Clinical chemistry and laboratory medicine最新文献

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The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI): a meta-analysis. 血清血管生成素-2水平与急性肾损伤(AKI)之间的相关性:一项荟萃分析。
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2024-06-26 DOI: 10.1515/cclm-2024-0365
Juncheng Zhang, Zhengjie Huang, Qin Lin, Weiping Hu, Hongbin Zhong, Fengling Zhang, Jiyi Huang
{"title":"The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI): a meta-analysis.","authors":"Juncheng Zhang, Zhengjie Huang, Qin Lin, Weiping Hu, Hongbin Zhong, Fengling Zhang, Jiyi Huang","doi":"10.1515/cclm-2024-0365","DOIUrl":"https://doi.org/10.1515/cclm-2024-0365","url":null,"abstract":"<p><strong>Introduction: </strong>The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI) is a topic of significant clinical interest. This meta-analysis aims to provide a comprehensive evaluation of this relationship.</p><p><strong>Content: </strong>A systematic search was conducted in PubMed, Embase, Web of Science, and Cochrane databases up to October 11, 2023. The included studies were evaluated using the Newcastle-Ottawa Scale (NOS) and Methodological Index for Non-Randomized Studies (MINORS). Weighted mean differences (WMD) and odds ratios (OR) were calculated using random-effects models. Sensitivity analysis, funnel plots, and Egger's test were used to assess the robustness and publication bias of the findings. Subgroup analyses were performed to explore potential variations between adults and children.</p><p><strong>Summary: </strong>Eighteen studies encompassing a total of 7,453 participants were included. The analysis revealed a significant elevation in serum angiopoietin-2 levels in patients with AKI compared to those without (WMD: 4.85; 95 % CI: 0.75 to 0.27; I²=93.2 %, p<0.001). Subgroup analysis indicated significantly higher angiopoietin-2 levels in adults with AKI (WMD: 5.17; 95 % CI: 3.51 to 6.83; I²=82.6 %, p<0.001), but not in children. Additionally, high serum angiopoietin-2 levels were associated with an increased risk of AKI (OR: 1.58; 95 % CI: 1.39 to 1.8; I²=89.1 %, p<0.001). Sensitivity analysis validated the robustness of these results, showing no substantial change in the overall effect size upon the exclusion of individual studies.</p><p><strong>Outlook: </strong>This meta-analysis supports a significant association between elevated serum angiopoietin-2 levels and increased risk of AKI. The observed differential association between adults and children highlights the need for further targeted research to understand these age-specific variations.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141445774","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}
引用次数: 0
Blood self-sampling devices: innovation, interpretation and implementation in total lab automation. 血液自采样装置:实验室全面自动化的创新、解释和实施。
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2024-06-25 DOI: 10.1515/cclm-2024-0508
Dennis C W Poland, Christa M Cobbaert
{"title":"Blood self-sampling devices: innovation, interpretation and implementation in total lab automation.","authors":"Dennis C W Poland, Christa M Cobbaert","doi":"10.1515/cclm-2024-0508","DOIUrl":"https://doi.org/10.1515/cclm-2024-0508","url":null,"abstract":"<p><p>The introduction of the vacuum tube in 1949 revolutionized blood collection, significantly improving sample quality and patient comfort. Over the past 75 years, laboratory diagnostics have evolved drastically, from manual to automated processes, reducing required test volumes by over 1,000 times. Despite these advancements, venous blood collection presents logistical challenges, including centralized scheduling and a large volume of biological waste due to the imbalance between the needed blood volume (often very little) and the collected volume (often in excess). The COVID-19 pandemic further emphasized the need for decentralized healthcare solutions and patient empowerment. Capillary blood collection, widely used in point-of-care testing, offers a promising alternative, particularly for patients facing frequently, or difficulties with, venous sampling. The Leiden University Medical Center in the Netherlands experienced a 15 % reduction in volume of laboratory tests during and after the pandemic, attributed to patient preference for local blood collection and testing. To address these challenges, self-sampling