Clinical chemistry and laboratory medicine最新文献

{"title":"Prevalence and detection of citrate contamination in clinical laboratory.","authors":"Nathan Lorde, Rousseau Gama, Tejas Kalaria","doi":"10.1515/cclm-2024-1389","DOIUrl":"https://doi.org/10.1515/cclm-2024-1389","url":null,"abstract":"<p><strong>Objectives: </strong>To study the prevalence of trisodium citrate (Na₃Citrate) contamination in hypernatraemic serum samples by direct measurement of citrate and to evaluate the performance of indirect markers for identification of Na₃Citrate contamination.</p><p><strong>Methods: </strong>Serum citrate was measured in all hypernatraemic serum samples (sodium ≥148 mmol/L) over a three-month period. The performance of serum chloride, sodium-chloride gap, indirect ion selective electrode (ISE)-direct ISE sodium disparity and osmolar gap in identification of Na₃Citrate contaminated samples was assessed against the 'gold-standard' direct citrate measurement.</p><p><strong>Results: </strong>In total, 27 Na₃Citrate contaminated samples were identified based on serum citrate concentration ≥1.5 mmol/L. The prevalence of citrate contamination was 3.1 % of hypernatraemic samples (n=875) and 0.017 % of all samples received for urea and electrolyte analysis (n=153,404). Most contaminated samples were from patients receiving haemodialysis (59.3 %), and the rest from inpatients. Cut-offs to give 100 % sensitivity were chloride ≤105 nmol/L (specificity 93.4 %), sodium-chloride gap ≥47 mmol/L (specificity 95.3 %), indirect ISE-direct ISE sodium disparity ≥3 mmol/L (specificity 81.9 %), and osmolar gap ≥39 mOsm/kg (specificity 2.8 %).</p><p><strong>Conclusions: </strong>Trisodium citrate contamination is uncommon. Most contaminated samples were from patients receiving haemodialysis, likely because of contamination with citrate catheter locking solution. Screening with serum chloride or sodium-chloride gap can confidently exclude Na₃Citrate contamination in over 90 % of hypernatraemic samples, and in nearly all samples with sodium ≥155 mmol/L if metabolic alkalosis has been excluded. In the remaining samples, Na₃Citrate contamination can only be definitively confirmed or excluded by measurement of serum citrate. We propose algorithms to identify spurious hypernatraemia.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074065","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":"Tumor specific protein 70 targeted tumor cell isolation technology can improve the accuracy of cytopathological examination.","authors":"Lixia Zhang, Yutong Zhou, Shuxian Yang, Qiong Zhu, Jian Xu, Yuan Mu, Chunrong Gu, Huanyu Ju, Rong Rong, Shiyang Pan","doi":"10.1515/cclm-2024-0878","DOIUrl":"https://doi.org/10.1515/cclm-2024-0878","url":null,"abstract":"<p><strong>Objectives: </strong>Although existing cytopathological examination is considered essential for the diagnosis of malignant serous effusions, its accuracy is pretty low. Tumor specific protein 70 (SP70), which is highly expressed on human tumor cell membrane, was identified in our previous study. This study aimed to explore whether SP70 targeted tumor cell isolation technology with immunomagnetic beads can improve the accuracy of cytopathological examination.</p><p><strong>Methods: </strong>Cytopathological analysis with SP70 targeted tumor cell isolation technology was used in this study. In total, 255 cases were enrolled. Serous effusions were analyzed by both existing cytopathological examination and the new cytopathological analysis concurrently.</p><p><strong>Results: </strong>The sensitivities of existing cytopathological examination and the new cytopathological analysis were 51.26 % and 85.43 %, respectively, while the specificities were 100 % for both. This new cytopathological analysis demonstrated a higher interobserver agreement with malignant diagnosis than the existing cytopathological examination (kappa coefficient: 0.720 vs<i>.</i> 0.316, p<0.001). In addition, it achieved superior diagnostic efficacy for malignancy differentiation compared to existing cytopathological examination (AUC: 0.927 vs<i>.</i> 0.756, p<0.001). The follow-up results showed that 74 malignant cases with final clinical diagnosis were positive only with the new cytopathological analysis. Among these cases, there were 58 negative and 16 atypical by the existing cytopathological examination. In these malignant cases, 74.3 % (55/74) had been confirmed to have serosa metastasis based on radiographic evidence, and 73.7 % (28/38) harbored tumor hotspot mutations.</p><p><strong>Conclusions: </strong>As illustrated in this work, cytopathological analysis with SP70 targeted tumor cell isolation technology can improve the accuracy of existing cytopathological examination prominently.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074067","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":"Evaluation of AUTION EYE AI-4510 flow cell morphology analyzer for counting particles in urine.","authors":"Matthijs Oyaert, Timo Kouri, Eva Carton, Sigrid Deprez, Stijn Lambrecht, Marijn Speeckaert","doi":"10.1515/cclm-2024-1163","DOIUrl":"https://doi.org/10.1515/cclm-2024-1163","url":null,"abstract":"<p><strong>Objectives: </strong>We evaluated the performance of a novel flow cell morphology analyzer AUTION EYE AI-4510 for counting particles in urine.</p><p><strong>Methods: </strong>Analytical performance was assessed according to the EFLM European Urinalysis Guideline 2023. Trueness was compared by analyzing 1.012 fresh urine samples with the AUTION EYE AI-4510 (ARKRAY, Inc., Kyoto, Japan) against phase-contrast visual microscopy. Poisson statistics were utilized in assessment of imprecision of particle counts both with quality control material and patient specimens.