Svetlana Karbysheva, Paula Morovic, Petri Bellova, Marvin Sven Berger, Maik Stiehler, Sebastian Meller, Stephanie Kirschbaum, Philippe Lindenlaub, Armin Zgraggen, Michael Oberle, Michael Fuchs, Carsten Perka, Andrej Trampuz, Anna Conen
{"title":"Synovial fluid D-lactate - a pathogen-specific biomarker for septic arthritis: a prospective multicenter study.","authors":"Svetlana Karbysheva, Paula Morovic, Petri Bellova, Marvin Sven Berger, Maik Stiehler, Sebastian Meller, Stephanie Kirschbaum, Philippe Lindenlaub, Armin Zgraggen, Michael Oberle, Michael Fuchs, Carsten Perka, Andrej Trampuz, Anna Conen","doi":"10.1515/cclm-2024-0556","DOIUrl":"https://doi.org/10.1515/cclm-2024-0556","url":null,"abstract":"<p><strong>Objectives: </strong>The performance of synovial fluid biomarker D-lactate to diagnose septic arthritis (SA) and differentiate it from crystal-induced arthritis (CA), other non-infectious rheumatic joint diseases (RD) and osteoarthrosis (OA) was evaluated.</p><p><strong>Methods: </strong>Consecutive adult patients undergoing synovial fluid aspiration due to joint pain were prospectively included in different German and Swiss centers. Synovial fluid was collected for culture, leukocyte count and differentiation, detection of crystals, and D-lactate concentration. Youden's J statistic was used to determine optimal D-lactate cut-off value on the receiver operating characteristic (ROC) curve by maximizing sensitivity and specificity.</p><p><strong>Results: </strong>In total 231 patients were included. Thirty-nine patients had SA and 192 aseptic arthritis (56 patients with OA, 68 with CA, and 68 with RD). The median concentration of synovial fluid D-lactate was significantly higher in patients with SA than in those with OA, CA, and RD (p<0.0001, p<0.0001 and p<0.0001, respectively). The optimal cut-off of synovial fluid D-lactate to diagnose SA was 0.033 mmol/L with a sensitivity of 92.3 % and specificity of 85.4 % independent of previous antimicrobial treatment. Sensitivity and specificity of synovial fluid leukocyte count at a cut-off of 20,000 cells/µL was 81.1 % and 80.8 %, respectively.</p><p><strong>Conclusions: </strong>Synovial fluid D-lactate showed a high performance for diagnosing SA which was superior to synovial fluid leukocyte count. Given its high sensitivity and specificity, it serves as both an effective screening tool for SA and a differentiator between SA and RD, especially CA.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342852","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}
Ivana Lapić, Dunja Rogić, Mirjana Fuček, Ines Alpeza Viman
{"title":"Comment on Lippi et al.: EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) recommendations for reinforcing cyber-security and managing cyber-attacks in medical laboratories.","authors":"Ivana Lapić, Dunja Rogić, Mirjana Fuček, Ines Alpeza Viman","doi":"10.1515/cclm-2024-1093","DOIUrl":"https://doi.org/10.1515/cclm-2024-1093","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342851","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}
Anne Winther-Larsen, Else Marie Vestergaard, Anders Abildgaard
{"title":"Clinical value of smear review of flagged samples analyzed with the Sysmex XN hematology analyzer.","authors":"Anne Winther-Larsen, Else Marie Vestergaard, Anders Abildgaard","doi":"10.1515/cclm-2024-0973","DOIUrl":"https://doi.org/10.1515/cclm-2024-0973","url":null,"abstract":"<p><strong>Objectives: </strong>A smear review is typically made in flagged differential counts performed with hematology analyzers although the clinical value of such reviews is uncertain. Therefore, we evaluated the differences in differential counts between Sysmex XN-9000 and a smear review in flagged samples. Furthermore, the clinical value of blasts identified was investigated.</p><p><strong>Methods: </strong>Data on all differential counts performed in a two-year period were identified at two laboratories. In patients with blasts, the electronic health record was reviewed. Agreement between automated and manual differential counts was evaluated by Bland-Altman plots. Concordance between the two methods categorized according to reference intervals was evaluated and adjusted for irrelevant non-concordance caused by random analytical error.</p><p><strong>Results: </strong>In total, 5,500 flagged differential counts were identified from 4,092 patients. A good agreement between the automated and manual differential count was found for all cell types (-0.480 × 10<sup>9</sup>/L to 0.297 × 10<sup>9</sup>/L). The concordance between the two methods was excellent for all cell types, except for monocytes (82 %) where the automated estimates were higher than the manual in 19 % of samples. Blasts were identified in 241 (1 %) of smear reviews. Acute leukemia was diagnosed in 13 (5 %) patients, and only in one patient contributed the detection of blasts to the suspicion of acute leukemia.