Scandinavian Journal of Clinical & Laboratory Investigation最新文献

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Consideration of immunochromatographic strip positive results for screening of alpha-thalassemia in elevated hemoglobin F samples. 免疫层析试纸阳性结果筛选高血红蛋白F样品中-地中海贫血的考虑。
IF 1.4 4区 医学
Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-01-01 Epub Date: 2025-06-27 DOI: 10.1080/00365513.2025.2524849
Moe Theingi, Pinyaphat Khamphikham, Sakorn Pornprasert
{"title":"Consideration of immunochromatographic strip positive results for screening of alpha-thalassemia in elevated hemoglobin F samples.","authors":"Moe Theingi, Pinyaphat Khamphikham, Sakorn Pornprasert","doi":"10.1080/00365513.2025.2524849","DOIUrl":"10.1080/00365513.2025.2524849","url":null,"abstract":"<p><p>The screening test for early detection of α-thalassemia is essential in effective management and genetic counseling. The immunochromatographic (IC) strip test is widely used for α-thalassemia screening due to its simplicity and high sensitivity. This study explores the causes of false-positive IC strip results in subjects with HbF >5% who tested negative for common α<sup>0</sup>-thalassemia --<sup>SEA</sup>, --<sup>Thai</sup> and --<sup>Chiang Rai</sup> type deletions. Fifty whole blood samples were tested using IC strips, and resulting positive samples were retested with washed red blood cells (RBCs) and plasma. Follow-up testing included molecular analysis to detect common hemoglobinopathies in washed RBCs, including α<sup>+</sup>-thalassemia -α<sup>3.7</sup> and -α<sup>4.2</sup> deletions, Hb Constant Spring (CS), Hb Quong Sze (QS) and Hb Westmead (WM), as well as antinuclear antibodies (ANAs) screening in plasma. Ten of 50 EDTA whole-blood samples tested positive using the IC strip test, with eight showing positivity in plasma and seven in washed RBCs. Among them, one plasma-positive sample was also positive for ANA, suggesting potential antibody interference. Of the seven RBC-positive samples, three had common hemoglobinopathies: two with the -α<sup>3.7</sup> deletion and one with Hb CS. The remaining four RBC-positive cases had no detectable mutations but were infants under three months of age. Since most false positives occur in infants under 8 months, caution is recommended when testing this age group. Additionally, washing red cells can help reduce antibody interference. Further molecular studies, such as Sanger sequencing, MLPA and NGS, should be initiated in cases without obvious causes.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"346-352"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508018","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}
引用次数: 0
Extreme biochemical patient results in a routine hospital laboratory. 常规医院化验室的极端生化病人结果。
IF 1.4 4区 医学
Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-01-01 Epub Date: 2025-08-19 DOI: 10.1080/00365513.2025.2546326
Joachim Baech, Lærke Andersen, Stine Linding Andersen
{"title":"Extreme biochemical patient results in a routine hospital laboratory.","authors":"Joachim Baech, Lærke Andersen, Stine Linding Andersen","doi":"10.1080/00365513.2025.2546326","DOIUrl":"10.1080/00365513.2025.2546326","url":null,"abstract":"<p><p>Biochemical tests are crucial in acute patient care, and the validity of the results is important. We aimed to evaluate extreme results reported in a routine hospital laboratory and to review patient characteristics. This is a retrospective cohort study of extreme laboratory results reported at the Department of Clinical Biochemistry, Aalborg University Hospital, Denmark (2022-2024). For six common analytes (sodium, potassium, creatinine, calcium, phosphate, and magnesium), the most extreme low (<i>n</i> = 25) and high (<i>n</i> = 25) results were identified. Electronic health records of 284 unique patients were reviewed to determine pathophysiological causes, pre-analytical errors, clinical course, and 7-day survival. Among 5,794,014 biochemical test results, 300 extreme results (0.005%) were identified, with 261 (87.0%) being compatible with a pathophysiological cause, and 39 (13.0%) being caused by a pre-analytical error. For high results, renal failure was the predominant cause (54.1%), particularly affecting creatinine, phosphate, and potassium. For low results, low creatinine was caused by muscle atrophy, while for other analytes, the most common causes were malnutrition, alcoholism, sepsis, diarrhea/emesis, and diuretics. The 7-day survival was lower for patients with extremely high results (77.4%) compared to low (94.5%). In conclusion, in a routine hospital laboratory, extreme biochemical test results were often pathophysiological, with pre-analytical errors accounting for around 10% of the reported results. Survival was generally high and patients with extremely low results had higher survival compared to those with extremely high results. Results inform the laboratory's decision-making on the handling and release of extreme biochemical results.