Pub Date : 2024-02-01Epub Date: 2024-02-06DOI: 10.1080/00365513.2024.2312152
Cathrine Scavenius, Eva Rabing Brix Petersen, Dorte Møller Jensen, Lene Ringholm, Jakoba Sevdal Danielsen, Elisabeth Reinhardt Mathiesen, David McIntyre, Peter Damm, Martin Overgaard, Tine Dalsgaard Clausen
Regional variations in the prevalence of gestational diabetes mellitus (GDM) have been found across Denmark. The objectives of this exploratory survey were to evaluate adherence to the national guideline for screening and diagnosing GDM and to identify variations in pre-analytical or analytical factors, which could potentially contribute to variations in GDM prevalence across regions. In a national interview-based survey, obstetric departments and laboratories throughout Denmark handling GDM screening or diagnostic testing were invited to participate. Survey questionnaires were completed through personal interviews. In total, 21 of 22 identified obstetric departments and 44 of 45 identified laboratories participated. Adherence to guideline among obstetric departments ranged 67-100% and uniformity in laboratory procedures was high. However, the gestational age at the time of late diagnostic testing with oral glucose tolerance test (OGTT) varied considerably, with 48% (10/21) of departments testing outside the recommended 24-28 weeks' gestation. Procedural heterogeneity was most pronounced for the parts not described in current guidelines, with choice of laboratory equipment being the most diverse factor ranging 3-39% nationally. In conclusion, the overall adherence to the national guidelines was high across regions, and obstetric departments and laboratories had high uniformity in the procedures for screening and diagnosing GDM. Uniformity was generally high for procedures included in the guideline and low if not included. However, a high proportion of GDM testing was performed outside the recommended gestational window in late pregnancy, which may be a pre-analytical contributor to regional differences in GDM prevalence.
{"title":"Pre-analytical diagnostic differences despite high adherence to guidelines for gestational diabetes mellitus.","authors":"Cathrine Scavenius, Eva Rabing Brix Petersen, Dorte Møller Jensen, Lene Ringholm, Jakoba Sevdal Danielsen, Elisabeth Reinhardt Mathiesen, David McIntyre, Peter Damm, Martin Overgaard, Tine Dalsgaard Clausen","doi":"10.1080/00365513.2024.2312152","DOIUrl":"10.1080/00365513.2024.2312152","url":null,"abstract":"<p><p>Regional variations in the prevalence of gestational diabetes mellitus (GDM) have been found across Denmark. The objectives of this exploratory survey were to evaluate adherence to the national guideline for screening and diagnosing GDM and to identify variations in pre-analytical or analytical factors, which could potentially contribute to variations in GDM prevalence across regions. In a national interview-based survey, obstetric departments and laboratories throughout Denmark handling GDM screening or diagnostic testing were invited to participate. Survey questionnaires were completed through personal interviews. In total, 21 of 22 identified obstetric departments and 44 of 45 identified laboratories participated. Adherence to guideline among obstetric departments ranged 67-100% and uniformity in laboratory procedures was high. However, the gestational age at the time of late diagnostic testing with oral glucose tolerance test (OGTT) varied considerably, with 48% (10/21) of departments testing outside the recommended 24-28 weeks' gestation. Procedural heterogeneity was most pronounced for the parts not described in current guidelines, with choice of laboratory equipment being the most diverse factor ranging 3-39% nationally. In conclusion, the overall adherence to the national guidelines was high across regions, and obstetric departments and laboratories had high uniformity in the procedures for screening and diagnosing GDM. Uniformity was generally high for procedures included in the guideline and low if not included. However, a high proportion of GDM testing was performed outside the recommended gestational window in late pregnancy, which may be a pre-analytical contributor to regional differences in GDM prevalence.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"30-37"},"PeriodicalIF":2.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139692823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-01DOI: 10.1080/00365513.2024.2309613
