Clinical chemistry and laboratory medicine最新文献

{"title":"Construction of platelet count-optical method reflex test rules using Micro-RBC#, Macro-RBC%, \"PLT clumps?\" flag, and \"PLT abnormal histogram\" flag on the Mindray BC-6800plus hematology analyzer in clinical practice.","authors":"Yang Fei, Zhi-Gang Xiong, Liang Huang, Chi Zhang","doi":"10.1515/cclm-2024-0739","DOIUrl":"https://doi.org/10.1515/cclm-2024-0739","url":null,"abstract":"<p><strong>Objectives: </strong>Utilizing RBC or PLT-related parameters to establish rules for the PLT-O reflex test can assist laboratories in quickly identifying specimens with interfered PLT-I that require PLT-O retesting.</p><p><strong>Methods: </strong>Prospective PLT-I and PLT-O testing was performed on 6857 EDTA-anticoagulated whole blood samples, split randomly into training and validation cohorts at a 2:3 ratio. Reflex and non-reflex groups were distinguished based on the differences between PLT-I and PLT-O results. By comparing RBC and PLT parameter differences and flags in the training set, we pinpointed factors linked to PLT-O reflex testing. Utilizing Lasso regression, then refining through univariate and multivariate logistic regression, candidate parameters were selected. A predictive nomogram was constructed from these parameters and subsequently validated using the validation set. ROC curves were also plotted.</p><p><strong>Results: </strong>Significant differences were observed between the reflex and non-reflex groups for 19 parameters including RBC, MCV, MCH, MCHC, RDW-CV, RDW-SD, Micro-RBC#, Micro-RBC%, Macro-RBC#, Macro-RBC%, MPV, PCT, P-LCC, P-LCR, PLR,\"PLT clumps?\" flag, \"PLT abnormal histogram\" flag, \"IDA Anemia?\" flag, and \"RBC abnormal histogram\" flag. After further analysis, Micro-RBC#, Macro-RBC%,\"PLT clumps?\", and \"PLT abnormal histogram\" flag were identified as candidate parameters to develop a nomogram with an AUC of 0.636 (95 %CI: 0.622-0.650), sensitivity of 42.9 % (95 %CI: 37.8-48.1 %), and specificity of 90.5 % (95 %C1: 89.6-91.3 %).</p><p><strong>Conclusions: </strong>The established rules may help laboratories improve efficiency and increase accuracy in determining platelet counts as a supplement to ICSH41 guidelines.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105023","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":"Analytical verification of the Atellica VTLi point of care high sensitivity troponin I assay.","authors":"Christopher M Florkowski, Vanessa Buchan, Bobby V Li, Felicity Taylor, Minh Phan, Martin Than, John W Pickering","doi":"10.1515/cclm-2024-0312","DOIUrl":"10.1515/cclm-2024-0312","url":null,"abstract":"<p><strong>Objectives: </strong>The Siemens Point-of-Care Testing (POC) Atellica^® VTLi high-sensitivity troponin I (hsTnI) device has been previously validated. Verification independently provides evidence that an analytical procedure fulfils concordance with laboratory assays, imprecision, and hemolysis interference requirements.</p><p><strong>Methods: </strong>Five whole blood samples spanning the measuring interval were analysed 20 times in succession. Hemolysis interference was assessed at three troponin concentrations by spiking five hemolysate concentrations to plasma to achieve free hemoglobin concentrations 35-1,000 mg/dL. Concordance between whole blood (VTLi) and plasma on laboratory analysers (Beckman, Roche, Siemens) was assessed by Pearson correlation and kappa statistics at the (LOQ) and upper reference limit (URL). This was repeated for frozen plasma samples.</p><p><strong>Results: </strong>Coefficients of variation for whole blood were <10 % for whole blood troponin concentrations of 9.2 and 15.9 ng/L, thus below the URL. Hemolysis positively interfered; at 250 mg/dL affecting the low troponin sample (+3 ng/L; +60 %) and high troponin sample (+37 ng/L; +24 %). Correlation coefficients were 0.98, 0.90 and 0.97 between VTLi and Beckman, Roche and Siemens assays respectively. Corresponding kappa statistics were 0.80, 0.73 and 0.84 at the LOQ and 0.70, 0.44 and 0.67 at the URL.</p><p><strong>Conclusions: </strong>Concordances between VTLi and laboratory assays were at least non-inferior to those between laboratory assays. Imprecision met manufacturer claims and was consistent with a high sensitivity assay. There is potential for hemolysis interference, highlighting the need for quality samples. The results support performance characteristics previously reported in validation studies, and the device offers acceptable performance for use within intended medical settings.