Cammie Tran, Duncan J Topliss, Hans G Schneider, Ego Seeman, Daniel Clayton-Chubb, Johannes T Neumann, Nadira Kakoly, Zhen Zhou, Sultana Monira Hussain, Amanda J Rickard, David P Q Clark, Raj C Shah, Robyn L Woods, John J McNeil
Objectives: As thyroid disorders are common amongst the elderly, this study aims to evaluate the reference interval (RI) for thyroid stimulating hormone (TSH) in healthy adults aged 70 years and over.
Methods: A proposed RI was determined from the Australian participants of the ASPirin in Reducing Events in the Elderly (ASPREE) randomised trial. Participants had no history of cardiovascular disease, thyroid cancer, dementia, or life-threatening illnesses. Participants prescribed with any thyroid-related medication at baseline were excluded. TSH levels were measured using a commercial chemiluminescence microparticle immunoassay. The RI was determined using the middle 95th percentile of the logarithmic transformed data of baseline TSH. Cox proportional hazard regression models were used to validate the RI by assessing disease incidence over time.
Results: A total of 10,995 participants had baseline TSH measures. Median (IQR) age was 73.9 (71.8-77.3) years. We propose a RI of 0.34-3.75 mU/L. TSH levels did not differ by age or sex. At baseline, there was no association between symptoms associated with thyroid disease and levels of TSH. Over the follow-up period of up to 11 years, no association was seen between baseline TSH levels and relevant disease outcomes for participants within the RI.
Conclusions: From a group of initially healthy, community-dwelling adults aged >=70 years, we propose a RI of TSH to best represent euthyroidism. This concentration was not associated with an increased risk of thyroid related symptoms or outcomes, confirming its appropriateness for clinical use.
研究目的由于甲状腺疾病在老年人中很常见,本研究旨在评估 70 岁及以上健康成年人促甲状腺激素(TSH)的参考区间(RI):方法:根据 "ASPirin in Reducing Events in the Elderly (ASPREE) "随机试验的澳大利亚参与者确定建议的参考区间。参与者无心血管疾病、甲状腺癌、痴呆或危及生命的疾病史。基线时服用任何甲状腺相关药物的参试者均被排除在外。使用商用化学发光微粒子免疫测定法测定 TSH 水平。使用基线 TSH 对数变换数据的中间 95 百分位数确定 RI。通过评估随时间变化的疾病发病率,使用考克斯比例危险回归模型来验证 RI:共有 10995 名参与者进行了 TSH 基线测量。中位(IQR)年龄为 73.9(71.8-77.3)岁。我们提出的 RI 为 0.34-3.75 mU/L。TSH 水平没有年龄或性别差异。基线时,甲状腺疾病相关症状与 TSH 水平之间没有关联。在长达11年的随访期间,在RI范围内的参与者的基线TSH水平与相关疾病结果之间未发现任何关联:从一组年龄大于等于 70 岁、最初健康、居住在社区的成年人中,我们提出了最能代表甲状腺功能亢进的促甲状腺激素 RI。该浓度与甲状腺相关症状或结果的风险增加无关,因此适合临床使用。
{"title":"Establishing the TSH reference intervals for healthy adults aged over 70 years: the Australian ASPREE cohort study.","authors":"Cammie Tran, Duncan J Topliss, Hans G Schneider, Ego Seeman, Daniel Clayton-Chubb, Johannes T Neumann, Nadira Kakoly, Zhen Zhou, Sultana Monira Hussain, Amanda J Rickard, David P Q Clark, Raj C Shah, Robyn L Woods, John J McNeil","doi":"10.1515/cclm-2024-0848","DOIUrl":"https://doi.org/10.1515/cclm-2024-0848","url":null,"abstract":"<p><strong>Objectives: </strong>As thyroid disorders are common amongst the elderly, this study aims to evaluate the reference interval (RI) for thyroid stimulating hormone (TSH) in healthy adults aged 70 years and over.