首页 > 最新文献

Clinical chemistry最新文献

英文 中文
Regulatory Fragmentation in Europe and Its Risks for Patient Access and Safety: Subcontracting Work Flow Steps of In-House Diagnostic Procedures 欧洲的监管碎片化及其对患者访问和安全的风险:内部诊断程序的分包工作流程步骤
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-10-15 DOI: 10.1093/clinchem/hvaf123
Raymond Nistor-Gallo, Kurt Zatloukal, Karin Schwenoha
The European Union (EU) In Vitro Diagnostic Regulation (IVDR) imposes stringent obligations on laboratories using in-house in vitro diagnostic devices (IH-IVDs), yet offers limited clarity on whether discrete work flow steps may be subcontracted while maintaining compliance with Article 5(5). This Special Report identifies 3 systemic challenges that amplify regulatory uncertainty: (a) fragmented national implementation of the IVDR, (b) disparities in the application of ISO 15189-based quality systems, and (c) the withdrawal of Conformité Européene (CE)-marked IVDs from the market, often replaced by research use only (RUO) products that shift the regulatory burden to public laboratories. These dynamics disproportionately affect diagnostics for rare diseases, emerging pathogens, and precision medicine, areas where commercial IVDs are often unavailable or withdrawn for cost reasons. Laboratories are increasingly compelled to adopt RUO products within IH-IVD work flows, accepting legal and clinical responsibility for analytical validity without clear regulatory protection. At the same time, innovation in academic and translational settings is hindered by uneven national oversight, premature enforcement of deferred IVDR clauses, and the absence of a harmonized European compliance model. We analyze these pressures through the lens of the respective Medical Device Coordination Group (MDCG) guidance, current national practices, and ISO 5649:2024—a newly published standard offering risk-based governance of IH-IVDs. ISO 5649 enables safe subcontracting under strict accountability and provides a structured compliance pathway aligned with the IVDR. Without urgent coordination across Member States and adoption of such frameworks, the EU risks undermining both patient access and diagnostic innovation under the banner of regulatory harmonization.
欧盟(EU)体外诊断法规(IVDR)对使用内部体外诊断设备(ih - ivd)的实验室施加了严格的义务,但在保持符合第5(5)条的情况下,是否可以分包离散的工作流程步骤提供了有限的清晰度。本特别报告确定了放大监管不确定性的3个系统性挑战:(a)各国对IVDR实施的分散,(b)基于ISO 15189的质量体系应用的差异,以及(c)有conformit europvac (CE)标记的ivd从市场上撤回,通常被仅用于研究的(RUO)产品所取代,将监管负担转移到公共实验室。这些动态对罕见病、新发病原体和精准医疗的诊断产生了不成比例的影响,在这些领域,商业ivd往往无法获得或因成本原因而被撤销。实验室越来越多地被迫在IH-IVD工作流程中采用RUO产品,在没有明确监管保护的情况下承担分析有效性的法律和临床责任。与此同时,由于国家监督不平衡、推迟IVDR条款的过早执行以及缺乏统一的欧洲合规模式,学术和翻译环境中的创新受到阻碍。我们通过各自的医疗器械协调小组(MDCG)指南、当前的国家实践和ISO 5649:2024(一个新发布的基于风险的ih - ivd治理标准)来分析这些压力。ISO 5649在严格的问责制下实现安全的分包,并提供与IVDR一致的结构化合规途径。如果没有成员国之间的紧急协调和采用这些框架,欧盟就有可能在监管协调的旗帜下破坏患者可及性和诊断创新。
{"title":"Regulatory Fragmentation in Europe and Its Risks for Patient Access and Safety: Subcontracting Work Flow Steps of In-House Diagnostic Procedures","authors":"Raymond Nistor-Gallo, Kurt Zatloukal, Karin Schwenoha","doi":"10.1093/clinchem/hvaf123","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf123","url":null,"abstract":"The European Union (EU) In Vitro Diagnostic Regulation (IVDR) imposes stringent obligations on laboratories using in-house in vitro diagnostic devices (IH-IVDs), yet offers limited clarity on whether discrete work flow steps may be subcontracted while maintaining compliance with Article 5(5). This Special Report identifies 3 systemic challenges that amplify regulatory uncertainty: (a) fragmented national implementation of the IVDR, (b) disparities in the application of ISO 15189-based quality systems, and (c) the withdrawal of Conformité Européene (CE)-marked IVDs from the market, often replaced by research use only (RUO) products that shift the regulatory burden to public laboratories. These dynamics disproportionately affect diagnostics for rare diseases, emerging pathogens, and precision medicine, areas where commercial IVDs are often unavailable or withdrawn