Peter H Nissen, Torben Stamm Mikkelsen, Carsten Schriver Højskov, Johanne Andersen Højbjerg
{"title":"A case of platelet δ-granule defect identified by decreased CD63 expression and decreased serotonin release measured by flow cytometry and liquid chromatography tandem mass spectrometry.","authors":"Peter H Nissen, Torben Stamm Mikkelsen, Carsten Schriver Højskov, Johanne Andersen Højbjerg","doi":"10.1080/00365513.2024.2309613","DOIUrl":"10.1080/00365513.2024.2309613","url":null,"abstract":"","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"68-70"},"PeriodicalIF":2.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139651628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-01Epub Date: 2024-02-16DOI: 10.1080/00365513.2024.2318616
Ivana Lapić, Anamarija Bogić, Ivana Stojan, Dunja Rogić
This study aimed to assess analytical characteristics and diagnostic accuracy in management of venous thromboembolism (VTE) in the Emergency Department (ED) of the Abbott D-dimer assay applied on the Alinity c clinical chemistry analyzer (Abbott Laboratories, Chicago, IL) compared to the INNOVANCE D-dimer assay (Siemens Healthineers, Marburg, Germany). Precision was determined at three concentration levels following the CLSI EP15-A3 protocol. Method comparison and diagnostic accuracy were assessed using samples obtained from 85 patients who were referred for diagnostic imaging and D-dimer testing due to clinically suspected VTE. Within-run coefficients of variation (CVs) were 3.0%, 0.5% and 0.5% at D-dimer concentrations of 0.54, 1.42 and 2.68 mg/L FEU, while respective between-run CVs were 2.0%, 3.4% and 2.7%, hence fulfilling the desirable biological variation criteria for imprecision (<12.6%). Passing-Bablok regression analysis yielded a small proportional difference between the two compared assays (y = 1.09 (95% confidence interval (CI): 1.01-1.18) x + 0.09 (95%CI: -0.09 to 0.16)), while Bland-Altman analysis showed significant negative absolute (-0.6 mg/L FEU, 95%CI: -0.9 to -0.3) and relative mean bias (-14.1%, 95%CI: -20.3 to -7.9). Spearman's ρ was 0.979 (95%CI: 0.967-0.986). Inter-assay agreement relative to the cut-off was 92% (kappa coefficient = 0.547 (95%CI: 0.255-0.839)). Diagnostic sensitivity, specificity, positive and negative predictive values of the Abbott assay were 100%, 9.2%, 25.3% and 100%, respectively, compared to the following data for the INNOVANCE assay: 95.0%, 15.4%, 25.7% and 90.9%. Abbott D-dimer assay has shown excellent analytical precision, high comparability with the INNOVANCE D-dimer and high NPV at manufacturer's cut-off.
{"title":"Abbott D-dimer assay: analytical performance and diagnostic accuracy in management of venous thromboembolism.","authors":"Ivana Lapić, Anamarija Bogić, Ivana Stojan, Dunja Rogić","doi":"10.1080/00365513.2024.2318616","DOIUrl":"10.1080/00365513.2024.2318616","url":null,"abstract":"<p><p>This study aimed to assess analytical characteristics and diagnostic accuracy in management of venous thromboembolism (VTE) in the Emergency Department (ED) of the Abbott D-dimer assay applied on the Alinity c clinical chemistry analyzer (Abbott Laboratories, Chicago, IL) compared to the INNOVANCE D-dimer assay (Siemens Healthineers, Marburg, Germany). Precision was determined at three concentration levels following the CLSI EP15-A3 protocol. Method comparison and diagnostic accuracy were assessed using samples obtained from 85 patients who were referred for diagnostic imaging and D-dimer testing due to clinically suspected VTE. Within-run coefficients of variation (CVs) were 3.0%, 0.5% and 0.5% at D-dimer concentrations of 0.54, 1.42 and 2.68 mg/L FEU, while respective between-run CVs were 2.0%, 3.4% and 2.7%, hence fulfilling the desirable biological variation criteria for imprecision (<12.6%). Passing-Bablok regression analysis yielded a small proportional difference between the two compared assays (<i>y</i> = 1.09 (95% confidence interval (CI): 1.01-1.18) <i>x</i> + 0.09 (95%CI: -0.09 to 0.16)), while Bland-Altman analysis showed significant negative absolute (-0.6 mg/L FEU, 95%CI: -0.9 to -0.3) and relative mean bias (-14.1%, 95%CI: -20.3 to -7.9). Spearman's <i>ρ</i> was 0.979 (95%CI: 0.967-0.986). Inter-assay agreement relative to the cut-off was 92% (kappa coefficient = 0.547 (95%CI: 0.255-0.839)). Diagnostic sensitivity, specificity, positive and negative predictive values of the Abbott assay were 100%, 9.2%, 25.3% and 100%, respectively, compared to the following data for the INNOVANCE assay: 95.0%, 15.4%, 25.7% and 90.9%. Abbott D-dimer assay has shown excellent analytical precision, high comparability with the INNOVANCE D-dimer and high NPV at manufacturer's cut-off.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"53-61"},"PeriodicalIF":2.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139741931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01Epub Date: 2024-01-24DOI: 10.1080/00365513.2023.2286651