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105022","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":"IVDCheckR - simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool.","authors":"Yadwinder Kaur, Daniel Rosenkranz, Anna Bloemer, Ozan Aykurt, Gunnar Brandhorst, Folker Spitzenberger, Astrid Petersmann","doi":"10.1515/cclm-2024-0477","DOIUrl":"https://doi.org/10.1515/cclm-2024-0477","url":null,"abstract":"<p><strong>Objectives: </strong>A recent challenge for clinical laboratories is the lack of clear guidelines for handling significant modifications of CE-marked assays. The modifications may involve, for example, extending measurement intervals, changing dilution procedures or using non-validated sample materials. The challenge arises due to the amended Regulation (EU) 2017/746 on <i>in vitro</i> diagnostic medical devices (IVDR), which is now poised for implementation, despite the extended transition periods. The IVDR application imposes challenges not only for diagnostic companies but also for clinical laboratories when using laboratory developed tests (LDTs), often referred to as in-house assays. In this context, a coherent and meticulously structured LDT documentation is highly beneficial. While laboratories are obliged to meet the IVDR requirements, the absence of a streamlined framework or guideline hampers the ability to gain a comprehensive overview on the requirements and possible options for their fulfilment.</p><p><strong>Methods: </strong>To address this issue, we introduce a web based digital tool powered by an R Shiny web application. This tool facilitates a seamless implementation of IVDR requirements for LDTs across diverse laboratory environments in terms of their transparency and validity. Our approach focuses on adequate handling of significant modifications of CE-marked <i>in vitro</i> diagnostic medical devices (IVD).</p><p><strong>Results: </strong>IVDRCheckR is an open-source tool that is easily accessible and free from system dependencies. The tool promotes a seamless process and a guide to enhance transparency, reliability, and validity of laboratory examination results based on LDTs. Additionally, the tool further provides modules for evaluating quality control data and quantitative method comparison data.</p><p><strong>Conclusions: </strong>Our Shiny web application-based platform is a digitised, user-friendly tool that simplifies the documentation for LDTs according to IVDR requirements with special emphasis on solutions for handling modifications to CE-marked assays.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142079495","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":"Comparative analysis of BCR::ABL1 p210 mRNA transcript quantification and ratio to ABL1 control gene converted to the International Scale by chip digital PCR and droplet digital PCR for monitoring patients with chronic myeloid leukemia.","authors":"Wannachai Saisaard, Weerapat Owattanapanich","doi":"10.1515/cclm-2024-0456","DOIUrl":"https://doi.org/10.1515/cclm-2024-0456","url":null,"abstract":"<p><strong>Objectives: </strong>Chronic myeloid leukemia (CML) is characterized by the Philadelphia chromosome, leading to the <i>BCR::ABL1</i> fusion gene and hyper-proliferation of granulocytes. Tyrosine kinase inhibitors (TKIs) are effective, and minimal residual disease (MRD) monitoring is crucial. Digital PCR platforms offer increased precision compared to quantitative PCR but lack comparative studies.</p><p><strong>Methods: </strong>Eighty CML patient samples were analyzed in parallel using digital droplet PCR (ddPCR) (QXDx™ BCR-ABL %IS Kit) and chip digital PCR (cdPCR) (Dr. PCR™ BCR-ABL1 Major IS Detection Kit).</p><p><strong>Results: </strong>Overall, qualitative and quantitative agreement was good. Sensitivity analysis showed positive percentage agreement and negative percentage agreement were both ≥90 %, and the quadratic weighted kappa index for molecular response (MR) level categorization was 0.94 (95 %CI 0.89, 0.98). MR levels subgroup analysis showed perfect categorical agreement on MR level at MR3 or above, while 35.4 % (17/48) of patient samples with MR4 or below showed discordant categorizations. Overall, Lin's concordance correlation coefficient (CCC) for the ratio of %<i>BCR::ABL1</i>/<i>ABL1</i> converted to the International Scale (<i>BCR::ABL1</i> ^IS) was almost perfect quantitative agreement (Lin's CCC=0.99). By subgroups of MR levels, Lin's CCC showed a quantitative agreement of <i>BCR::ABL1</i> ^IS decreased as MR deepened.</p><p><strong>Conclusions: </strong>Both cdPCR and ddPCR demonstrated comparable performance in detecting <i>BCR::ABL1</i> transcripts with high concordance in MR3 level or above. Choosing between platforms may depend on cost, workflow, and sensitivity requirements.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016507","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":"Is sweat conductivity still a relevant screening test for cystic fibrosis? Participation over 10 years.","authors":"Natasha Robbins, R John Massie, Avis McWhinney, Natasha Heather, Lawrence Greed, Peter Graham, Samantha Shepherd, Trisha Andersen, Ronda F Greaves","doi":"10.1515/cclm-2024-0909","DOIUrl":"https://doi.org/10.1515/cclm-2024-0909","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016508","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}

{"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}

{"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}

{"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":"Hb D-Iran interference on HbA_1c measurement.","authors":"Iacopo Iacomelli, Chiara Giulietti, Renata Paleari","doi":"10.1515/cclm-2024-0641","DOIUrl":"https://doi.org/10.1515/cclm-2024-0641","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":"141888639","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}