Clinical chemistry and laboratory medicine最新文献

{"title":"A vision to the future: value-based laboratory medicine","authors":"Mario Plebani, Janne Cadamuro, Pieter Vermeersch, Snežana Jovičić, Tomris Ozben, Tommaso Trenti, Brian McMillan, Christopher R. Lowe, Jochen Lennerz, Elizabeth Macintyre, Carlo Gabelli, Sverre Sandberg, Andrea Padoan, Joesph R. Wiencek, Giuseppe Banfi, Ira M. Lubin, Matthias Orth, Anna Carobene, Tomáš Zima, Christa M. Cobbaert, Ron H.N. van Schaik, Giuseppe Lippi","doi":"10.1515/cclm-2024-1022","DOIUrl":"https://doi.org/10.1515/cclm-2024-1022","url":null,"abstract":"The ultimate goal of value-based laboratory medicine is maximizing the effectiveness of laboratory tests in improving patient outcomes, optimizing resources and minimizing unnecessary costs. This approach abandons the oversimplified notion of test volume and cost, in favor of emphasizing the clinical utility and quality of diagnostic tests in the clinical decision-making. Several key elements characterize value-based laboratory medicine, which can be summarized in some basic concepts, such as organization of <jats:italic>in vitro</jats:italic> diagnostics (including appropriateness, integrated diagnostics, networking, remote patient monitoring, disruptive innovations), translation of laboratory data into clinical information and measurable outcomes, sustainability, reimbursement, ethics (e.g., patient empowerment and safety, data protection, analysis of big data, scientific publishing). Education and training are also crucial, along with considerations for the future of the profession, which will be largely influenced by advances in automation, information technology, artificial intelligence, and regulations concerning <jats:italic>in vitro</jats:italic> diagnostics. This collective opinion paper, composed of summaries from presentations given at the two-day European Federation of Laboratory Medicine (EFLM) Strategic Conference “A vision to the future: value-based laboratory medicine” (Padova, Italy; September 23–24, 2024), aims to provide a comprehensive overview of value-based laboratory medicine, projecting the profession into a more clinically effective and sustainable future.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":6.8,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142180391","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":"Inaccuracy definition of Bence Jones proteinuria in the EFLM Urinalysis Guideline 2023.","authors":"Michele Mussap, Alberto Dolci, Maria Stella Graziani","doi":"10.1515/cclm-2024-1001","DOIUrl":"https://doi.org/10.1515/cclm-2024-1001","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153288","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":"Circulating tumor DNA measurement: a new pillar of medical oncology?","authors":"Bohuslav Melichar","doi":"10.1515/cclm-2024-0986","DOIUrl":"https://doi.org/10.1515/cclm-2024-0986","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139493","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":"Why is single sample rule out of non-ST elevation myocardial infarction using high-sensitivity cardiac troponin T safe when analytical imprecision is so high? A joint statistical and clinical demonstration.","authors":"James Daniel Hatherley, Guy Miller, Paul Collinson, Eduard Shantsila, Hannah Fearon, Angela Lambert, Yusuf Khand, Aleem Khand","doi":"10.1515/cclm-2024-0647","DOIUrl":"https://doi.org/10.1515/cclm-2024-0647","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105024","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":"Evaluation of the analytical and clinical performance of a high-sensitivity troponin I point-of-care assay in the Mersey Acute Coronary Syndrome Rule Out Study (MACROS-2).","authors":"Ahmed Dakshi, James Hatherley, Paul Collinson, Suzannah Phillips, Lisa Bailey, Guy Miller, Matthew Shaw, Aleem Khand","doi":"10.1515/cclm-2024-0138","DOIUrl":"https://doi.org/10.1515/cclm-2024-0138","url":null,"abstract":"<p><strong>Objectives: </strong>The objective of this study is to evaluate the analytical and diagnostic performance of a high-sensitivity point-of-care (POC) cardiac troponin I assay, the Quidel TriageTrue™ (QuidelOrtho Inc, San Diego, USA), compared to central laboratory testing (CLT) in accelerated diagnostic protocols (ADP) in real time in a clinical environment.</p><p><strong>Methods: </strong>In a nested sub-study of a pragmatic randomised control trial, consecutive patients with suspected acute coronary syndrome (ACS) and chest pain <12 h duration were randomised to the ESC 0/1 and 0/3-h ADP. Subjects underwent sampling for Quidel TriageTrue POC hs-TnI whole blood and plasma, CLT hs-TnT Roche Elecsys and a validated, NICE approved CLT High sensitivity cardiac troponin I (hs-TnI) (Siemens Attellica) at each time point. Assay imprecision was assessed by repeat analysis of whole blood samples at three levels (low, near 10 % CV 5-10 ng/L, medium, approximating 99th percentile 15-25 ng/L and high, 3-5 times the 99th percentile, 60-100 ng/L). Final diagnosis was adjudicated at 6 weeks by Roche hs-TnT using the 4th universal definition of myocardial infarction (MI).