Iratxe Duñabeitia, Daniel González-Devesa, Silvia Varela-Martínez, Jose Carlos Diz-Gómez, Carlos Ayán-Pérez
This study aimed to systematically revise the available evidence on the effects of physical exercise training programmes on people with hypothyroidism. Comparative studies were searched in six electronic databases until April 2023. The Physiotherapy Evidence Database and the Methodological Index for Non-Randomized Studies were used to determine the methodological quality of the randomized controlled trials and comparative studies respectively. A total of 10 studies were found showing a low to moderate methodological quality. Most of them were performed in women with subclinical hypothyroidism. Exercise seemed to be safe, with aerobic and resistance training leading to improvements in outcomes related to physical and mental health. The performed meta-analysis with data from 120 participants indicated that exercise showed a non-significant trend towards reducing thyroid-stimulating hormone levels (Hedges'g -0.96; 95% CI -2.71; 0.79, p = 0.160; I2 = 92%). When the analysis was performed by comparing the experimental, and control groups with data from 180 participants the results remained non-significant (SMD -1.09; CI 95% -2.88; 0.70, p = 0.23; I2 = 95%). Similar findings were obtained when pooling data for FT3 and FT4 levels. Exercise does not have a significant impact on thyroid function, although its practice can lead to secondary outcomes related to physical and mental health.
本研究旨在系统地修订关于体育锻炼计划对甲状腺功能减退患者影响的现有证据。截至2023年4月,在6个电子数据库中检索了比较研究。使用物理治疗证据数据库和非随机研究方法学指数分别确定随机对照试验和比较研究的方法学质量。总共有10项研究显示出低到中等的方法学质量。大多数是在亚临床甲状腺功能减退的妇女中进行的。运动似乎是安全的,有氧和阻力训练可以改善与身心健康相关的结果。对来自120名参与者的数据进行的荟萃分析表明,运动对降低促甲状腺激素水平没有显著的趋势(Hedges'g -0.96;95% ci -2.71;0.79, p = 0.160;i2 = 92%)。当通过比较实验组和对照组180名参与者的数据进行分析时,结果仍然不显著(SMD -1.09;Ci 95% -2.88;0.70, p = 0.23;i2 = 95%)。当合并FT3和FT4水平的数据时,也得到了类似的发现。运动对甲状腺功能没有显著影响,尽管运动可能导致与身心健康相关的次要后果。
{"title":"Effect of physical exercise in people with hypothyroidism: systematic review and meta-analysis.","authors":"Iratxe Duñabeitia, Daniel González-Devesa, Silvia Varela-Martínez, Jose Carlos Diz-Gómez, Carlos Ayán-Pérez","doi":"10.1080/00365513.2023.2286651","DOIUrl":"10.1080/00365513.2023.2286651","url":null,"abstract":"<p><p>This study aimed to systematically revise the available evidence on the effects of physical exercise training programmes on people with hypothyroidism. Comparative studies were searched in six electronic databases until April 2023. The Physiotherapy Evidence Database and the Methodological Index for Non-Randomized Studies were used to determine the methodological quality of the randomized controlled trials and comparative studies respectively. A total of 10 studies were found showing a low to moderate methodological quality. Most of them were performed in women with subclinical hypothyroidism. Exercise seemed to be safe, with aerobic and resistance training leading to improvements in outcomes related to physical and mental health. The performed meta-analysis with data from 120 participants indicated that exercise showed a non-significant trend towards reducing thyroid-stimulating hormone levels (Hedges'g -0.96; 95% CI -2.71; 0.79, <i>p</i> = 0.160; I2 = 92%). When the analysis was performed by comparing the experimental, and control groups with data from 180 participants the results remained non-significant (SMD -1.09; CI 95% -2.88; 0.70, <i>p</i> = 0.23; I2 = 95%). Similar findings were obtained when pooling data for FT3 and FT4 levels. Exercise does not have a significant impact on thyroid function, although its practice can lead to secondary outcomes related to physical and mental health.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"523-532"},"PeriodicalIF":2.1,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138434858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01Epub Date: 2024-01-24DOI: 10.1080/00365513.2024.2301779
