Vincenzo Roccaforte, Giovanni Sabbatini, Rossella Panella, Massimo Daves, Paolo Formenti, Miriam Gotti, Andrea Galimberti, Marta Spreafico, Andrea Piccin, Giuseppe Lippi, Angelo Pezzi, Stefano Pastori
{"title":"The potential role of leukocytes cell population data (CPD) for diagnosing sepsis in adult patients admitted to the intensive care unit.","authors":"Vincenzo Roccaforte, Giovanni Sabbatini, Rossella Panella, Massimo Daves, Paolo Formenti, Miriam Gotti, Andrea Galimberti, Marta Spreafico, Andrea Piccin, Giuseppe Lippi, Angelo Pezzi, Stefano Pastori","doi":"10.1515/cclm-2024-1202","DOIUrl":"https://doi.org/10.1515/cclm-2024-1202","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of the study was to evaluate the predictive value of cell population data (CPD) parameters in comparison with procalcitonin (PCT) and C-reactive protein (CRP) for an early diagnosis of sepsis in intensive care unit (ICU). The effect of renal function on CPD, PCT and CRP, in septic and non-septic patients was also investigated.</p><p><strong>Methods: </strong>This is a retrospective, observational and single-center study, performed with data collected from patients consecutively admitted to the ICU of the Edoardo Bassini Hospital in Milan. Patients were divided in septic and non-septic according to Sepsis-III criteria. The control group was formed by critically ill patients without sepsis. Patients with sepsis were further divided in patients with sepsis and patients with septic shock.</p><p><strong>Results: </strong>A significant difference between septic and non-septic patients was found for neutrophils complexity (NE-SSC), neutrophils fluorescence intensity (NE-SFL), width of dispersion of neutrophils fluorescence (NE-WY), monocytes complexity (MO-X), monocytes fluorescence intensity (MO-Y), PCT and CRP parameters. PCT, neutrophils sixe (NE-FSC), NE-WY, width of dispersion of neutrophils size (NE-WZ) and MO-X discriminated sepsis and septic-shock patients. CPD parameters were not influenced by renal function. CPD, PCT and CRP had a heterogeneous diagnostic performance efficiency in the prediction of sepsis. Overall, NE-SSC, NE-SFL, width of dispersion of neutrophils complexity (NE-WX), MO-X, MO-Y, PCT and CRP displayed the best diagnostic performance for sepsis.</p><p><strong>Conclusions: </strong>This study suggested that some CPD parameters (i.e., NE-SFL and MO-X) might provide useful information for diagnosis and management of sepsis.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143032151","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}
Jasper Van Heuverswyn, Nico Callewaert, Kathleen Croes, Cathelijne Lyphout, Stijn Lambrecht, Nick Verougstraete
{"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":"Beyond test results: the strategic importance of metadata for the integration of AI in laboratory medicine.","authors":"Fabio Del Ben","doi":"10.1515/cclm-2025-0070","DOIUrl":"https://doi.org/10.1515/cclm-2025-0070","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":"143022165","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}
Angelique Masetto, Tina Leber, Tobias Frömel, Christoph Peter, Kai Prager, Matthias Grimmler
{"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 (<sup>75</sup>SeHCAT) 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<sup>®</sup>) 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<sup>®</sup>), 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}
Hongkyung Kim, Oh Joo Kweon, Sumi Yoon, Yong Kwan Lim, Bohyun Kim
{"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}
{"title":"Interest of hair tests to discriminate a tail end of a doping regimen from a possible unpredictable source of a prohibited substance in case of challenging an anti-doping rule violation.","authors":"Pascal Kintz","doi":"10.1515/cclm-2024-1407","DOIUrl":"https://doi.org/10.1515/cclm-2024-1407","url":null,"abstract":"<p><p>The presence of letrozole, an aromatase inhibitor, in an athlete's sample constitutes one of the more frequent anti-doping rules violation. It is possible to challenge this violation but it is the athletes who have to demonstrate their innocence. The conditions to evidence/establish the absence of fault or negligence hinge on two points: 1. the athletes or their legal representatives have to present verified circumstances of contamination and the source of contamination has to be identified; and 2. there have to be verified claims by the athlete about the fact that the intake of the prohibited substance was not known, i.e. that the violation was not intentional. This corresponds to the suggested shift terminology from \"contaminated product\" to \"unpredictable source of a prohibited substance\". In the recent years, several top athletes challenged their ADRV with a low urine letrozole concentration and requested a hair test. In three cases, letrozole concentration in segmented hair, particularly in the segment corresponding to the urine AAF was significantly lower than 1 pg/mg, which is the limit of quantification of the method. Considering that a ¼ of a 2.5 mg therapeutic dose of letrozole produces a hair concentration of approximately 30 pg/mg, it is easy to establish that the dose that entered in the body of these athletes was incidental. Nevertheless, all three athletes were sentenced a 2-years ban as the source of contamination was not identified. In that sense, the WADA dogma contradicts scientific evidence, and from a forensic perspective, this appears difficult to understand.