Clinical chemistry and laboratory medicine最新文献

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-11-28 Print Date: 2025-01-29 DOI: 10.1515/cclm-2024-2001

引用次数: 0

Can Theranos resurrect from its ashes? Theranos能从灰烬中复活吗？

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-07-18 DOI: 10.1515/cclm-2025-0651

Miyo K Chatanaka, Eleftherios P Diamandis, Mario Plebani

{"title":"Can Theranos resurrect from its ashes?","authors":"Miyo K Chatanaka, Eleftherios P Diamandis, Mario Plebani","doi":"10.1515/cclm-2025-0651","DOIUrl":"https://doi.org/10.1515/cclm-2025-0651","url":null,"abstract":"Theranos was a biotechnology company which, in the 2010s, promised to revolutionize traditional clinical chemistry testing by using novel technology, microvolumes of blood obtained by finger pricks, and performance of tests outside traditional clinical chemistry laboratories, such as in pharmacies. Theranos did not publish any details of their technology, nor sought to evaluate it independently. Despite this, it attracted millions of dollars of investments, and at a point, its market valuation reached $9 billion. Around 2015 the Theranos business practices and technology were scrutinized and it was revealed that they misled investors, doctors, and patients by falsely claiming of using their own technology, when in fact, they were using traditional clinical chemistry analyzers. The leaders of Theranos are now serving prison time. This year it was announced that a new effort is underway, by people who are related to Theranos, to start a new company, with objectives that partially overlap with those of the old company. Here, we comment on these new developments, with the hope that the lessons learned from the past will guide the new leaders to find success while mentioning that some new developments in the field will likely pose formidable competition.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648755","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

MAGLUMI^® Tacrolimus (CLIA) assay: analytical performances and comparison with LC-MS/MS and ARCHITECT Tacrolimus (CMIA) assay. MAGLUMI®他克莫司（CLIA）法：分析性能及与LC-MS/MS和ARCHITECT他克莫司（CMIA）法的比较。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-07-16 DOI: 10.1515/cclm-2025-0181

Mingpeng Fu, Shanchun Chen, Xianliang Zheng, Xuehong Li, Honggao Sun, Jin Chen, Hua Pei

{"title":"MAGLUMI® Tacrolimus (CLIA) assay: analytical performances and comparison with LC-MS/MS and ARCHITECT Tacrolimus (CMIA) assay.","authors":"Mingpeng Fu, Shanchun Chen, Xianliang Zheng, Xuehong Li, Honggao Sun, Jin Chen, Hua Pei","doi":"10.1515/cclm-2025-0181","DOIUrl":"https://doi.org/10.1515/cclm-2025-0181","url":null,"abstract":"Objectives: Tacrolimus has been a cornerstone of immunosuppressive therapy over the past two decades. Due to its narrow therapeutic window and pharmacokinetic variability, drug monitoring is vital for enhancing the efficacy and safety during therapy. In the present study, we evaluated the analytical performances of the MAGLUMI® Tacrolimus assay based on chemiluminescent immunoassay (CLIA), and compared with LC-MS/MS and the previously validated ARCHITECT Tacrolimus assay based on chemiluminescent microparticle immunoassay (CMIA).Methods: We assessed the precision, limit of blank (LoB), limit of quantification (LoQ), limit of detection (LoD) and linearity of the MAGLUMI® Tacrolimus assay using patient whole blood samples. Interference was assessed by introducing potential interferents into clinical samples. We also analyzed the correlation and agreement with the gold standard method (LC-MS/MS) and another previously validated high-performing ARCHITECT Tacrolimus (CMIA) assay by including 125 whole blood samples from patients and 44 spiked samples.Results: MAGLUMI® Tacrolimus (CLIA) assay exhibits superior precision, as coefficients of variation (CVs) for reproducibility and between-run precision were 0.55-3.63 % and 2.18-5.14 %, respectively. The LoB and LoQ were 0.1 μg/L and 0.5 μg/L. All samples in LoD verification had tacrolimus concentrations above LoB. The assay exhibited excellent linearity (r=0.99990, 0.5-50 μg/L) with no interference. Additionally, the results of the MAGLUMI® Tacrolimus (CLIA) assay showed strong correlation and concordance with LC-MS/MS and the CMIA assay.Conclusions: The MAGLUMI® Tacrolimus (CLIA) assay has excellent performance and strong concordance with LC-MS/MS and the ARCHITECT assay, making it a good alternative for tacrolimus measurement.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636401","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