devices are emerging, empowering patients and streamlining sample logistics. However, challenges such as cost, transportation regulations, and sample volume adequacy persists. Robust devices tailored for total lab automation and sustainable practices are crucial for widespread adoption. Despite hurdles, the integration of self-sampling into diagnostic processes is inevitable, heralding a shift towards patient-centered, proactive healthcare. Practical recommendations include robust device design, ease of use, affordability, sustainability, sufficient quality and acceptability by seamless integration into laboratory workflows. Although obstacles remain, self-sampling represents the future of laboratory diagnostics, offering convenience, cost-effectiveness, interoperability and patient empowerment.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141442205","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}
引用次数: 0
A falsely elevated blood alcohol concentration (BAC) related to an intravenous administration of phenytoin sodium. 与静脉注射苯妥英钠有关的血液酒精浓度(BAC)假性升高。
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2024-06-21 DOI: 10.1515/cclm-2024-0665
Laurent Leuger, Chadi Abbara, Antoine Baudriller, Xavier Dieu, Marie Briet, Guillaume Drevin
{"title":"A falsely elevated blood alcohol concentration (BAC) related to an intravenous administration of phenytoin sodium.","authors":"Laurent Leuger, Chadi Abbara, Antoine Baudriller, Xavier Dieu, Marie Briet, Guillaume Drevin","doi":"10.1515/cclm-2024-0665","DOIUrl":"https://doi.org/10.1515/cclm-2024-0665","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141436331","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}
引用次数: 0
Can we identify patients carrying targeted deleterious DPYD variants with plasma uracil and dihydrouracil? A GPCO-RNPGx retrospective analysis. 我们能否通过血浆尿嘧啶和二氢尿嘧啶来识别携带定向有害 DPYD 变体的患者?GPCO-RNPGx 回顾性分析。
IF 6.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2024-06-19 DOI: 10.1515/cclm-2024-0317
Manon Launay, Laure Raymond, Jérôme Guitton, Marie-Anne Loriot, Etienne Chatelut, Vincent Haufroid, Fabienne Thomas, Marie-Christine Etienne-Grimaldi
{"title":"Can we identify patients carrying targeted deleterious <i>DPYD</i> variants with plasma uracil and dihydrouracil? A GPCO-RNPGx retrospective analysis.","authors":"Manon Launay, Laure Raymond, Jérôme Guitton, Marie-Anne Loriot, Etienne Chatelut, Vincent Haufroid, Fabienne Thomas, Marie-Christine Etienne-Grimaldi","doi":"10.1515/cclm-2024-0317","DOIUrl":"https://doi.org/10.1515/cclm-2024-0317","url":null,"abstract":"<p><strong>Objectives: </strong>Dihydropyrimidine dehydrogenase (DPD) deficiency is the main cause of severe fluoropyrimidine-related toxicities. The best strategy for identifying DPD-deficient patients is still not defined. The EMA recommends targeted <i>DPYD</i> genotyping or uracilemia (U) testing. We analyzed the concordance between both approaches.</p><p><strong>Methods: </strong>This study included 19,376 consecutive French patients with pre-treatment plasma U, UH2 and targeted <i>DPYD</i> genotyping (*2A, *13, D949V, *7) analyzed at Eurofins Biomnis (2015-2022).</p><p><strong>Results: </strong>Mean U was 9.9 ± 10.1 ng/mL (median 8.7, range 1.6-856). According to French recommendations, 7.3 % of patients were partially deficient (U 16-150 ng/mL) and 0.02 % completely deficient (U≥150 ng/mL). <i>DPYD</i> variant frequencies were *2A: 0.83 %, *13: 0.17 %, D949V: 1.16 %, *7: 0.05 % (2 homozygous patients with U at 22 and 856 ng/mL). Variant carriers exhibited higher U (median 13.8 vs. 8.6 ng/mL), and lower UH2/U (median 7.2 vs. 11.8) and UH2/U<sup>2</sup> (median 0.54 vs. 1.37) relative to wild-type patients (p<0.00001). Sixty-six% of variant carriers exhibited uracilemia <16 ng/mL, challenging correct identification of DPD deficiency based on U. The sensitivity (% patients with a deficient phenotype among variant carriers) of U threshold at 16 ng/mL was 34 %. The best discriminant marker for identifying variant carriers was UH2/U<sup>2</sup>. UH2/U<sup>2</sup><0.942 (29.7 % of patients) showed enhanced sensitivity (81 %) in identifying deleterious genotypes across different variants compared to 16 ng/mL U.</p><p><strong>Conclusions: </strong>These results reaffirm the poor concordance between DPD phenotyping and genotyping, suggesting that both approaches may be complementary and that targeted <i>DPYD</i> genotyping is not sufficiently reliable to identify all patients with complete deficiency.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418192","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}