</p><p><strong>Results: </strong>A total of 1,157 patients consented and had both investigational POC whole blood and plasma and central lab hs-cTn available. The median age was 59, 47.2 % were female and 15 % had suffered a previous MI. Assay imprecision of whole blood POC TriageTrue revealed 10 % CV at 8.6 ng/L (>50 % lower than 99th percentile [20.5 ng/L]) and a 20 % CV at 1.2 ng/L. Receiver operator characteristics (ROC) curves were computed for each assay against adjudicated index type 1 MI to study clinical performance. At all-time points there were excellent performance for whole blood POC TriageTrue: area under the curve (AUC) 0.97 [95 % CI 0.94-098], 0.98 [95 % CI 0.97-1.00] and 0.95 [95 % CI 0.92-0.98] at time 0, 1 and 3 h respectively. There was statistical equivalence for performance of whole blood and plasma POC TriageTrue hs-TnI and laboratory Siemens Atellica hs-TnI.</p><p><strong>Conclusions: </strong>The whole blood POC TriageTrue hs-TnI assay demonstrates imprecision levels consistent with high sensitivity characteristics and has a clinical performance equivalent to an established, validated and NICE approved laboratory Siemens Atellica hs-TnI.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139495","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":"Contribution of laboratory medicine and emerging technologies to cardiovascular risk reduction via exposome analysis: an opinion of the IFCC Division on Emerging Technologies.","authors":"Damien Gruson, Elie Fux, Tuğba Kemaloğlu Öz, Bernard Gouget, Woochang Lee, Swarup Shah, Yan Liu, Sven Ebert, Ronda Greaves, Sergio Bernardini, He Sarina Yang, Luis Figueroa Montes","doi":"10.1515/cclm-2024-0788","DOIUrl":"https://doi.org/10.1515/cclm-2024-0788","url":null,"abstract":"<p><p>This opinion article highlights the critical role of laboratory medicine and emerging technologies in cardiovascular risk reduction through exposome analysis. The exposome encompasses all external and internal exposures an individual faces throughout their life, influencing the onset and progression of cardiovascular diseases (CVD). Integrating exposome data with genetic information allows for a comprehensive understanding of the multifactorial causes of CVD, facilitating targeted preventive interventions. Laboratory medicine, enhanced by advanced technologies such as metabolomics and artificial intelligence (AI), plays a pivotal role in identifying and mitigating these exposures. Metabolomics provides detailed insights into metabolic changes triggered by environmental factors, while AI efficiently processes complex datasets to uncover patterns and associations. This integration fosters a proactive approach in public health and personalized medicine, enabling earlier detection and intervention. The article calls for global implementation of exposome technologies to improve population health, emphasizing the need for robust technological platforms and policy-driven initiatives to seamlessly integrate environmental data with clinical diagnostics. By harnessing these innovative technologies, laboratory medicine can significantly contribute to reducing the global burden of cardiovascular diseases through precise and personalized risk mitigation strategies.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139494","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":"External quality assurance (EQA): navigating between quality and sustainability.","authors":"Mario Plebani","doi":"10.1515/cclm-2024-0975","DOIUrl":"https://doi.org/10.1515/cclm-2024-0975","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139497","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":"Construction of platelet count-optical method reflex test rules using Micro-RBC#, Macro-RBC%, \"PLT clumps?\" flag, and \"PLT abnormal histogram\" flag on the Mindray BC-6800plus hematology analyzer in clinical practice.","authors":"Yang Fei, Zhi-Gang Xiong, Liang Huang, Chi Zhang","doi":"10.1515/cclm-2024-0739","DOIUrl":"https://doi.org/10.1515/cclm-2024-0739","url":null,"abstract":"<p><strong>Objectives: </strong>Utilizing RBC or PLT-related parameters to establish rules for the PLT-O reflex test can assist laboratories in quickly identifying specimens with interfered PLT-I that require PLT-O retesting.</p><p><strong>Methods: </strong>Prospective PLT-I and PLT-O testing was performed on 6857 EDTA-anticoagulated whole blood samples, split randomly into training and validation cohorts at a 2:3 ratio. Reflex and non-reflex groups were distinguished based on the differences between PLT-I and PLT-O results. By comparing RBC and PLT parameter differences and flags in the training set, we pinpointed factors linked to PLT-O reflex testing. Utilizing Lasso regression, then refining through univariate and multivariate logistic regression, candidate parameters were selected. A predictive nomogram was constructed from these parameters and subsequently validated using the validation set. ROC curves were also plotted.</p><p><strong>Results: </strong>Significant differences were observed between the reflex and non-reflex groups for 19 parameters including RBC, MCV, MCH, MCHC, RDW-CV, RDW-SD, Micro-RBC#, Micro-RBC%, Macro-RBC#, Macro-RBC%, MPV, PCT, P-LCC, P-LCR, PLR,\"PLT clumps?\" flag, \"PLT abnormal histogram\" flag, \"IDA Anemia?\" flag, and \"RBC abnormal histogram\" flag. After further analysis, Micro-RBC#, Macro-RBC%,\"PLT clumps?