Clinical chemistry最新文献

{"title":"A Comprehensive Review of Estradiol, Progesterone, Luteinizing Hormone, and Follicle-Stimulating Hormone in the Context of Laboratory Medicine to Support Women's Health.","authors":"Dina N Greene,Sofia B Ahmed,Sarah Daccarett,Juliana M Kling,Thomas S Lorey,Chantal L Rytz,Kristi J Smock,Gabrielle Winston-McPherson","doi":"10.1093/clinchem/hvaf039","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf039","url":null,"abstract":"BACKGROUNDThere have been conflicting messages about the influence of female sex hormones on women's health, with historical messaging indicating that use of estrogen and/or progesterone in peri- or postmenopause poses a significant clinical risk to cisgender women. More recent guidance indicates that the benefit of hormone therapy (HT) outweighs the risks for symptomatic women. Exogenous estrogen use is also indicated for contraception and gender-affirming care. Despite the potential for broad applications, robust reference intervals for estradiol, progesterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are lacking, and guidelines indicate that measurement of 17-β-estradiol (E2), progesterone, LH, or FSH does not facilitate care in women who may be experiencing menopausal symptoms or women taking exogenous HT.CONTENTHere we review the physiological roles of estrogen, progesterone, LH, and FSH. We examine the modes of administration for estrogen and progesterone, clarify the nomenclature related to exogenous hormone use, and comprehensively review the literature for studies evaluating normal concentrations of these female gonadal axis hormones during the menstrual cycle. The content primarily focuses on cisgender women, but some aspects of these hormones in transgender women will also be discussed.SUMMARYCurrently, E2, LH, FSH, and progesterone reference intervals for women remain incomplete. Although there are a variety of clinical indications that benefit women using HT, symptoms and shared decision-making should guide care. Collaborative efforts between clinicians and laboratory professionals to better define therapeutic or reference intervals for these hormones can advance women's health globally.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"73 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143849544","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":"Reevaluating the Threshold for Low Total Testosterone.","authors":"Adith S Arun,Thomas J S Durant,Joe M El-Khoury,Harlan M Krumholz","doi":"10.1093/clinchem/hvaf025","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf025","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"173 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143846394","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":"Cardiac Biomarkers in Pulmonary Embolism: Revealing or Redundant?","authors":"A Mark Richards","doi":"10.1093/clinchem/hvaf019","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf019","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"25 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143846395","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":"Help Us to Help You: Recommendations for Continued Enforcement Discretion for Common Infectious Disease Test Modifications under the FDA Final Rule.","authors":"Kyle G Rodino,Paige M K Larkin,Erin H Graf","doi":"10.1093/clinchem/hvaf018","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf018","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"20 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143846396","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":"Instrument Multiplexing: Amplified Throughput for Measurement of Vitamin B1 in Whole Blood Using Parallel Liquid Chromatography Systems Interfaced to a Single Mass Spectrometer","authors":"Preejith P Vachali, Erik Kish-Trier, Sophie Steckel, Elizabeth L Frank","doi":"10.1093/clinchem/hvaf029","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf029","url":null,"abstract":"Background Thiamine diphosphate (TDP), the active form of vitamin B1, plays an essential role in energy metabolism. TDP is analyzed in the clinical laboratory to assess the nutritional status of individuals at risk of deficiency. In recent years, demand for vitamin B1 testing has increased dramatically, prompting implementation of a high-throughput assay. We developed a method using rapid sample preparation and multiplex electrospray LC-MS/MS analysis. Methods Whole blood samples were deproteinized using trichloroacetic acid after the addition of isotope-labeled analyte (TDP-d3). TDP was separated by reversed-phase chromatography on extended pH, trifunctional silane-bonded C18 columns and analyzed using positive electrospray ionization and multiple reaction monitoring mass spectrometry. The system consisted of 4 LC instruments plumbed to a single mass spectrometer. TDP eluted in 3.15 ± 0.08 min with a run time of 9.0 min for a single stream; results for 4 streams were produced every 2.25 min. Passivation of the system was required to optimize sensitivity and peak quality. Results The method was linear from 20 to 1000 nmol/L. Spike-recovery experiments showed an accuracy of ±15%. The intra- and inter-day assay imprecision was ≤3%. Repeated injections of calibrators and QC materials across the four LC streams showed excellent parity (<2% imprecision). No carryover was detected. Each plate produced 81 results in 4.5 h. Conclusions An accurate, specific, and high-throughput LC-MS/MS method was developed and validated to measure TDP in whole blood. Simple, fast sample preparation was employed for adaptation to a staggered injection, multiple LC-stream platform, which minimized mass spectrometer idle time significantly and improved efficiency.