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"395-401"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144875034","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}
引用次数: 0
Performance comparison of Mindray EH-2090 Urinalysis analyzers and Sysmex UF-5000. 迈瑞EH-2090尿液分析仪与Sysmex UF-5000的性能比较。
IF 1.4 4区 医学
Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-01-01 Epub Date: 2025-09-01 DOI: 10.1080/00365513.2025.2550350
Juan Chen, Chen Zhang, Qiaoping Xu, Zhicheng Wu
{"title":"Performance comparison of Mindray EH-2090 Urinalysis analyzers and Sysmex UF-5000.","authors":"Juan Chen, Chen Zhang, Qiaoping Xu, Zhicheng Wu","doi":"10.1080/00365513.2025.2550350","DOIUrl":"10.1080/00365513.2025.2550350","url":null,"abstract":"<p><p>In this study, we used manual microscopy as the gold standard, and compared the analytical and clinical performance of EH-2090 and UF-5000 to evaluate their application characteristics in daily clinical practice. Results show the EH-2090 has comparable analytical performance to Sysmex UF-5000. In clinical performance, the EH-2090 shows better counting accuracy for urine formed elements except bacteria. Besides, the EH-2090 could provide more accurate assessment especially in samples with yeast cells, crystals and dysmorphic red blood cells.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"436-443"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144967074","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}
引用次数: 0
Comparison of serum antinuclear antibodies in Guillain-Barré syndrome and chronic inflammatory demyelinating polyradiculoneuropathy: a retrospective case-control study. 格林-巴勒综合征和慢性炎性脱髓鞘性多根神经病变血清抗核抗体的比较:一项回顾性病例对照研究。
IF 1.3 4区 医学
Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-01-01 Epub Date: 2025-05-04 DOI: 10.1080/00365513.2025.2496267
Yu Tu, Xuan Gong, Jiewei Peng, Peipei Zhu, Wenyan Zhuo, Xueying Yu
{"title":"Comparison of serum antinuclear antibodies in Guillain-Barré syndrome and chronic inflammatory demyelinating polyradiculoneuropathy: a retrospective case-control study.","authors":"Yu Tu, Xuan Gong, Jiewei Peng, Peipei Zhu, Wenyan Zhuo, Xueying Yu","doi":"10.1080/00365513.2025.2496267","DOIUrl":"10.1080/00365513.2025.2496267","url":null,"abstract":"<p><p>Serum antinuclear antibodies (ANAs) facilitate the diagnosis and evaluation of patients with many systemic autoimmune conditions. However, there are no systematic reports concerning differences in Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Therefore, we assessed the differences in serum ANAs in GBS and CIDP patients and control subjects in a Chinese cohort. A retrospective enrollment of 417 patients was conducted for this study, consisting of 158 clinically confirmed GBS patients, 115 CIDP patients, and 144 non-GBS and CIDP inpatients as a control group. The measurement of serum ANAs, including autoantibodies against the Ro52 protein (anti-Ro52 antibody), anti-Sjogren's-syndrome-related antigen A antibodies (anti-SSA), anti-mitochondrial antibody M2 (AMA-M2), etc., was performed on all enrolled patients. Additionally, erythrocyte sedimentation rate (ESR), anti-streptolysin O (ASO), and C-reactive protein (CRP) values were also assessed. The results revealed significantly higher positive rates of Anti-Ro52 antibody, AMA-M2, and Anti-SSA antibody in the GBS group compared to the CIDP and control groups (<i>adjusted p < 0.001</i>). In the GBS group, Anti-Ro52 and AMA-M2 antibody positivity was moderate to severe, while anti-SSA antibody positivity was mild. In the GBS group, the most common finding for a serum ANAs burden score was 3 (58, 36.71%), which was higher than the CIDP group where a score of 1 was the most common finding (14, 12.17%). Anti-Ro52 antibodies, anti-SSA antibodies, and AMA-M2 were closely associated with GBS. Differential positivity of serum ANAs in GBS and CIDP patients was proposed to provide a reference for clinical diagnosis and treatment methods.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"242-247"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144044424","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}