Steef Kurstjens, Marjon J den Besten, Dorien A M van Dartel, Marloes C C van Gend, Lizzy Meerts, Rein M J Hoedemakers
At home collection of capillary blood using Hem-Col tubes (Labonovum) could offer a solution to patients with chronic conditions, who require frequent laboratory analyses. The collection tubes contain a conservation buffer to stabilize analytes for up to 5 days. In this validation study it was investigated whether analytes are measured accurately in Hem-Col tubes 5 days after collection. Forty-six healthy volunteers donated blood via venepuncture as well as capillary blood by finger prick using Hem-Col tubes. The analytes were measured within 2 h for the venepuncture and after 120 h for the Hem-Col method. The results of each analyte were analysed using Passing-Bablok regression analyses. The analytes that met the predefined acceptance criteria were total cholesterol, LDL-cholesterol, thyroid stimulating hormone (TSH) and glycated haemoglobin (HbA1c). HDL-cholesterol, C-reactive protein (CRP), ferritin, bilirubin total, creatinine, gGT and triglycerides met two out of three acceptance criteria. All other analytes did not meet the predefined criteria. The Hem-Col method is suitable for the measurement of total cholesterol, LDL-cholesterol, thyroid stimulating hormone (TSH) and glycated haemoglobin (HbA1c). However, due to this limited set of valid tests and practical limitations, routine application of this novel collection system in daily practice is limited.
{"title":"Validation of the Hem-Col capillary blood collection system for routine laboratory analyses.","authors":"Steef Kurstjens, Marjon J den Besten, Dorien A M van Dartel, Marloes C C van Gend, Lizzy Meerts, Rein M J Hoedemakers","doi":"10.1080/00365513.2024.2301779","DOIUrl":"10.1080/00365513.2024.2301779","url":null,"abstract":"<p><p>At home collection of capillary blood using Hem-Col tubes (Labonovum) could offer a solution to patients with chronic conditions, who require frequent laboratory analyses. The collection tubes contain a conservation buffer to stabilize analytes for up to 5 days. In this validation study it was investigated whether analytes are measured accurately in Hem-Col tubes 5 days after collection. Forty-six healthy volunteers donated blood via venepuncture as well as capillary blood by finger prick using Hem-Col tubes. The analytes were measured within 2 h for the venepuncture and after 120 h for the Hem-Col method. The results of each analyte were analysed using Passing-Bablok regression analyses. The analytes that met the predefined acceptance criteria were total cholesterol, LDL-cholesterol, thyroid stimulating hormone (TSH) and glycated haemoglobin (HbA1c). HDL-cholesterol, C-reactive protein (CRP), ferritin, bilirubin total, creatinine, gGT and triglycerides met two out of three acceptance criteria. All other analytes did not meet the predefined criteria. The Hem-Col method is suitable for the measurement of total cholesterol, LDL-cholesterol, thyroid stimulating hormone (TSH) and glycated haemoglobin (HbA1c). However, due to this limited set of valid tests and practical limitations, routine application of this novel collection system in daily practice is limited.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"604-607"},"PeriodicalIF":2.1,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139404233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01Epub Date: 2024-01-24DOI: 10.1080/00365513.2023.2294470
Christine Rasmussen, Michael M Richter, Nicole J Jensen, Niklas Heinz, Bolette Hartmann, Jens J Holst, Sasha A S Kjeldsen, Nicolai J Wewer Albrechtsen
Background: Plasma concentrations of glucagon, GLP-1 and GIP are reported in numerous clinical trials as outcome measures but preanalytical guidelines are lacking. We addressed the impact of commonly used blood containers in metabolic research on measurements of glucagon, GLP-1 and GIP in humans.
Methods: Seventeen overweight individuals were subjected to an overnight fast followed by an intravenous infusion of amino acids to stimulate hormonal secretion. Blood was sampled into five containers: EDTA-coated tubes supplemented with DMSO (control), a neprilysin inhibitor, aprotinin (a kallikrein inhibitor) or a DPP-4 inhibitor, and P800 tubes. Plasma was kept on ice before and after centrifugation and stored at -80 Celsius until batch analysis using validated sandwich ELISAs or radioimmunoassays (RIA).