</p><p><strong>Results: </strong>Relative imprecision against theoretical Poisson imprecision, R(CV), was estimated to be 1.1 for red blood cells (RBC), 1.0 for white blood cells (WBC), 0.9 for squamous epithelial cells (SEC) and 1.1 for bacteria. The agreement with visual microscopy (Cohen's weighted kappa) was 0.93 for RBC, 0.95 for WBC, 0.90 for SEC, 0.79 for non-squamous epithelial cells (NSEC), 0.67 for combined casts, 0.90 for crystals and 0.88 for bacteria. No clinically significant bias was observed. Limits of quantitation at CV=30 % reached 4 × 10⁶/L for RBC and 5 × 10⁶/L for WBC. Differentiation of urinary crystals was improved as compared to previous data on digital cuvette imaging.</p><p><strong>Conclusions: </strong>The ARKRAY AUTION EYE AI-4510 provided a desirable imprecision, met the criteria for linearity, LoQ and carry-over, and showed an optimum comparison to visual microscopy for RBC, WBC, SEC and crystals as defined in the EFLM European Urinalysis Guideline 2023. The identification of kidney damage is recommended to be improved by using user-defined review rules. Performance of bacteria counting needs to be confirmed against urine bacterial cultures.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051678","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":"From errors to excellence: the pre-analytical journey to improved quality in diagnostics. A scoping review.","authors":"George K John, Emmanuel J Favaloro, Samantha Austin, Md Zahidul Islam, Abishek B Santhakumar","doi":"10.1515/cclm-2024-1277","DOIUrl":"https://doi.org/10.1515/cclm-2024-1277","url":null,"abstract":"<p><p>This scoping review focuses on the evolution of pre-analytical errors (PAEs) in medical laboratories, a critical area with significant implications for patient care, healthcare costs, hospital length of stay, and operational efficiency. The Covidence Review tool was used to formulate the keywords, and then a comprehensive literature search was performed using several databases, importing the search results directly into Covidence (n=379). Title, abstract screening, duplicate removal, and full-text screening were done. The retrieved studies (n=232) were scanned for eligibility (n=228) and included in the review (n=83), and the results were summarised in a PRISMA flow chart. The review highlights the role of healthcare professionals in preventing PAEs in specimen collection and processing, as well as analyses. The review also discusses the use and advancements of artificial intelligence (AI) and machine learning in reducing PAEs and identifies inadequacies in standard definitions, measurement units, and education strategies. It demonstrates the need for further research to ensure model validation, address the regulatory validation of Risk Probability Indexation (RPI) models and consider regulatory, safety, and privacy concerns. The review suggests that comprehensive studies on the effectiveness of AI and software platforms in real-world settings and their implementation in healthcare are lacking, presenting opportunities for further research to advance patient care and improve the management of PAEs.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045432","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":"Computer simulation approaches to evaluate the interaction between analytical performance characteristics and clinical (mis)classification: a complementary tool for setting indirect outcome-based analytical performance specifications.","authors":"Hikmet Can Çubukçu","doi":"10.1515/cclm-2024-1195","DOIUrl":"https://doi.org/10.1515/cclm-2024-1195","url":null,"abstract":"<p><p>Simulation-based approaches for setting indirect outcome-based analytical performance specifications (APS) predominantly involve test repetition through analytical reruns or resampling. These methodologies assess the agreement between original and simulated measurement results, determining the APS corresponding to pre-established performance thresholds. For APS related to imprecision and bias, both analytical performance characteristics (APCs) are typically considered in simulations, whereas for APS regarding measurement uncertainty, bias is excluded in alignment with traceability standards. This paper introduces the \"APS Simulator,\" a novel tool designed to complement the existing APS Calculator by simulating APS under various scenarios involving imprecision, bias, and measurement uncertainty. The APS Simulator facilitates simulations using distinct analytical rerun and resampling models, enabling laboratory professionals to explore a wide range of performance levels for their specific needs. While the APS Simulator provides valuable insights, significant challenges remain in the broader application of indirect outcome-based APS. These include incorporating sources of diagnostic uncertainty, setting appropriate thresholds for performance metrics, validating clinical decision limits, and accounting for population data characteristics. Addressing these limitations will be essential to enhancing the standardization and robustness of APS determination. The source code and desktop application for the APS Simulator are freely available at https://github.com/hikmetc/APS_Simulator, providing a user-friendly platform for researchers and clinicians to further explore these methodologies.