Clinical chemistry and laboratory medicine最新文献

{"title":"Sigma Metrics misconceptions and limitations.","authors":"Xincen Duan, Elvar Theodorsson, Wei Guo, Tony Badrick","doi":"10.1515/cclm-2024-1380","DOIUrl":"https://doi.org/10.1515/cclm-2024-1380","url":null,"abstract":"<p><strong>Objectives: </strong>This paper further explores the Sigma Metric (SM) and its application in clinical chemistry. It discusses the SM, assay stability, and control failure relationship.</p><p><strong>Content: </strong>: SM is not a valid measure of assay stability or the likelihood of failure. When an out-of-control event occurs for an assay with a higher SM value, the same QC rule will have greater power to detect error than assays with a lower SM value. Thus, it is easier to prevent errors from happening for higher SM assays. This rationale encourages using more frequent QC events and more QC samples for a QC scheme of a low SM assay or simply more QC cost for low SM assays. A laboratory can have a high-precision instrument that frequently fails and a low-precision instrument that hardly ever fails. Parvin's patient risk model presumes the bracketed continuous mode (BCM) testing workflow. If overlooked when designing QC schemes, this leads to the common misconception of the SM that one can save the cost of QC since assays with high SM require less frequent QC to ensure patient risk. There is no evidence that an assay's precision is correlated with its failure rate. Schmidt et al., in a series of papers, showed that an assay with a higher P_f or shift in probability will have a higher expected number of unacceptable results. Incorporating P_f into the QC design process presents significant challenges despite the proactive quality control (PQC) methodology.</p><p><strong>Summary: </strong>Unfortunately, TEa Six Sigma, as widely practiced in Clinical Chemistry, is not based on classical Six Sigma mathematical statistics. Classical Six Sigma would facilitate comparing results across activities where the principles of Six Sigma are employed.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876206","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 promising new direct immunoassay for urinary free cortisol determination.","authors":"Véronique Raverot, Khalid Hablouj, Pauline Perrin, Hélène Lasolle, Gérald Raverot","doi":"10.1515/cclm-2024-1192","DOIUrl":"https://doi.org/10.1515/cclm-2024-1192","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827362","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 performance in preanalytical phase EQA: can laboratories mitigate common pitfalls?","authors":"Anna Linko-Parvinen, Jonna Pelanti, Tanja Vanhelo, Pia Eloranta, Hanna-Mari Pallari","doi":"10.1515/cclm-2024-0990","DOIUrl":"https://doi.org/10.1515/cclm-2024-0990","url":null,"abstract":"<p><strong>Objectives: </strong>Preanalytical phase is an elemental part of laboratory diagnostics, but is prone to humane errors. The aim of this study was to evaluate performance in preanalytical phase external quality assessment (EQA) cases. We also suggest preventive actions for risk mitigation.</p><p><strong>Methods: </strong>We included 12 EQA rounds (Labquality Ltd.) with three patient cases (36 cases, 54-111 participants, 7-15 countries) published in 2018-2023. We graded performance according to percentage of correct responses in each case as ≥900 % excellent, 70-89 % good, 50-69 % satisfactory, 30-49 % fair and <30 % poor. Performance was simultaneously failed with ≥10 % of responses leading to harmful events.</p><p><strong>Results: </strong>Overall performance was excellent in 7, good in 12, satisfactory in 10, fair in 4 and poor in 3 cases. Additionally, 7 cases showed failed performance. Routine requests with incorrect sample tubes or incorrect sample handling were detected with good performance. Lower performance was seen with sudden abnormal results, with rare requests, with false patient identification (never-events) and with incorrect test requests. Information technology (IT) solutions (preanalytical checklists, autoverification rules and patient specific notifications) could have prevented 33 of 36 preanalytical errors.</p><p><strong>Conclusions: </strong>While most common errors were detected with good performance, samples with rare requests or those requiring individualised consideration are vulnerable to human misinterpretation. In many instances, samples with preanalytical errors should have been identified and rejected before reaching the laboratory or being directed to analysis. Optimising IT solutions to effectively detect these preanalytical errors allows for focus on infrequent events demanding accessible professional consultation. EQA preanalytical cases may help in education of correct actions in these occasions.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142821912","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 different serum albumin assays influence calcium status in haemodialysis patients: a comparative study against free calcium as a reference method.","authors":"Osama Eisa, Mohammed Dafaalla, Mark Wright, Muhammad Faisal, Kevin Stuart, Nuthar Jassam","doi":"10.1515/cclm-2024-1030","DOIUrl":"https://doi.org/10.1515/cclm-2024-1030","url":null,"abstract":"<p><strong>Objectives: </strong>Accurate assessment of calcium levels is crucial for optimal management of regular Haemodialysis (HD) patients. Different calcium adjustment equations and albumin methods; including bromocresol purple (BCP) and bromocresol green (BCG) assays are employed by laboratories, which cause considerable discrepancies between reported results. The aim of this study is to assess the influence of albumin assays on calcium status in stable haemodialysis patients against free calcium (fCa) as a gold standard test.