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Analytical performance specifications (APS) are used for the quantitative assessment of assay analytical performance, with the aim of providing information appropriate for clinical care of patients. One of the major locations where APS are used is in the routine clinical laboratory. These may be used to assess and monitor assays in a range of settings including method selection, method verification or validation, external quality assurance, internal quality control and assessment of measurement uncertainty. The aspects of assays that may be assessed include imprecision, bias, selectivity, sample type, analyte stability and interferences. This paper reviews the practical use of APS in a routine clinical laboratory, using the laboratory I supervise as an example. [ABSTRACT FROM AUTHOR]

The clinical laboratory is often evaluated for the volume of testing. However, it is undeniable that laboratory tests affect clinical decision-making and are included in many clinical guidelines, meaning their contribution to determining clinical outcomes. Therefore, the clinical laboratory professional has the task of enhancing laboratory tests by optimizing the request and reporting phase and addressing patient outcomes. This opinion paper, presenting practical examples of managing value-based health care in the clinical laboratory context, underlines the need to shift towards value-based management to optimize outcome-based health care. [ABSTRACT FROM AUTHOR]

Following the COVID-19 pandemic, the concepts of value-based medicine (VBM) and value-based laboratory medicine (VBLM) are receiving increasing interest to improve the quality, sustainability and safety of healthcare. Laboratory medicine is well positioned to support the transition to value-based healthcare as it helps to improve clinical outcomes and healthcare sustainability by reducing the time to diagnosis, improving diagnostic accuracy, providing effective guidance for tailored therapies and monitoring, and supporting screening and wellness care. However, the perception of the value of laboratory medicine is still limited, to the extent that it has been defined a “profession without a face”, often lacking visibility to patients and the public. In addition, in recent decades, clinical laboratories have sought to improve the ration between outcomes and costs by increasing efficiency and reducing the cost per test rather than improving clinical outcomes. The aim of this paper is to propose a 10-point manifesto for implementing value-based laboratory medicine in clinical practice. [ABSTRACT FROM AUTHOR]

Over the past decades, liquid biopsy, especially circulating tumor DNA (ctDNA), has received tremendous attention as a noninvasive detection approach for clinical applications, including early diagnosis of cancer and relapse, real-time therapeutic efficacy monitoring, potential target selection and investigation of drug resistance mechanisms. In recent years, the application of next-generation sequencing technology combined with AI technology has significantly improved the accuracy and sensitivity of liquid biopsy, enhancing its potential in solid tumors. However, the increasing integration of such promising tests to improve therapy decision making by oncologists still has complexities and challenges. Here, we propose a conceptual framework of ctDNA technologies and clinical utilities based on bibliometrics and highlight current challenges and future directions, especially in clinical applications such as early detection, minimal residual disease detection, targeted therapy, and immunotherapy. We also discuss the necessities of developing a dynamic field of translational cancer research and rigorous clinical studies that may support therapeutic strategy decision making in the near future. [ABSTRACT FROM AUTHOR]

To explore the usefulness of neutrophil-to-lymphocyte count ratio (NLR), procalcitonin (PCT), and interleukin-6 (IL-6) for the severity assessment of bacterial sepsis. This study enrolled 100 patients with bacterial sepsis (disease group) who presented to Jinhua Central Hospital between March 2022 and March 2023 and 90 healthy individuals (control group). The patients were categorized into sepsis (64 cases), severe sepsis (18 cases), and septic shock (18 cases) groups according to the disease severity. The groups were compared in terms of the NLR, PCT, and IL-6, as well as the usefulness of these parameters, both alone and in combination, for the severity assessment of bacterial sepsis. The NLR, PCT, and IL-6 levels were significantly different among the three groups, with increasing values corresponding with disease aggravation. The area under the curve (AUC) values of the combinations of NLR, PCT, and IL-6 levels were higher than those of single markers. The sensitivity and AUC value of the combination of PCT and IL-6 levels were the highest (0.87), with a similar AUC value of the combination of NLR, PCT, and IL-6 (0.865); however, the specificity was significantly improved with the latter (0.938 vs. 0.859). NLR, PCT, and IL-6 levels are significantly increased in bacterial sepsis, and the combination of PCT, and IL-6 levels can improve the sensitivity of the evaluation ability for severe sepsis, and is more economical. [ABSTRACT FROM AUTHOR]

