Federica D'Aurizio, Jürgen Kratzsch, Damien Gruson, Petra Petranović Ovčariček, Luca Giovanella
{"title":"Free thyroxine measurement in clinical practice: how to optimize indications, analytical procedures, and interpretation criteria while waiting for global standardization.","authors":"Federica D'Aurizio, Jürgen Kratzsch, Damien Gruson, Petra Petranović Ovčariček, Luca Giovanella","doi":"10.1080/10408363.2022.2121960","DOIUrl":"https://doi.org/10.1080/10408363.2022.2121960","url":null,"abstract":"<p><p>Thyroid dysfunctions are among the most common endocrine disorders and accurate biochemical testing is needed to confirm or rule out a diagnosis. Notably, true hyperthyroidism and hypothyroidism in the setting of a normal thyroid-stimulating hormone level are highly unlikely, making the assessment of free thyroxine (FT4) inappropriate in most new cases. However, FT4 measurement is integral in both the diagnosis and management of relevant central dysfunctions (central hypothyroidism and central hyperthyroidism) as well as for monitoring therapy in hyperthyroid patients treated with anti-thyroid drugs or radioiodine. In such settings, accurate FT4 quantification is required. Global standardization will improve the comparability of the results across laboratories and allow the development of common clinical decision limits in evidence-based guidelines. The International Federation of Clinical Chemistry and Laboratory Medicine Committee for Standardization of Thyroid Function Tests has undertaken FT4 immunoassay method comparison and recalibration studies and developed a reference measurement procedure that is currently being validated. However, technical and implementation challenges, including the establishment of different clinical decision limits for distinct patient groups, still remain. Accordingly, different assays and reference values cannot be interchanged. Two-way communication between the laboratory and clinical specialists is pivotal to properly select a reliable FT4 assay, establish reference intervals, investigate discordant results, and monitor the analytical and clinical performance of the method over time.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":"60 2","pages":"101-140"},"PeriodicalIF":10.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9340485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Metabolomics of asthma, COPD, and asthma-COPD overlap: an overview.","authors":"Sanjukta Dasgupta, Nilanjana Ghosh, Parthasarathi Bhattacharyya, Sushmita Roy Chowdhury, Koel Chaudhury","doi":"10.1080/10408363.2022.2140329","DOIUrl":"https://doi.org/10.1080/10408363.2022.2140329","url":null,"abstract":"<p><p>The two common progressive lung diseases, asthma and chronic obstructive pulmonary disease (COPD), are the leading causes of morbidity and mortality worldwide. Asthma-COPD overlap, referred to as ACO, is another complex pulmonary disease that manifests itself with features of both asthma and COPD. The disease has no clear diagnostic or therapeutic guidelines, thereby making both diagnosis and treatment challenging. Though a number of studies on ACO have been documented, gaps in knowledge regarding the pathophysiologic mechanism of this disorder exist. Addressing this issue is an urgent need for improved diagnostic and therapeutic management of the disease. Metabolomics, an increasingly popular technique, reveals the pathogenesis of complex diseases and holds promise in biomarker discovery. This comprehensive narrative review, comprising 99 original research articles in the last five years (2017-2022), summarizes the scientific advances in terms of metabolic alterations in patients with asthma, COPD, and ACO. The analytical tools, nuclear magnetic resonance (NMR), gas chromatography-mass spectrometry (GC-MS), and liquid chromatography-mass spectrometry (LC-MS), commonly used to study the expression of the metabolome, are discussed. Challenges frequently encountered during metabolite identification and quality assessment are highlighted. Bridging the gap between phenotype and metabotype is envisioned in the future.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":"60 2","pages":"153-170"},"PeriodicalIF":10.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9334352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Päivi Lakkisto, Louise Torp Dalgaard, Thalia Belmonte, Sara-Joan Pinto-Sietsma, Yvan Devaux, David de Gonzalo-Calvo