</p><p><strong>Methods: </strong>103 paired serum and fCa samples were collected from a cohort of stable HD patients. Albumin levels were measured by either the BCP or BCG method, and samples were also analysed for the total calcium (T.Ca), phosphate, bicarbonate, and pH levels. The performance of BCG-based and BCP-based adjusted calcium equations was compared using Z-scores scatter plots, intraclass correlation coefficient and Cohen Kappa statistic, with fCa being the reference standard.</p><p><strong>Results: </strong>Unadjusted T.Ca achieved a 70 % overall classification agreement with fCa and identified 61 % of the \"true\" hypocalcaemic samples. Adjusted calcium concentrations, calculated by either BCP- or BCG-based equation, were poor predictors of fCa; with more than 50 % of the hypocalcaemic samples being misclassified as normocalcaemic. Notably, both equations misclassified the calcium status in 5 (4.9 %) patients with severe hypocalcaemia (i.e., potentially requiring calcium infusion) as mild hypocalcaemia.</p><p><strong>Conclusions: </strong>Our study showed evidence of hidden hypocalcaemia being missed by the current practice of using adjusted calcium in HD patients. Therefore, we recommend abandoning the adjustment procedure in samples from stable HD patients in favour of fCa measurement.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817226","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":"Current trends and future projections in the clinical laboratory test market: implications for resource management and strategic planning.","authors":"Giuseppe Lippi, Mario Plebani","doi":"10.1515/cclm-2024-1424","DOIUrl":"https://doi.org/10.1515/cclm-2024-1424","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812291","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":"Use of labile HbA_1c as a screening tool to minimize clinical misinterpration of HbA_1c.","authors":"Emilie De Muynck, Bruno Lapauw, Joris Delanghe, Stijn Lambrecht","doi":"10.1515/cclm-2024-1200","DOIUrl":"https://doi.org/10.1515/cclm-2024-1200","url":null,"abstract":"<p><strong>Objectives: </strong>Hemoglobin A_1c (HbA_1c) is an established tool in the diagnosis and follow-up of patients with diabetes. However, in some patients the interpretation of HbA_1c results faces challenges due to additional biological variation or non-steady-state conditions. This study aimed to demonstrate the value of the L-HbA_1c/HbA_1c-ratio as a tool to flag HbA_1c results, which do not reflect average glycemia \"as expected\" in routine clinical practice.</p><p><strong>Methods: </strong>A total of 450 samples of unique patients were selected based on the L-HbA_1c/HbA_1c-ratio determined on a Tosoh G8 analyzer resulting in a group with a high ratio (≥0.50), a group with a low ratio (≤0.27) and a group with a normal ratio (0.27-0.50). The relationship between HbA_1c and glycemic markers (fructosamine and random glucose) was established for all ratio groups. In a smaller cohort of type 1 diabetes patients, continuous glucose monitoring was used as glycemic marker.</p><p><strong>Results: </strong>The correlation between HbA_1c and glycemia (random glucose and fructosamine) differs significantly between the ratio groups. For the same HbA_1c level random glucose levels and protein-corrected fructosamine are higher in the high ratio group compared to the normal and low ratio groups, pointing to an underestimation of the glycemic status by HbA_1c in patients with high L-HbA_1c/HbA_1c-ratios. The sensitivity of a high ratio to predict a glycation gap lower than -1.5 NGSP units is 82 % and the specificity is 65 %.</p><p><strong>Conclusions: </strong>The results of this study reveal the usefulness of the L-HbA_1c/HbA_1c-ratio as an additional check in the interpretation of HbA_1c results in order to detect HbA_1c results not reflecting glycemia as expected.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817343","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":"Health literacy: a new challenge for laboratory medicine.","authors":"Federico Pennestrì, Giuseppe Banfi","doi":"10.1515/cclm-2024-1158","DOIUrl":"https://doi.org/10.1515/cclm-2024-1158","url":null,"abstract":"<p><p>Poor health literacy and inappropriate test prescribing hamper the value of laboratory medicine. The disintermediation between test producers and interpreters may happen both in Point of Care Tests, where doctor mediation is provided, but laboratory expert supervision is not, and in Direct to Consumer Testing, where no medical mediation is provided at all. In these cases, the respect for patient's autonomy must not preclude the principles of non-maleficence (as an individual concern) and justice (as a societal concern), as wrong test interpretation can generate confusion, anxiety, inappropriate social behavior, useless medical examinations and considerable cost increase. Considering how different is patient ability to understand test results (if any) and handle any physical and psychological consequence, promoting health literacy and professional laboratory mediation become crucial professional priorities. The aims of this review are 1) to describe the importance of health literacy on laboratory test interpretation, medical advice and therapeutic compliance; 2) to discuss doctor-level, patient-level and caregiver-level educational interventions in light of the four principles of the value-based framework (personal value, technical value, allocative value and societal value). Based on these premises, the authors support the need to enhance health literacy in patients, help doctors improve the communication of results and validate commercial tests under the scrutiny of scientific community.