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"39 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143813593","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":"Methylglyoxal-Induced Glycation of Plasma Albumin: From Biomarker Discovery to Clinical Use for Prediction of New-Onset Diabetes in Individuals with Prediabetes.","authors":"Arsênio Rodrigues Oliveira, Chloé Chevalier, Matthieu Wargny, Victoria Pakulska, Cédric Caradeuc, Chloé Cloteau, Marine P M Letertre, Nicolas Giraud, Gildas Bertho, Edith Bigot-Corbel, Maxime Carpentier, Georges Nouadje, Yohann Couté, Cédric Le May, Bertrand Cariou, Samy Hadjadj, Mikaël Croyal","doi":"10.1093/clinchem/hvaf035","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf035","url":null,"abstract":"<p><strong>Background: </strong>Methylglyoxal (MGO) is a potent glycating agent that contributes to the pathogenesis of diabetes. However, MGO is unstable in plasma without demanding sample preparation at blood collection, limiting its clinical utility as a biomarker. We aimed to discover reliable MGO-glycated albumin (ALB)-derived biomarkers and to assess their association with new-onset diabetes (NOD) in people with prediabetes.</p><p><strong>Methods: </strong>Bottom-up mass spectrometry-based proteomics was used to discover peptide biomarkers of MGO-glycated ALB, including MGO-derived hydroimidazolone (MGH)-ALB219-225, which proved to be biologically stable and reliable for large-scale analyses in human plasma. After assay validation, the IT-DIAB (Innovation Thérapeutique DIABète) prospective study, conducted in 300 individuals with impaired fasting plasma glucose (FPG) levels (110 to 125 mg/dL, 6.1 to 6.9 mmol/L), was used to assess the association between plasma MGH-ALB219-225 and NOD, defined as FPG ≥126 mg/dL (7 mmol/L), using Kaplan-Meier curves and Cox models.</p><p><strong>Results: </strong>In total, 113 participants of the IT-DIAB study developed NOD during a median follow-up of 5 years. There was a graded association between the baseline plasma MGH-ALB219-225 concentration and incident NOD (log-rank P < 0.0001), in contrast to a lack of association for plasma MGO and total or glycated ALB (commercial kit). After adjustment for age, sex, body mass index, FPG, hemoglobin (Hb) A1c, and ALB, the plasma levels of MGH-ALB219-225 were associated with NOD (hazard ratio [HR] per one SD [95% CI] = 1.50 [1.26-1.78]; P < 0.0001).</p><p><strong>Conclusions: </strong>MGH-ALB219-225 is a novel and stable peptide biomarker of MGO-glycated ALB, whose plasma levels are positively associated with an increased risk of NOD in individuals with prediabetes, independently of traditional risk factors. ClinicalTrials.gov Registration Number: NCT01218061.</p>","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":""},"PeriodicalIF":7.1,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794970","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":"Toward Improved Prostate Cancer Screening: Insights from the Göteborg-2 Trial.","authors":"Jacob E Tallman, Sigrid V Carlsson, Hans Lilja","doi":"10.1093/clinchem/hvaf032","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf032","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":""},"PeriodicalIF":7.1,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778985","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":"Improved 1H Nuclear Magnetic Resonance Spectroscopy Quantification of Plasma Creatinine.","authors":"Karen Friederike Gauß, Nele Friedrich, Ann-Kristin Henning, Marc Fenzlaff, Stephanie Könemann, Daniel Rosenkranz, Astrid Petersmann, Matthias Nauck","doi":"10.1093/clinchem/hvaf005","DOIUrl":"10.1093/clinchem/hvaf005","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"520-522"},"PeriodicalIF":7.1,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381820","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":"The Impact of Climate Change on Laboratory Medicine: A Global Health Perspective.","authors":"Melissa Richard-Greenblatt, Catherine L Omosule, Bernard Owusu Agyare, Saswati Das, Carol Devine, Margaret Mokomane, Sheri Scott, Manivanh Vongsouvath","doi":"10.1093/clinchem/hvaf012","DOIUrl":"10.1093/clinchem/hvaf012","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"438-444"},"PeriodicalIF":7.1,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604240","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":"Small Remnants versus Large Triglyceride-Rich Lipoproteins in Risk of Atherosclerotic Cardiovascular Disease.","authors":"Benjamin N Wadström, Anders B Wulff, Kasper M Pedersen, Børge G Nordestgaard","doi":"10.1093/clinchem/hvae222","DOIUrl":"10.1093/clinchem/hvae222","url":null,"abstract":"<p><strong>Background: </strong>Small remnants may penetrate the arterial intima more efficiently compared to large triglyceride-rich lipoproteins (TGRL). We tested the hypothesis that the importance of remnant cholesterol for the risk of atherosclerotic cardiovascular disease (ASCVD) may depend on the size of the remnants and TGRL carrying cholesterol.</p><p><strong>Methods: </strong>The cholesterol content of small remnants and large TGRL were measured in 25 572 individuals from the Copenhagen General Population Study (2003-2015) and in 222 721 individuals from the UK Biobank (2006-2010) using nuclear magnetic resonance spectroscopy. In the Copenhagen cohort during up to 15 years of follow-up and in the UK Biobank cohort during up to 16 years of follow-up, the numbers of individuals diagnosed with ASCVD (=myocardial infarction, ischemic stroke, and peripheral artery disease) in national health registries were 3869 and 11 424, respectively.</p><p><strong>Results: </strong>Compared to individuals with low cholesterol content in both small remnants and large TGRL (cutpoints were median cholesterol content), multivariable-adjusted hazard ratios for risk of ASCVD were 1.21 (95% confidence interval: 1.07-1.37) for individuals with high cholesterol content in small remnants only and 0.94 (0.83-1.07) for individuals with high cholesterol content in large TGRL only; the multivariable-adjusted hazard ratio for risk of ASCVD per 10 percentile-units higher cholesterol content in small remnants vs that in large TGRL was 1.04 (1.01-1.07). In the UK Biobank cohort, corresponding hazard ratios were 1.11 (1.03-1.20), 1.01 (0.93-1.09), and 1.05 (1.04-1.07), respectively.</p><p><strong>Conclusion: </strong>The importance of remnant cholesterol for the risk of ASCVD may depend on the size of the TGRL and remnants carrying cholesterol.</p>","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"463-473"},"PeriodicalIF":7.1,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064132","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}