</p><p><strong>Methods: </strong>A proposed RI was determined from the Australian participants of the ASPirin in Reducing Events in the Elderly (ASPREE) randomised trial. Participants had no history of cardiovascular disease, thyroid cancer, dementia, or life-threatening illnesses. Participants prescribed with any thyroid-related medication at baseline were excluded. TSH levels were measured using a commercial chemiluminescence microparticle immunoassay. The RI was determined using the middle 95th percentile of the logarithmic transformed data of baseline TSH. Cox proportional hazard regression models were used to validate the RI by assessing disease incidence over time.</p><p><strong>Results: </strong>A total of 10,995 participants had baseline TSH measures. Median (IQR) age was 73.9 (71.8-77.3) years. We propose a RI of 0.34-3.75 mU/L. TSH levels did not differ by age or sex. At baseline, there was no association between symptoms associated with thyroid disease and levels of TSH. Over the follow-up period of up to 11 years, no association was seen between baseline TSH levels and relevant disease outcomes for participants within the RI.</p><p><strong>Conclusions: </strong>From a group of initially healthy, community-dwelling adults aged >=70 years, we propose a RI of TSH to best represent euthyroidism. This concentration was not associated with an increased risk of thyroid related symptoms or outcomes, confirming its appropriateness for clinical use.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364667","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}
Qiaoxuan Zhang, Min Zhan, Xiongqiang Peng, Xing Jin, Jun Yan, Pengwei Zhang, Junhua Zhuang, Liqiao Han, Xianzhang Huang
Objectives: Serum cystatin C (CysC) is a reliable and ideal endogenous marker for accurately assessing early changes in glomerular filtration rate (GFR), surpassing the limitations of creatinine-based estimated GFR. To improve the precision of GFR calculation, the development of strategies for accurately measuring serum CysC is crucial.
Methods: In this study, the full-length CysC pure product and fully recombinant 15N-labeled CysC internal standard were subjected to protein cleavage. Subsequently, an LC-MS/MS method was developed for the absolute quantification of serum CysC. The traceability of the method was assigned calibrator using the amino acid reference measurement procedure (RMP). It involved calibrating the instrument using an amino acid reference material with known amino acid concentrations for calibration and comparison purposes.
Results: The total imprecision of the method was determined to be ≤8.2 %, and a lower functional limit of quantification (LLoQ) was achieved. The recoveries ranged from 97.36 to 103.26 %. The relative bias between this candidate RMP for measurement of ERM-DA471-IFCC and the target value was 1.74 %. The linearity response was observed within the concentration range of 0.21-10.13 mg/L, with a high R2 value of 0.999. The results obtained using our method was consistent with those obtained using other certified RMPs.
Conclusions: With the establishment of this highly selective and accurate serum CysC measurement method, it is now possible to assess the correlation between immunoassay results of serum CysC and the intended target when discrepancies are suspected in the clinical setting.
