes related to personalised medicine requires that specialists in Laboratory Medicine cope with cutting-edge, and little-known, technology with an interpretation that is highly complex from a clinical point of view. This review summarises the current situation of personalised medicine, the role of laboratory medicine in its implementation, and the challenges that need to be faced

[Medical biology in the face of the evolution of health care needs]. / Rapport des Académies nationales de médecine et de pharmacie sur la biologie médicale La biologie médicale face aux défis de l'évolution des besoins de santé.

Since the publication of the ordinance of January 13th 2010, ratified by the law of May 30th 2013, medical biology in France has undergone a massive restructuration with the emergence of groups of several hundred laboratories. This evolution, which leads to a considerable reduction in the number of structures, causes numerous problems related to increased industrialization and financialization, difficulties of accreditation and disappearance of the proximity link between the biologist and the prescriber or the patient. It also leads to a clear disaffection of students, especially medical students, for this specialty whose medical character has been clearly affirmed by the law. This report takes stock of the current situation of medical biology and makes recommendations to strengthen the role of the medical biologist in the health system and patients' care.