引用次数: 0
A novel modification approach for the one sample Kolmogorov-Smirnov test in large sample size. 大样本量单样本Kolmogorov-Smirnov检验的一种新的修正方法。
IF 1.3 4区 医学
Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-01-01 Epub Date: 2025-06-05 DOI: 10.1080/00365513.2025.2512384
Ugurcan Sayili, Mehmet Guven Gunver
{"title":"A novel modification approach for the one sample Kolmogorov-Smirnov test in large sample size.","authors":"Ugurcan Sayili, Mehmet Guven Gunver","doi":"10.1080/00365513.2025.2512384","DOIUrl":"10.1080/00365513.2025.2512384","url":null,"abstract":"<p><p>This study aims to propose and evaluate a modified version of the One-Sample Kolmogorov-Smirnov (K-S) test that addresses its current limitations in large sample groups, with the goal of improving its accuracy and reliability in assessing normality assumptions in medical research data. In addition to the classical K-S test, a logarithmic modification was applied to reduce the impact of sample size. This modification replaces the sample size in the test calculation with a logarithmic formula (ln n<sup>2</sup>) to prevent z-values from becoming excessively small in large samples. Statistical analyses were conducted using Microsoft 365/Excel, SPSS 21.0 and STATA/MP18 with a geometric approach employed to assess data normality using the Geometric Approach to Normality Testing. The study analyzed real-world laboratory data obtained from the complete blood count (CBC) results of 122,310 adult patients (aged ≥18 years) who were treated at Cerrahpaşa Medical Faculty Hospital throughout 2022. The modified K-S test with the proposed logarithmic modification (ln n<sup>2</sup>) reduced the tendency to reject normality solely due to large sample size. The modified test was able to confirm that some hematological parameters did indeed fit normal distribution models, while discriminating those that did not. In particular, analysis of the data set trimmed by 0.5% showed further improvement in test performance. Consequently, the proposed modification is shown to provide a more sensitive method for assessing the assumption of normal distribution in large data sets. The method can be easily integrated into existing statistical software, making it accessible for routine use in large-scale data analysis.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"287-298"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144235041","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}
引用次数: 0
Screening efficacy of erythroferrone and hepcidin in identifying thalassemia with iron-deficiency anemia among pregnant women. 红细胞铁酮和hepcidin对孕妇地中海贫血合并缺铁性贫血的筛查效果。
IF 1.4 4区 医学
Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-01-01 Epub Date: 2025-09-04 DOI: 10.1080/00365513.2025.2553294
Nan Huang, Jianlong Zhuang, Yufang Wang, Xiaofeng Zheng, Zixuan Chen, Hailong Huang, Zhishan Zhang
{"title":"Screening efficacy of erythroferrone and hepcidin in identifying thalassemia with iron-deficiency anemia among pregnant women.","authors":"Nan Huang, Jianlong Zhuang, Yufang Wang, Xiaofeng Zheng, Zixuan Chen, Hailong Huang, Zhishan Zhang","doi":"10.1080/00365513.2025.2553294","DOIUrl":"10.1080/00365513.2025.2553294","url":null,"abstract":"<p><p>This study investigated the prevalence of Thalassemia (Thal) gene in pregnant women in the Quanzhou area, China. And explored the clinical application value of Erythroferrone (ERFE) and Hepcidin in screening pregnant women with Thal complicated by Iron-deficiency anemia (IDA, defined as serum ferritin (SF) < 20 μg/L). From January 2020 to December 2022, the detection rate of Thal in suspected Thal populations was 35.9%, with 256 pregnant women having Thal, and 11.3% of them also had IDA. From April 2023 to September 2024, 50 pregnant women with simple IDA and 54 with Thal complicated by IDA were selected. Blood samples were collected to detect ERFE, Hepcidin, and other indicators. Binary logistic regression analysis showed that ERFE, Hepcidin, MCH, and SF had a significant impact on Thal screening. The combined detection of these four indicators had the highest AUC at 0.916 (sensitivity 92.0%, specificity 81.5%). The study concluded that pregnant women with Thal are at risk of developing IDA, and routine screening for Thal complicated by IDA is prone to miss cases. ERFE and Hepcidin have higher screening value than MCH and SF, and the combined detection of the four indicators provides high diagnostic efficacy in distinguishing simple IDA from Thal complicated by IDA.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"444-451"},"PeriodicalIF":1.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144993425","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}
