Clinical chemistry and laboratory medicine最新文献_第4页

Recommendations for the integration of standardized quality indicators for glucose point-of-care testing. 葡萄糖即时检测标准化质量指标整合建议。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-05-22 DOI: 10.1515/cclm-2025-0448

Julie L V Shaw, Saranya Arnoldo, Ihssan Bouhtiany, Davor Brinc, Miranda Brun, Christine Collier, Anna Fuezery, Angela W S Fung, Yun Huang, Sukhbir Kaur, Michael Knauer, Elie Kostantin, Lyne Labrecque, Felix Leung, Vinita Thakur, Allison Venner, Paul Yip, Vincent De Guire

{"title":"Recommendations for the integration of standardized quality indicators for glucose point-of-care testing.","authors":"Julie L V Shaw, Saranya Arnoldo, Ihssan Bouhtiany, Davor Brinc, Miranda Brun, Christine Collier, Anna Fuezery, Angela W S Fung, Yun Huang, Sukhbir Kaur, Michael Knauer, Elie Kostantin, Lyne Labrecque, Felix Leung, Vinita Thakur, Allison Venner, Paul Yip, Vincent De Guire","doi":"10.1515/cclm-2025-0448","DOIUrl":"https://doi.org/10.1515/cclm-2025-0448","url":null,"abstract":"Objectives: Quality indicator (QI) monitoring is essential to quality assurance for point of care testing (POCT). QI standardization is needed in the POCT field to provide clear guidance to hospitals and produce National and International benchmarks. A central aim was to standardize POCT QIs with existing QIs of the MQI program recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for central laboratory testing for integration in Comparison programs.Methods: Process mapping and risk assessment of the POC glucose testing process were used to establish potential QI. Group consensus was used to rank each potential QI based on the ability to retrieve data for the specific QI. Higher scores were attributed to QI where data could be retrieved electronically and automatically. The highest scoring QI were chosen for follow-up. Members of the working group (authors) were asked to submit data from their own institutions for each QI to evaluate the feasibility of monitoring each QI and to develop preliminary benchmarks.Results: Five QI recommendations are provided for glucose POCT, including: positive patient identification, operator training, internal quality control monitoring, external quality assessment and critical results follow-up. Preliminary QI data are presented along with implementation strategies and challenges associated with each recommended QI.Conclusions: This study builds upon previous work by the Canadian Society of Clinical Chemists in developing a process to establish QIs for POCT based on process mapping and risk assessment. The recommended QIs are applicable to most other types of POCT, in addition to glucose testing.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144149625","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

Growing importance of vocabularies in medical laboratories. 词汇在医学实验室中日益重要。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-05-22 DOI: 10.1515/cclm-2025-0545

Marco Pradella

引用次数: 0

High myoglobin plasma samples risk being reported as falsely low due to antigen excess - follow up after a 2-year period of using a mitigating procedure. 高肌红蛋白血浆样本由于抗原过量而被误报为低风险-使用缓解程序2年后随访。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-05-22 DOI: 10.1515/cclm-2025-0409

Anders O Olsson, Karin Lundberg, Esmira Becirevic, Malin Stenberg, Joakim Sandstedt

{"title":"High myoglobin plasma samples risk being reported as falsely low due to antigen excess - follow up after a 2-year period of using a mitigating procedure.","authors":"Anders O Olsson, Karin Lundberg, Esmira Becirevic, Malin Stenberg, Joakim Sandstedt","doi":"10.1515/cclm-2025-0409","DOIUrl":"https://doi.org/10.1515/cclm-2025-0409","url":null,"abstract":"Objectives: Antigen excess (AE) or high dose hook-effect can seriously affect the reported concentration of an analyte, which may impact clinical decisions. This study analyze to what extent the Roche Elecsys® Myoglobin assay is affected by antigen excess and how this can affect the reported myoglobin concentration.Methods: A dilution series experiment was conducted on a patient sample with a very high myoglobin concentration (>150,000 μg/L). Based on this, an AE mitigation procedure based on sample dilutions was developed and implemented. A retrospective analysis of reported patient results was performed to assess the potential frequency of samples that could be affected by AE.Results: In the dilution experiment the Roche Elecsys® Myoglobin assay was susceptive to AE, where samples with concentrations >115,000 μg/L may be reported as <3,000 μg/L. Dilution series from patient samples (n=20) subjected to the AE mitigation procedure showed the same pattern as the dilution experiment. The percentage of samples >115,000 µ/L increased significantly after the AE mitigation procedure had been implemented. After implementation of the AE mitigation procedure, the maximum myoglobin concentration observed was 780,000 μg/L.Conclusions: If the Roche Elecsys® Myoglobin assay is used according to the manufacturer, extremely high myoglobin samples risk being reported as only mildly elevated or near normal. This may affect clinical decisions. Thus, we suggest an AE mitigation procedure with automatic dilution of samples where myoglobin concentrations exceed 500 μg/L to mitigate this risk. Roche needs to take further actions to eliminate the consequences of the AE interference.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144149621","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

