Clinical chemistry最新文献_第9页

The Application of Digital PCR as a Reference Measurement Procedure to Support the Accuracy of Quality Assurance for Infectious Disease Molecular Diagnostic Testing. 应用数字PCR作为参考测量程序支持传染病分子诊断检测质量保证的准确性。

IF 9.3 2区医学

Clinical chemistry Pub Date : 2024-12-26 DOI: 10.1093/clinchem/hvae187

Samreen Falak,Denise M O'Sullivan,Megan H Cleveland,Simon Cowen,Eloise J Busby,Alison S Devonshire,Esmeralda Valiente,Gerwyn M Jones,Martin Kammel,Mojca Milavec,Laura Vierbaum,Ingo Schellenberg,Heinz Zeichhardt,Andreas Kummrow,Peter M Vallone,Rainer Macdonald,Jim F Huggett

{"title":"The Application of Digital PCR as a Reference Measurement Procedure to Support the Accuracy of Quality Assurance for Infectious Disease Molecular Diagnostic Testing.","authors":"Samreen Falak,Denise M O'Sullivan,Megan H Cleveland,Simon Cowen,Eloise J Busby,Alison S Devonshire,Esmeralda Valiente,Gerwyn M Jones,Martin Kammel,Mojca Milavec,Laura Vierbaum,Ingo Schellenberg,Heinz Zeichhardt,Andreas Kummrow,Peter M Vallone,Rainer Macdonald,Jim F Huggett","doi":"10.1093/clinchem/hvae187","DOIUrl":"https://doi.org/10.1093/clinchem/hvae187","url":null,"abstract":"BACKGROUNDNucleic acid amplification tests (NAATs) assist in the diagnosis of numerous infectious diseases. They are typically sensitive and specific and can be quickly developed and adapted. Far more challenging is the development of standards to ensure NAATs are performing within specification; reference materials take time to develop and suitable reference measurement procedures (RMPs) have not been available. This study investigated digital PCR (dPCR) RMP delivery of traceability for NAAT external quality assessment (EQA).METHODSThree National Metrology Institutes (NMIs) applied reverse transcription (RT)-dPCR as a candidate RMP to estimate the RNA quantity in 32 independent severe acute respiratory syndrome coronavirus 2 materials. The results were combined to value assign the respective materials: 21 materials were used in 6 rounds of EQA over 17 months for 61 laboratories for COVID-19 testing results compared with reference values.RESULTSThe agreement between the 3 NMIs showed <2-fold difference between laboratories. EQA laboratory reverse transcription quantitative PCR (RT-qPCR) values estimation of viral RNA quantity showed good median agreement with RT-dPCR reference value; however, RT-qPCR differences were generally between 10- and 50-fold between laboratories.CONCLUSIONThis work demonstrates how RT-dPCR can provide reference values for whole virus materials for NAAT quality assurance. RT-dPCR values guided EQA control material selection and provided EQA participants with traceability to RNA copy number delivered through the RMP. This approach can be used to support routine reference material use as well as to standardize quality assurance for NAATs where established reference materials are not available, such as in disease outbreaks.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"130 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142887495","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

Transitioning Alzheimer Disease Blood Biomarkers into Primary Care: Are We There Yet? 将阿尔茨海默病血液生物标志物转化为初级保健：我们做到了吗？

IF 9.3 2区医学

Clinical chemistry Pub Date : 2024-12-26 DOI: 10.1093/clinchem/hvae211

Katheryn A Q Cousins,Leslie M Shaw

引用次数: 0

Evolving Perspectives on Immune Repertoire Profiling: Challenges and Opportunities in the Era of Long-Read Sequencing. 免疫库分析的发展前景：长读测序时代的挑战和机遇。

IF 9.3 2区医学

Clinical chemistry Pub Date : 2024-12-26 DOI: 10.1093/clinchem/hvae219

Martin A Smith

引用次数: 0

Remnant Cholesterol: Quantification, Concentrations by Sex and Age, and Risk of Ischemic Heart Disease 残余胆固醇：定量，按性别和年龄的浓度，和缺血性心脏病的风险

