Clinical chemistry and laboratory medicine最新文献_第9页

Enhanced patient-based real-time quality control using the graph-based anomaly detection. 利用基于图形的异常检测，加强基于患者的实时质量控制。

IF 6.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2024-05-16 DOI: 10.1515/cclm-2024-0124

Xueling Shang, Minglong Zhang, Dehui Sun, Yufang Liang, Tony Badrick, Yanwei Hu, Qingtao Wang, Rui Zhou

{"title":"Enhanced patient-based real-time quality control using the graph-based anomaly detection.","authors":"Xueling Shang, Minglong Zhang, Dehui Sun, Yufang Liang, Tony Badrick, Yanwei Hu, Qingtao Wang, Rui Zhou","doi":"10.1515/cclm-2024-0124","DOIUrl":"https://doi.org/10.1515/cclm-2024-0124","url":null,"abstract":"Objectives: Patient-based real-time quality control (PBRTQC) is an alternative tool for laboratories that has gained increasing attention. Despite the progress made by using various algorithms, the problems of data volume imbalance between in-control and out-of-control results, as well as the issue of variation remain challenges. We propose a novel integrated framework using anomaly detection and graph neural network, combining clinical variables and statistical algorithms, to improve the error detection performance of patient-based quality control.Methods: The testing results of three representative analytes (sodium, potassium, and calcium) and eight independent variables of patients (test date, time, gender, age, department, patient type, and reference interval limits) were collected. Graph-based anomaly detection network was modeled and used to generate control limits. Proportional and random errors were simulated for performance evaluation. Five mainstream PBRTQC statistical algorithms were chosen for comparison.Results: The framework of a patient-based graph anomaly detection network for real-time quality control (PGADQC) was established and proven feasible for error detection. Compared with classic PBRTQC, the PGADQC showed a more balanced performance for both positive and negative biases. For different analytes, the average number of patient samples until error detection (ANPed) of PGADQC decreased variably, and reductions could reach up to approximately 95 % at a small bias of 0.02 taking calcium as an example.Conclusions: The PGADQC is an effective framework for patient-based quality control, integrating statistical and artificial intelligence algorithms. It improves error detection in a data-driven fashion and provides a new approach for PBRTQC from the data science perspective.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140943765","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 final part of the CRESS trilogy - how to evaluate the quality of stability studies. CRESS 三部曲的最后一部分--如何评估稳定性研究的质量。

IF 6.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2024-05-16 DOI: 10.1515/cclm-2024-0527

Michael Cornes, Pieter Vermeersch, Ana-Maria Šimundić, Alexander Von Meyer, Tomáš Šálek, Brendan Meyer, Sean Costelloe, Vincent De Guire, Ruben Gomez-Rioja, Janne Cadamuro

{"title":"The final part of the CRESS trilogy - how to evaluate the quality of stability studies.","authors":"Michael Cornes, Pieter Vermeersch, Ana-Maria Šimundić, Alexander Von Meyer, Tomáš Šálek, Brendan Meyer, Sean Costelloe, Vincent De Guire, Ruben Gomez-Rioja, Janne Cadamuro","doi":"10.1515/cclm-2024-0527","DOIUrl":"https://doi.org/10.1515/cclm-2024-0527","url":null,"abstract":"High quality laboratory results are critical for patient management. However, poor sample quality can impact these results and patient safety. To ensure reliable and accurate results laboratories must be aware of each analyte's stability under various storage conditions and matrices to guarantee correct and dependable outcomes. This knowledge allows laboratories to define the allowable delay between sample collection and centrifugation/analysis for all analytes to guarantee appropriate results quality and interpretation. The EFLM WG-PRE therefore established a 4-step plan to tackle this issue, aiming to standardize and harmonize stability studies for improved comparison and meta-analysis. The plan included the development of checklists and how-to guides for performing and reporting stability studies as well as a central resource of stability data. This manuscript deals with the issue of evaluating publications and incorporating them into a central resource. To evaluate stability studies, the CRESS checklist was used to structure 20 sections used to judge the quality of studies. Each section has 4 levels of quality, with scores converted to numerical values and weighted based on expert opinion. Based on this, a final score ranging from A to D was determined. The procedure was then tested on six manuscripts and checked for agreement between expert judgements. The results demonstrated that the proposed evaluation process is a useful tool to distinguish between best in class manuscripts and those of lower quality. The EFLM WG-PRE strongly believes that the provided recommendations and checklists will help improving stability studies both in quality and standardisation.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140920702","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