\", and \"PLT abnormal histogram\" flag were identified as candidate parameters to develop a nomogram with an AUC of 0.636 (95 %CI: 0.622-0.650), sensitivity of 42.9 % (95 %CI: 37.8-48.1 %), and specificity of 90.5 % (95 %C1: 89.6-91.3 %).</p><p><strong>Conclusions: </strong>The established rules may help laboratories improve efficiency and increase accuracy in determining platelet counts as a supplement to ICSH41 guidelines.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105023","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":"External quality assessment performance in ten countries: an IFCC global laboratory quality project.","authors":"Renze Bais, Anne Vassault, Ivan M Blasutig, Pradeep Kumar Dabla, Ji Lin, Armand Perret-Liaudet, Annette Thomas, Kandace A Cendejas, Sarah E Wheeler, Jean-Marc Giannoli, Qing H Meng, Egon P Amann","doi":"10.1515/cclm-2024-0859","DOIUrl":"https://doi.org/10.1515/cclm-2024-0859","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to assess the validity of external quality assessment (EQA) laboratory results across various cultural and environmental contexts and to identify potential improvement areas.</p><p><strong>Methods: </strong>The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a 2-year study (2022 and 2023) in which EQA materials, related software and online training was provided by a commercial vendor to 100 laboratories in ten IFCC member society countries. The results were analysed on a monthly basis by the TF-GLQ, to show the number of submissions per country, tests per lab, acceptability rates, random failures and to get a measure of which analytes performed poorly.</p><p><strong>Results: </strong>The EQA material was dispatched on a quarterly basis. Some countries had problems with customs releasing the material in a timely manner, resulting in laboratories not receiving them on time leading to no submission. We report here the results for the second year of the survey. The number of examinations varied between laboratories, ranging from seven to 84 analytes. Of the ten countries surveyed, six averaged greater than 90 % acceptable results over the whole 12-months cycle, one had unacceptable results for two of the nine months they returned results and the other four were considered to not perform to an acceptable standard.</p><p><strong>Conclusions: </strong>All 100 participating laboratories indicated satisfaction with the EQA survey and related services, including on-site training, and report handling. However, specimen receiving issues, suggest benefits in dispatching materials for a full 12-month cycle. Significant discrepancies in EQA performance indicate that four countries require long-term assistance, training and guidance. To ensure reliable patient results, promoting EQA in certain countries is essential to achieve the required level of quality.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139496","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":"Analytical verification of the Atellica VTLi point of care high sensitivity troponin I assay.","authors":"Christopher M Florkowski, Vanessa Buchan, Bobby V Li, Felicity Taylor, Minh Phan, Martin Than, John W Pickering","doi":"10.1515/cclm-2024-0312","DOIUrl":"https://doi.org/10.1515/cclm-2024-0312","url":null,"abstract":"<p><strong>Objectives: </strong>The Siemens Point-of-Care Testing (POC) Atellica^® VTLi high-sensitivity troponin I (hsTnI) device has been previously validated. Verification independently provides evidence that an analytical procedure fulfils concordance with laboratory assays, imprecision, and hemolysis interference requirements.</p><p><strong>Methods: </strong>Five whole blood samples spanning the measuring interval were analysed 20 times in succession. Hemolysis interference was assessed at three troponin concentrations by spiking five hemolysate concentrations to plasma to achieve free hemoglobin concentrations 35-1,000 mg/dL. Concordance between whole blood (VTLi) and plasma on laboratory analysers (Beckman, Roche, Siemens) was assessed by Pearson correlation and kappa statistics at the (LOQ) and upper reference limit (URL). This was repeated for frozen plasma samples.</p><p><strong>Results: </strong>Coefficients of variation for whole blood were <10 % for whole blood troponin concentrations of 9.2 and 15.9 ng/L, thus below the URL. Hemolysis positively interfered; at 250 mg/dL affecting the low troponin sample (+3 ng/L; +60 %) and high troponin sample (+37 ng/L; +24 %). Correlation coefficients were 0.98, 0.90 and 0.97 between VTLi and Beckman, Roche and Siemens assays respectively. Corresponding kappa statistics were 0.80, 0.73 and 0.84 at the LOQ and 0.70, 0.44 and 0.67 at the URL.</p><p><strong>Conclusions: </strong>Concordances between VTLi and laboratory assays were at least non-inferior to those between laboratory assays. Imprecision met manufacturer claims and was consistent with a high sensitivity assay. There is potential for hemolysis interference, highlighting the need for quality samples. The results support performance characteristics previously reported in validation studies, and the device offers acceptable performance for use within intended medical settings.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105022","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}