Clinical chemistry and laboratory medicine最新文献

{"title":"The current status of serum insulin measurements and the need for standardization.","authors":"Curt Rohlfing, Gregory Petroski, Maya Hatten-Beck, Steven Hanson, Andrew N Hoofnagle, Randie R Little, Kuanysh Kabytaev","doi":"10.1515/cclm-2025-0552","DOIUrl":"10.1515/cclm-2025-0552","url":null,"abstract":"<p><strong>Objectives: </strong>Insulin assays are used to assess insulin resistance and to aid in the diagnosis of conditions such as insulinoma and various forms of hypoglycemia. However, discrepancies among commercial assays limit their clinical and research utility. This study evaluates the current comparability of the most widely used insulin assays.</p><p><strong>Methods: </strong>Forty serum samples, including those from healthy individuals and patients with type 1 or type 2 diabetes, were analyzed by nine manufacturers using 12 commercial immunoassays. Results from each assay were compared both to the isotope dilution mass spectrometry (IDMS) method and across the different immunoassays.</p><p><strong>Results: </strong>Intra-assay repeatability was excellent (ICCs>0.99), but substantial inter-assay variability was observed. Differences relative to LC-MS ranged from -298.2 to +302.6 pmol/L. Several assays overestimated insulin concentrations at low levels and underestimated them at higher levels. Only one assay method showed full agreement with the IDMS method.</p><p><strong>Conclusions: </strong>Despite all methods claiming traceability to the WHO 66/304 standard, significant variability persists among insulin assays. These findings highlight the urgent need for insulin assay standardization using commutable certified reference materials.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12452087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144844769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative analysis of population-based and personalized reference intervals for biochemical markers in peri-menopausal women: population from the PALM cohort study.","authors":"Jiaming Wu, Penghui Feng, Jinming Zhang, Xingtong Chen, Rong Chen, Min Luo, Falin He","doi":"10.1515/cclm-2025-0658","DOIUrl":"https://doi.org/10.1515/cclm-2025-0658","url":null,"abstract":"<p><strong>Objectives: </strong>Significant changes in clinical biochemical markers occur during the peri-menopausal period. Traditional population-based reference intervals (popRIs) may not reflect individual physiological variability, limiting clinical interpretation. This study aimed to establish personalized reference intervals (prRIs) for menopausal women and compare them with popRIs.</p><p><strong>Methods: </strong>We analyzed 899 healthy women aged 35-64 from the Peking Union Medical College Hospital Aging Longitudinal Cohort of Women in Midlife (PALM) cohort. 13 biochemical markers were evaluated across reproductive, menopausal transition, and postmenopausal stages. Six key biomarkers were selected through Kruskal-Wallis tests and ranked by their importance in menopausal status classification using a Random Forest model. Biological variation (BV) data were used to calculate total variation (TV) and index of individuality (II). The prRIs were constructed based on BV estimates, and the reference interval index (RII) was applied to compare popRIs and prRIs.</p><p><strong>Results: </strong>ALT, TG, and FSH showed significant differences across menopausal stages and ranked highly in the Random Forest model. These markers also had large BV and differed across three menopausal stages. Most II values ranged from 0.6 to 1.4, and all median RII values were below 1.0, suggesting limited utility of popRIs. Crea in reproductive women had the highest proportion of RII>1.0, while FSH showed RII<0.5 in over 90 % of women in the menopausal transition.</p><p><strong>Conclusions: </strong>For women in the menopausal transition with high BV estimates, combining popRIs with prRIs improves interpretation. Larger, more diverse cohorts are needed to validate and optimize prRIs for clinical application.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144844796","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":"Recent decline in patient serum folate test levels using Roche Diagnostics Folate III assay.","authors":"Anders Larsson, Johan Saldeen, Frida Duell","doi":"10.1515/cclm-2025-0723","DOIUrl":"https://doi.org/10.1515/cclm-2025-0723","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144844768","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":"Cryoglobulin pre-analysis over the weekend.","authors":"Corrie de Kat Angelino, Chantal P Rovers, Joannes F M Jacobs","doi":"10.1515/cclm-2025-0850","DOIUrl":"https://doi.org/10.1515/cclm-2025-0850","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144820702","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":"Hemolysis detection using the GEM 7000 at the point of care in a pediatric hospital setting: does it affect outcomes?","authors":"Ridwan B Ibrahim, Nazmin Bithi, Charlene