Results: Measures of fasting plasma glucagon did not depend on sampling containers, whether measured by ELISA or RIA. Amino acid-induced hyperglucagonemia was numerically higher when blood was collected into P800 tubes or tubes with aprotinin. The use of p800 tubes resulted in higher concentrations of GLP-1 by RIA compared to control tubes but not for measurements with sandwich ELISA. Plasma concentrations of GIP measured by ELISA were higher in control tubes and negatively affected by P800 and the addition of aprotinin.
Conclusions: The choice of blood containers impacts on measurements of plasma concentrations of glucagon, GLP-1 and GIP, and based on this study, we recommend using EDTA-coated tubes without protease inhibitors or P800 tubes for measurements of glucagon, GLP-1 and GIP in clinical trials.
{"title":"Preanalytical impact on the accuracy of measurements of glucagon, GLP-1 and GIP in clinical trials.","authors":"Christine Rasmussen, Michael M Richter, Nicole J Jensen, Niklas Heinz, Bolette Hartmann, Jens J Holst, Sasha A S Kjeldsen, Nicolai J Wewer Albrechtsen","doi":"10.1080/00365513.2023.2294470","DOIUrl":"10.1080/00365513.2023.2294470","url":null,"abstract":"<p><strong>Background: </strong>Plasma concentrations of glucagon, GLP-1 and GIP are reported in numerous clinical trials as outcome measures but preanalytical guidelines are lacking. We addressed the impact of commonly used blood containers in metabolic research on measurements of glucagon, GLP-1 and GIP in humans.</p><p><strong>Methods: </strong>Seventeen overweight individuals were subjected to an overnight fast followed by an intravenous infusion of amino acids to stimulate hormonal secretion. Blood was sampled into five containers: EDTA-coated tubes supplemented with DMSO (control), a neprilysin inhibitor, aprotinin (a kallikrein inhibitor) or a DPP-4 inhibitor, and P800 tubes. Plasma was kept on ice before and after centrifugation and stored at -80 Celsius until batch analysis using validated sandwich ELISAs or radioimmunoassays (RIA).</p><p><strong>Results: </strong>Measures of fasting plasma glucagon did not depend on sampling containers, whether measured by ELISA or RIA. Amino acid-induced hyperglucagonemia was numerically higher when blood was collected into P800 tubes or tubes with aprotinin. The use of p800 tubes resulted in higher concentrations of GLP-1 by RIA compared to control tubes but not for measurements with sandwich ELISA. Plasma concentrations of GIP measured by ELISA were higher in control tubes and negatively affected by P800 and the addition of aprotinin.</p><p><strong>Conclusions: </strong>The choice of blood containers impacts on measurements of plasma concentrations of glucagon, GLP-1 and GIP, and based on this study, we recommend using EDTA-coated tubes without protease inhibitors or P800 tubes for measurements of glucagon, GLP-1 and GIP in clinical trials.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"591-598"},"PeriodicalIF":2.1,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138831346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01Epub Date: 2024-01-24DOI: 10.1080/00365513.2023.2281400
David Núñez-Jurado, Jorge Montenegro-Martínez, Ricardo Rubio-Sánchez, Manuel Conde-Sánchez, Inmaculada Domínguez-Pascual
Background: Glycated hemoglobin measurements are a valuable tool for long-term blood glucose monitoring and the diagnosis of diabetes. Its widespread use has been made possible due to the development of new analytical methods with improved performances and standardization with reference materials. The aim of the present study was to evaluate the Trinity Biotech Premier Hb9210 analyzer for the measurement of HbA1c.Methods: The precision was assessed using the CLSI EP-15A3 and EP-10A3 protocols. The latter was also used to investigate linearity, carryover, and linear drift. The comparison study was performed between Premier Hb910 and Tosoh HLC-723 G8 through Passing-Bablok regression and the Bland-Altman plot. The Fleiss Kappa index was used to assess the degree of agreement. The interference of Hb variants was investigated using samples with Hb variants S, C, D, E, J, and Seville.Results: Within-run and between-run imprecision fell between 0.37% and 1.16%. No statistically significant nonlinearity, carry-over, and/or drift were observed. The resulting regression line of the Passing-Bablok analysis was y = 0.00 + 1.00x. The Pearson correlation coefficient was 0.997. In the Bland-Altman plot, the relative bias was 0.01%. The overall Fleiss Kappa index was 0.9. No interference from hemoglobin variants was observed.Conclusion: The Premier Hb9210 demonstrated a high degree of automation, reproducibility, good agreement, minimal carry-over effect, and excellent linearity across the wide range of HbA1c levels commonly found in diabetic patients and was not influenced by Hb variants.