</p><p><strong>Conclusions: </strong>Our findings indicate that routine smear review of all flagged samples do not contribute with additional, significant information. After local validation and dialogue with clinical departments, such reviews may potentially be omitted to increase cost-effectiveness and reduce turn-around-time.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342850","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}
Patricia Kaiser, Udo Kramer, Hannah Rosenthal, Christian Genz, Nathalie Weiss, Ingo Schellenberg, Michael Spannagl
{"title":"New concept for control material in glucose point-of-care-testing for external quality assessment schemes.","authors":"Patricia Kaiser, Udo Kramer, Hannah Rosenthal, Christian Genz, Nathalie Weiss, Ingo Schellenberg, Michael Spannagl","doi":"10.1515/cclm-2024-0822","DOIUrl":"https://doi.org/10.1515/cclm-2024-0822","url":null,"abstract":"<p><strong>Objectives: </strong>Until now, the external quality assessment (EQA) of glucose point-of-care testing (POCT) has lacked a high quality, suitable and commutable control material to assess measurement accuracy. Here we present a concept for determining the accuracy of glucose measurements, which uses human whole blood and does not require stabilising agents.</p><p><strong>Methods: </strong>This new generation of quality control samples uses a bead that contains a specific amount of glucose. The bead is then dissolved in a whole blood matrix by the EQA participant immediately before the POCT. We analysed its suitability as an EQA material with respect to its reproducibility, homogeneity and stability, and applied it in an EQA pilot study. The glucose target value was determined using the reference measurement procedure and served as an evaluation criterion for the accuracy of the EQA survey results.</p><p><strong>Results: </strong>The homogeneity and stability of the new control material fulfilled the quality requirements of ISO 17043. Based on the reference measurement value for glucose, the results of the pilot EQA scheme showed a pass rate of 84.6 % for the participating POCT devices. The acceptance limit was a 15 % permitted deviation from the target value according to Rili-BAEK. All of the device collectives deviated from the target value by 0-4.4 % with the exception of one device type, which deviated by 21 %.</p><p><strong>Conclusions: </strong>The new concept offers, for the first-time, whole blood-based trueness controls for glucose POCT analysis for external quality assurance. The concept does not require the addition of any stabilising reagent and is easy to use.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281348","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}
Mei Liu, Sihua Yu, Siyao Li, Xiaowen Yu, Heqiao Wang, Jiaqi Wang, Pan Wang, Zihan Su, Yajing Fu, Yongjun Jiang, Min Zhao, Zining Zhang, Hong Shang
{"title":"Agreement of lymphocyte subsets detection permits reference intervals transference between flow cytometry systems: direct validation using established reference intervals.","authors":"Mei Liu, Sihua Yu, Siyao Li, Xiaowen Yu, Heqiao Wang, Jiaqi Wang, Pan Wang, Zihan Su, Yajing Fu, Yongjun Jiang, Min Zhao, Zining Zhang, Hong Shang","doi":"10.1515/cclm-2024-0603","DOIUrl":"https://doi.org/10.1515/cclm-2024-0603","url":null,"abstract":"<p><strong>Objectives: </strong>With the increasing demand and application of lymphocyte subsets detection in clinical laboratories, different single-platform flow cytometer (FCM) systems have been developed. There is an urgent need to establish the reference intervals (RIs) for different single-platform FCMs and transferring them from one FCM system to another provides a much more feasible and convenient approach. This study aimed to explore the transferability of RIs for lymphocyte subsets across different flow cytometry platforms.</p><p><strong>Methods: </strong>We first conducted the pairwise method comparison across four FCM platforms, including NovoCyte, BriCyteE6, DxFLEX, and FACSCantoII systems. Next, the transferability of RIs of lymphocyte subsets was evaluated. Furthermore, we conducted the RIs transference based on the FACSCantoII system, BriCyteE6 system and DxFLEX system, except for NK cells. The transferred RIs were further verified by calculating the bias (CV) between the established ones.