IF 9.3 2区医学

Clinical chemistry Pub Date : 2024-12-26 DOI: 10.1093/clinchem/hvae217

Mie Balling, Shoaib Afzal, Anette Varbo, Børge G Nordestgaard, Anne Langsted

{"title":"Remnant Cholesterol: Quantification, Concentrations by Sex and Age, and Risk of Ischemic Heart Disease","authors":"Mie Balling, Shoaib Afzal, Anette Varbo, Børge G Nordestgaard, Anne Langsted","doi":"10.1093/clinchem/hvae217","DOIUrl":"https://doi.org/10.1093/clinchem/hvae217","url":null,"abstract":"Background Observational and genetic causal studies have shown an association between high concentrations of remnant cholesterol and increased risk of ischemic heart disease. However, findings from randomized intervention trials that reduced plasma triglycerides, a surrogate marker of remnant cholesterol, have been conflicting. The exact mechanisms by which remnant cholesterol contributes to atherosclerosis and, ultimately, ischemic heart disease remain incompletely understood. Additionally, insight on sex and age differences and the importance of measurement differences of remnant cholesterol in plasma concentrations and risk of ischemic heart disease are sparse. Content This review covers current knowledge regarding remnant cholesterol and its role in ischemic heart disease, with particular attention to measurement and sex- and age-specific differences. Summary Findings from observational, genetic, and mechanistic studies support the notion that higher remnant cholesterol may be an important cause of ischemic heart disease in both women and men. Concentrations of remnant cholesterol vary by age, with a sharp increase at early adulthood for men and around menopause for women. Remnant cholesterol can be calculated from a standard lipid profile and in addition measured directly using manual ultracentrifugation, automated assays, and nuclear magnetic resonance spectroscopy. Irrespective of the method used to assess plasma concentrations, high concentrations of remnant cholesterol are consistently associated with increased risk of myocardial infarction and ischemic heart disease in observational and genetic causal studies; cholesterol rather than triglycerides in remnants drive this risk. Importantly, results from ongoing randomized clinical trials aiming specifically at lowering remnant cholesterol and ischemic heart disease are eagerly awaited.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"14 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142887498","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

Optimal Cutoff Values and Utility of High-Sensitivity Troponin T and NT-proBNP for the Risk Stratification of Patients with Acute Pulmonary Embolism 高敏感性肌钙蛋白T和NT-proBNP对急性肺栓塞患者风险分层的最佳临界值和效用

IF 9.3 2区医学

Clinical chemistry Pub Date : 2024-12-20 DOI: 10.1093/clinchem/hvae212

Timothy M Matthews, Gregory A Peters, Grace Wang, Nora Horick, Kyle E Chang, Savanah Harshbarger, Christiana Prucnal, Drew A Birrenkott, Karsten Stannek, Eun Sang Lee, Isabel Dhar, Jesse O Wrenn, William B Stubblefield, Christopher Kabrhel

