Clinical chemistry and laboratory medicine最新文献

{"title":"Performance evaluation of the introduction of full sample traceability system within the specimen collection process.","authors":"Emanuela Foglia, Elisabetta Garagiola, Lucrezia Ferrario, Mario Plebani","doi":"10.1515/cclm-2024-0854","DOIUrl":"https://doi.org/10.1515/cclm-2024-0854","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the efficacy, safety and efficiency performances related to the introduction of innovative traceability platforms and integrated blood collection systems, for the improvement of a total testing process, thus also assessing the economic and organizational sustainability of these innovative technologies.</p><p><strong>Methods: </strong>A mixed-method approach was utilized. A key-performance indicators dashboard was created based on a narrative literature review and expert consensus and was assessed through a real-life data collection from the University Hospital of Padova, Italy, comparing three scenarios over time (2013, 2016, 2019) with varying levels of technological integration. The economic and organizational sustainability was determined considering all the activities performed from the tube check-in to the validation of the results, with the integration of the management of the prevalent errors occurred during the process.</p><p><strong>Results: </strong>The introduction of integrated venous blood collection and full sample traceability systems resulted in significant improvements in laboratory performance. Errors in samples collected in inappropriate tubes decreased by 42 %, mislabelled samples by 47 %, and samples with irregularities by 100 %. Economic analysis revealed a cost saving of 12.7 % per tube, equating to a total saving of 447,263.80 € over a 12-month period. Organizational efficiency improved with a reduction of 13,061.95 h in time spent on sample management, allowing for increased laboratory capacity and throughput.</p><p><strong>Conclusions: </strong>Results revealed the strategic relevance of introducing integrated venous blood collection and full sample traceability systems, within the Laboratory setting, with a real-life demonstration of TLA economic and organizational sustainability, generating an overall improvement of the process efficiency.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616110","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":"Navigation between EQA and sustainability.","authors":"Tony Badrick, Zoe Vayanos, John Sioufi","doi":"10.1515/cclm-2024-1240","DOIUrl":"https://doi.org/10.1515/cclm-2024-1240","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616109","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":"How has the external quality assessment/proficiency testing of semen analysis been developed in the past 34 years: a review.","authors":"Yan Zheng, Yingbi Wu, Lin Yu, Yelin Jia, Tingting Yang, Qingyuan Cheng, Jiao Qin, Xiao Liu, Min Jiang, Fuping Li","doi":"10.1515/cclm-2024-1062","DOIUrl":"https://doi.org/10.1515/cclm-2024-1062","url":null,"abstract":"<p><p>Male infertility has become an important issue of global concern. Semen analysis is the cornerstone of male fertility assessment. External quality assessment (EQA) of sperm concentration, motility, and morphology is widely recognized in the world. However, over the past 34 years, the implementation of EQA for semen analysis has varied across different countries, and there is no global consensus. The goal of this paper is to first explore the overall development of EQA during this period. Secondly, it aims to discuss the extent of difference of participating laboratories in different countries. Finally, the paper examines the differences in EQA programs developed by various EQA providers in order to seek a global standard. In total, 29 papers met the inclusion criteria and were included in this review. There is inconsistent in the implementation of EQA across different countries, and there is no global consensus. Policies for EQA of semen analysis vary from country to country. Some countries mandate laboratory participation, while others permit voluntary involvement. Different EQA organizers choose different ways to calculate assigned value and acceptance limits. The coefficient of variation (CV) for each EQA item was large. The CVs of concentration, motility, morphology, and viability were 12.7-138.0 %, 17.0-127.0 %, 7-375 %, and 6-41.1 %, respectively. The results of the semen analysis varied considerably among the participating laboratories. The collaborative efforts of national policymakers, EQA organizers, and all participating laboratories are essential to improving the current situation.