Clinical chemistry and laboratory medicine最新文献

{"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}

{"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 (K₂EDTA) 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}

{"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}

{"title":"A comparative analysis of current С-peptide assays compared to a reference method: can we overcome inertia to standardization?","authors":"Curt Rohlfing, Gregory Petroski, Shawn M Connolly, Steven Hanson, Randie R Little, Kuanysh Kabytaev","doi":"10.1515/cclm-2024-1260","DOIUrl":"10.1515/cclm-2024-1260","url":null,"abstract":"<p><strong>Objectives: </strong>C-peptide is an equimolar by-product of insulin biosynthesis. It is used clinically to assess insulin secretion and differentiate types of diabetes. However, the lack of standardization across assays limits its broader application. This study aimed to examine discrepancies between the leading C-peptide measurement methods used in clinical laboratories and propose a solution to reduce them based on a complete traceability chain.</p><p><strong>Methods: </strong>Two sets of serum samples were distributed to 10 manufacturers of C-peptide assays. The first set (A, n=20) was analyzed independently by each manufacturer, who then returned their results to us. Subsequently, we sent out the second set (B, n=20) along with the reference values for set A. For set B, each manufacturer provided both non-calibrated and recalibrated values for each sample. The recalibration was performed according to each manufacturer's internal standard protocols. We assessed how recalibration affected agreement between methods and alignment with the reference method. Non-parametric statistical approaches, including Passing-Bablok regression, level of agreement, and standard deviation analysis, were applied to compare data from multiple perspectives.</p><p><strong>Results: </strong>Despite most manufacturers using the same WHO C-peptide calibrator material, significant disagreement was observed between methods prior to recalibration. Recalibration with matrix-appropriate serum samples reduced the discordance among assays, bringing them closer to the reference method. Overall, recalibration reduced both systematic bias and individual assay disagreement.</p><p><strong>Conclusions: </strong>These findings underscore the importance of appropriate calibration schemes to improve agreement across C-peptide assays, enhancing the accuracy of C-peptide testing for clinical practice.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969894","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":"Plasmacytoid dendritic cell proliferation and acute myeloid leukemia with minimal differentiation (AML-M0).","authors":"Suwen Yang, Wei Shi, Sai Qiao, Qianwen Hu, Xiaofen Wang","doi":"10.1515/cclm-2024-1357","DOIUrl":"https://doi.org/10.1515/cclm-2024-1357","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945809","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":"Evaluating the accuracy of ChatGPT in classifying normal and abnormal blood cell morphology.","authors":"Davide Negrini, Laura Pighi, Marco Tosi, Giuseppe Lippi","doi":"10.1515/cclm-2024-1469","DOIUrl":"https://doi.org/10.1515/cclm-2024-1469","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945805","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 pre-analytical factors impacting urine test strip and chemistry results.","authors":"Mary Kathryn Bohn, Anselmo Fabros, Ashley Di Meo","doi":"10.1515/cclm-2024-1233","DOIUrl":"https://doi.org/10.1515/cclm-2024-1233","url":null,"abstract":"<p><strong>Objectives: </strong>Careful consideration of the pre-analytical process for urine examination is essential to avoid errors and support accurate results and decision-making. Our objective was to assess the impact of various pre-analytical factors on urine test strip and quantitative chemistry results, including stability, tube type, fill volume, and centrifugation.</p><p><strong>Methods: </strong>Residual random urine specimens were identified. Stability of 10 urine test strips and 13 quantitative chemistry parameters were assessed at eight time points (2, 4, 6, 8, 24, 48, 72, and 96 h) at room temperature (RT) and 2-8 °C (n=10-20 samples). The effect of additional pre-analytical variables was assessed, including using preservative tubes for urine chemistry as well as preservative tube underfilling and centrifugation on urine test strip results (n=10 samples).</p><p><strong>Results: </strong>Seven of the ten urine tests strips evaluated met the minimal agreement criteria for stability (Cohen's kappa >0.70) across all conditions. A Cohen's kappa value of <0.70 was observed for pH (48 h), glucose (72 h), and protein (96 h) at RT. All 13 urine chemistry analytes remained stable at defined time points and conditions. Underfilling preservative tubes for urine test strips and centrifugation demonstrated no significant effect. The impact of using preservative tubes for urine chemistry was negligible with the exception of sodium and osmolality.