Constant Gillot, Clara David, Jean-Michel Dogné, Julien Cabo, Jonathan Douxfils, Julien Favresse
{"title":"Neutralizing antibodies against KP.2 and KP.3: why the current vaccine needs an update.","authors":"Constant Gillot, Clara David, Jean-Michel Dogné, Julien Cabo, Jonathan Douxfils, Julien Favresse","doi":"10.1515/cclm-2024-0919","DOIUrl":"https://doi.org/10.1515/cclm-2024-0919","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141987580","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 effects of drone transportation on routine laboratory, immunohematology, flow cytometry and molecular analyses.","authors":"Steven Weekx, Philippe Van Lint, Sam Jacobs","doi":"10.1515/cclm-2024-0420","DOIUrl":"https://doi.org/10.1515/cclm-2024-0420","url":null,"abstract":"<p><strong>Objectives: </strong>Transportation of medical samples between laboratories or hospital sites is typically performed by motorized ground transport. Due to the increased traffic congestions in urban environments, drone transportation has become an attractive alternative for fast shipping of samples. In accordance with the CLSI guidelines and the ISO 15189 standard, the impact of this transportation type on sample integrity and performance of laboratory tests must be thoroughly validated.</p><p><strong>Methods: </strong>Blood samples from 36 healthy volunteers and bacterial spiked urine samples were subjected to a 20-40 min drone flight before they were analyzed and compared with their counterparts that stayed on the ground. Effects on stability of 30 routine biochemical and hematological parameters, immunohematology tests and flow cytometry and molecular tests were evaluated.</p><p><strong>Results: </strong>No clinically relevant effects on blood group typing, flow cytometry lymphocyte subset testing and on the stability of the multicopy opacity-associated proteins (<i>Opa</i>) genes in bacterial DNA nor on the number of Abelson murine leukemia viral oncogene homolog 1 (<i>abl</i>) housekeeping genes in human peripheral blood cells were seen. For three of the 30 biochemistry and hematology parameters a statistically significant difference was found: gamma-glutamyl transferase (gamma-GT), mean corpuscular hemoglobin (MCH) and thrombocyte count. A clinically relevant effect however was only seen for potassium and lactate dehydrogenase (LDH).</p><p><strong>Conclusions: </strong>Multi-rotor drone transportation can be used for medical sample transportation with no effect on the majority of the tested parameters, including flow cytometry and molecular analyses, with the exception of a limited clinical impact on potassium and LDH.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141981862","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}
Patti Shih, Sverre Sandberg, Jan Balla, Banu Isbilen Basok, Jennifer J Brady, Bernard Croal, Nathalie De Vos, Mathias Karlsson, Piret Kedars, Tomris Ozben, Marina Pijanovic, Mario Plebani, Matthias Orth
{"title":"Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement.","authors":"Patti Shih, Sverre Sandberg, Jan Balla, Banu Isbilen Basok, Jennifer J Brady, Bernard Croal, Nathalie De Vos, Mathias Karlsson, Piret Kedars, Tomris Ozben, Marina Pijanovic, Mario Plebani, Matthias Orth","doi":"10.1515/cclm-2024-0876","DOIUrl":"https://doi.org/10.1515/cclm-2024-0876","url":null,"abstract":"<p><p>Direct-to-consumer testing (DTCT) refers to commercial laboratory tests initiated by laypersons without the involvement of healthcare professionals. As this market grows in size and variety of products, a clear definition of DTCT to ground the conceptualization of their harms and benefits is needed. We describe how three different modalities of DTCT (home self-testing, self-sampled tests, and direct access tests) present caveats to the traditional testing process ('brain-to-brain loop'), and how this might differ between medical vs. non-medical laboratories. We make recommendations for ways to improve quality and reduce errors with respect to DTCT. The potential benefits and harms of DTCT will invariably depend on the context and situation of individual consumers and the types of tests involved. Importantly, implications for both consumers and the healthcare system should be considered, such as the effects on improving health outcomes and reducing unnecessary testing and use of clinical resources. 'Consumer initiation' must be a central defining characteristic of DTCT, to clearly demarcate the key drawbacks as well as opportunities of this type of testing from a laboratory specialists' perspective. The concept of 'consumer initiated testing' should also help define DTCT regulation, and provide a locus of efforts to support consumers as the main decision-makers in the purchasing and conducting of these tests in the absence of clinician gatekeeping.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141981860","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}
Guanglu Che, Xiaojuan Liu, Fang Liu, Li Chang, Qiuxia Yang
{"title":"Two cases of <i>MTHFR</i> C677T polymorphism typing failure by Taqman system due to <i>MTHFR</i> 679 GA heterozygous mutation.","authors":"Guanglu Che, Xiaojuan Liu, Fang Liu, Li Chang, Qiuxia Yang","doi":"10.1515/cclm-2024-0245","DOIUrl":"10.1515/cclm-2024-0245","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906111","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}
Hui Qi Low, Christopher-John L Farrell, Tze Ping Loh, Chun Yee Lim