for cost reasons. Laboratories are increasingly compelled to adopt RUO products within IH-IVD work flows, accepting legal and clinical responsibility for analytical validity without clear regulatory protection. At the same time, innovation in academic and translational settings is hindered by uneven national oversight, premature enforcement of deferred IVDR clauses, and the absence of a harmonized European compliance model. We analyze these pressures through the lens of the respective Medical Device Coordination Group (MDCG) guidance, current national practices, and ISO 5649:2024—a newly published standard offering risk-based governance of IH-IVDs. ISO 5649 enables safe subcontracting under strict accountability and provides a structured compliance pathway aligned with the IVDR. Without urgent coordination across Member States and adoption of such frameworks, the EU risks undermining both patient access and diagnostic innovation under the banner of regulatory harmonization.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"1 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145295854","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
Analytical Error of Cardiac Troponin and Impact on the Performance of Accelerated Diagnostic Protocols in Patients with Acute Chest Pain 急性胸痛患者心肌肌钙蛋白分析误差及其对加速诊断方案性能的影响
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-10-15 DOI: 10.1093/clinchem/hvaf116
Nasir Saeed, Ingar Z Restan, Ole-Thomas Steiro, Hilde L Tjora, Jørund Langørgen, Øyvind Skadberg, Øistein R Mjelva, Vernon V S Bonarjee, Rune O Bjørneklett, Trude Steinsvik, Kjell Vikenes, Torbjørn Omland, Fred S Apple, Allan S Jaffe, Nicholas L Mills, Paul O Collinson, Peter A Kavsak, Kristin M Aakre
Background This study simulates how assay-specific bias influences the diagnostic performance of 0/1-h accelerated diagnostic protocols (ADPs) for 3 different high-sensitivity cardiac troponin (hs-cTn) assays. Methods We included 1493 patients presenting with chest pain. hs-cTnT (Roche Diagnostics), hs-cTnI from Abbott Diagnostics (hs-cTnI-A), and Siemens Healthineers (hs-cTnI-S) were measured at admission. The absolute total error observed in a state-of-the-art EQA study were added to the admission concentrations, producing 6 new variables being adjusted for maximum possible bias (if analytical variation is 0) (+biasmean, +biasmax95%CI, +biasmin95%CI, −biasmean, −biasmax95%CI, −biasmin95%CI). The influence of this “worst-case scenario” bias was compared after calculating sensitivity, specificity, negative and positive predictive values, and rule-out proportion for 30-day myocardial infarction or death for the observed and bias-adjusted hs-cTn concentrations. Results For 0-h rule-out, hs-cTnI-S and hs-cTnT had a sensitivity of >99.0%, compared to 97.7% for hs-cTnI-A. After adding the bias, sensitivity was unchanged for hs-cTnI-S (99.5%), but lower for hs-cTnT (95.5%), and hs-cTnI-A (96.2%). For the 0-/1-h algorithm, adding bias reduced sensitivity to 95.5% for hs-cTnT, while both hs-cTnI algorithms were unchanged (100.0%). Rule-out proportions for 0 h ranged from 0% to 60.0% for hs-cTnT, 28.2%–62.7% for hs-cTnI-A, and 3.5%–35.5% for hs-cTnI-S. For the 0-/1-h algorithm, ranges were 57.7%–75.8% (hs-cTnT), 52.8%–67.5% (hs-cTnI-A), and 45.7%–61.2% (hs-cTnI-S), Conclusion Analytical bias of hs-cTn assays affects the clinical rule-out rate of the 0/1-h ADPs more than the diagnostic sensitivity. Bias may have a greater influence on the proportion of patients requiring hospital admission and may contribute to the heterogeneity of the reported rule-out rates of current ADPs. ClinicalTrials.gov Registration Number: NCT02620202