引用次数: 0
Consensus statement on extracellular vesicles in liquid biopsy for advancing laboratory medicine. 关于液体活检中细胞外囊泡的共识声明,以推动实验室医学的发展。
IF 6.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2024-06-19 DOI: 10.1515/cclm-2024-0188
Xingli Dong, Yusheng Lin, Kai Li, Gaofeng Liang, Xiaoyi Huang, Jingxuan Pan, Lu Wang, Dongmei Zhang, Tingjiao Liu, Tong Wang, Xiaomei Yan, Long Zhang, Xiaowu Li, Xiujuan Qu, Da Jia, Yong Li, Hao Zhang
{"title":"Consensus statement on extracellular vesicles in liquid biopsy for advancing laboratory medicine.","authors":"Xingli Dong, Yusheng Lin, Kai Li, Gaofeng Liang, Xiaoyi Huang, Jingxuan Pan, Lu Wang, Dongmei Zhang, Tingjiao Liu, Tong Wang, Xiaomei Yan, Long Zhang, Xiaowu Li, Xiujuan Qu, Da Jia, Yong Li, Hao Zhang","doi":"10.1515/cclm-2024-0188","DOIUrl":"https://doi.org/10.1515/cclm-2024-0188","url":null,"abstract":"<p><p>Extracellular vesicles (EVs) represent a diverse class of nanoscale membrane vesicles actively released by cells. These EVs can be further subdivided into categories like exosomes and microvesicles, based on their origins, sizes, and physical attributes. Significantly, disease-derived EVs have been detected in virtually all types of body fluids, providing a comprehensive molecular profile of their cellular origins. As a result, EVs are emerging as a valuable addition to liquid biopsy techniques. In this collective statement, the authors share their current perspectives on EV-related research and product development, with a shared commitment to translating this newfound knowledge into clinical applications for cancer and other diseases, particularly as disease biomarkers. The consensus within this document revolves around the overarching recognition of the merits, unresolved questions, and existing challenges surrounding EVs. This consensus manuscript is a collaborative effort led by the Committee of Exosomes, Society of Tumor Markers, Chinese anti-Cancer Association, aimed at expediting the cultivation of robust scientific and clinically applicable breakthroughs and propelling the field forward with greater swiftness and efficacy.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418193","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}
引用次数: 0
The role of functional vitamin D deficiency and low vitamin D reservoirs in relation to cardiovascular health and mortality. 功能性维生素 D 缺乏症和低维生素 D 储库在心血管健康和死亡率中的作用。
IF 6.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2024-06-19 DOI: 10.1515/cclm-2024-0391
Markus Herrmann, Martin H Keppel, Sieglinde Zelzer, Nerea Alonso, Etienne Cavalier, Marcus Kleber, Dietmar Enko, Hubert Scharnagl, Stefan Pilz, Winfried März
{"title":"The role of functional vitamin D deficiency and low vitamin D reservoirs in relation to cardiovascular health and mortality.","authors":"Markus Herrmann, Martin H Keppel, Sieglinde Zelzer, Nerea Alonso, Etienne Cavalier, Marcus Kleber, Dietmar Enko, Hubert Scharnagl, Stefan Pilz, Winfried März","doi":"10.1515/cclm-2024-0391","DOIUrl":"https://doi.org/10.1515/cclm-2024-0391","url":null,"abstract":"<p><strong>Objectives: </strong>The role of vitamin D deficiency in cardiovascular disease (CVD) is controversial. Inherent biological and analytical limitations compromise the specificity of widely used 25-hydroxyvitamin D [25(OH)D] cut-offs. Simultaneous determination of 25(OH)D and 24,25-dihydroxyvitamin D [24,25(OH)<sub>2</sub>D] permits a functional assessment of vitamin D metabolism. The present study compared the associations of functional vitamin D deficiency and low vitamin D reservoirs with CVD mortality and CVD burden.</p><p><strong>Methods: </strong>25(OH)D, 24,25(OH)<sub>2</sub>D, the degree of coronary obstruction on angiography, high-sensitive cardiac troponin T (hs-cTnT), N-terminal brain natriuretic peptide (NT-proBNP), and 10-year CVD mortality were obtained from 2,456 participants of the LURIC (Ludwigshafen Risk and Cardiovascular Health) study.