Navigating the path of reproducibility in microRNA-based biomarker research with ring trials. 利用环形试验为基于 microRNA 的生物标记物研究的可重复性导航。

IF 6.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2024-05-16 DOI: 10.1515/cclm-2024-0531

Miron Sopić, Yvan Devaux, David de Gonzalo-Calvo

引用次数: 0

Validation of the enhanced liver fibrosis (ELF)-test in heparinized and EDTA plasma for use in reflex testing algorithms for metabolic dysfunction-associated steatotic liver disease (MASLD). 验证肝素化血浆和乙二胺四乙酸（EDTA）血浆中的肝纤维化（ELF）增强检测，用于代谢功能障碍相关性脂肪性肝病（MASLD）的反射检测算法。

IF 6.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2024-05-15 DOI: 10.1515/cclm-2024-0470

Koen C van Son, Anne-Marieke van Dijk, Stan Driessen, Anne Linde Mak, Julia J Witjes, Veera A T Houttu, Diona Zwirs, Max Nieuwdorp, Bert-Jan H van den Born, Johan C Fischer, Maarten E Tushuizen, Joost P H Drenth, Henrike M Hamer, Ulrich H W Beuers, Joanne Verheij, Adriaan Georgius Holleboom

引用次数: 0

Comparison of a two-step Tempus600 hub solution single-tube vs. container-based, one-step pneumatic transport system. 两步式 Tempus600 集线器解决方案单管与集装箱式一步式气动运输系统的比较。

IF 6.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2024-05-15 DOI: 10.1515/cclm-2024-0057

Marc Luginbühl, Kathrin Frey, Joanna Gawinecka, Arnold von Eckardstein, Lanja Saleh

{"title":"Comparison of a two-step Tempus600 hub solution single-tube vs. container-based, one-step pneumatic transport system.","authors":"Marc Luginbühl, Kathrin Frey, Joanna Gawinecka, Arnold von Eckardstein, Lanja Saleh","doi":"10.1515/cclm-2024-0057","DOIUrl":"https://doi.org/10.1515/cclm-2024-0057","url":null,"abstract":"Objectives: Efficient and timely transportation of clinical samples is pivotal to ensure accurate diagnoses and effective patient care. During the transportation process, preservation of sample integrity is crucial to avoid pre-analytical aberrations on laboratory results. Here, we present a comparative analysis between a two-step Tempus600 hub solution single-tube and a one-step, container-based pneumatic transport system (PTS) from Airco, for the in-house transportation of blood samples.Methods: Ten blood samples from healthy volunteers were split in 10 mL collection tubes filled at full or half capacity for transportation with the two PTS (about 250 m). To compare the impact of transportation, markers of hemolysis such as lactate dehydrogenase (LDH), potassium (K+), and the hemolysis index (HI), were determined. Additionally, differences in HI in routine samples and repeated transportation was investigated. To assess and compare the mechanistic impact profiles, we recorded the acceleration profiles of the two PTS using a shock data logger.Results: Transportation using the Tempus600 hub solution resulted in 49 and 46 % higher HI with samples filled to total or half capacity, respectively. Routine samples transported with the Tempus600 hub solution showed a higher median HI by 23 and 33 %. Additionally, shock logger analysis showed an elevated amount of shocks (6.5 fold) and shock intensities (1.8 fold).Conclusions: The Tempus600 hub solution caused an increased number of unreportable LDH or K+ results based on the hemolysis index. However, it was only statistically significant for LDH (p<0.01 and p<0.08) - while the comparisons for K+ were not statistically significant (p<0.28 and p<0.56).","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140915858","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