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812292","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":"Knowledge among clinical personnel on the impact of hemolysis using blood gas analyzers.","authors":"Trine Muhs Nielsen, Charlotte Gils, Mads Nybo","doi":"10.1515/cclm-2024-1018","DOIUrl":"https://doi.org/10.1515/cclm-2024-1018","url":null,"abstract":"<p><strong>Objectives: </strong>In the light of a rapidly increasing use of POCT blood gas testing, where tests and interpretation are performed by non-laboratory personnel, the objective was to investigate the knowledge among personnel in the Nordic countries using blood gas analyzers with focus on the interference from hemolysis.</p><p><strong>Methods: </strong>Information was obtained from a self-developed, pre-tested online questionnaire. The questions covered demographic information about the respondents and specific questions on handling of and knowledge about blood gas analyses and the impact of hemolysis. The questionnaire was distributed by e-mail to relevant colleagues on behalf of the Nordic preanalytical scientific working group under the Nordic Federation of Clinical Chemistry.</p><p><strong>Results: </strong>A total of 117 respondents completed the questionnaire. 62.7 % respondents both used the analyzer and interpreted the results. 59.6 % respondents did not know to which degree the blood gas analyzer can identify hemolysis. 4.4 % answered that all levels or high levels of hemolysis can be detected. 3.9 % considered the result valid despite hemolysis if it is released from the instrument. 73.7 % of all respondents knew that hemolysis alters potassium measurements, while knowledge about the effect on PaO₂ and bicarbonate measurements were more divergent.</p><p><strong>Conclusions: </strong>The knowledge about blood gas analyzers with focus on the interference from hemolysis is sparse among non-laboratory personnel using the blood gas analyzers. This emphasizes the need for better education and competence management, which perhaps is even more important for these analyses than for other point-of-care tests.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799562","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":"Concentrations and agreement over 10 years with different assay versions and analyzers for troponin T and N-terminal pro-B-type natriuretic peptide.","authors":"Peter A Kavsak, Lorna Clark, Andrew Worster, Sukhbinder Dhesy-Thind","doi":"10.1515/cclm-2024-1382","DOIUrl":"https://doi.org/10.1515/cclm-2024-1382","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142794520","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":"Measurement of 1,25-dihydroxyvitamin D in serum by LC-MS/MS compared to immunoassay reveals inconsistent agreement in paediatric samples.","authors":"Jonathan C Y Tang, Rachel Dunn, John J Dutton, Amrou Farag, Isabelle Piec, Allison Chipchase, Julie Greeves, William D Fraser, Emma A Webb","doi":"10.1515/cclm-2024-1032","DOIUrl":"https://doi.org/10.1515/cclm-2024-1032","url":null,"abstract":"<p><strong>Objectives: </strong>Automated immunoassays for 1,25-dihydroxyvitamin D (1,25(OH)₂D) have increased the use of serum measurements in clinical and research settings, but disagreement with LC-MS/MS methods remains an issue.</p><p><strong>Methods: </strong>In this study, we examined this problem using samples obtained from healthy young adults, n=80, mean age 21.7 (18-32) years, and a large cohort of paediatric samples, n=422, mean age 7.3 (0-17) years. We compared serum concentrations of 1,25(OH)₂D3/D2 produced by the DiaSorin LIAISON^® XL immunoassay against an LC-MS/MS method with immunoaffinity enrichment and DAPTAD derivation.</p><p><strong>Results: </strong>Both assays showed intra/inter-assay imprecision of ≤9.4 % across their respective assay range. DEQAS between April 2020 to Jan 2024 (n=80) showed mean bias (SD, 95 %CI) for DiaSorin -0.6 % (6.2, -12.8 to 11.6) and LC-MS/MS of +1.3 % (7.4, -13.3 to 15.8) against their respective method group means. Comparison of measurements in the adult samples showed a strong correlation (r²=0.9331) and concordance (CCC=0.959) between the two methods. LC-MS/MS values were lower than DiaSorin by an overall mean (±SD, 95 %CI) of -1.6 (±14.3, -29.6 to 26.5) pmol/L with an increased negative bias at higher concentrations. In the paediatric samples, weaker correlation (r²=0.6536) and concordance (CCC=0.782) were observed, with greater bias mean (±SD, 95 %CI) of -9.8 (±23.4, -55.7 to 35.9) pmol/L. The variability in the paediatric samples was not associated with concentration or participant age. There was an increase in the correlation and concordance when 1,25(OH)₂D2 was included in the analysis.</p><p><strong>Conclusions: </strong>It is likely that the metabolites of vitamin D present in the paediatric population contributed to the measurement of 1,25(OH)₂D. The inconsistent agreement highlights the need for better assay harmonisation and paediatric reference intervals using LC-MS/MS method.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142794530","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}