Hernandez, Hanna Uhrova, Brandy D Recio, Sridevi Devaraj","doi":"10.1515/cclm-2025-0890","DOIUrl":"https://doi.org/10.1515/cclm-2025-0890","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144820703","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":"Supplementation of pyridoxal-5'-phosphate in aminotransferase reagents: a matter of patient safety.","authors":"Mauro Panteghini","doi":"10.1515/cclm-2025-0947","DOIUrl":"https://doi.org/10.1515/cclm-2025-0947","url":null,"abstract":"<p><p>As aminotransferases represent the first-level tests to detect individuals with hepatocellular damage, standardization of their measurements is a priority need for patient care. The obtaining of the harmonization in aminotransferase results is however strongly dependent on supplementation of pyridoxal-5'-phosphate (P-5-P) in aminotransferase reagents as this exclusively enables reporting of measured values on clinical samples that are traceable to the IFCC reference measurements procedures, representing the highest metrological level defining the respective measurable enzyme quantity. The lack of P-5-P addition in the employed commercial reagents is the most frequent cause of unacceptably biased results of aminotransferases, which opposes to consistency of results across laboratories and commercial assays. Nevertheless, only about one-third of medical laboratories include P-5-P in their aminotransferase measurements. This demonstrates a lack of awareness of the clinical benefits of P-5-P supplementation, which is not just an analytical preference, but it represents a laboratory priority for providing a high-quality service in pertinent clinical situations.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144815925","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":"HCV serology: an unfinished agenda.","authors":"Claudio Galli, Mario Plebani","doi":"10.1515/cclm-2025-0501","DOIUrl":"10.1515/cclm-2025-0501","url":null,"abstract":"<p><p>Over 50 years have elapsed since the clinical definition of non-A, non-B hepatitis and 36 years since the unveiling of hepatitis C virus (HCV) and the availability of specific serological assays, but few advances in the serological diagnosis of HCV infection have occurred. Testing for anti-HCV is still based on the detection of reactivity towards the structural Core region of HCV, which appears to be dominant throughout the different phases of infection, plus antibodies towards antigens expressed by several non-structural regions. Unlike testing for other viral diseases, antibodies towards the envelope region are not detectable by the first line assays employed for screening or diagnosis and are scarcely represented in the supplementary assays employed to confirm the reactivity by screening assays. Clinical laboratories are often confronting issues on samples that give discrepant results among assays and are not confirmed by supplemental testing. Results obtained on those samples are usually labelled as 'indeterminate' and are often considered as false positive - though a true reference to define anti-HCV positivity is still lacking. The diagnostic answer is then deprived of clinical significance and affects patient management and counselling. The only advance, though not recent, has been the availability of assays detecting the HCV core antigen, which is considered as a surrogate of HCV RNA, with lesser sensitivity but bearing some operational and economic advantages in diagnosis and population screening, and lately of assays combining HCV antigen and anti-HCV detection. This paper summarizes the history of HCV serology and provides some insights on its limitations and potential developments.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798347","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":"Oral salt loading combined with postural stimulation tests for confirming and subtyping primary aldosteronism.","authors":"Jenny Yeuk Ki Cheng, Wai Shan Clara Lo, Teresa Kam Chi Tsui, Wing Kar Edith Chow, Kitty Kit Ting Cheung, Ronald Ching Wan Ma, Risa Ozaki, Chung Shun Ho","doi":"10.1515/cclm-2025-0644","DOIUrl":"https://doi.org/10.1515/cclm-2025-0644","url":null,"abstract":"<p><strong>Objectives: </strong>Primary aldosteronism (PA) is an underdiagnosed yet important condition. This study aimed to evaluate the diagnostic performance of a combined protocol using oral salt loading and postural stimulation tests (PST), named the balance study, to confirm and subtype PA.</p><p><strong>Methods: </strong>We retrospectively analyzed the data of 402 patients with either confirmed PA or essential hypertension who underwent the balance study. Biochemical markers were measured using liquid chromatography-tandem mass spectrometry. Receiver operating characteristic curves were used to assess the diagnostic performance. The cut-off values for biochemical markers were determined by Youden J's statistics.