</p><p><strong>Results: </strong>Neither low 25(OH)D concentrations nor functional vitamin D deficiency were associated with the number of atherosclerotic coronary arteries or the degree of coronary obstruction. Over a median follow-up of 9.9 years, 454 participants died (23.6 %) due to CVD. CVD mortality was doubled in individuals with 25(OH)D concentrations below the widely used cut-off for deficiency of <50 nmol/L [20 ng/mL] (21.6 vs. 11.5 %). In individuals with and without functional vitamin D deficiency, CVD mortality was 25.0 and 16.7 %, respectively. NT-proBNP and heart failure prevalence were also higher in vitamin D deficient individuals.</p><p><strong>Conclusions: </strong>Vitamin D deficient individuals have markedly higher CVD mortality, but only marginally higher hs-cTnT concentrations. A higher prevalence of heart failure and higher NT-proBNP concentrations suggest a link between vitamin D deficiency and cardiac function. The traditional and metabolic assessment of vitamin D status showed comparable associations for the different parameters of cardiac health.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418194","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}
引用次数: 0
Ethical Checklists for Clinical Research Projects and laboratory medicine: two tools to evaluate compliance with bioethical principles in different settings. 临床研究项目和实验室医学伦理核对表:评估不同环境下生物伦理原则遵守情况的两种工具。
IF 6.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2024-06-18 DOI: 10.1515/cclm-2024-0604
Julián Verona, Yilmaz Gülsen, Martina Zaninotto, Sody Munsaka, Nafija Serdarevic, Sudip K Datta, Joesph Wiencek, Nilda Fink
{"title":"Ethical Checklists for Clinical Research Projects and laboratory medicine: two tools to evaluate compliance with bioethical principles in different settings.","authors":"Julián Verona, Yilmaz Gülsen, Martina Zaninotto, Sody Munsaka, Nafija Serdarevic, Sudip K Datta, Joesph Wiencek, Nilda Fink","doi":"10.1515/cclm-2024-0604","DOIUrl":"https://doi.org/10.1515/cclm-2024-0604","url":null,"abstract":"<p><strong>Objectives: </strong>To develop two ethical checklists to evaluate (i) management of ethical concerns in research projects and (ii) awareness of ethical conduct of healthcare laboratory professionals.</p><p><strong>Methods: </strong>Comprehensive discussion among the members of IFCC Task Force on Ethics based on pertinent literature.</p><p><strong>Results: </strong>This Checklist for Clinical Research Projects should be useful to evaluate research proposals from an ethical perspective before submitting it to an IRB or its equivalent, thereby diminishing rejection rates and resulting in more time-effective projects. The checklist designed to evaluate the ethical conduct in laboratory medicine could be useful for self evaluation (internal audits) and for certification/accreditation processes performed by third parties.</p><p><strong>Conclusions: </strong>These checklists are simple but powerful tools useful to guide professionals to adhere to ethical principles in their practice, especially in developing countries where accredited ethics committees may be difficult to find.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141330518","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}
引用次数: 0
Point-of-care testing: state-of-the art and perspectives. 护理点检测:最新技术与展望。
IF 6.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2024-06-17 DOI: 10.1515/cclm-2024-0675
Mario Plebani, James H Nichols, Peter B Luppa, Dina Greene, Laura Sciacovelli, Julie Shaw, Adil I Khan, Paolo Carraro, Guido Freckmann, Wayne Dimech, Martina Zaninotto, Michael Spannagl, Jim Huggett, Gerald J Kost, Tommaso Trenti, Andrea Padoan, Annette Thomas, Giuseppe Banfi, Giuseppe Lippi
{"title":"Point-of-care testing: state-of-the art and perspectives.","authors":"Mario Plebani, James H Nichols, Peter B Luppa, Dina Greene, Laura Sciacovelli, Julie Shaw, Adil I Khan, Paolo Carraro, Guido Freckmann, Wayne Dimech, Martina Zaninotto, Michael Spannagl, Jim Huggett, Gerald J Kost, Tommaso Trenti, Andrea Padoan, Annette Thomas, Giuseppe Banfi, Giuseppe Lippi","doi":"10.1515/cclm-2024-0675","DOIUrl":"https://doi.org/10.1515/cclm-2024-0675","url":null,"abstract":"<p><p>Point-of-care testing (POCT) is becoming an increasingly popular way to perform laboratory tests closer to the patient. This option has several recognized advantages, such as accessibility, portability, speed, convenience, ease of use, ever-growing test panels, lower cumulative healthcare costs when used within appropriate clinical pathways, better patient empowerment and engagement, and