{"title":"Development of circulating microRNA-based biomarkers for medical decision-making: a friendly reminder of what should NOT be done.","authors":"Päivi Lakkisto, Louise Torp Dalgaard, Thalia Belmonte, Sara-Joan Pinto-Sietsma, Yvan Devaux, David de Gonzalo-Calvo","doi":"10.1080/10408363.2022.2128030","DOIUrl":"https://doi.org/10.1080/10408363.2022.2128030","url":null,"abstract":"<p><p>Circulating cell-free microRNAs (miRNAs) represent a major reservoir for biomarker discovery. Unfortunately, their implementation in clinical practice is limited due to a profound lack of reproducibility. The great technical variability linked to major pre-analytical and analytical caveats makes the interpretation of circulating cell-free miRNA data challenging and leads to inconsistent findings. Additional efforts directed to standardization are fundamental. Several well-established protocols are currently used by independent groups worldwide. Nonetheless, there are some specific aspects in specimen collection and processing, sample handling, miRNA quantification, and data analysis that should be considered to ensure reproducibility of results. Here, we have addressed this challenge using an alternative approach. We have highlighted and discussed common pitfalls that negatively impact the robustness of circulating miRNA quantification and their application for clinical decision-making. Furthermore, we provide a checklist usable by investigators to facilitate and ensure the control of the whole miRNA quantification and analytical process. We expect that these recommendations improve the reproducibility of findings, and ultimately, facilitate the incorporation of circulating miRNA profiles into clinical practice as the next generation of disease biomarkers.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":"60 2","pages":"141-152"},"PeriodicalIF":10.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9397688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nadia Güell, Pablo Mozas, Alba Jimenez-Rueda, Milos Miljkovic, Jordi Juncà, Marc Sorigue
{"title":"Methodological and conceptual challenges to the flow cytometric classification of leukemic lymphoproliferative disorders.","authors":"Nadia Güell, Pablo Mozas, Alba Jimenez-Rueda, Milos Miljkovic, Jordi Juncà, Marc Sorigue","doi":"10.1080/10408363.2022.2114418","DOIUrl":"https://doi.org/10.1080/10408363.2022.2114418","url":null,"abstract":"<p><p>The diagnosis of leukemic B-cell lymphoproliferative disorders (B-LPDs) is made by integrating clinical, cytological, cytometric, cytogenetic, and molecular data. This leaves room for differences and inconsistencies between experts. In this study, we examine methodological and conceptual aspects of the flow cytometric classification of leukemic B-LPDs that could explain them. Among methodological aspects, we discuss (1) the different statistical tests used to select and evaluate markers, (2) how these markers are analyzed, (3) how scores are interpreted, (4) different degrees to which diagnostic information is used, and (5) and the impact of differences in study populations. Among conceptual aspects, we discuss (1) challenges to integrating different biological data points, (2) the under examination of the costs of misclassification (false positives and false negatives), and finally, (3) we delve into the impact of the lack of a true diagnostic gold standard and the indirect evidence suggesting poor reproducibility in the diagnosis of leukemic B-LPDs. We then outline current harmonization efforts and our personal approach. We conclude that numerous flow cytometry scores and diagnostic systems are now available; however, as long as the considerations discussed remain unaddressed, external reproducibility and interobserver agreement will not be achieved, and the field will not be able to move forward if a true gold standard is not found.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":"60 2","pages":"83-100"},"PeriodicalIF":10.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9710703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vinita Thakur, Olatunji Anthony Akerele, Edward Randell
{"title":"Lean and Six Sigma as continuous quality improvement frameworks in the clinical diagnostic laboratory.","authors":"Vinita Thakur, Olatunji Anthony Akerele, Edward Randell","doi":"10.1080/10408363.2022.2106544","DOIUrl":"https://doi.org/10.1080/10408363.2022.2106544","url":null,"abstract":"<p><p>Processes to enhance customer-related services in healthcare organizations are complex and it can be difficult to achieve efficient patient-focused services. Laboratories make an integral part of the healthcare service industry where healthcare providers deal with critical patient results. Errors in these processes may cost a human life, create a negative impact on an organization's reputation, cause revenue loss, and open doors for expensive lawsuits. To overcome these complexities, healthcare organizations must implement an approach that helps healthcare service providers to reduce waste, variation, and work imbalance in the service processes. Lean and Six Sigma are used as continuous process improvement frameworks in laboratory medicine. Six Sigma uses an approach that involves problem-solving, continuous improvement and quantitative statistical process control. Six Sigma is a technique based on the DMAIC process (Define, Measure, Analyze, Improve, and Control) to improve quality performance. Application of DMAIC in a healthcare organization provides guidance on how to handle quality that is directed toward patient satisfaction in a healthcare service industry. The Lean process is a technique for process management in which waste reduction is the primary purpose; this is accomplished by implementing waste mitigation practices and methodologies for quality improvement. Overall, this article outlines the frameworks for continuous quality and process improvement in healthcare organizations, with a focus on the impacts of Lean and Six Sigma on the performance and quality service delivery system in clinical laboratories. It also examines the role of utilization management and challenges that impact the implementation of Lean and Six Sigma in clinical laboratories.