{"title":"Evaluation of the Premier Hb9210 instrument for HbA1c determination.","authors":"David Núñez-Jurado, Jorge Montenegro-Martínez, Ricardo Rubio-Sánchez, Manuel Conde-Sánchez, Inmaculada Domínguez-Pascual","doi":"10.1080/00365513.2023.2281400","DOIUrl":"10.1080/00365513.2023.2281400","url":null,"abstract":"<p><p><b>Background:</b> Glycated hemoglobin measurements are a valuable tool for long-term blood glucose monitoring and the diagnosis of diabetes. Its widespread use has been made possible due to the development of new analytical methods with improved performances and standardization with reference materials. The aim of the present study was to evaluate the Trinity Biotech Premier Hb9210 analyzer for the measurement of HbA1c.<b>Methods:</b> The precision was assessed using the CLSI EP-15A3 and EP-10A3 protocols. The latter was also used to investigate linearity, carryover, and linear drift. The comparison study was performed between Premier Hb910 and Tosoh HLC-723 G8 through Passing-Bablok regression and the Bland-Altman plot. The Fleiss Kappa index was used to assess the degree of agreement. The interference of Hb variants was investigated using samples with Hb variants S, C, D, E, J, and Seville.<b>Results:</b> Within-run and between-run imprecision fell between 0.37% and 1.16%. No statistically significant nonlinearity, carry-over, and/or drift were observed. The resulting regression line of the Passing-Bablok analysis was <i>y = 0.00 + 1.00x.</i> The Pearson correlation coefficient was 0.997. In the Bland-Altman plot, the relative bias was 0.01%. The overall Fleiss Kappa index was 0.9. No interference from hemoglobin variants was observed.<b>Conclusion:</b> The Premier Hb9210 demonstrated a high degree of automation, reproducibility, good agreement, minimal carry-over effect, and excellent linearity across the wide range of HbA1c levels commonly found in diabetic patients and was not influenced by Hb variants.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"569-575"},"PeriodicalIF":2.1,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138462408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To evaluate cystatin C (CysC) and estimation of glomerular filtration rate (GFR) calculated using the formula, CKD-EPI-CysC (eGFRCKD-EPI-CysC) for renal impairment diagnosis and predicting the prognosis of patients with multiple myeloma (MM). One hundred-fourteen patients with MM and 38 healthy individuals were recruited for the study. Data on clinical characteristics and renal function-related biochemical indicators were collected and analyzed. Patients with MM had increased levels of CysC (1.25 (0.97-2.31) vs. 0.84 (0.80-0.92), respectively, p < 0.001) and decreased levels of eGFRCKD-EPI-CysC (53.0 (24.4-81.1) vs. 97.2 (87.0-104.5), respectively, p < 0.001), compared with healthy individuals. There were significantly more patients with elevated CysC levels than with elevated sCr levels (64.9% vs. 41.2%, respectively, p < 0.001). The CKD-EPI-CysC formula detected more patients with eGFR < 60 ml/(min × 1.73 m2) than the CKD-EPI-sCr formula (52.63% vs. 37.72%, respectively, p < 0.001). Correlation analysis found that only CysC, eGFRCKD-EPI-CysC, and eGFRCKD-EPI-sCr-CysC strongly correlated with β2-microglobulin in group ISS-I. Logistic regression analysis was used to screen CysC (OR = 1.495, 95% CI = 1.097-2.038, p = 0.011) and eGFRCKD-EPI-CysC (OR = 0.980, 95% CI = 0.967-0.993, p = 0.003) as independent prognostic indicators for 2-year-progression-free survival (PFS) of patients with MM. Receiver operating characteristic curve analysis found that CysC values >1.70 mg/L had 67.6% sensitivity and 65.2% specificity and eGFRCKD-EPI-CysC values <38.62 ml/(min × 1.73 m2) had 65.2% sensitivity and 67.6% specificity for 2-year PFS of patients with MM. In summary, CysC and eGFRCKD-EPI-CysC were more sensitive than sCr and eGFRCKD-EPI-sCr for predicting renal impairment in patients newly diagnosed with MM. Increased CysC and decreased eGFRCKD-EPI-CysC levels were effective predictors of 2-year PFS of patients with MM.