本研究模拟了检测特异性偏倚如何影响3种不同的高灵敏度心肌肌钙蛋白(hs-cTn)检测的0/1-h加速诊断方案(ADPs)的诊断性能。方法纳入1493例胸痛患者。入院时测量hs-cTnT(罗氏诊断)、雅培诊断(hs-cTnI- a)和西门子医疗(hs-cTnI- s)的hs-cTnI。在最先进的EQA研究中观察到的绝对总误差被添加到入场浓度中,产生6个新变量,以调整最大可能的偏差(如果分析变异为0)(+biasmean, +biasmax95%CI, +biasmin95%CI, - biasmean, - biasmax95%CI, - biasmin95%CI)。在计算了观察到的和经过偏差调整的hs-cTn浓度对30天心肌梗死或死亡的敏感性、特异性、阴性和阳性预测值以及排除比例后,比较了这种“最坏情况”偏差的影响。结果对于0-h的排除,hs-cTnI-S和hs-cTnT的敏感性为99.0%,而hs-cTnI-A的敏感性为97.7%。加入偏倚后,hs-cTnI-S的敏感性保持不变(99.5%),但hs-cTnT(95.5%)和hs-cTnI-A(96.2%)的敏感性较低。对于0-/1-h算法,添加偏置将hs-cTnT的灵敏度降低到95.5%,而hs-cTnI算法不变(100.0%)。hs-cTnT 0 h的排除率为0% ~ 60.0%,hs-cTnI-A为28.2% ~ 62.7%,hs-cTnI-S为3.5% ~ 35.5%。0/1 h算法的取值范围分别为57.7% ~ 75.8% (hs-cTnT)、52.8% ~ 67.5% (hs-cTnI-A)和45.7% ~ 61.2% (hs-cTnI-S)。结论hs-cTn检测的分析偏倚对0/1 h ADPs临床排除率的影响大于诊断敏感性。偏倚可能对需要住院的患者比例有更大的影响,并可能导致报告的当前adp排除率存在异质性。ClinicalTrials.gov注册号:NCT02620202
{"title":"Analytical Error of Cardiac Troponin and Impact on the Performance of Accelerated Diagnostic Protocols in Patients with Acute Chest Pain","authors":"Nasir Saeed, Ingar Z Restan, Ole-Thomas Steiro, Hilde L Tjora, Jørund Langørgen, Øyvind Skadberg, Øistein R Mjelva, Vernon V S Bonarjee, Rune O Bjørneklett, Trude Steinsvik, Kjell Vikenes, Torbjørn Omland, Fred S Apple, Allan S Jaffe, Nicholas L Mills, Paul O Collinson, Peter A Kavsak, Kristin M Aakre","doi":"10.1093/clinchem/hvaf116","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf116","url":null,"abstract":"Background This study simulates how assay-specific bias influences the diagnostic performance of 0/1-h accelerated diagnostic protocols (ADPs) for 3 different high-sensitivity cardiac troponin (hs-cTn) assays. Methods We included 1493 patients presenting with chest pain. hs-cTnT (Roche Diagnostics), hs-cTnI from Abbott Diagnostics (hs-cTnI-A), and Siemens Healthineers (hs-cTnI-S) were measured at admission. The absolute total error observed in a state-of-the-art EQA study were added to the admission concentrations, producing 6 new variables being adjusted for maximum possible bias (if analytical variation is 0) (+biasmean, +biasmax95%CI, +biasmin95%CI, −biasmean, −biasmax95%CI, −biasmin95%CI). The influence of this “worst-case scenario” bias was compared after calculating sensitivity, specificity, negative and positive predictive values, and rule-out proportion for 30-day myocardial infarction or death for the observed and bias-adjusted hs-cTn concentrations. Results For 0-h rule-out, hs-cTnI-S and hs-cTnT had a sensitivity of >99.0%, compared to 97.7% for hs-cTnI-A. After adding the bias, sensitivity was unchanged for hs-cTnI-S (99.5%), but lower for hs-cTnT (95.5%), and hs-cTnI-A (96.2%). For the 0-/1-h algorithm, adding bias reduced sensitivity to 95.5% for hs-cTnT, while both hs-cTnI algorithms were unchanged (100.0%). Rule-out proportions for 0 h ranged from 0% to 60.0% for hs-cTnT, 28.2%–62.7% for hs-cTnI-A, and 3.5%–35.5% for hs-cTnI-S. For the 0-/1-h algorithm, ranges were 57.7%–75.8% (hs-cTnT), 52.8%–67.5% (hs-cTnI-A), and 45.7%–61.2% (hs-cTnI-S), Conclusion Analytical bias of hs-cTn assays affects the clinical rule-out rate of the 0/1-h ADPs more than the diagnostic sensitivity. Bias may have a greater influence on the proportion of patients requiring hospital admission and may contribute to the heterogeneity of the reported rule-out rates of current ADPs. ClinicalTrials.gov Registration Number: NCT02620202","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"5 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145295801","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
Harnessing Personalized Nutrition and Clinical Chemistry: Opportunities to Improve Public Health. 利用个性化营养和临床化学:改善公众健康的机会。
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-10-13 DOI: 10.1093/clinchem/hvaf114
John C Mathers
BACKGROUNDThe past 2 decades have seen rapid advances in the development of the concept of personalized nutrition (PN) interventions, and in its application. PN has evolved from attempts to understand the well-recognized interindividual variability in response to dietary intervention that have been facilitated by developments in -omics technologies, systems thinking, and behavioral psychology. The PN concept is predicated on the idea that it is possible to collect, and to use, specific information about individuals, including clinical chemistry, as an evidence base for more effective dietary advice, products, or