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051674","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 journey to pre-analytical quality.","authors":"Mario Plebani","doi":"10.1515/cclm-2025-0057","DOIUrl":"https://doi.org/10.1515/cclm-2025-0057","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045491","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":"Failing methemoglobin blood gas analyses in a sodium nitrite intoxication.","authors":"Jasper Van Heuverswyn, Nico Callewaert, Kathleen Croes, Cathelijne Lyphout, Stijn Lambrecht, Nick Verougstraete","doi":"10.1515/cclm-2024-1298","DOIUrl":"https://doi.org/10.1515/cclm-2024-1298","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022170","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":"Biochemical evidence of vitamin B12 deficiency: a crucial issue to address supplementation in pregnant women.","authors":"Simona Ferraro, Cristina Cereda, Gianvincenzo Zuccotti","doi":"10.1515/cclm-2024-1405","DOIUrl":"https://doi.org/10.1515/cclm-2024-1405","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022166","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":"Towards routine high-throughput analysis of fecal bile acids: validation of an enzymatic cycling method for the quantification of total bile acids in human stool samples on fully automated clinical chemistry analyzers.","authors":"Angelique Masetto, Tina Leber, Tobias Frömel, Christoph Peter, Kai Prager, Matthias Grimmler","doi":"10.1515/cclm-2024-1414","DOIUrl":"https://doi.org/10.1515/cclm-2024-1414","url":null,"abstract":"<p><strong>Objectives: </strong>Bile acid diarrhea is a common but underdiagnosed condition. Because the gold standard test (⁷⁵SeHCAT) is time-consuming and not widely available, fecal bile acid excretion is typically assessed by chromatography and mass spectrometry. Although enzymatic cycling assays are well established for the rapid and cost-effective analysis of total bile acids (TBA) in serum or plasma, their full potential has yet not been extended to stool samples in clinical routine.</p><p><strong>Methods: </strong>The performance of the 'Total bile acids 21 FS' reagent (DiaSys) was evaluated in fecal matrix according to CLSI guidelines and EU-IVD Regulations (2017/745), and compared to an established microplate-based kit (IDK^®) by measuring patient stool samples (n=122). Method agreement was assessed by Passing-Bablok and Bland-Altman analysis. The quantification of eight individual BAs was assessed using HPLC-MS/MS as reference method.</p><p><strong>Results: </strong>The DiaSys assay showed linearity between 3.5 and 130 μmol/L, good repeatability, total precision, and reproducibility with CVs of 1.7 %, 3.5 %, and 3.0 %. Limit of blank (LoB), detection (LoD), and quantitation (LoQ) were ≤0.17, ≤0.3, and 3.5 μmol/L, respectively. No significant interference from endogenous substances was observed. The methods showed good correlation up to 140 μmol/L (r=0.988), despite differences in the quantification of individual BAs, with mean deviations of 7 % (DiaSys) and 31 % (IDK^®), respectively.</p><p><strong>Conclusions: </strong>The advantages of enzymatic TBA analysis on fully automated clinical chemistry platforms can be exploited for the routine analysis of stool samples. However, cycling assays may benefit from reference standards that take into account the composition of the fecal BA pool.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001218","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":"Performance of the automated digital cell image analyzer UIMD PBIA in white blood cell classification: a comparative study with sysmex DI-60.","authors":"Hongkyung Kim, Oh Joo Kweon, Sumi Yoon, Yong Kwan Lim, Bohyun Kim","doi":"10.1515/cclm-2024-1323","DOIUrl":"https://doi.org/10.1515/cclm-2024-1323","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to evaluate the performance of PBIA (UIMD, Seoul, Republic of Korea), an automated digital morphology analyzer using deep learning, for white blood cell (WBC) classification in peripheral blood smears and compare it with the widely used DI-60 (Sysmex, Kobe, Japan).</p><p><strong>Methods: </strong>A total of 461 slides were analyzed using PBIA and DI-60. For each instrument, pre-classification performance was evaluated on the basis of post-classification results verified by users. Pre- and post-classification results were compared with manual WBC differentials, and the ability to identify abnormal cells was assessed.</p><p><strong>Results: </strong>The pre-classification performance of PBIA was better than that of DI-60 for most cell classes. PBIA had an accuracy of 90.0 % and Cohen's kappa of 0.934, higher than DI-60 (45.5 % accuracy and 0.629 kappa) across all cell classes. The pre-classification performance of both instruments decreased when abnormal cells were observed in manual counts, but PBIA still performed better. PBIA also appeared to show better correlation with manual WBC differential counts, particularly in pre-classification (Pearson's correlation coefficient: 0.696-0.944 vs. 0.230-0.882 for neutrophils, lymphocytes, monocytes, eosinophils, basophils, and blasts), although the mean differences varied by cell class. For abnormal cells identified in manual counts, PBIA exhibited more false positives for blasts (30.5 vs. 2.3 %), while DI-60 had a higher rate of false negatives (42.1 vs. 6.1 %). Both instruments exhibited high false negative rates for atypical lymphocytes.</p><p><strong>Conclusions: </strong>PBIA demonstrated better performance than DI-60, highlighting its clinical utility. Further multicenter studies are required for full validation.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001209","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}