Immune checkpoint inhibitors (ICIs) promote antitumour immune responses by blocking inhibitory signals expressed by T cells and have significant clinical benefits in the treatment of oral squamous cell carcinoma (OSCC). With the advancement of immunotherapy, an increasing number of ICIs have been developed or are in clinical trial stages. However, drug resistance and immune-related adverse events (irAEs) associated with ICIs have limited the clinical application of immunotherapy in OSCC, and the optimal drug regimen for ICIs and the optimal duration of ICIs administration also deserves to be further discussed. New therapeutic regimens and drug delivery technologies are key to promoting the further development of ICIs. This article elucidates the mechanism of ICIs' action and presents a review of their clinical applications and current development status in OSCC. Additionally, it summarizes the current challenges and outlines future research directions for ICIs therapy, with the aim of offering fresh insights to researchers. [ABSTRACT FROM AUTHOR]

In addition to the correct implementation of calibration traceability, the definition and fulfillment of maximum allowable measurement uncertainty (MAU) are essential in assuring that laboratory measurements are clinically usable. Across the entire calibration hierarchy, three major contributors to the measurement uncertainty (MU) budget are identified, starting with the higher-order reference providers, extending through the in vitro diagnostic (IVD) manufacturers and their processes for assigning calibrator values, and ending with medical laboratories generating the random variability of results reported to clinicians. To understand if it is possible to achieve MAU and, consequently, to fix the possible drawbacks, the definition of combined MU budget limits across the entire calibration hierarchy has a central role. In particular, quality specifications for MU of reference and commercial calibrator materials should be defined according to the MAU on clinical samples. All involved stakeholders (i.e., higher-order reference providers, IVD manufacturers, medical laboratories) should be prepared to improve their performance whenever the clinical application of the test is made questionable by the failure to achieve MAU. [ABSTRACT FROM AUTHOR]

This document provides information on the Thirteenth International Symposium on Molecular Diagnostics, which will take place in Graz, Austria in June 2024. It covers various topics related to laboratory medicine, including the new EU regulation on in vitro diagnostic medical devices, the importance of external quality assessment schemes in the context of COVID-19, and the use of molecular 'liquid biopsies' in prenatal screening and enterovirus detection. The document also explores topics such as gynecology, sexually transmitted infections, telomere shortening, epigenetic changes, and the development of diagnostic platforms and encapsulation technology for living cells. Additionally, it discusses the validation and implementation of molecular assays for the detection and quantification of pathogens, as well as various research studies conducted in different fields. [Extracted from the article]

As a cover term for the negotiation of propositional information and reader engagement, metadiscourse has gained considerable attention from scholars of academic discourse. Recent studies have extended to previously unexplored structures that realize metadiscourse, such as 'metadiscursive nouns' (Jiang and Hyland 2018. Nouns and academic interactions: A neglected feature of metadiscourse. Applied Linguistics 39. 508–531). Among various linguistic resources, verbs are often regarded as a linguistic element undertaking multiple discourse acts and functions in different contexts, with some acts and functions being metadiscursive. Based on previous studies on reporting verbs and functional sentence stems, this study proposes the concept of metadiscursive verb patterns (MVPs) and examines this linguistic resource in a self-built MedDEAP corpus of five million words, a clinical medicine English research article corpus consisting of 18 sub-disciplines. We conducted an intradisciplinary investigation into MVPs to analyze their structural and functional variations across the sub-disciplines of medical academic English. The findings revealed that most MVPs exhibit a preference for some sub-disciplines, and a few sub-disciplines reflect certain characteristic genre features in the use of certain MVPs. It is shown that medical academic discourse is characterized by methodological and conceptual cross-fertilization. Hence, variation in MVPs is a natural linguistic representation of interdisciplinary synergy. Based on our findings, we conclude by addressing the pedagogical implications for proper use of MVPs in academic writing. [ABSTRACT FROM AUTHOR]