目的:评估胱抑素C(CysC)和使用CKD-EPI-CysC(eGFRCKD-EPI-CysC)公式计算的肾小球滤过率(GFR)估算值,用于多发性骨髓瘤(MM)患者的肾功能损害诊断和预后预测。研究共招募了 14 名 MM 患者和 38 名健康人。研究收集并分析了临床特征和肾功能相关生化指标的数据。MM患者的CysC(1.25 (0.97-2.31) vs. 0.84 (0.80-0.92), p CKD-EPI-CysC(53.0 (24.4-81.1) vs. 97.2 (87.0-104.5),分别 p p 2)比 CKD-EPI-sCr 公式(52.63% vs. 37.72%,分别 p CKD-EPI-CysC,eGFRCKD-EPI-sCr-CysC 与 ISS-I 组的β2-微球蛋白密切相关。利用逻辑回归分析筛选出 CysC(OR = 1.495,95% CI = 1.097-2.038,p = 0.011)和 eGFRCKD-EPI-CysC(OR = 0.980,95% CI = 0.967-0.993,p = 0.003)作为 MM 患者 2 年无进展生存期(PFS)的独立预后指标。接收者操作特征曲线分析发现,CysC值>1.70 mg/L对MM患者2年无进展生存期的敏感性为67.6%,特异性为65.2%;eGFRCKD-EPI-CysC值2)对MM患者2年无进展生存期的敏感性为65.2%,特异性为67.6%。总之,CysC 和 eGFRCKD-EPI-CysC 比 sCr 和 eGFRCKD-EPI-sCr 对预测新诊断为 MM 患者的肾功能损害更敏感。CysC水平升高和eGFRCKD-EPI-CysC水平降低可有效预测MM患者的2年PFS。
{"title":"Cystatin C and eGFR<sub>CKD-EPI-CysC</sub>: novel biomarkers for renal impairment diagnosis and two-year progression-free survival in multiple myeloma.","authors":"Jian Niu, Jiajia Yu, Huifang Huang, Jinfang Shi, Dong Zheng, Jun Qiu","doi":"10.1080/00365513.2023.2297364","DOIUrl":"10.1080/00365513.2023.2297364","url":null,"abstract":"<p><p>To evaluate cystatin C (CysC) and estimation of glomerular filtration rate (GFR) calculated using the formula, CKD-EPI-CysC (eGFR<sub>CKD-EPI-CysC</sub>) for renal impairment diagnosis and predicting the prognosis of patients with multiple myeloma (MM). One hundred-fourteen patients with MM and 38 healthy individuals were recruited for the study. Data on clinical characteristics and renal function-related biochemical indicators were collected and analyzed. Patients with MM had increased levels of CysC (1.25 (0.97-2.31) vs. 0.84 (0.80-0.92), respectively, <i>p</i> < 0.001) and decreased levels of eGFR<sub>CKD-EPI-CysC</sub> (53.0 (24.4-81.1) vs. 97.2 (87.0-104.5), respectively, <i>p</i> < 0.001), compared with healthy individuals. There were significantly more patients with elevated CysC levels than with elevated sCr levels (64.9% vs. 41.2%, respectively, <i>p</i> < 0.001). The CKD-EPI-CysC formula detected more patients with eGFR < 60 ml/(min × 1.73 m<sup>2</sup>) than the CKD-EPI-sCr formula (52.63% vs. 37.72%, respectively, <i>p</i> < 0.001). Correlation analysis found that only CysC, eGFR<sub>CKD-EPI-CysC</sub>, and eGFR<sub>CKD-EPI-sCr-CysC</sub> strongly correlated with β<sub>2</sub>-microglobulin in group ISS-I. Logistic regression analysis was used to screen CysC (<i>OR</i> = 1.495, 95% <i>CI</i> = 1.097-2.038, <i>p</i> = 0.011) and eGFR<sub>CKD-EPI-CysC</sub> (<i>OR</i> = 0.980, 95% <i>CI</i> = 0.967-0.993, <i>p</i> = 0.003) as independent prognostic indicators for 2-year-progression-free survival (PFS) of patients with MM. Receiver operating characteristic curve analysis found that CysC values >1.70 mg/L had 67.6% sensitivity and 65.2% specificity and eGFR<sub>CKD-EPI-CysC</sub> values <38.62 ml/(min × 1.73 m<sup>2</sup>) had 65.2% sensitivity and 67.6% specificity for 2-year PFS of patients with MM. In summary, CysC and eGFR<sub>CKD-EPI-CysC</sub> were more sensitive than sCr and eGFR<sub>CKD-EPI-sCr</sub> for predicting renal impairment in patients newly diagnosed with MM. Increased CysC and decreased eGFR<sub>CKD-EPI-CysC</sub> levels were effective predictors of 2-year PFS of patients with MM.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"599-603"},"PeriodicalIF":2.1,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139032566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01Epub Date: 2024-01-24DOI: 10.1080/00365513.2024.2303707