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603555","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 the clinical performance of anti-mutated citrullinated vimentin antibody and 14-3-3 eta testing in rheumatoid arthritis.","authors":"Heather A Nelson, Thomas B Martins, Abdulrahman Saadalla, Vijayalakshmi Nandakumar","doi":"10.1515/cclm-2024-1112","DOIUrl":"https://doi.org/10.1515/cclm-2024-1112","url":null,"abstract":"<p><strong>Objectives: </strong>Early rheumatoid arthritis (RA) detection is crucial for improving patient prognosis. Anticyclic citrullinated peptide antibodies (anti-CCP) and rheumatoid factors (RF) support RA diagnosis but are undetectable in ∼20 % of cases. Recently, antibodies against mutated citrullinated vimentin (anti-MCV) and detection of 14-3-3 eta have emerged with implications for preclinical RA diagnosis and monitoring treatment. The objective of this study was to assess the clinical performance of anti-MCV antibodies and 14-3-3 eta in RA and to compare it to current RA criteria anti-CCP and RF markers, individually and in combination.</p><p><strong>Methods: </strong>A retrospective chart review of 326 subjects submitted for RA serology testing identified 134 RA positive and 192 RA negative disease control individuals. Fifty healthy controls specimens were also included. Performance of anti-MCV and 14-3-3 eta, alone and combined with CCP3.1 and RF, was assessed.</p><p><strong>Results: </strong>Anti-MCV had a sensitivity of 71 % and a specificity of 92 %. 14-3-3 eta had a sensitivity of 43 % and a specificity of 90 %. In comparison, CCP3.1 and RF displayed a sensitivity of 79 % and 84 % and a specificity of 92 % and 61 %, respectively. ROC curve analysis demonstrated CCP3.1 and anti-MCV had superior diagnostic performance compared to RF and 14-3-3 eta. In our cohort, anti-MCV and 14-3-3 eta failed to identify seronegative RA patients. Different combinations of double antibody positivity increased specificity at the cost of lost sensitivity.</p><p><strong>Conclusions: </strong>Individually, 14-3-3 eta, anti-MCV and CCP3.1 assays had ≥90 % specificity in diagnosed RA patients, with better sensitivities for anti-MCV and CCP3.1 than 14-3-3 eta. Overall diagnostic performance of anti-MCV was similar to CCP3.1 and RF, all of which outperformed 14-3-3 eta in our cohort.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582324","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":"Evidence for stability of cardiac troponin T concentrations measured with a high sensitivity TnT test in serum and lithium heparin plasma after six-year storage at -80 °C and multiple freeze-thaw cycles.","authors":"Linda M Henricks, Fred P H T M Romijn, Christa M Cobbaert","doi":"10.1515/cclm-2024-0787","DOIUrl":"https://doi.org/10.1515/cclm-2024-0787","url":null,"abstract":"<p><strong>Objectives: </strong>As high-sensitivity cardiac troponin T (hs-cTnT) is making the transition from diagnostic to prognostic use, a long-term stability study of 5th generation hs-cTnT according to EFLM CRESS recommendations was set up for investigation of frozen clinical specimens (two matrices).</p><p><strong>Methods: </strong>Study samples collected in serum tubes and lithium heparin tubes with gel from patients admitted for suspected minor myocardial damage were measured directly after completion of the study (0 years), and after 3-year and 6-year storage at -80 °C, and recovery of hs-cTnT concentrations after long-term storage (%hs-cTnT concentration compared to 0-year) was calculated. Hs-cTnT changes were also compared to decisive delta changes, such as the ones proposed in the ESC NSTEMI 0 h/1 h algorithm (<3 or >5 ng/L for ruling out and ruling in suspected NSTEMI patients).</p><p><strong>Results: </strong>Eighty-six patients were included in the study, whereof 28 both lithium heparin plasma and serum samples were collected simultaneously, in others only serum (n=30) or plasma (n=28). Multiple aliquots per patient were made, so that 479 serum and 473 plasma samples were available for analysis. Across the overall hs-cTnT measuring range, median recovery after 6 years was 105.4 % and 106.2 % for serum and plasma, respectively. Based on these decisive delta changes, serum showed consistent results upon long term storage (max 0.8 % of samples above delta threshold of >5 ng/L) as compared to heparin plasma (up to 19.2 % of samples above threshold).</p><p><strong>Conclusions: </strong>Over 6 years of storage at -80 °C, recovery of hs-cTnT in serum and heparin plasma was similar and within common lot-to-lot variation. Yet, when evaluating absolute delta increments around hs-cTnT clinical decision points, long-term stored sera displayed better clinical performance compared to heparin plasma samples.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544120","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 revised UK-NEQAS CSF-xanthochromia method for subarachnoid hemorrhage: outcome data provide evidence for clinical value.","authors":"Khin Moe Sam, Hans G Schneider","doi":"10.1515/cclm-2024-0995","DOIUrl":"https://doi.org/10.1515/cclm-2024-0995","url":null,"abstract":"<p><strong>Objectives: </strong>Subarachnoid haemorrhage (SAH) has a high morbidity and mortality and requires prompt diagnosis. In patients with negative findings on computed-tomogram of the brain (CT-Brain) cerebrospinal fluid (CSF)-xanthochromia is considered the test of choice if performed 12 h or more after symptom onset. We audited the accuracy, usefulness and timing of CSF-xanthochromia testing and the interpretation of equivocal CSF-xanthochromia findings. We also investigated mortality outcomes for defined subsets of patients.