{"title":"Optimal Cutoff Values and Utility of High-Sensitivity Troponin T and NT-proBNP for the Risk Stratification of Patients with Acute Pulmonary Embolism","authors":"Timothy M Matthews, Gregory A Peters, Grace Wang, Nora Horick, Kyle E Chang, Savanah Harshbarger, Christiana Prucnal, Drew A Birrenkott, Karsten Stannek, Eun Sang Lee, Isabel Dhar, Jesse O Wrenn, William B Stubblefield, Christopher Kabrhel","doi":"10.1093/clinchem/hvae212","DOIUrl":"https://doi.org/10.1093/clinchem/hvae212","url":null,"abstract":"Background Guidelines recommend using high-sensitivity troponin T (hsTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) to risk stratify hemodynamically stable patients with acute pulmonary embolism (PE). However, there are no evidence-based cutoff values defined for this clinical application. Methods We performed a single-center, retrospective cohort study of patients with imaging-confirmed PE and hsTnT and/or NT-proBNP (ElecsysTM, Roche) measured 12 h before or 24 h after PE Response Team (PERT) activation. We excluded hypotensive patients. Our primary outcome was a composite of adverse outcomes or critical interventions within 7 days. We calculated the area under the receiver operating curve (AUC, ROC) for hsTnT and NT-proBNP and determined the optimal cutoffs using the distance from (0,1). We performed a subgroup analysis on patients with PE and right ventricular dysfunction on imaging. Results Two hundred thirty-four patients were included in the hsTnT analysis, and 727 in the NT-proBNP analysis. Mean age was 62 years (SD = 17) and 47% were female. The AUC for hsTnT was 0.64 (95% CI, 0.56–0.71) with an optimal cutoff of 46 ng/L, corresponding to a sensitivity of 59% (95% CI, 49–69) and a specificity of 61% (95% CI, 53–69). The AUC for NT-proBNP was 0.56 (95% CI, 0.51–0.61) with an optimal cutoff of 1092 pg/mL, corresponding to a sensitivity of 53% (95% CI, 45–61) and a specificity of 59% (95% CI, 55–63). Conclusion We identified an optimal cutoff of 46 ng/L for hsTnT and 1092 pg/mL for NT-proBNP, though the AUC for both markers suggests low to moderate performance for the risk stratification of initially hemodynamically stable PERT patients. Use of these biomarkers to risk stratify PE may require reconsideration.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"86 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142858466","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

Correction to: Prospective and External Validation of an Ensemble Learning Approach to Sensitively Detect Intravenous Fluid Contamination in Basic Metabolic Panels. 更正：前瞻性和外部验证用于灵敏检测基础代谢面板中静脉注射液污染的集合学习方法。

IF 7.1 2区医学

Clinical chemistry Pub Date : 2024-12-18 DOI: 10.1093/clinchem/hvae216

引用次数: 0

Measurement of Serum Free Vitamin D Concentrations: Importance, Challenges, and the Emerging Role of Mass Spectrometry 血清游离维生素D浓度的测定：重要性、挑战和质谱法的新作用

IF 9.3 2区医学

Clinical chemistry Pub Date : 2024-12-11 DOI: 10.1093/clinchem/hvae202

Anastasia Alexandridou, Caroline S Stokes, Dietrich A Volmer

{"title":"Measurement of Serum Free Vitamin D Concentrations: Importance, Challenges, and the Emerging Role of Mass Spectrometry","authors":"Anastasia Alexandridou, Caroline S Stokes, Dietrich A Volmer","doi":"10.1093/clinchem/hvae202","DOIUrl":"https://doi.org/10.1093/clinchem/hvae202","url":null,"abstract":"Background Serum total 25-hydroxyvitamin D [25(OH)D] concentration is the most widely used clinical biomarker for vitamin D status. Under certain physiological and pathological conditions, however, total 25(OH)D may not always be the best index for vitamin D status. Instead, the nonprotein-bound (free) fraction of total 25(OH)D has been suggested as a more appropriate marker in certain clinical situations. Content Free 25(OH)D levels can either be calculated or measured directly. Calculated free 25(OH)D depends on the concentrations of total serum 25(OH)D, vitamin D binding protein (VDBP), and albumin, as well as the affinity between analyte and binding proteins. Differences in VDBP concentrations are observed between populations as a result of health status, gene polymorphisms, and the assay used for determination. Direct measurement methods for free 25(OH)D are often complicated (dialysis, ultrafiltration) or susceptible to interferences, cross-reactivity, and type of antibody (immunoassays). Therefore, it is very important to develop tools that allow either accurate and precise measurement of VDBP or direct measurement of free 25(OH)D. For the latter, liquid chromatography combined with tandem mass spectrometry (LC–MS/MS) has recently shown promise for analysis of free vitamin D. In the current review, we present the importance and challenges regarding free 25(OH)D determination and the role of LC–MS-based methods in future studies. Summary More research is required to determine the role of free 25(OH)D in the assessment of vitamin D status in healthy subjects and in various clinical conditions. Recent advances in technology, including mass spectrometry, can provide the required assays for this purpose.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"27 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142809731","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