</p><p><strong>Conclusions: </strong>These findings highlight the pre-analytical factors that impact urine specimen evaluation and may be useful in informing clinical laboratory practices. Acceptable stability window for urine test strips should be considered in the context of the proportion of pathological samples evaluated.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945806","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":"Comparison between monotest and traditional batch-based ELISA assays for therapeutic drug monitoring of infliximab and adalimumab levels and anti-drug antibodies.","authors":"Mikel Moneo, Ainhoa Ruiz Del Agua, Begoña Ruiz-Argüello, Noelia Rapun, Daniel Nagore, Rachid El Hamss","doi":"10.1515/cclm-2024-1258","DOIUrl":"10.1515/cclm-2024-1258","url":null,"abstract":"<p><strong>Objectives: </strong>To compare a new ready-to-use monotest immunoassay, CHORUS Promonitor, for the quantification of serum biological drug levels and anti-drug antibodies of anti-TNF agents, against the reference batch-based ELISA test, Promonitor.</p><p><strong>Methods: </strong>Blood samples were collected from patients treated with anti-TNF agents, infliximab (IFX) or adalimumab (ADL). IFX and ADL levels, as well as anti-IFX and anti-ADL antibodies were quantified and compared between the standard ELISA reference test, Promonitor, and the automated monotest ELISA assay, CHORUS Promonitor. Data analysis included both qualitative and quantitative comparison between both tests. For the qualitative comparison, overall percent agreement (OPA) was calculated. For the quantitative comparison, Passing-Bablok regression analysis and Bland-Altman analysis were used.</p><p><strong>Results: </strong>For IFX and ADL levels, the qualitative overall agreement between methods was 100 % (Cohen's coefficient=1). For anti-IFX and anti-ADL antibodies, OPA was 98.8 % and 97.3 %, respectively. Quantitative comparison indicated a very strong correlation between both assays: IFX (r=0.97, n=74), ADL (r=0.95, n=54), anti-IFX (r=0.93, n=72), and anti-ADL (r=0.97, n=61). The regression analysis determined an excellent comparability of drug levels between methods. Bland-Altman analysis showed a bias difference between assays of 6 % for IFX, 0 % for ADL, 24 % for anti-IFX, and 14 % for anti-ADL.</p><p><strong>Conclusions: </strong>Monotest CHORUS Promonitor was a reliable assay to quantify IFX, ADL, anti-IFX and anti-ADL in samples with comparable results to those obtained with the reference batch-based ELISA technique.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945804","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":"Evolution of autoimmune diagnostics over the past 10 years: lessons learned from the UK NEQAS external quality assessment EQA programs.","authors":"Emirena Garrafa, Teresa Carbone, Maria Infantino, Pierluigi Anzivino, Michela Boni, Sara Ghisellini, Valentina Muraro, Daniele Roselli, Maria Teresa Trevisan, Dina Patel, Nicola Bizzaro","doi":"10.1515/cclm-2024-0781","DOIUrl":"https://doi.org/10.1515/cclm-2024-0781","url":null,"abstract":"<p><strong>Objectives: </strong>External quality assessment (EQA) programs play a pivotal role in harmonizing laboratory practices, offering users a benchmark system to evaluate their own performance and identify areas requiring improvement. The objective of this study was to go through and analyze the UK NEQAS \"Immunology, Immunochemistry and Allergy\" EQA reports between 2012 and 2021 to assess the overall level of harmonization in autoimmune diagnostics and identify areas requiring improvement for future actions.</p><p><strong>Methods: </strong>The EQA programs reviewed included anti-nuclear (ANA), anti-dsDNA, anti-centromere, anti-extractable nuclear antigen (ENA), anti-phospholipids, anti-neutrophil cytoplasm (ANCA), anti-proteinase 3 (PR3), anti-myeloperoxidase (MPO), anti-glomerular basement membrane (GBM), rheumatoid factor (RF), anti-citrullinated protein antibodies (ACPA), mitochondrial (AMA), liver-kidney-microsomal (LKM), smooth muscle (ASMA), APCA, and celiac disease antibodies.</p><p><strong>Results: </strong>In the analyzed period, the number in participating laboratories showed an increase for almost all programs. Among solid phase methods, the use of ELISA techniques showed a progressive reduction, while new technologies, such as the fluoroenzymatic immunoassay, chemiluminescence immunoassay, Luminex and immunoblot showed an increased number of users. The number of results complying with the expected negative or positive target slightly increased for almost all antibodies in the last decade. A description of the most frequent causes of mistakes or misinterpretation for each specific test and method is also provided in this study.</p><p><strong>Conclusions: </strong>Although numerous challenges need to be addressed in the area of autoantibody detection to enhance testing quality and attain higher harmonization, the period analyzed revealed that the ever-expanding range of autoantibodies, coupled with the introduction of new tests and methodologies and the advent of automated platforms, has brought about significant changes in autoimmune diagnostics.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945807","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}