</p><p><strong>Methods: </strong>A retrospective audit of CSF-xanthochromia tests over 8 years was performed. The service uses the revised UK-NEQAS (United Kingdom National External Quality Assessment Service) method.</p><p><strong>Results: </strong>We analysed 543 cases (F=299, median age 44yrs) with 19 cases (3.5 %) having SAH. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CSF-xanthochromia testing were 100 , 98.1, 65.9, 100 % respectively (equivocal results were counted as positives). 280 cases (F=153, median age 43yrs) had LP performed more than 24 h after the onset of headache (median time to LP=72 h). The sensitivity and specificity of the CSF-xanthochromia were 100 and 97.4 % in this group with NPV 100 % and PPV 66.6 %. 183 (65.4 %) CSF- xanthochromia negative cases in this subgroup had follow up data and survived without SAH occurring in the 12 months follow up.</p><p><strong>Conclusions: </strong>In this study, supported by follow up outcome data, we show that CSF-xanthochromia testing using the revised UK-NEQAS method is fit-for-purpose for the use as a second line test to exclude SAH in patients with negative CT-brain including delayed presentation more than 24 h after headache onset.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521194","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":"Strategies to verify equimolar peptide release in mass spectrometry-based protein quantification exemplified for apolipoprotein(a).","authors":"Yuri E M van der Burgt, Fred P H T M Romijn, Maxim M Treep, L Renee Ruhaak, Christa M Cobbaert","doi":"10.1515/cclm-2024-0539","DOIUrl":"https://doi.org/10.1515/cclm-2024-0539","url":null,"abstract":"<p><strong>Objectives: </strong>Quantitative protein mass spectrometry (MS) is ideally suited for precision diagnostics and for reference standardization of protein analytes. At the Leiden Apolipoprotein Reference Laboratory we apply MS strategies to obtain detailed insight into the protein-to-peptide conversion in order to verify that quantifier peptides are not partly concealed in miscleaved protein backbone.</p><p><strong>Methods: </strong>Apolipoprotein(a) (apo(a)) was digested in a non-optimal manner to enhance the number of miscleaved peptides that were identified by high resolution liquid chromatography tandem-MS measurements. The protein-to-peptide conversion was carefully mapped with specific attention for miscleaved peptides that contain an apo(a) quantifier peptide. Four different isotopologues of each apo(a)-quantifier peptide were applied to evaluate linearity of internal peptide standards during measurement of specific real-life samples.</p><p><strong>Results: </strong>Two apo(a) quantifier peptides that were concealed in two different miscleaved peptides were included into a multiple reaction monitoring list in our targeted MS-based apo(a) quantifications to alert for potential protein digestion discrepancies. The presence of miscleaved peptides could be ruled out when applying our candidate reference measurement procedure (RMP) for apo(a) quantification.</p><p><strong>Conclusions: </strong>These data further corroborate the validity of our apo(a) candidate RMP as higher order method for certification of commercial Lp(a) tests that is endorsed by the International Federation of Clinical Chemistry and Laboratory Medicine. MS-based molecular detection and quantification of heterogeneous apo(a) proteoforms will allow manufacturers' transitioning from confounded lipoprotein(a) [Lp(a)] mass levels into accurate molar apo(a) levels.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496317","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":"Cell population data in venous thrombo-embolism and erysipelas: a potential diagnostic tool?","authors":"Yael Appelboom, Math P G Leers, Tom Schoenmakers, Daan J L van Twist","doi":"10.1515/cclm-2024-1050","DOIUrl":"https://doi.org/10.1515/cclm-2024-1050","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496314","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":"Particulate matter in water: an overlooked source of preanalytical error producing erroneous chemistry test results.","authors":"Tong Wang, Stephanie Pizarro-Falcon, Allison Quiros, Raffick A R Bowen","doi":"10.1515/cclm-2024-1151","DOIUrl":"https://doi.org/10.1515/cclm-2024-1151","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496316","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":"Multi-cancer early detection: searching for evidence.","authors":"Giuseppe Lippi, Karl J Lackner, Bohuslav Melichar, Peter Schlattmann, Ronda Greaves, Philippe Gillery, Mario Plebani","doi":"10.1515/cclm-2024-1201","DOIUrl":"https://doi.org/10.1515/cclm-2024-1201","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496315","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}