services.CONTENTThis paper provides a narrative review of recent developments in the design and testing of PN interventions, including use of clinical chemistry measurements. The term PN is used to include all approaches that employ specific information about individuals to tailor interventions that are designed to be more relevant to, and effective for, that individual. In addition, the paper considers the potential for PN approaches to contribute to better public health.SUMMARYThere is good evidence that PN interventions can improve eating behavior with potential to improve health but much remains to be done to make PN interventions more effective, to reduce the burden on participants, and to enable cost-effective and equitable scale-up before they can make a significant contribution to better public health.
在过去的20年里,个性化营养(PN)干预概念的发展及其应用取得了快速进展。在组学技术、系统思维和行为心理学的发展推动下,人们试图理解饮食干预对个体间的影响。PN概念基于这样一种理念,即可以收集和使用个人的特定信息,包括临床化学,作为更有效的饮食建议、产品或服务的证据基础。本文提供了近期发展的设计和测试PN干预,包括使用临床化学测量的叙述回顾。“PN”一词用于包括所有采用有关个人的具体信息来定制干预措施的方法,这些干预措施旨在与该个人更相关,更有效。此外,本文还考虑了PN方法有助于改善公共卫生的潜力。有很好的证据表明,PN干预可以改善饮食行为,并有可能改善健康,但要使PN干预更有效,减轻参与者的负担,并使其具有成本效益和公平的规模扩大,才能对改善公共卫生做出重大贡献,还有很多工作要做。
{"title":"Harnessing Personalized Nutrition and Clinical Chemistry: Opportunities to Improve Public Health.","authors":"John C Mathers","doi":"10.1093/clinchem/hvaf114","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf114","url":null,"abstract":"BACKGROUNDThe past 2 decades have seen rapid advances in the development of the concept of personalized nutrition (PN) interventions, and in its application. PN has evolved from attempts to understand the well-recognized interindividual variability in response to dietary intervention that have been facilitated by developments in -omics technologies, systems thinking, and behavioral psychology. The PN concept is predicated on the idea that it is possible to collect, and to use, specific information about individuals, including clinical chemistry, as an evidence base for more effective dietary advice, products, or services.CONTENTThis paper provides a narrative review of recent developments in the design and testing of PN interventions, including use of clinical chemistry measurements. The term PN is used to include all approaches that employ specific information about individuals to tailor interventions that are designed to be more relevant to, and effective for, that individual. In addition, the paper considers the potential for PN approaches to contribute to better public health.SUMMARYThere is good evidence that PN interventions can improve eating behavior with potential to improve health but much remains to be done to make PN interventions more effective, to reduce the burden on participants, and to enable cost-effective and equitable scale-up before they can make a significant contribution to better public health.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"136 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145277321","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
Quantitative Analysis of a Novel Metabolite Panel to Estimate GFR (Panel eGFR) in Serum and Plasma Using LC-MS/MS. 使用LC-MS/MS定量分析一种新的代谢物面板来估计血清和血浆中的GFR(面板eGFR)。
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-10-10 DOI: 10.1093/clinchem/hvaf110
Nora Fino,Lesley A Inker,Seiei Shiba,Ogechi M Adingwupu,Josef Coresh,Ben Haaland,Michael G Shlipak,Andrew Levey,Jesse C Seegmiller, ,