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001206","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":"What does cancer screening have to do with tomato growing?","authors":"Miyo K Chatanaka, Eleftherios P Diamandis","doi":"10.1515/cclm-2024-1408","DOIUrl":"https://doi.org/10.1515/cclm-2024-1408","url":null,"abstract":"<p><p>Cancer screening is considered to be a major strategy for combatting cancer. The United States Preventive Services Task Force (USPSTF) recommends screening for five cancers, but the strength of evidence about the effectiveness of screening is limited. To gain insights into the efficacy of early detection requires prospective, blinded, placebo-controlled clinical trials with decades of follow-up and inclusion of millions of participants. Recently, Bretthauer et al. estimated lifetime gained with cancer screening tests by using a meta-analysis of 18 large randomized clinical trials which included more than two million subjects. They asked if cancer screening tests are saving lives and how much life is extended due to commonly used cancer screening tests. Colorectal cancer screening with sigmoidoscopy prolonged lifetime by 110 days, while fecal testing and mammography screening did not prolong life. A modest extension of 37 days was noted for prostate cancer screening with prostate-specific antigen testing and 107 days with lung cancer screening using computed tomography, but these estimates were not statistically significant. The authors concluded that current cancer screening strategies do not significantly prolong life. Based on these data, and the known biological behavior of some cancers, we hypothesized that the current strategies of treating cancer, after detection, could be modified to avoid the side effects of screening, which is a major determinant of the patient's overall survival.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001220","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}
Chiara Cosma, Ilaria Talli, Elisa Pangrazzi, Andrea Padoan, Helena Cerutti, Martina Zaninotto, Carlo Gabelli, Mario Plebani
{"title":"Progranulin measurement with a new automated method: a step forward in the diagnostic approach to neurodegenerative disorders.","authors":"Chiara Cosma, Ilaria Talli, Elisa Pangrazzi, Andrea Padoan, Helena Cerutti, Martina Zaninotto, Carlo Gabelli, Mario Plebani","doi":"10.1515/cclm-2024-1143","DOIUrl":"https://doi.org/10.1515/cclm-2024-1143","url":null,"abstract":"<p><strong>Objectives: </strong>Mutations in the <i>GRN</i> gene encoded glycoprotein progranulin (PGRN), cause 5-10 % of all cases of frontotemporal lobar degeneration (FTLD). The aim of our study was to verify the analytical and clinical performance of an automated chemiluminescent immunoassay method for PGRN measurement recently developed (Chorus Evo, Diesse Diagnostica, Italy).</p><p><strong>Methods: </strong>Five plasma pools and residual plasma samples (K<sub>2</sub>EDTA) from 25 control subjects (11 males, 62-79 years; 14 females, 54-76 years) and 151 patients (70 males, 53-81 years; 81 females, 44-82 years) with different neurodegenerative disorders (NDs), were assayed. In 61 out of 151 patients, genetic <i>GRN</i> screening was carried.</p><p><strong>Results: </strong>Within-run imprecision (CV%) ranged from 3.8 % (11.5 pg/L) to 10.8 % (2.5 pg/L), and between-run, from 5.6 % (68.7 pg/L) to 10.7 % (2.8 pg/L). At genetic screening, 3 out of 61 patients were classified as <i>GRN</i>+ carriers, 18 as \"other mutations\" and 40 as \"no-mutations\" carriers. The PGRN median level in <i>GRN</i>+ carriers (15.9 pg/L) was significantly lower than that in control subjects (32.8 pg/L; p=0.006), in <i>GRN</i>- (27.50 pg/L; p=0.007), in other mutation carriers (24.80 pg/L; p=0.05) and in NDs patients (22.40 pg/L; p=0.05) ROC analysis, demonstrates the accuracy of progranulin levels in discriminating between \"<i>GRN</i>+\" and \"<i>GRN</i>-\" carriers (AUC 0.985) as well as \"<i>GRN</i>+\" and \"other mutations\" carriers (AUC 0.870).</p><p><strong>Conclusions: </strong>The new automated progranulin method, for robust analytical performance, is suitable for use in the clinical setting, supporting clinicians in making a differential diagnosis in patients with neurodegenerative disorder.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001211","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}
Christina M Trambas, Yvonne S Reidy, Kristin M Aakre
{"title":"Early rule-out high-sensitivity troponin protocols require continuous analytical robustness: a caution regarding the potential for troponin assay down-calibration.","authors":"Christina M Trambas, Yvonne S Reidy, Kristin M Aakre","doi":"10.1515/cclm-2024-1395","DOIUrl":"https://doi.org/10.1515/cclm-2024-1395","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001204","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}