Using Bland-Altman plot-based harmonization algorithm to optimize the harmonization for immunoassays. 使用基于 Bland-Altman 图的协调算法优化免疫测定的协调。

IF 6.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2024-05-15 DOI: 10.1515/cclm-2024-0187

Huiling Fang, Ruifeng Yang, Jiayue Guo, Xinxin Ren, Xin Chang, Lan Kang, Yuqing Zhu

{"title":"Using Bland-Altman plot-based harmonization algorithm to optimize the harmonization for immunoassays.","authors":"Huiling Fang, Ruifeng Yang, Jiayue Guo, Xinxin Ren, Xin Chang, Lan Kang, Yuqing Zhu","doi":"10.1515/cclm-2024-0187","DOIUrl":"https://doi.org/10.1515/cclm-2024-0187","url":null,"abstract":"Objectives: Harmonization has been recommended by the International Organization for Standard (ISO) to achieve equivalent results across in vitro diagnostic measurement devices (IVD-MDs). We aim to evaluate the effectiveness of Bland-Altman plot-based harmonization algorithm (BA-BHA) created in this study and compare it with weighted Deming regression-based harmonization algorithm (WD-BHA) proposed in ISO 21151:2020.Methods: Eighty patient sera were used as the harmonization reference material (HRM) to develop IVD-MD-specific harmonization algorithms. Another panel of 40 patient sera was used to validate the effectiveness of harmonization algorithms. We compared regression slopes, intercepts, Bland-Altman plot layouts, percent differences, limits of agreement (LoAs), between-method coefficients of variation (CV) before and after harmonization.Results: After harmonization by WD-BHA, acceptable slopes and intercepts between measured values and HRM targets were observed in weighted Deming regression, but not in Passing-Bablok analysis. Mean differences were -5.5 to 5.0 % and differences at specific levels were -33.9 to 23.9 %. LoAs were -64.6 to 74.6 %. Between-method CV was 22.9 % (±12.9 %). However, after harmonization by BA-BHA, both weighted Deming and Passing-Bablok regressions equations presented harmonized results. Mean differences were -0.3 to 0.2 % and differences at specific levels were -1.1 to 1.6 %. LoAs were -23.3 to 23.2 %. Between-method CV was 8.4 % (±4.0 %). The data points were evenly distributed at both sides of the mean in Bland-Altman plots.Conclusions: The inequivalence of test results between different methods can be improved but unacceptable analytical differences at specific levels may be hidden in terms of an acceptable slope and intercept on WD-BHA. The new protocol BA-BHA may be a viable alternative to optimize the harmonization for immunoassays.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140920704","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

Interaction of heparin with human cardiac troponin complex and its influence on the immunodetection of troponins in human blood samples. 肝素与人心肌肌钙蛋白复合物的相互作用及其对人体血液样本中肌钙蛋白免疫检测的影响。

IF 6.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2024-05-14 DOI: 10.1515/cclm-2024-0066

Natalia S Riabkova, Agnessa P Bogomolova, Alexander E Kogan, Ivan A Katrukha, Alexandra V Vylegzhanina, Dmitry V Pevzner, Amina K Alieva, Anastasia V Bereznikova, Alexey G Katrukha