{"title":"Sigma metric is more correlated with analytical imprecision than bias.","authors":"Hui Qi Low, Christopher-John L Farrell, Tze Ping Loh, Chun Yee Lim","doi":"10.1515/cclm-2024-0882","DOIUrl":"https://doi.org/10.1515/cclm-2024-0882","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901138","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}
Daniel J Whitbread, Rachel Nice, Sarah Benyon, Coralie Bingham, Richard A Oram, Timothy J McDonald
{"title":"Utility and limitations of monitoring kidney transplants using capillary sampling.","authors":"Daniel J Whitbread, Rachel Nice, Sarah Benyon, Coralie Bingham, Richard A Oram, Timothy J McDonald","doi":"10.1515/cclm-2024-0049","DOIUrl":"https://doi.org/10.1515/cclm-2024-0049","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888641","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":"Clinical utility of personalized reference intervals for CEA in the early detection of oncologic disease.","authors":"Débora Martínez-Espartosa, Estíbaliz Alegre, Hugo Casero-Ramírez, Jorge Díaz-Garzón, Pilar Fernández-Calle, Patricia Fuentes-Bullejos, Nerea Varo, Álvaro González","doi":"10.1515/cclm-2024-0546","DOIUrl":"https://doi.org/10.1515/cclm-2024-0546","url":null,"abstract":"<p><strong>Objectives: </strong>Personalized reference intervals (prRI) have been proposed as a diagnostic tool for assessing measurands with high individuality. Here, we evaluate clinical performance of prRI using carcinoembryonic antigen (CEA) for cancer detection and compare it with that of reference change values (RCV) and other criteria recommended by clinical guidelines (e.g. 25 % of change between consecutive CEA results (RV25) and the cut-off point of 5 μg/L (CP5)).</p><p><strong>Methods: </strong>Clinical and analytical data from 2,638 patients collected over 19 years were retrospectively evaluated. A total 15,485 CEA results were studied. For each patient, we calculated prRI and RCV using computer algorithms based on the combination of different strategies to assess the number of CEA results needed, consideration of one or two limits of reference interval and the intraindividual biological variation estimate (CV<sub>I</sub>) used: (a) publicly available (CV<sub>I-EU</sub>), (b) CV<sub>I</sub> calculated using an indirect method (CV<sub>I-NOO</sub>) and (c) within-person BV (CV<sub>P</sub>). For each new result identified falling outside the prRI, exceeding the RCV interval, RV25 or CP5, we searched for records identifying the presence of tumour at 3 and 12 months after the test. The sensitivity, specificity and predictive power of each strategy were calculated.</p><p><strong>Results: </strong>PrRI approaches derived using CV<sub>I-EU</sub>, and both limits of reference interval achieve the best sensitivity (87.5 %) and NPV (99.3 %) at 3 and 12 months of all evaluated criteria. Only 3 results per patients are enough to calculate prRIs that reach this diagnostic performance.</p><p><strong>Conclusions: </strong>PrRI approaches could be an effective tool to rule out new oncological findings during the active surveillance of patients.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888637","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}
Jonathan S Atkins, Brian G Keevil, Angela E Taylor, Christian Ludwig, James M Hawley
{"title":"Development and validation of a novel 7α-hydroxy-4-cholesten-3-one (C4) liquid chromatography tandem mass spectrometry method and its utility to assess pre-analytical stability.","authors":"Jonathan S Atkins, Brian G Keevil, Angela E Taylor, Christian Ludwig, James M Hawley","doi":"10.1515/cclm-2024-0275","DOIUrl":"https://doi.org/10.1515/cclm-2024-0275","url":null,"abstract":"<p><strong>Objectives: </strong>7α-Hydroxy-4-cholesten-3-one (C4) is the common intermediary of both primary bile acids. C4 is recommended by the British Society of Gastroenterology for the investigation of bile acid diarrhoea (BAD) in patients with chronic diarrhoea. This project aimed to develop and validate an assay to quantitate C4 in serum and assess the stability of C4 in unseparated blood.</p><p><strong>Methods: </strong>Accuracy was underpinned by calibrating to quantitative nuclear magnetic resonance analysis. C4 was analysed in a 96-well plate format with a deuterated C4 internal standard and liquid-liquid extraction. Validation followed the 2018 Food and Drug Administration guidelines. To assess C4 stability, healthy volunteers (n=12) donated 8 fasted samples each. Samples were incubated at 20 °C for up to 72 h and retrieved, centrifuged, aliquoted and frozen for storage at different time points prior to C4 analysis.</p><p><strong>Results: </strong>The C4 method demonstrated excellent analytical performance and passed all validation criteria. The method was found to be accurate, precise, free from matrix effects and interference. After 72 h of delayed sample separation, C4 concentration gradually declined by up to 14 % from baseline. However, the change was not significant for up to 12 h.</p><p><strong>Conclusions: </strong>We present a robust method of analysing serum C4, offering a convenient alternative to <sup>75</sup>SeHCAT for BAD investigation. C4 was found to decline in unseparated blood over time; however, after 12 h the mean change was <5 % from baseline. Our results suggest C4 is suitable for collection from both primary and secondary care prior to gastroenterology referral.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888638","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}