{"title":"Absolute quantitation of human serum cystatin C: candidate reference method by <sup>15</sup>N-labeled recombinant protein isotope dilution UPLC-MS/MS.","authors":"Qiaoxuan Zhang, Min Zhan, Xiongqiang Peng, Xing Jin, Jun Yan, Pengwei Zhang, Junhua Zhuang, Liqiao Han, Xianzhang Huang","doi":"10.1515/cclm-2024-0300","DOIUrl":"https://doi.org/10.1515/cclm-2024-0300","url":null,"abstract":"<p><strong>Objectives: </strong>Serum cystatin C (CysC) is a reliable and ideal endogenous marker for accurately assessing early changes in glomerular filtration rate (GFR), surpassing the limitations of creatinine-based estimated GFR. To improve the precision of GFR calculation, the development of strategies for accurately measuring serum CysC is crucial.</p><p><strong>Methods: </strong>In this study, the full-length CysC pure product and fully recombinant <sup>15</sup>N-labeled CysC internal standard were subjected to protein cleavage. Subsequently, an LC-MS/MS method was developed for the absolute quantification of serum CysC. The traceability of the method was assigned calibrator using the amino acid reference measurement procedure (RMP). It involved calibrating the instrument using an amino acid reference material with known amino acid concentrations for calibration and comparison purposes.</p><p><strong>Results: </strong>The total imprecision of the method was determined to be ≤8.2 %, and a lower functional limit of quantification (LLoQ) was achieved. The recoveries ranged from 97.36 to 103.26 %. The relative bias between this candidate RMP for measurement of ERM-DA471-IFCC and the target value was 1.74 %. The linearity response was observed within the concentration range of 0.21-10.13 mg/L, with a high R<sup>2</sup> value of 0.999. The results obtained using our method was consistent with those obtained using other certified RMPs.</p><p><strong>Conclusions: </strong>With the establishment of this highly selective and accurate serum CysC measurement method, it is now possible to assess the correlation between immunoassay results of serum CysC and the intended target when discrepancies are suspected in the clinical setting.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342849","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}
Anna E Bugrova, Polina A Strelnikova, Alexey S Kononikhin, Natalia V Zakharova, Elizaveta O Diyachkova, Alexander G Brzhozovskiy, Maria I Indeykina, Ilya N Kurochkin, Alexander V Averyanov, Evgeny N Nikolaev
Objectives: The COVID-19 pandemic has exposed a number of key challenges that need to be urgently addressed. Mass spectrometric studies of blood plasma proteomics provide a deep understanding of the relationship between the severe course of infection and activation of specific pathophysiological pathways. Analysis of plasma proteins in whole blood may also be relevant for the pandemic as it requires minimal sample preparation.
Methods: The frozen whole blood samples were used to analyze 203 plasma proteins using multiple reaction monitoring (MRM) mass spectrometry and stable isotope-labeled peptide standards (SIS). A total of 131 samples (FRCC, Russia) from patients with mild (n=41), moderate (n=39) and severe (n=19) COVID-19 infection and healthy controls (n=32) were analyzed.
Results: Levels of 94 proteins were quantified and compared. Significant differences between all of the groups were revealed for 44 proteins. Changes in the levels of 61 reproducible COVID-19 markers (SERPINA3, SERPING1, ORM1, HRG, LBP, APOA1, AHSG, AFM, ITIH2, etc.) were consistent with studies performed with serum/plasma samples. The best-performing classifier built with 10 proteins achieved the best combination of ROC-AUC (0.97-0.98) and accuracy (0.90-0.93) metrics and distinguished patients from controls, as well as patients by severity.
Conclusions: Here, for the first time, frozen whole blood samples were used for proteomic analysis and assessment of the status of patients with COVID-19. The results obtained with frozen whole blood samples are consistent with those from plasma and serum.