BACKGROUNDEstimated glomerular filtration rate (eGFR) using creatinine (eGFRcr), cystatin C (eGFRcys), or both (eGFRcr-cys) is not sufficiently accurate in many settings, often due to non-glomerular filtration rate (GFR) determinants of the filtration markers. In principle, using a panel of endogenous markers (panel eGFR) could reduce the impact of non-GFR determinants of each marker, improving the accuracy of eGFR. Using global untargeted metabolomics, we previously identified 33 endogenous metabolites that correlate highly with measured GFR.METHODSA LC-MS/MS measurement procedure was developed to quantify 11 endogenous metabolites from serum and plasma. The assay was evaluated in 99 participants with measured GFR (mGFR) from 2 research studies, including a subgroup of 51 participants with large errors in eGFRcr and large discordance between eGFRcr and eGFRcys. Performance of eGFR models using single metabolites and all metabolites (panel eGFR-11) compared to mGFR was assessed by leave-one-out cross-validated root mean square error (RMSE).RESULTSAssay CV for single metabolites ranged from 1.1% to 6.3% over the course of 21 days. RMSE of eGFR in single metabolite models ranged from 0.184 to 0.324. RMSEs for panel eGFR-11, eGFRcr, and eGFRcr-cys were 0.195, 0.251, and 0.201, respectively, and 0.155, 0.290, and 0.203, respectively, in the subgroup with large errors and large discordance.CONCLUSIONSA precise metabolite (LC-MS/MS) measurement procedure shows promise for more accurate GFR estimation when eGFRcr is unreliable, offering a potential new confirmatory test for GFR evaluation.
背景:使用肌酐(eGFRcr)、胱抑素C (eGFRcys)或两者(egfrcrcys)估算肾小球滤过率(eGFR)在许多情况下不够准确,通常是由于滤过标志物的非肾小球滤过率(GFR)决定因素。原则上,使用一组内源性标记物(面板eGFR)可以减少每个标记物的非gfr决定因素的影响,提高eGFR的准确性。使用全球非靶向代谢组学,我们先前确定了33种内源性代谢物与测量的GFR高度相关。方法建立LC-MS/MS测定方法,定量测定血清和血浆中11种内源性代谢物。该方法在来自2项研究的99名受试者中进行了评估,受试者测量了GFR (mGFR),其中包括51名受试者的eGFRcr误差较大,eGFRcr和eGFRcys之间存在较大差异。与mGFR相比,使用单一代谢物和所有代谢物(面板eGFR-11)的eGFR模型的性能通过留一交叉验证的均方根误差(RMSE)进行评估。结果在21天内,单一代谢物的检测CV范围为1.1% ~ 6.3%。单一代谢物模型中eGFR的RMSE范围为0.184 ~ 0.324。面板eGFR-11、eGFRcr和eGFRcr-cys的rmse分别为0.195、0.251和0.201,在误差大、不一致性大的亚组中,rmse分别为0.155、0.290和0.203。结论在eGFRcr不可靠的情况下,精确代谢物(LC-MS/MS)测量方法有望更准确地估计GFR,为GFR评估提供了一种潜在的新的验证性测试方法。
{"title":"Quantitative Analysis of a Novel Metabolite Panel to Estimate GFR (Panel eGFR) in Serum and Plasma Using LC-MS/MS.","authors":"Nora Fino,Lesley A Inker,Seiei Shiba,Ogechi M Adingwupu,Josef Coresh,Ben Haaland,Michael G Shlipak,Andrew Levey,Jesse C Seegmiller, , ","doi":"10.1093/clinchem/hvaf110","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf110","url":null,"abstract":"BACKGROUNDEstimated glomerular filtration rate (eGFR) using creatinine (eGFRcr), cystatin C (eGFRcys), or both (eGFRcr-cys) is not sufficiently accurate in many settings, often due to non-glomerular filtration rate (GFR) determinants of the filtration markers. In principle, using a panel of endogenous markers (panel eGFR) could reduce the impact of non-GFR determinants of each marker, improving the accuracy of eGFR. Using global untargeted metabolomics, we previously identified 33 endogenous metabolites that correlate highly with measured GFR.METHODSA LC-MS/MS measurement procedure was developed to quantify 11 endogenous metabolites from serum and plasma. The assay was evaluated in 99 participants with measured GFR (mGFR) from 2 research studies, including a subgroup of 51 participants with large errors in eGFRcr and large discordance between eGFRcr and eGFRcys. Performance of eGFR models using single metabolites and all metabolites (panel eGFR-11) compared to mGFR was assessed by leave-one-out cross-validated root mean square error (RMSE).RESULTSAssay CV for single metabolites ranged from 1.1% to 6.3% over the course of 21 days. RMSE of eGFR in single metabolite models ranged from 0.184 to 0.324. RMSEs for panel eGFR-11, eGFRcr, and eGFRcr-cys were 0.195, 0.251, and 0.201, respectively, and 0.155, 0.290, and 0.203, respectively, in the subgroup with large errors and large discordance.CONCLUSIONSA precise metabolite (LC-MS/MS) measurement procedure shows promise for more accurate GFR estimation when eGFRcr is unreliable, offering a potential new confirmatory test for GFR evaluation.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"37 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145261506","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 New International Patient-Based External Quality Assessment Program to Monitor Harmonization and Standardization Efforts 一个新的国际以患者为基础的外部质量评估计划,以监测协调和标准化的努力
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-10-10 DOI: 10.1093/clinchem/hvaf122