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":"60 1","pages":"63-81"},"PeriodicalIF":10.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9396906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"DropWise: current role and future perspectives of dried blood spots (DBS), blood microsampling, and their analysis in sports drug testing.","authors":"M Thevis, Katja Walpurgis, A Thomas","doi":"10.1080/10408363.2022.2103085","DOIUrl":"https://doi.org/10.1080/10408363.2022.2103085","url":null,"abstract":"<p><p>For decades, blood testing has been an integral part of routine doping controls. The breadth of information contained in blood samples has become considerably more accessible for anti-doping purposes over the last 10 years through technological advancements regarding analytical instrumentation as well as enhanced sample collection systems. Particularly, microsampling of whole blood and serum, for instance as dried blood spots (DBS), has opened new avenues in sports drug testing and substantially increased the availability and cost-effectiveness of doping control specimens. Thus, microvolume blood specimens possess the potential to improve monitoring of blood hormone and drug levels, support evaluation of circulating drug concentrations in competition, and enhance the stability of labile markers and target analytes in blood passport analyses as well as peptide hormone and steroid ester detection. Further, the availability of the fraction of lysed erythrocytes for anti-doping purposes warrants additional investigation, considering the sequestering capability of red blood cells (RBCs) for certain substances, as a complementary approach in support of the clean sport.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":"60 1","pages":"41-62"},"PeriodicalIF":10.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9334296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sophie Steels, Marijke Proesmans, Xavier Bossuyt, Lieven Dupont, Glynis Frans
{"title":"Laboratory biomarkers in the diagnosis and follow-up of treatment of allergic bronchopulmonary aspergillosis in cystic fibrosis.","authors":"Sophie Steels, Marijke Proesmans, Xavier Bossuyt, Lieven Dupont, Glynis Frans","doi":"10.1080/10408363.2022.2101612","DOIUrl":"https://doi.org/10.1080/10408363.2022.2101612","url":null,"abstract":"<p><p>Allergic bronchopulmonary aspergillosis (ABPA), a severe inflammatory respiratory disease, is caused by a hypersensitivity reaction to the colonization of the airways with <i>Aspergillus fumigatus</i>. 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.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":"60 1","pages":"1-24"},"PeriodicalIF":10.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9696076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dorsa Sohaei, Morley Hollenberg, Sok-Ja Janket, Eleftherios P Diamandis, Gennady Poda, Ioannis Prassas
{"title":"The therapeutic relevance of the Kallikrein-Kinin axis in SARS-cov-2-induced vascular pathology.","authors":"Dorsa Sohaei, Morley Hollenberg, Sok-Ja Janket, Eleftherios P Diamandis, Gennady Poda, Ioannis Prassas","doi":"10.1080/10408363.2022.2102578","DOIUrl":"https://doi.org/10.1080/10408363.2022.2102578","url":null,"abstract":"<p><p>While coronavirus disease 2019 (COVID-19) begins as a respiratory infection, it progresses as a systemic disease involving multiorgan microthromboses that underly the pathology. SARS-CoV-2 enters host cells <i>via</i> attachment to the angiotensin-converting enzyme 2 (ACE2) receptor. ACE2 is widely expressed in a multitude of tissues, including the lung (alveolar cells), heart, intestine, kidney, testis, gallbladder, vasculature (endothelial cells), and immune cells. Interference in ACE2 signaling could drive the aforementioned systemic pathologies, such as endothelial dysfunction, microthromboses, and systemic inflammation, that are typically seen in patients with severe COVID-19. ACE2 is a component of the renin-angiotensin system (RAS) and is intimately associated with the plasma kallikrein-kinin system (KKS). As many papers are published on the role of ACE and ACE2 in COVID-19, we will review the role of bradykinin, and more broadly the KSS, in SARS-CoV-2-induced vascular dysfunction. Furthermore, we will discuss the possible therapeutic interventions that are approved and in development for the following targets: coagulation factor XII (FXII), tissue kallikrein (KLK1), plasma kallikrein (KLKB1), bradykinin (BK), plasminogen activator inhibitor (PAI-1), bradykinin B1 receptor (BKB1R), bradykinin B2 receptor (BKB2R), ACE, furin, and the NLRP3 inflammasome. Understanding these targets may prove of value in the treatment of COVID-19 as well as in other virus-induced coagulopathies in the future.