</p><p><strong>Results: </strong>For PA confirmation, urinary aldosterone (UALD; area under the curve [AUC] 0.894), urinary tetrahydroaldosterone (UTHA; AUC 0.875), the sum of UALD and UTHA (SUM; AUC 0.884), and supine plasma aldosterone (PALD; AUC 0.902) showed comparable performance. Corresponding cut-offs were: UALD>38 nmol/day, UTHA>160 nmol/day, SUM>259 nmol/day, and supine PALD>273 pmol/L. For PA subtyping, the difference or ratio between erect and supine PALD in PST achieved an AUC of 0.90. An increase of less than 19 pmol/L or less than 5 % from a supine to an erect position suggested an aldosterone-producing adenoma.</p><p><strong>Conclusions: </strong>This combined protocol using oral salt loading and PST could help confirm a diagnosis of PA and predict the subtype. UTHA and supine PALD may add value to UALD for PA confirmation, whereas the erect/supine PALD ratio from PST could assist in PA subtyping. Further studies are required to validate these findings.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798348","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":"Establishment of region-, age- and sex-specific reference intervals for aldosterone and renin with sandwich chemiluminescence immunoassays.","authors":"Lin-Lin Cao, Bing Gu, Liqiong Yao, Gang Li, Chunling Wang, Huijun Cui, Ran Xu, Hui Wang","doi":"10.1515/cclm-2025-0587","DOIUrl":"https://doi.org/10.1515/cclm-2025-0587","url":null,"abstract":"<p><strong>Objectives: </strong>Accurate measurement of plasma aldosterone (ALD) and renin is important in primary aldosteronism screening and diagnosis. The high variability of ALD and renin due to salt intake, age, and sex, as well as the lack of immunoassay standardization necessitates the establishment of region-, age-, sex- and assay-specific reference intervals (RIs). This study established RIs for ALD and renin using novel sandwich chemiluminescent immunoassays.</p><p><strong>Methods: </strong>ALD and renin were measured on a fully automated chemiluminescence platform (Maglumi X8, Snibe, China). The analytic performances were estimated following CLSI guidelines. A total of 2,281 healthy participants from Beijing, Jiangsu, Henan, Gansu and Guangdong were recruited.</p><p><strong>Results: </strong>Total imprecision were 1.42-5.09 % for ALD and 1.07-4.11 % for renin. The maximum dilution rates were 50× and 10× for ALD and renin. Interferences of 22 and six interferents for ALD and renin were acceptable. The sandwich ALD immunoassay results highly correlated with LC-MS/MS (<i>r</i>=0.994). The RI of ALD was partitioned based on salt intake, with central 95 % RIs for males of 16.9-185 ng/L (46.8-513 pmol/L) in Guangdong and 26.5-242 ng/L (73.5-671 pmol/L) in other four regions. Females showed an age-dependent decline in ALD levels (RIs in Guangdong: 26.9-442 ng/L [74.6-1,226 pmol/L, 18-40 years], 32.4-326 ng/L [89.9-904 pmol/L, 41-60 years], 21.2-199 ng/L [58.8-552 pmol/L, >60 years], whereas males exhibited no significant change. Renin RIs: females: 3.43-89.2 mU/L (18-40 years), 0.92-67.1 mU/L (41-60 years), 0.66-55 mU/L (>60 years); males: 2.23-95.1 mU/L (≤60 years), 1.71-68.9 mU/L (>60 years).</p><p><strong>Conclusions: </strong>This is the first study to establish accurate ALD and renin RIs for sandwich immunoassays. Region-, age- and sex-specific RIs were recommended, which will enhance the accuracy of clinical screening and diagnosis of primary aldosteronism.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793628","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":"Total laboratory automation: fit for its intended purposes?","authors":"Mario Plebani","doi":"10.1515/cclm-2025-0855","DOIUrl":"https://doi.org/10.1515/cclm-2025-0855","url":null,"abstract":"<p><p>Since the 1980s, automation has profoundly transformed clinical laboratory operations, enhancing efficiency, standardization, and throughput. This technological evolution has enabled laboratories to meet rising testing demands, address persistent workforce shortages, and control operational costs. Beyond analytical consolidation, significant progress has been made through the integration of pre-analytical and post-analytical phases, thereby improving the overall quality of the Total Testing Process (TTP). Despite the well-recognized benefits of Total Laboratory Automation (TLA) - notably improved worker safety and faster turnaround times - a number of limitations have emerged, particularly concerning operational challenges and the lack of evidence for clinical effectiveness. Future improvements should focus on the integration of pre-pre-analytical processes, miniaturization of testing platforms, consolidation of all laboratory medicine subspecialties, and enhanced data management. However, the most critical issue remains the limited evidence supporting the impact of TLA on key clinical outcomes - such as reduced length of stay in emergency departments and hospital wards, optimized diagnostic-therapeutic pathways, improved quality of care, and reduced morbidity and mortality.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793629","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}