Vitamin D metabolome in preterm infants: insights into postnatal metabolism. 早产儿维生素D代谢组：对产后代谢的见解。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-05-22 DOI: 10.1515/cclm-2025-0311

Tomas Matejek, Lukas Prchal, Bara Zapletalova, Veronika Pokorna, Jana Malakova, Vladimir Palicka, Ondrej Soukup

{"title":"Vitamin D metabolome in preterm infants: insights into postnatal metabolism.","authors":"Tomas Matejek, Lukas Prchal, Bara Zapletalova, Veronika Pokorna, Jana Malakova, Vladimir Palicka, Ondrej Soukup","doi":"10.1515/cclm-2025-0311","DOIUrl":"https://doi.org/10.1515/cclm-2025-0311","url":null,"abstract":"Objectives: To describe the structure of vitamin D metabolome and investigate the possible cause of high serum levels of C3 epimers of 25-(OH)D in preterm infants, we compared the vitamin D metabolites in umbilical cord blood with serum samples taken at 28 days of age.Methods: We analysed 40 preterm infants (29+0-32+6 weeks of gestation). Cholecalciferol, 25-(OH)D, and its C3-epimers were measured using liquid chromatography. A microsomal study with human liver and kidney microsomes was conducted to assess vitamin D metabolism. Identified metabolites were then examined in cord blood and serum samples.Results: Cholecalciferol, 25-(OH)D, and its C3-epimers were significantly lower in cord blood compared to serum at 28 days of age (p<0.001 for all metabolites). Conversely, metabolites from the microsomal study (monohydroxylated-, dihydroxylated-, and mono-oxylated dihydroxylated-cholecalciferol and their C3-epimers) were significantly higher in cord blood (p<0.001 for all).Conclusions: Our findings indicate that cholecalciferol, 25-(OH)D, and its C3-epimers increase during the first month of life, suggesting functional biosynthesis and postnatal accumulation of these metabolites. Conversely, based on microsomal study results, it seems that biotransformation responsible for a degradation of vitamin D during the first month of life in preterm infants is functionally impaired.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144149628","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 cost-effective assessment for the combination of indirect immunofluorescence and solid-phase assay in ANA-screening. 间接免疫荧光法和固相法联合用于ana筛选的成本效益评估。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-05-22 DOI: 10.1515/cclm-2025-0170

Nicoletta Gallo, Giulia Musso, Mario Plebani

{"title":"A cost-effective assessment for the combination of indirect immunofluorescence and solid-phase assay in ANA-screening.","authors":"Nicoletta Gallo, Giulia Musso, Mario Plebani","doi":"10.1515/cclm-2025-0170","DOIUrl":"https://doi.org/10.1515/cclm-2025-0170","url":null,"abstract":"Objectives: Anti-nuclear antibodies (ANA) testing on indirect immunofluorescence (IIF) has been for a long time the gold standard assay in the diagnosis of rheumatic diseases; more recently different solid phase assays (SPA) have been recommended to increase specificity of positive results. The best combination of the different assays should both reduce the time to diagnosis and the costs of testing.Methods: Serum samples from 995 unselected outpatients were analysed simultaneously using IIF and a fluorescent enzyme SPA as initial screening test. Any IIF or SPA positive sample was further analysed for individual antibody specificities and three algorithm models with different timelines were adopted. The cost-effectiveness assessment was performed by calculating the total number of positive patients and the cost of diagnosis for each algorithm.Results: IIF and SPA were both positive in 112 (11.3 %) patients, and both negative in 597 (60 %) patients; 257 results (25.8 %) were conflicting between the two methods. The three algorithms resulted in a different number of positive patients and had a different cost per single diagnosis: the combined algorithm revealed the highest number of positive patients with a lower cost per diagnosis than the traditional one.Conclusions: The combined approach of two different methods ensures the highest reliability of ANA screening test; however, specific appropriate SPA testing might be chosen according to IIF pattern as recommended in International guidelines. Each clinical laboratory should carefully evaluate its diagnostic algorithm for ANA testing on the volume and type of requests, eventually designing new cost-effective reimbursement models based on patients outcomes.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144149616","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

Diagnostic performance of morphological analysis and red blood cell parameter-based algorithms in the routine laboratory screening of heterozygous haemoglobinopathies. 形态学分析和基于红细胞参数的算法在杂合血红蛋白病常规实验室筛查中的诊断性能。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-05-22 DOI: 10.1515/cclm-2025-0210

Germain Simon, François Boemer, Géraldine Luis, André Gothot, Françoise Tassin, Aurore Keutgens