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":"60 1","pages":"25-40"},"PeriodicalIF":10.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9341058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jiří Janoušek, Veronika Pilařová, Kateřina Macáková, Anderson Nomura, Jéssica Veiga-Matos, Diana Dias da Silva, Fernando Remião, Luciano Saso, Kateřina Malá-Ládová, Josef Malý, Lucie Nováková, Přemysl Mladěnka
{"title":"Vitamin D: sources, physiological role, biokinetics, deficiency, therapeutic use, toxicity, and overview of analytical methods for detection of vitamin D and its metabolites.","authors":"Jiří Janoušek, Veronika Pilařová, Kateřina Macáková, Anderson Nomura, Jéssica Veiga-Matos, Diana Dias da Silva, Fernando Remião, Luciano Saso, Kateřina Malá-Ládová, Josef Malý, Lucie Nováková, Přemysl Mladěnka","doi":"10.1080/10408363.2022.2070595","DOIUrl":"https://doi.org/10.1080/10408363.2022.2070595","url":null,"abstract":"<p><p>Vitamin D has a well-known role in the calcium homeostasis associated with the maintenance of healthy bones. It increases the efficiency of the intestinal absorption of dietary calcium, reduces calcium losses in urine, and mobilizes calcium stored in the skeleton. However, vitamin D receptors are present ubiquitously in the human body and indeed, vitamin D has a plethora of non-calcemic functions. In contrast to most vitamins, sufficient vitamin D can be synthesized in human skin. However, its production can be markedly decreased due to factors such as clothing, sunscreens, intentional avoidance of the direct sunlight, or the high latitude of the residence. Indeed, more than one billion people worldwide are vitamin D deficient, and the deficiency is frequently undiagnosed. The chronic deficiency is not only associated with rickets/osteomalacia/osteoporosis but it is also linked to a higher risk of hypertension, type 1 diabetes, multiple sclerosis, or cancer. Supplementation of vitamin D may be hence beneficial, but the intake of vitamin D should be under the supervision of health professionals because overdosing leads to intoxication with severe health consequences. For monitoring vitamin D, several analytical methods are employed, and their advantages and disadvantages are discussed in detail in this review.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":"59 8","pages":"517-554"},"PeriodicalIF":10.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10615445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Technical quality assurance and quality control for medical laboratories: a review and proposal of a new concept to obtain integrated and validated QA/QC plans.","authors":"Huub H van Rossum","doi":"10.1080/10408363.2022.2088685","DOIUrl":"https://doi.org/10.1080/10408363.2022.2088685","url":null,"abstract":"<p><p>Technical quality assurance (QA) and quality control (QA/QC) are important activities within medical laboratories to ensure the adequate quality of obtained test results. QA/QC tools available at medical laboratories include external QC and internal QC, patient-based real-time quality control (PBRTQC) tools such as moving average quality control (MAQC), limit checks, delta checks, and multivariate checks, and finally, analyzer flagging. Recently, for PBRTQC tools, new optimization and validation methods based on error detection simulation have been developed to obtain laboratory-specific insights into PBRTQC error detection. These developments have enabled implementation and application of these individual tools in routine clinical practice. As a next step, they also enable performance comparison of the individual QA/QC tools and integration of all the individual QA/QC tools in order to obtain the most powerful and efficient QA/QC plans. In this review, a brief overview of the individual QA/QC tools and their characteristics is provided and the error detection simulation approaches are explained. Finally, a new concept entitled integrated quality assurance and control (IQAC) is presented. To enable IQAC, a conceptual framework is suggested and demonstrated for sodium, based on available published data. The proposed IQAC framework provides ways and tools by which the performance of different QA/QC tools can be compared in a so-called QA/QC error detection table to enable optimization and validation of the overall QA/QC plan in terms of alarm rate as well as pre-analytical, analytical, and post-analytical error detection performance.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":"59 8","pages":"586-600"},"PeriodicalIF":10.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10668719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}