Anne Elisabeth Solsvik, Pernille Fauskanger, Anne Stavelin, Eva Rønneseth, Sverre Sandberg
Background External quality assessment (EQA) should strive to monitor and reflect variation across laboratories and measuring systems. We introduce a newly developed patient-based EQA program named Noklus Patient Median (NOPAM) that is freely available for the participants. The results from NOPAM enable laboratories to (a) compare their result to their peer group, (b) assess equivalence between measurement procedures, and (c) monitor the long-term median value within a laboratory. Methods Daily instrument-specific medians and percentages of patient results outside reference limits for the measurand in question are sent from laboratories to the program. For a particular grouping within a specific time frame, the program estimates distribution statistics of center and dispersion. Results In total, 40 common measurands are included in NOPAM. The 1-year results for selected measurands (alanine aminotransferase, chloride, creatinine, and free thyroxine) for the largest instrument groups are presented. An example of an upward shift for alkaline phosphatase (ALP) for 3 instruments within one laboratory is presented. This shift is notable both for the daily median and the percentage of results above the upper reference limit. However, a corresponding bias is not reflected in the instrument group for ALP. Conclusions A patient-based dynamic EQA program offers several advantages over traditional EQA programs. Among the most significant benefits are the frequent performance monitoring and the elimination of the commutability problems. Our results show that there are important differences between frequently used measurement procedures. NOPAM can be used to monitor standardization and harmonization efforts.
背景:外部质量评价(EQA)应努力监控和反映实验室和测量系统之间的差异。我们推出了一个新开发的基于患者的EQA程序,名为Noklus患者中位数(NOPAM),该程序对参与者免费提供。NOPAM的结果使实验室能够(a)将其结果与同行组进行比较,(b)评估测量程序之间的等效性,以及(c)监测实验室内的长期中位数。方法每日仪器特定的中位数和患者结果超出参考值限制的百分比从实验室发送到程序。对于特定时间框架内的特定分组,该程序估计中心和分散的分布统计。结果NOPAM共包含40项常用措施。1年的结果选择测量(丙氨酸转氨酶,氯化物,肌酐,游离甲状腺素)为最大的仪器组提出。介绍了一个实验室内3台仪器的碱性磷酸酶(ALP)向上移位的例子。这种变化对于每日中位数和高于参考上限的结果百分比都是值得注意的。然而,在ALP的仪器组中没有反映出相应的偏倚。结论基于患者的动态EQA项目与传统EQA项目相比具有诸多优势。最重要的好处之一是频繁的性能监视和消除可交换性问题。我们的结果表明,经常使用的测量程序之间存在重要差异。NOPAM可用于监测标准化和协调工作。
{"title":"A New International Patient-Based External Quality Assessment Program to Monitor Harmonization and Standardization Efforts","authors":"Anne Elisabeth Solsvik, Pernille Fauskanger, Anne Stavelin, Eva Rønneseth, Sverre Sandberg","doi":"10.1093/clinchem/hvaf122","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf122","url":null,"abstract":"Background External quality assessment (EQA) should strive to monitor and reflect variation across laboratories and measuring systems. We introduce a newly developed patient-based EQA program named Noklus Patient Median (NOPAM) that is freely available for the participants. The results from NOPAM enable laboratories to (a) compare their result to their peer group, (b) assess equivalence between measurement procedures, and (c) monitor the long-term median value within a laboratory. Methods Daily instrument-specific medians and percentages of patient results outside reference limits for the measurand in question are sent from laboratories to the program. For a particular grouping within a specific time frame, the program estimates distribution statistics of center and dispersion. Results In total, 40 common measurands are included in NOPAM. The 1-year results for selected measurands (alanine aminotransferase, chloride, creatinine, and free thyroxine) for the largest instrument groups are presented. An example of an upward shift for alkaline phosphatase (ALP) for 3 instruments within one laboratory is presented. This shift is notable both for the daily median and the percentage of results above the upper reference limit. However, a corresponding bias is not reflected in the instrument group for ALP. Conclusions A patient-based dynamic EQA program offers several advantages over traditional EQA programs. Among the most significant benefits are the frequent performance monitoring and the elimination of the commutability problems. Our results show that there are important differences between frequently used measurement procedures. NOPAM can be used to monitor standardization and harmonization efforts.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"102 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145260661","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