</p><p><strong>Results: </strong>The results of lymphocyte subsets detection based on the NovoCyte, BriCyteE6, DxFLEX, and FACSCantoII systems were comparable and it was feasible to transfer the RIs of lymphocyte subsets detected by the four FCM systems. The RIs of lymphocyte subsets detection using FACSCantoII, DxFLEX, and BriCyteE6 systems were established. Upon transferring the RIs of lymphocyte subsets from the FACSCantoII system to the BriCyteE6 system, and DxFLEX system except for NK cells, the CV between the transferred RIs and the established ones was below 20 % for all parameters.</p><p><strong>Conclusions: </strong>The present study illustrated that the RIs of lymphocyte subsets could be transferred across different flow cytometry systems except for NK cells with different definition strategies.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281324","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}
Eyal Podolsky, Natasha Hudek, Nicola McCleary, Christopher McCudden, Justin Presseau, Jamie C Brehaut
{"title":"How do experts determine where to intervene on test ordering? An interview study.","authors":"Eyal Podolsky, Natasha Hudek, Nicola McCleary, Christopher McCudden, Justin Presseau, Jamie C Brehaut","doi":"10.1515/cclm-2024-0948","DOIUrl":"https://doi.org/10.1515/cclm-2024-0948","url":null,"abstract":"<p><strong>Objectives: </strong>Lab testing is a high-volume activity that is often overused, leading to wasted resources and inappropriate care. Improving test ordering practices in tertiary care involves deciding where to focus scarce intervention resources, but clear guidance on how to optimize these resources is lacking. We aimed to explore context-sensitive factors and processes that inform individual decisions about laboratory stewardship interventions by speaking to key interest holders in this area.</p><p><strong>Methods: </strong>We conducted semi-structured interviews with test-ordering intervention development experts and authors of test-ordering guidance documents to explore five broad topics: 1) processes used to prioritize tests for intervention; 2) factors considered when deciding which tests to target; 3) measurement of these factors; 4) interventions selected; 5) suggestions for a framework to support these decisions. Transcripts were double coded using directed-content and thematic analysis.</p><p><strong>Results: </strong>We interviewed 14 intervention development experts. Experts noted they frequently consider test volume, test value, and patient care when deciding on a test to target. Experts indicated that quantifying many relevant factors was challenging. Processes to support these decisions often involved examining local data, obtaining buy-in, and relying on an existing guideline. Suggestions for building a framework emphasized the importance of collaboration, consideration of context and resources, and starting with \"easy wins\" to gain support and experience.</p><p><strong>Conclusions: </strong>Our study provides insight into the factors and processes experts consider when deciding which tests to target for intervention and can inform the development of a framework to guide the selection of tests for intervention and guideline development.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281346","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}
Yinling Wang, Jun Zheng, Yang Liu, Dongqi Li, Danning Jin, Hong Luan
{"title":"Atypical cells in urine sediment: a novel biomarker for early detection of bladder cancer.","authors":"Yinling Wang, Jun Zheng, Yang Liu, Dongqi Li, Danning Jin, Hong Luan","doi":"10.1515/cclm-2024-0650","DOIUrl":"https://doi.org/10.1515/cclm-2024-0650","url":null,"abstract":"<p><strong>Objectives: </strong>Atypical cells (Atyp.C), as a new parameter determined by an automated urine analyzer, can be suspected of being malignant tumor cells. We evaluated the extent to which the Atyp.C can predict the existence of malignant tumor cells.</p><p><strong>Methods: </strong>A total of 3,315 patients (1,751 in the training cohort and 1,564 in the testing cohort) were recruited and divided into five groups, namely, primary bladder cancer (BCa), recurrent BCa, post-treatment monitoring of BCa, other urological tumors, and controls. Urine Atyp. C, bacteria, white blood cell, and red blood cell were measured by a Sysmex UF-5000 analyzer. We compared the Atyp.C values across the different groups, sexes, and tumor stages. The diagnostic performance of Atyp.C alone and in combination with other parameters for detecting BCa was evaluated using receiver operating characteristic (ROC) curve analysis.