{"title":"Diagnostic performance of morphological analysis and red blood cell parameter-based algorithms in the routine laboratory screening of heterozygous haemoglobinopathies.","authors":"Germain Simon, François Boemer, Géraldine Luis, André Gothot, Françoise Tassin, Aurore Keutgens","doi":"10.1515/cclm-2025-0210","DOIUrl":"https://doi.org/10.1515/cclm-2025-0210","url":null,"abstract":"Objectives: The aim of this study was to carry out a cross-analysis of the morphological abnormalities (MA) and the electrophoretic profile (EP) of blood samples suspect for heterozygous haemoglobinopathies (HTZ HGP). Screening for HTZ HGP was based on erythrocyte parameters provided by the Sysmex XN analysers.Methods: A total of 596,000 blood samples was included in the study. According to the results of the mean corpuscular haemoglobin concentration (MCHC), the percentage of microcytes (Micro%) and the standard deviation of the red blood cell distribution width (RDW-SD), 842 different adults were screened as suspect for HTZ HGP and underwent simultaneous morphological analysis of red blood cells (RBCMA) and haemoglobin fraction analysis.Results: The majority (72.8 %) of HTZ HGP suspects presented a pathological EP, mostly compatible with a confirmed β-thalassaemia trait (50.1 %) or a heterozygous β-haemoglobin variant (12.2 %). MA were identified in 360 (42.8 %) samples and 70 (8.3 %) of these had 3 or more MA. The most common MA was poikilocytosis (28.1 %). Patients with at least 1 MA detected were more likely to have a pathological EP (p=0.003). However, correlation between the number of MA detected and the type of EP was negligible.Conclusions: Screening for HTZ HGP based on erythrocyte parameters measured on Sysmex XN analysers is a relevant tool with a positive predictive value of 72.8 % and definitely superior to microscopic RBCMA which now appears to be of low added value and obsolete in this indication.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144149619","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

The neglected issue of pyridoxal- 5' phosphate. 吡哆醛- 5′磷酸被忽视的问题。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-05-22 DOI: 10.1515/cclm-2025-0550

Carmen Ricós, Maria Carmen Perich, M Pilar Fernandez-Calle

引用次数: 0

Effect of long-term frozen storage on stability of kappa free light chain index. 长期冷冻贮藏对卡帕游离轻链指数稳定性的影响。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-05-08 DOI: 10.1515/cclm-2025-0125

Martin Schmidauer, Klaus Berek, Gabriel Bsteh, Michael Auer, Robert Barket, Franziska Di Pauli, Michaela Hassler, Dejan Milosajevic, Anne Zinganell, Janette Walde, Florian Deisenhammer, Harald Hegen

{"title":"Effect of long-term frozen storage on stability of kappa free light chain index.","authors":"Martin Schmidauer, Klaus Berek, Gabriel Bsteh, Michael Auer, Robert Barket, Franziska Di Pauli, Michaela Hassler, Dejan Milosajevic, Anne Zinganell, Janette Walde, Florian Deisenhammer, Harald Hegen","doi":"10.1515/cclm-2025-0125","DOIUrl":"https://doi.org/10.1515/cclm-2025-0125","url":null,"abstract":"Objectives: To investigate whether frozen storage duration influences κ-FLC index.Methods: CSF and serum samples of patients with multiple sclerosis collected for routine diagnostic purposes had been stored at -20 °C. κ-FLC and albumin concentrations were measured at two different timepoints, i.e. before and after storage. The κ-FLC index was calculated as (CSF κ-FLC/serum κ-FLC)/(CSF albumin/serum albumin).Results: A total of 70 patients were included showing median CSF κ-FLC concentration of 0.25 (25th-75th percentile: 0.12-0.43) mg/dL, serum κ-FLC concentration of 1.05 (0.86-1.34) mg/dL, CSF albumin concentration of 17.7 (14.6-26.1) mg/dL and serum albumin concentration of 4230 (3898-4488) mg/dL. The κ-FLC index was 44 (25-108). With increasing frozen storage duration, the absolute concentrations of CSF κ-FLC, serum κ-FLC, CSF albumin and serum albumin decreased, while the κ-FLC index remained stable. The observed changes in absolute concentrations evened out by using CSF/serum ratios of κ-FLC and albumin when calculating the κ-FLC index.Conclusions: Frozen storage at -20 °C has no relevant impact on κ-FLC index.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172883","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

The Unholy Grail of cancer screening: or is it just about the Benjamins? 癌症筛查的“圣杯”：还是只与本杰明有关？

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-05-08 DOI: 10.1515/cclm-2025-0531

Miyo K Chatanaka, George M Yousef, Eleftherios P Diamandis

引用次数: 0

Biomarkers to measure the need and the effectiveness of therapeutic supplementation: a critical issue. 衡量治疗补充的需要和有效性的生物标志物：一个关键问题。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-05-08 DOI: 10.1515/cclm-2025-0518

Simona Ferraro, Martina Tosi, Elvira Verduci, Bruno Mario Cesana, Gianvincenzo Zuccotti

引用次数: 0