{"title":"Targeted MRM-analysis of plasma proteins in frozen whole blood samples from patients with COVID-19: a retrospective study.","authors":"Anna E Bugrova, Polina A Strelnikova, Alexey S Kononikhin, Natalia V Zakharova, Elizaveta O Diyachkova, Alexander G Brzhozovskiy, Maria I Indeykina, Ilya N Kurochkin, Alexander V Averyanov, Evgeny N Nikolaev","doi":"10.1515/cclm-2024-0800","DOIUrl":"https://doi.org/10.1515/cclm-2024-0800","url":null,"abstract":"<p><strong>Objectives: </strong>The COVID-19 pandemic has exposed a number of key challenges that need to be urgently addressed. Mass spectrometric studies of blood plasma proteomics provide a deep understanding of the relationship between the severe course of infection and activation of specific pathophysiological pathways. Analysis of plasma proteins in whole blood may also be relevant for the pandemic as it requires minimal sample preparation.</p><p><strong>Methods: </strong>The frozen whole blood samples were used to analyze 203 plasma proteins using multiple reaction monitoring (MRM) mass spectrometry and stable isotope-labeled peptide standards (SIS). A total of 131 samples (FRCC, Russia) from patients with mild (n=41), moderate (n=39) and severe (n=19) COVID-19 infection and healthy controls (n=32) were analyzed.</p><p><strong>Results: </strong>Levels of 94 proteins were quantified and compared. Significant differences between all of the groups were revealed for 44 proteins. Changes in the levels of 61 reproducible COVID-19 markers (SERPINA3, SERPING1, ORM1, HRG, LBP, APOA1, AHSG, AFM, ITIH2, etc.) were consistent with studies performed with serum/plasma samples. The best-performing classifier built with 10 proteins achieved the best combination of ROC-AUC (0.97-0.98) and accuracy (0.90-0.93) metrics and distinguished patients from controls, as well as patients by severity.</p><p><strong>Conclusions: </strong>Here, for the first time, frozen whole blood samples were used for proteomic analysis and assessment of the status of patients with COVID-19. The results obtained with frozen whole blood samples are consistent with those from plasma and serum.</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":"142342853","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}
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
Objectives: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
目的:评估滑液生物标志物 D-乳酸盐诊断化脓性关节炎(SA)并与晶体诱导性关节炎(CA)、其他非感染性风湿性关节病(RD)和骨关节病(OA)鉴别的性能:方法:在德国和瑞士的不同中心对因关节疼痛而接受滑液抽吸的连续成年患者进行了前瞻性研究。采集的滑膜液进行培养、白细胞计数和分化、晶体检测以及 D-乳酸盐浓度检测。通过最大限度地提高灵敏度和特异性,采用尤登 J 统计法确定接收者操作特征曲线(ROC)上的最佳 D-乳酸盐临界值:结果:共纳入 231 名患者。39名患者患有SA,192名患者患有无菌性关节炎(56名患者患有OA,68名患者患有CA,68名患者患有RD)。SA患者滑膜液D-乳酸的中位浓度明显高于OA、CA和RD患者(p结论:滑膜液 D-乳酸在诊断 SA 方面表现出较高的性能,优于滑膜液白细胞计数。鉴于其灵敏度和特异性都很高,它既是筛查 SA 的有效工具,也是区分 SA 和 RD(尤其是 CA)的指标。
{"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
Objectives: 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.
Methods: 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.
Results: 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 × 109/L to 0.297 × 109/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.
Conclusions: 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.
{"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
Objectives: 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.
Methods: 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.
Results: 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 %.
Conclusions: 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.
{"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
Objectives: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
目的:随着临床实验室对淋巴细胞亚群检测的需求和应用日益增多,不同的单平台流式细胞仪(FCM)系统应运而生。建立不同单平台流式细胞仪的参考区间(RIs)迫在眉睫,而将其从一种流式细胞仪系统转移到另一种流式细胞仪系统则是一种更可行、更方便的方法。本研究旨在探索不同流式细胞仪平台淋巴细胞亚群参考区间的可转移性:我们首先在四种 FCM 平台(包括 NovoCyte、BriCyteE6、DxFLEX 和 FACSCantoII 系统)上进行了方法配对比较。接着,我们评估了淋巴细胞亚群 RIs 的可转移性。此外,除 NK 细胞外,我们还基于 FACSCantoII 系统、BriCyteE6 系统和 DxFLEX 系统进行了 RIs 转移。通过计算已建立的RIs之间的偏差(CV),进一步验证了转移的RIs:结果:基于 NovoCyte、BriCyteE6、DxFLEX 和 FACSCantoII 系统的淋巴细胞亚群检测结果具有可比性,转移四种 FCM 系统检测到的淋巴细胞亚群的 RIs 是可行的。利用 FACSCantoII、DxFLEX 和 BriCyteE6 系统检测淋巴细胞亚群的 RIs 已经确定。将 FACSCantoII 系统的淋巴细胞亚群检测 RI 转移到 BriCyteE6 系统和 DxFLEX 系统后,除 NK 细胞外,所有参数的转移 RI 与建立的 RI 之间的 CV 值均低于 20%:本研究表明,除 NK 细胞外,淋巴细胞亚群的 RIs 可通过不同的定义策略在不同的流式细胞仪系统间转移。
{"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
Objectives: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
{"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}