Is time a significant factor in the release of potassium from lithium heparin plasma and serum? 时间是影响肝素锂血浆和血清中钾释放的重要因素吗？

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-07-15 DOI: 10.1515/cclm-2025-0676

Astrid Petersmann, Uta Ceglarek, Karen Friederike Gauß, Winfried März, Alexander von Meyer, Matthias Nauck

引用次数: 0

Utilization analysis of laboratory tests using health insurance claims data: advancing nationwide diagnostic stewardship monitoring systems. 使用医疗保险索赔数据的实验室检测利用分析：推进全国诊断管理监测系统。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-07-15 DOI: 10.1515/cclm-2025-0641

Se-Eun Koo, Jiyeon Kim, Kuenyoul Park

{"title":"Utilization analysis of laboratory tests using health insurance claims data: advancing nationwide diagnostic stewardship monitoring systems.","authors":"Se-Eun Koo, Jiyeon Kim, Kuenyoul Park","doi":"10.1515/cclm-2025-0641","DOIUrl":"https://doi.org/10.1515/cclm-2025-0641","url":null,"abstract":"Objectives: Diagnostic stewardship aims to optimize laboratory testing practices by ensuring appropriate test utilization while minimizing unnecessary testing. However, the nationwide monitoring systems for laboratory test utilization remain underdeveloped. In this study, we analyzed nationwide health insurance claims data to identify inappropriate test utilization patterns and inform diagnostic stewardship interventions.Methods: We analyzed the health insurance claims data from the Health Insurance Review and Assessment Service of Korea from January 2018 to December 2023. Three laboratory tests with concerns were evaluated. Inappropriate test utilization was classified based on adherence to recommended methodologies and institutional testing practices.Results: The proportion of tuberculosis cultures performed using both liquid and solid media increased from 84.6 % in 2018 to 91.4 % in 2023; however, some institutions continued to perform >90 % of tests using only a single medium. Regional disparities were observed, with nonmetropolitan areas exhibiting higher rates of inappropriate tuberculosis testing. Stool ova and parasite tests showed a persistent reliance on direct smear-only methods. The correlation between endemic parasitic regions and the high proportions of direct smear-only tests suggests an urgent need for improved diagnostic methodologies. Despite longstanding recommendations against their use, bleeding time tests remained frequently ordered. The total number of bleeding time test claims exceeded 400,000 annually, with a limited decline over time.Conclusions: Systematic monitoring frameworks based on nationwide claims data can identify inappropriate test utilization and support diagnostic stewardship efforts by informing targeted interventions, thereby optimizing laboratory resource allocation and enhancing patient safety.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625479","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

What matters most: an age-friendly approach to pathology and laboratory medicine. 最重要的是：对病理学和检验医学采取一种对老年人友好的方法。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-07-14 DOI: 10.1515/cclm-2025-0616

Melody Boudreaux Nelson, Candice Coffey

{"title":"What matters most: an age-friendly approach to pathology and laboratory medicine.","authors":"Melody Boudreaux Nelson, Candice Coffey","doi":"10.1515/cclm-2025-0616","DOIUrl":"https://doi.org/10.1515/cclm-2025-0616","url":null,"abstract":"Under the Age-Friendly Health System initiative, \"What Matters\" is defined as knowing the older adult's specific health outcome goals and care preferences. This involves multiple settings of care (e.g., hospital, skilled nursing facility, outpatient visits) and can include end-of-life care. However, the establishment of testing frequency criterion and the development of wide-scale diagnostic algorithms are often left undefined in older adults with poor prognosis and/or shortened life expectancy. Thus, multidisciplinary development of Geriatric 5M-informed optimization plans at the institution level and quality improvement strategies within the laboratory community may further the successful implementation of age-friendly efforts. While patients, end-users, and systems can attribute to implementation barriers, the development of an evidence-base wherein laboratory expertise is directly associated with patient outcomes is vital. Thus, a concentrated, cooperative age-friendly approach centered on What Matters may present a sustainable strategy for early transformation. Future research centered on piloted interventions on the laboratory's role in older adult care and end of life diagnostic management is needed.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144612123","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