reduction of certain pre-analytical errors, especially those related to specimen transportation. On the other hand, POCT also poses some limitations and risks, namely the risk of lower accuracy and reliability compared to traditional laboratory tests, quality control and connectivity issues, high dependence on operators (with varying levels of expertise or training), challenges related to patient data management, higher costs per individual test, regulatory and compliance issues such as the need for appropriate validation prior to clinical use (especially for rapid diagnostic tests; RDTs), as well as additional preanalytical sources of error that may remain undetected in this type of testing, which is usually based on whole blood samples (i.e., presence of interfering substances, clotting, hemolysis, etc.). There is no doubt that POCT is a breakthrough innovation in laboratory medicine, but the discussion on its appropriate use requires further debate and initiatives. This collective opinion paper, composed of abstracts of the lectures presented at the two-day expert meeting \"Point-Of-Care-Testing: State of the Art and Perspective\" (Venice, April 4-5, 2024), aims to provide a thoughtful overview of the state-of-the-art in POCT, its current applications, advantages and potential limitations, as well as some interesting reflections on the future perspectives of this particular field of laboratory medicine.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141330519","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}
引用次数: 0
Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems. 使用抽真空管的静脉采血系统:一项系统性综述,重点关注集成系统与组合系统的安全性、有效性和经济影响。
IF 6.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2024-06-17 DOI: 10.1515/cclm-2024-0460
Marta Rigoni, Francesco Tessarolo
{"title":"Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems.","authors":"Marta Rigoni, Francesco Tessarolo","doi":"10.1515/cclm-2024-0460","DOIUrl":"10.1515/cclm-2024-0460","url":null,"abstract":"<p><p>Venous blood collection systems (VBCSs) are combinations of <i>in-vitro</i> diagnostics and medical devices, usually available as integrated set. However, purchasing and using a combination of devices from different sets is considered by clinical laboratories as an option to achieve specific sampling tasks or reduce costs. This systematic review aimed to retrieve available evidence regarding safety, efficacy, and economic aspects of VBCSs, focusing on differences between integrated and combined systems. The literature review was carried out in PubMed. Cited documents and resources made available by scientific organisations were also screened. Extracted evidence was clustered according to Quality/Efficacy/Performance, Safety, and Costs/Procurement domains and discussed in the current European regulatory framework. Twenty documents published between 2010 and 2021 were included. There was no evidence to suggest equivalence between combined and integrated VBCSs in terms of safety and efficacy. Scientific society's consensus documents and product standards report that combined VBCS can impact operators' and patients' safety. Analytical performances and overall efficacy of combined VBCSs are not guaranteed without whole system validation and verification. EU regulatory framework clearly allocates responsibilities for the validation and verification of an integrated VBCS, but not for combined VBCSs, lacking information about the management of product nonconformities and post-market surveillance. Laboratory validation of combined VBCS demands risk-benefit and cost-benefit analyses, a non-negligible organisational and economic burden, and investment in knowledge acquisition. Implications in terms of laboratory responsibility and legal liability should be part of a comprehensive assessment of safety, efficacy, and cost carried out during device procurement.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327294","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}
引用次数: 0
Expert-level detection of M-proteins in serum protein electrophoresis using machine learning. 利用机器学习对血清蛋白电泳中的 M 蛋白进行专家级检测。
IF 6.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2024-06-17 DOI: 10.1515/cclm-2024-0222
Eike Elfert, Wolfgang E Kaminski, Christian Matek, Gregor Hoermann, Eyvind W Axelsen, Carsten Marr, Armin P Piehler
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