Solav Aziz Ali, Anna Elise Engell, Bent Struer Lind, Henrik Løvendahl Jørgensen
The aim of this study was to assess the possible association between P-Mg and subsequent high levels of HbA1c. The study involves data from primary health care patients and data from patients treated in hospitals located in the capital region of Denmark. P-Mg and HbA1c levels were analyzed from 121,575 patients in the period 2010-2022. Patients were categorized in a diabetic and non-diabetic group. Out of 121,575 patients, 8,532 were categorized as diabetic. A reverse J-shaped association between P-Mg and HbA1c levels ≥ 48 mmol/mol was observed with nadir at P-Mg of 0.90 mmol/L. The unadjusted hazard ratio (HR) for having a first HbA1c measurement ≥ 48 mmol/mol is 1.54 (95% Cl 1.50; 1.57) per 0.1 mmol/L decrease in P-Mg when P-Mg is lower than 0.90 mmol/L. After adjusting for age and gender, the HR remained significant at 1.45 (95% Cl 1.41; 1.48).For P-Mg levels above 0.90 mmol/L, the unadjusted HR per 0.1 mmol/L increase in P-Mg was 1.04 (95% Cl 1.02; 1.06). After adjusting for age and gender the HR remained significant at 1.06 (95% Cl 1.05; 1.08). In conclusion, this study found that patients with dysmagnesemia have a higher risk of developing diabetes even after adjusting for age and gender. Hyper- or hypomagnesemia in patients could be a biomarker for predicting the risk of developing diabetes.
{"title":"Dysmagnesemia as a predictor of developing diabetic levels of hemoglobin A1c.","authors":"Solav Aziz Ali, Anna Elise Engell, Bent Struer Lind, Henrik Løvendahl Jørgensen","doi":"10.1080/00365513.2024.2303707","DOIUrl":"10.1080/00365513.2024.2303707","url":null,"abstract":"<p><p>The aim of this study was to assess the possible association between P-Mg and subsequent high levels of HbA<sub>1c.</sub> The study involves data from primary health care patients and data from patients treated in hospitals located in the capital region of Denmark. P-Mg and HbA<sub>1c</sub> levels were analyzed from 121,575 patients in the period 2010-2022. Patients were categorized in a diabetic and non-diabetic group. Out of 121,575 patients, 8,532 were categorized as diabetic. A reverse J-shaped association between P-Mg and HbA<sub>1c</sub> levels ≥ 48 mmol/mol was observed with nadir at P-Mg of 0.90 mmol/L. The unadjusted hazard ratio (HR) for having a first HbA<sub>1c</sub> measurement ≥ 48 mmol/mol is 1.54 (95% Cl 1.50; 1.57) per 0.1 mmol/L decrease in P-Mg when P-Mg is lower than 0.90 mmol/L. After adjusting for age and gender, the HR remained significant at 1.45 (95% Cl 1.41; 1.48).For P-Mg levels above 0.90 mmol/L, the unadjusted HR per 0.1 mmol/L increase in P-Mg was 1.04 (95% Cl 1.02; 1.06). After adjusting for age and gender the HR remained significant at 1.06 (95% Cl 1.05; 1.08). In conclusion, this study found that patients with dysmagnesemia have a higher risk of developing diabetes even after adjusting for age and gender. Hyper- or hypomagnesemia in patients could be a biomarker for predicting the risk of developing diabetes.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"608-613"},"PeriodicalIF":2.1,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139472686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}