{"title":"Interaction of heparin with human cardiac troponin complex and its influence on the immunodetection of troponins in human blood samples.","authors":"Natalia S Riabkova, Agnessa P Bogomolova, Alexander E Kogan, Ivan A Katrukha, Alexandra V Vylegzhanina, Dmitry V Pevzner, Amina K Alieva, Anastasia V Bereznikova, Alexey G Katrukha","doi":"10.1515/cclm-2024-0066","DOIUrl":"10.1515/cclm-2024-0066","url":null,"abstract":"Objectives: Heparin is a highly charged polysaccharide used as an anticoagulant to prevent blood coagulation in patients with presumed myocardial infarction and to prepare heparin plasma samples for laboratory tests. There are conflicting data regarding the effects of heparin on the measurement of cardiac isoforms of troponin I (cTnI) and troponin T (cTnT), which are used for the immunodiagnosis of acute myocardial infarction. In this study, we investigated the influence of heparin on the immunodetection of human cardiac troponins.Methods: Gel filtration (GF) techniques and sandwich fluoroimmunoassay were performed. The regions of сTnI and cTnT that are affected by heparin were investigated with a panel of anti-cTnI and anti-cTnT monoclonal antibodies, specific to different epitopes.Results: Heparin was shown to bind to the human cardiac full-size ternary troponin complex (ITC-complex) and free cTnT, which increased their apparent molecular weights in GF studies. Heparin did not bind to the low molecular weight ITC-complex and to binary cTnI-troponin С complex. We did not detect any sites on cTnI in the ITC-complex that were specifically affected by heparin. In contrast, cTnT regions limited to approximately 69-99, 119-138 and 145-164 amino acid residues (aar) in the ITC-complex and a region that lies approximately between 236 and 255 aar of free cTnT were prone to heparin influence.Conclusions: Heparin binds to the ITC-complex via cTnT, interacting with several sites on the N-terminal and/or central parts of the cTnT molecule, which might influence the immunodetection of analytes in human blood.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140911646","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 influence of undetected hemolysis on POCT potassium results in the emergency department. 未检测到的溶血对急诊科 POCT 钾检测结果的影响。

IF 6.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2024-05-13 DOI: 10.1515/cclm-2024-0202

Andrei N Tintu, Antonio Buño Soto, Viviane Van Hoof, Suzanne Bench, Anthony Malpass, Ulf Martin Schilling, Kevin Rooney, Paloma Oliver Sáez, Lasse Relker, Peter Luppa

{"title":"The influence of undetected hemolysis on POCT potassium results in the emergency department.","authors":"Andrei N Tintu, Antonio Buño Soto, Viviane Van Hoof, Suzanne Bench, Anthony Malpass, Ulf Martin Schilling, Kevin Rooney, Paloma Oliver Sáez, Lasse Relker, Peter Luppa","doi":"10.1515/cclm-2024-0202","DOIUrl":"10.1515/cclm-2024-0202","url":null,"abstract":"Objectives: This study aimed to evaluate discrepancies in potassium measurements between point-of-care testing (POCT) and central laboratory (CL) methods, focusing on the impact of hemolysis on these measurements and its impact in the clinical practice in the emergency department (ED).Methods: A retrospective analysis was conducted using data from three European university hospitals: Technische Universitat Munchen (Germany), Hospital Universitario La Paz (Spain), and Erasmus University Medical Center (The Netherlands). The study compared POCT potassium measurements in EDs with CL measurements. Data normalization was performed in categories for potassium levels (kalemia) and hemolysis. The severity of discrepancies between POCT and CL potassium measurements was assessed using the reference change value (RCV).Results: The study identified significant discrepancies in potassium between POCT and CL methods. In comparing POCT normo- and mild hypokalemia against CL results, differences of -4.20 % and +4.88 % were noted respectively. The largest variance in the CL was a +4.14 % difference in the mild hyperkalemia category. Additionally, the RCV was calculated to quantify the severity of discrepancies between paired potassium measurements from POCT and CL methods. The overall hemolysis characteristics, as defined by the hemolysis gradient, showed considerable variation between the testing sites, significantly affecting the reliability of potassium measurements in POCT.Conclusions: The study highlighted the challenges in achieving consistent potassium measurement results between POCT and CL methods, particularly in the presence of hemolysis. It emphasised the need for integrated hemolysis detection systems in future blood gas analysis devices to minimise discrepancies and ensure accurate POCT results.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140897503","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

Diurnal and day-to-day biological variation of salivary cortisol and cortisone. 唾液皮质醇和可的松的昼夜生物变化。