Performance of afternoon (16:00 h) serum cortisol for the diagnosis of Cushing's syndrome. 下午（16:00 h）血清皮质醇水平对库欣综合征的诊断价值。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-07-11 DOI: 10.1515/cclm-2025-0133

Hippolyte Dupuis, Emilie Merlen, Julien Elices-Diez, Pierre Balayé, Christine Cortet, Arnaud Jannin, Christine Do Cao, Claire Douillard, Benoit Soulez, Nassima Ramdane, Benoit Soudan, Marie-Christine Vantyghem, Stéphanie Espiard

{"title":"Performance of afternoon (16:00 h) serum cortisol for the diagnosis of Cushing's syndrome.","authors":"Hippolyte Dupuis, Emilie Merlen, Julien Elices-Diez, Pierre Balayé, Christine Cortet, Arnaud Jannin, Christine Do Cao, Claire Douillard, Benoit Soulez, Nassima Ramdane, Benoit Soudan, Marie-Christine Vantyghem, Stéphanie Espiard","doi":"10.1515/cclm-2025-0133","DOIUrl":"https://doi.org/10.1515/cclm-2025-0133","url":null,"abstract":"Introduction: Late-night salivary cortisol (LNSC), which assesses the loss of the circadian rhythm of cortisol, is one of the first-line tests performed to diagnose Cushing's syndrome (CS). Unfortunately, access to LNSC is still limited in some institutions. Alternatively, midnight serum cortisol can be measured, often combined with additional cortisol sampling over 24 h. This study investigates the performance of afternoon serum cortisol (F16h) for the positive diagnosis of hypercortisolism.Methods: Retrospective study including consecutive patients evaluated for suspicion of CS by at least two tests among urine-free cortisol (UFC), overnight 1-mg dexamethasone suppression test (DST), and midnight serum cortisol (F00h). Patients assessed for adrenal incidentalomas or Cushing's disease recurrence were excluded.Results: Of the 589 included patients (41.3 % women, mean age 50.7 ± 16.3 years), 49 (8.3 %) were diagnosed with CS. F16h demonstrated significant correlations with DST, UFC, and F00h (r=0.24, p<0.001, r=0.41, p<0.001 and r=0.42, p<0.001, respectively). The optimal cut-off of the F16h was 218 nmol/L, achieving 83.7 % sensitivity, 67.4 % specificity, and a 97.8 % negative predictive value. The area under the ROC curve (AUC) for the F16h did not differ from UFC (0.83 vs. 0.79, p=0.3), yet its sensitivity was higher using the optimal diagnostic threshold. The AUC for the F16h was significantly lower than that for F00h and DST.Conclusions: Given the limited diagnostic accuracy of both F16h and UFC, particularly in mild to moderate CS, efforts should prioritize expanding access to reliable LNSC assays for circadian rhythm assessment. Meanwhile, F16h may help rule out CS when LNSC is unavailable.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144599640","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 novel immunoprecipitation-based targeted liquid chromatography-tandem mass spectrometry analysis for accurate determination for copeptin in human serum. 一种新的基于免疫沉淀的靶向液相色谱-串联质谱分析方法用于准确测定人血清中copeptin。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-07-10 DOI: 10.1515/cclm-2025-0022

Danni Mu, Xiaoli Ma, Yichen Ma, Danchen Wang, Yutong Zou, Ying Zhu, Jian Zhong, Dandan Sun, Yicong Yin, Yumeng Gao, Yuemeng Li, Shi Chen, Huijuan Zhu, Songlin Yu, Ling Qiu, Xinqi Cheng