Risk vs Prevalence: Weighing Routine DYPD Variant Testing Prior to Fluoropyrimidine-Based Chemotherapy. 风险与流行:权衡基于氟嘧啶的化疗前常规DYPD变异检测
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-10-03 DOI: 10.1093/clinchem/hvaf089
Nicholas E Larkey,Mark R Girton
{"title":"Risk vs Prevalence: Weighing Routine DYPD Variant Testing Prior to Fluoropyrimidine-Based Chemotherapy.","authors":"Nicholas E Larkey,Mark R Girton","doi":"10.1093/clinchem/hvaf089","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf089","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"98 1","pages":"1097-1098"},"PeriodicalIF":9.3,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145209156","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
Optimizing Estimation: Perspective on Drug Dosing Using New CKD-EPI Equations. 优化估计:基于新CKD-EPI方程的药物给药视角。
IF 6.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-10-03 DOI: 10.1093/clinchem/hvaf031
Edward J Filippone, Walter K Kraft
{"title":"Optimizing Estimation: Perspective on Drug Dosing Using New CKD-EPI Equations.","authors":"Edward J Filippone, Walter K Kraft","doi":"10.1093/clinchem/hvaf031","DOIUrl":"10.1093/clinchem/hvaf031","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"1014-1017"},"PeriodicalIF":6.3,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143741818","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
Supratherapeutic Carbamazepine Concentration Following a Recent SARS-CoV-2 Infection. 近期SARS-CoV-2感染后的超治疗卡马西平浓度。
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-10-03 DOI: 10.1093/clinchem/hvaf062
Maxwell L Harsha,Mark A Marzinke
{"title":"Supratherapeutic Carbamazepine Concentration Following a Recent SARS-CoV-2 Infection.","authors":"Maxwell L Harsha,Mark A Marzinke","doi":"10.1093/clinchem/hvaf062","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf062","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"76 1","pages":"1018-1022"},"PeriodicalIF":9.3,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145209157","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
ADLM 2025 Annual Meeting Abstracts: Where Science Meets Wonder. ADLM 2025年年会摘要:科学遇见奇迹的地方。
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-10-03 DOI: 10.1093/clinchem/hvaf105
Ivan M Blasutig,Kacy Peterson,Steven W Cotten
{"title":"ADLM 2025 Annual Meeting Abstracts: Where Science Meets Wonder.","authors":"Ivan M Blasutig,Kacy Peterson,Steven W Cotten","doi":"10.1093/clinchem/hvaf105","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf105","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"62 1","pages":"1095-1096"},"PeriodicalIF":9.3,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145209154","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
Commentary on Supratherapeutic Carbamazepine Concentration Following a Recent SARS-CoV-2 Infection. 最近SARS-CoV-2感染后卡马西平超治疗性浓度的评论
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-10-03 DOI: 10.1093/clinchem/hvaf091
Sarah R Delaney
{"title":"Commentary on Supratherapeutic Carbamazepine Concentration Following a Recent SARS-CoV-2 Infection.","authors":"Sarah R Delaney","doi":"10.1093/clinchem/hvaf091","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf091","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"99 1","pages":"1023"},"PeriodicalIF":9.3,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145209158","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
期刊
Clinical chemistry
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1