</p><p><strong>Results: </strong>The Atyp.C value of the primary BCa group was significantly higher than that in the other groups, except recurrent BCa group. The Atyp.C value was closely related to tumor staging. Atyp.C combined with bacteria had the highest diagnostic performance for primary BCa [training cohort AUC: 0.781 (95 % CI: 0.761-0.801); testing cohort AUC: 0.826 (95 % CI: 0.806-0.845)]. The AUC value of diagnosed recurrent BCa by Atyp.C plus bacteria for the training cohort was 0.784 (95 % CI: 0.762-0.804).</p><p><strong>Conclusions: </strong>Atyp.C was high in primary BCa patients and the combination of bacteria and Atyp.C showed high predictive value for primary BCa, suggesting that Atyp.C may be a useful objective indicator for the early detection of BCa.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281325","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}
Joris R Delanghe, Jan Van Elslande, Maaike J Godefroid, Alexandre M Thieuw Barroso, Marc L De Buyzere, Thomas M Maenhout
{"title":"Colorimetric correcting for sample concentration in stool samples.","authors":"Joris R Delanghe, Jan Van Elslande, Maaike J Godefroid, Alexandre M Thieuw Barroso, Marc L De Buyzere, Thomas M Maenhout","doi":"10.1515/cclm-2024-0961","DOIUrl":"https://doi.org/10.1515/cclm-2024-0961","url":null,"abstract":"<p><strong>Objectives: </strong>Fecal immunochemical tests (FIT) for hemoglobin are currently considered the screening investigation of choice for colorectal cancer and are worldwide recommended. Similarly, fecal calprotectin is a widely used test for monitoring intestinal inflammation. The pre-analytical issues regarding stool samples have hardly been dealt with and are difficult to solve. Currently, there are no reference analytes available which allow to correct test results for the variable water content of the stool sample. Studies on preanalytics of stool samples have generally focused on sample preparation and sample storage, but generally have paid little attention to the variability in sample hydration and sample composition.</p><p><strong>Methods: </strong>Stercobilin is a stable heme metabolite which is abundant in stool. Stercobilin concentration can be simply assayed in stool extracts using colorimetry (determination of the I index). Serum indices (H, I and L) and bilirubin concentration of fecal extracts were determined on a Atellica Platform (Siemens).</p><p><strong>Results: </strong>The inter-individual variation of stercobilin was found to be high. Assaying stercobilin allows to correct for stool sample dilution. The median value of the I-index was used as a reference for correcting the data. Correcting fecal blood results for sample dilution resulted in a significant increase in positive tests (from 9.3 to 11.7 %). For calprotectin, correction resulted in 3.1 % extra positive results and 7.7 % negative results.</p><p><strong>Conclusions: </strong>Except in the case of obstructive jaundice, this correction can be applied. Correcting test results of common fecal analytes like FIT and calprotectin may result in a better tailored test interpretation.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281326","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}
Miyo K Chatanaka, George M Yousef, Eleftherios P Diamandis
{"title":"The Unholy Grail of cancer screening: or is it just about the Benjamins?","authors":"Miyo K Chatanaka, George M Yousef, Eleftherios P Diamandis","doi":"10.1515/cclm-2024-1013","DOIUrl":"10.1515/cclm-2024-1013","url":null,"abstract":"<p><p>The biotechnology company Grail developed a non-invasive blood test (Galleri test) which is claimed to detect 50 types of cancer at early and potentially curable stages. The initially promising results from prospective studies, and the anticipated financial success of Grail led the sequencing giant Illumina to purchase Grail for $8 billion (2021). Following this event, Grail collaborated with the UK National Health System to further clarify the test's capability, in a 3-year prospective trial, along with the standard of care. At the end of the first year, UK-NHS announced that they will suspend the trial due to unsatisfactory clinical performance and until they analyze the data for the first year (which already enrolled 140,000 participants). Legal and financial issues between the interested parties are currently in flux. We previously expressed concerns about the sensitivity and specificity of the Galleri test. In this opinion paper, we revisit the hyped technology, and we provide new suggestions on the use of this test.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281350","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}