{"title":"A novel immunoprecipitation-based targeted liquid chromatography-tandem mass spectrometry analysis for accurate determination for copeptin in human serum.","authors":"Danni Mu, Xiaoli Ma, Yichen Ma, Danchen Wang, Yutong Zou, Ying Zhu, Jian Zhong, Dandan Sun, Yicong Yin, Yumeng Gao, Yuemeng Li, Shi Chen, Huijuan Zhu, Songlin Yu, Ling Qiu, Xinqi Cheng","doi":"10.1515/cclm-2025-0022","DOIUrl":"https://doi.org/10.1515/cclm-2025-0022","url":null,"abstract":"Objectives: Copeptin, a stable and simple-to-measure surrogate marker for arginine vasopressin (AVP), demonstrates excellent clinical values, particularly in diagnosing polyuria-polydipsia syndromes. However, conventional immunoassay methods are limited and lack comparability. Our aim was to establish a targeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantifying copeptin in human serum.Methods: Copeptin was extracted from serum using immunoprecipitation, digested with trypsin, and prepared using anion exchange solid-phase extraction before LC-MS/MS detection. The analytical performance was validated in accordance with current guidelines. The method was compared to an immunofluorescent assay on the B.R.A.H.M.S platform.Results: The LC-MS/MS method had a runtime of 8.5 min. The within-run precision ranged from 5.2 to 12.1 %, and total coefficients of variation ranged from 8.1 to 13.5 %. Copeptin quantitation showed linearity within the range of 5-1,000 pg/mL, with a limit of detection of 2.5 pg/mL. Recovery rates ranged from 95.2 to 103.1 %, and no significant matrix effect was observed with internal standard correction. The LC-MS/MS method had a good consistency with the immunoassay (r=0.926, slope=0.989). The reference interval for healthy individuals was 3.66-58.25 pg/mL.Conclusions: We demonstrated the accuracy and reliability of this targeted LC-MS/MS method for quantifying copeptin. This innovative application showed satisfactory precision, a wide linear range, and a low limit of detection. Clinical studies are anticipated to be conducted to assess diagnostic accuracy using this method.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144599639","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

External quality assessment in resource-constrained laboratories: a survey of practices and perceptions in Nepal. 资源受限实验室的外部质量评估：尼泊尔实践和观念调查。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-07-07 DOI: 10.1515/cclm-2025-0698

Vivek Pant, Santosh Pradhan, Tony Badrick

引用次数: 0

Cellular expression of PD-1, PD-L1 and CTLA-4 in patients with JAK2^V617F mutated myeloproliferative disorders. JAK2V617F突变的骨髓增生性疾病患者中PD-1、PD-L1和CTLA-4的细胞表达

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-07-03 DOI: 10.1515/cclm-2025-0306

Christoph Winkler, Markus Anliker, Stefan Schmidt, Clemens Feistritzer, Britta Höchsmann, Hubert Schrezenmeier, Anita Siller, Andrea Griesmacher, Lorin Loacker

{"title":"Cellular expression of PD-1, PD-L1 and CTLA-4 in patients with JAK2V617F mutated myeloproliferative disorders.","authors":"Christoph Winkler, Markus Anliker, Stefan Schmidt, Clemens Feistritzer, Britta Höchsmann, Hubert Schrezenmeier, Anita Siller, Andrea Griesmacher, Lorin Loacker","doi":"10.1515/cclm-2025-0306","DOIUrl":"https://doi.org/10.1515/cclm-2025-0306","url":null,"abstract":"Objectives: The acquired, somatic JAK2V617F mutation is the most common molecular aberration in patients with myeloproliferative neoplasms (MPN) and also significantly involved in the regulation of T cell immunity. PD-1, PD-L1 and CTLA-4 are key immune checkpoint regulators that are elevated in patients with solid tumors, infectious diseases and chronic inflammation. We aimed further investigating the significance of immune checkpoint expression in JAK2V617F positive MPN.Methods: The surface expression of PD-L1, PD-1 and CTLA-4 on peripheral blood leukocytes was determined by flow cytometry in 27 patients with JAK2V617F positive MPN and in a control group of 26 healthy individuals and analyzed by immune checkpoint and leukocyte subpopulation. In addition, the concentration of soluble PD-L1 (sPD-L1) in plasma was examined by ELISA.Results: PD-1, PD-L1 and CTLA-4 are significantly overexpressed on the surface of granulocytes in JAK2 positive patients compared to the control group. Soluble PD-L1 (sPD-L1) is elevated in the plasma of JAK2 positive patients and increases with decreased renal function. In CD8+ T-cells and CD4+ T-cells there is a significant negative correlation between PD-1 expression or sPD-L1 concentration and their corresponding cell count.Conclusions: Our study shows a significant increase of immune checkpoint regulators on the cellular surface as well as soluble PD-L1 in JAK2 mutated patients compared to healthy individuals. Increased activation of the JAK2/STAT signaling pathway by JAK2V617F appears to be a mechanism of reduced immune activation in patients with MPN. Immune checkpoint inhibition might therefore represent a potential additional therapeutic target in this disease group.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144552430","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