In Reply to Beyond the Screen Positive Rate: Racial Equity Considerations for Serum Screening for Open Neural Tube Defects. 回复 "超越筛查阳性率：开放性神经管缺陷血清筛查的种族公平考虑。

IF 7.1 2区医学

Clinical chemistry Pub Date : 2024-12-02 DOI: 10.1093/clinchem/hvae154

Geralyn Messerlian, Glenn E Palomaki

引用次数: 0

Clonality Determination by Detecting Unmodified Monoclonal Serum Free Light Chains Using On-Probe Extraction Coupled with Liquid Chromatography-High-Resolution Mass Spectrometry. 利用探针萃取与液相色谱-高分辨质谱联用技术检测未修饰的单克隆血清游离光链以确定克隆性

IF 7.1 2区医学

Clinical chemistry Pub Date : 2024-12-02 DOI: 10.1093/clinchem/hvae130

Priscilla S W Yeung, Yajing Liu, Samuel Yang, Ashley Ruan, Christina R Kerr, Carolyn V Wong, Run-Zhang Shi, David J Iberri, Ruben Y Luo

{"title":"Clonality Determination by Detecting Unmodified Monoclonal Serum Free Light Chains Using On-Probe Extraction Coupled with Liquid Chromatography-High-Resolution Mass Spectrometry.","authors":"Priscilla S W Yeung, Yajing Liu, Samuel Yang, Ashley Ruan, Christina R Kerr, Carolyn V Wong, Run-Zhang Shi, David J Iberri, Ruben Y Luo","doi":"10.1093/clinchem/hvae130","DOIUrl":"10.1093/clinchem/hvae130","url":null,"abstract":"Background: Serum free light chains (FLCs) are an essential clinical biomarker for the diagnosis and monitoring of patients with plasma cell neoplasms. The current widely used immunoassay methods quantify total serum FLCs, which include monoclonal FLCs as well as FLCs in the polyclonal background. Patients with chronic diseases, inflammatory disorders, or renal dysfunction can have elevated total FLCs that lead to ambiguous results. These patients may benefit from a direct measurement of monoclonal FLCs. The purpose of this study was to develop a method that couples on-probe extraction (OPEX) with liquid chromatography-high-resolution mass spectrometry (LC-HR-MS), abbreviated to OPEX-MS, to directly determine the clonality of FLCs.Methods: OPEX immunocapture was performed using microprobes loaded with anti-kappa or anti-lambda light chain antibodies. Captured proteins were separated by reversed-phase LC and analyzed by HR-MS.Results: Four cohorts of samples from unique patients were tested based on immunoassay FLC results. The LC-HR-MS analysis in the OPEX-MS method provides both a unique retention time along with deconvoluted masses of FLC monomers and dimers for each clone. The study found that 16 out of 49 (33%) kappa FLC elevated samples as well as 83 out of 100 (83%) dual kappa and lambda FLC elevated samples did not have monoclonal FLCs, which is consistent with the knowledge that there is often no clonal population in samples with mildly elevated FLC immunoassay results.Conclusions: The OPEX-MS method can serve as a complementary approach to directly determine clonality in patients with difficult-to-interpret FLC immunoassay results.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"1436-1442"},"PeriodicalIF":7.1,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388717","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

Progressive Motor Regression in a 3-Year-Old: Dietary Trends Revive an Overlooked Diagnosis. 一名3岁儿童的进行性运动衰退：饮食趋势使被忽视的诊断重新出现。

IF 7.1 2区医学

Clinical chemistry Pub Date : 2024-12-02 DOI: 10.1093/clinchem/hvae125

Ashley R Rackow, Claire E Knezevic

引用次数: 0