IF 6.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2024-05-09 DOI: 10.1515/cclm-2024-0196

Elisa Danese, Andrea Padoan, Davide Negrini, Elisa Paviati, Matteo De Pastena, Alessandro Esposito, Giuseppe Lippi, Martina Montagnana

{"title":"Diurnal and day-to-day biological variation of salivary cortisol and cortisone.","authors":"Elisa Danese, Andrea Padoan, Davide Negrini, Elisa Paviati, Matteo De Pastena, Alessandro Esposito, Giuseppe Lippi, Martina Montagnana","doi":"10.1515/cclm-2024-0196","DOIUrl":"https://doi.org/10.1515/cclm-2024-0196","url":null,"abstract":"Objectives: There is a growing interest in the relevance of salivary cortisol and cortisone concentrations in stress-related research. To correctly attribute the magnitude of salivary cortisol and cortisone variation as an effect of a stressful event, a coherent understanding of the day-to-day intra-individual and inter-individual variability across the diurnal cycle of the two steroids is required. However, such information is currently lacking.Methods: This study aimed to overcome these existing limitations by performing an investigation of the biological variation (BV) of salivary cortisol and cortisone within one day and between five days using an LC-MS/MS method. Saliva samples were collected from 20 healthy volunteers immediately after waking up, at 8:00, 12:00, 15:00, 19:00 and 23:00 on each day over five days. All samples were analyzed in duplicate in one run. Nested ANOVA was used to calculate the sums of squares for analytical and biological components of variation.Results: The within-subject BV of salivary cortisol and cortisone (CVI) ranged from a minimum of 29.3 and 19.0 % to a maximum of 56.5 and 49.1 %, respectively, while the between-subject biological variation (CVG) ranged from 29.7 and 29.0 % to 51.6 and 43.6 %. The reference change values (RCVs) ranged from 96 to 245 % for cortisol and from 55 to 194 % for cortisone. A medium index of individuality was observed for both compounds at all time points.Conclusions: This study provides updated BV estimates and RCVs for different times of day that can be used to assess the magnitude of change in biomarkers in future stress-related research.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140891644","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, near-patient testing and patient self-testing: warning points. 护理点检测、就近病人检测和病人自我检测：警示点。

IF 6.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2024-05-08 DOI: 10.1515/cclm-2024-0525

Giuseppe Banfi, Borut Božič, Murat Cihan, Daria Pašalić, Federico Pennestrì, Mario Plebani

{"title":"Point-of-care testing, near-patient testing and patient self-testing: warning points.","authors":"Giuseppe Banfi, Borut Božič, Murat Cihan, Daria Pašalić, Federico Pennestrì, Mario Plebani","doi":"10.1515/cclm-2024-0525","DOIUrl":"10.1515/cclm-2024-0525","url":null,"abstract":"Point-of-care testing (POCT), near-patient testing (NPT) and patient self-tests (PST) are diagnostic examinations performed at the time and place of patient care. While POCT and NPT are performed and analyzed by medical professionals, PST are based on samples and parameters directly collected and analyzed by lay users. These tests are spreading both in high income countries and in low to middle income countries as they are expected to improve healthcare efficiency and equity, by saving resources, releasing pressure from hospitals and reducing logistical barriers. However, accurate multidisciplinary assessment is mandatory to ensure that what they promise is real. We reviewed some important ethical aspects, international standards and regulations. The current risks associated with alternative ways of testing are explained by the principles of respect for patient autonomy and non-maleficence. Further evidence from multidisciplinary assessment is needed to evaluate pros and cons in light of the principles of beneficence and justice. Although POCT or NPT need common regulation and accurate provider training to ensure safe and appropriate interpretation of results, PST needs even more attention as they are subject to direct patient use. Randomized controlled trails including patient education should be conducted in order to provide reliable evidence on clinical outcomes, patient acceptance and cost-effectiveness. Mandatory regulation is needed to avoid harm and EU regulation should help different countries maintain a safe use of devices in a global population of producers and users.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140850778","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