引用次数: 0
The effects of storage conditions on the stability of salivary melatonin in synthetic fiber swabs for home sampling. 储存条件对家用合成纤维拭子唾液褪黑素稳定性的影响。
IF 1.3 4区 医学
Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-01-01 Epub Date: 2025-04-10 DOI: 10.1080/00365513.2025.2487987
Jennifer Anton, Charlotte S Larsen, Majken Gudmundsson, Lasse K Bak
{"title":"The effects of storage conditions on the stability of salivary melatonin in synthetic fiber swabs for home sampling.","authors":"Jennifer Anton, Charlotte S Larsen, Majken Gudmundsson, Lasse K Bak","doi":"10.1080/00365513.2025.2487987","DOIUrl":"10.1080/00365513.2025.2487987","url":null,"abstract":"<p><p>Home sampling of saliva is noninvasive, easy, and convenient, especially for multiple sampling. Such samples are therefore appropriate for the measurement of melatonin, a biomarker for circadian dysregulation. However, home sampling is restricted by access to appropriate storage conditions. This study, therefore, evaluated the effect of common storage conditions on the stability of melatonin in synthetic fiber swabs employed for home sampling. Saliva was provided by healthy volunteers during daytime, pooled and subsequently divided into fractions, each spiked with different amounts of melatonin. Synthetic fiber swabs were allowed to accumulate saliva from these fractions followed by storage at room temperature, 4 °C or -20 °C for 24, 48 or 72 h. The melatonin levels were analyzed employing a commercial ELISA assay. Differences in concentrations at each storage condition were evaluated with a two-way repeated measures ANOVA followed by a Tukey multiple comparison test. Samples were significantly more stable at -20 °C compared to room temperature and 4 °C, irrespective of the storage duration. However, no significant decrease from baseline was observed for samples stored at either 4 °C or -20 °C after 72 h. In comparison, a significant decrease was observed at room temperature after just 24 h. In conclusion, storage at -20 °C may be considered the gold standard for synthetic fiber swabs for quantification of salivary melatonin. However, storage at 4 °C ensures stability for 72 h while also ensuring convenience for home sampling. It is therefore our recommendation that such home samples are refrigerated, transported cold and centrifuged within 72 h of collection.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":"85 3","pages":"180-183"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143996072","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}
引用次数: 0
Increased serum anti-angiogenic factor levels in insulin-resistant obese children and adolescents with or without liver steatosis (NAFL). 伴有或不伴有肝脂肪变性(NAFL)的胰岛素抵抗型肥胖儿童和青少年血清抗血管生成因子水平升高。
IF 1.3 4区 医学
Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-01-01 Epub Date: 2025-05-14 DOI: 10.1080/00365513.2025.2502947
Samed Emre Darılmaz, Melike Zeynep Tugrul Aksakal, Gozde Ceylan, Canan Kucukgergin, Aylin Yetim Sahin, Seldag Bekpinar
{"title":"Increased serum anti-angiogenic factor levels in insulin-resistant obese children and adolescents with or without liver steatosis (NAFL).","authors":"Samed Emre Darılmaz, Melike Zeynep Tugrul Aksakal, Gozde Ceylan, Canan Kucukgergin, Aylin Yetim Sahin, Seldag Bekpinar","doi":"10.1080/00365513.2025.2502947","DOIUrl":"10.1080/00365513.2025.2502947","url":null,"abstract":"<p><p>This study aimed to investigate the effect of obesity on angiogenesis and its relationship with liver steatosis in obese children and adolescents. The study ıncluded 81 obese ın chıldren and 30 healthy controls. Obese subjects were subdıvıded by ultrasound ınto three groups: no steatosıs, grade 1 lıver steatosıs (NAFL), and grade 2 NAFL. Obese individuals, regardless of the presence of NAFL, exhibited significant insulin resistance (<i>p</i> < .01) compared to their lean counterparts. All obese subjects showed elevated serum ALT, wıth a sıgnıfıcantly greater ın those wıth NAFL. Marked dyslipidemia by decreased high-density lipoprotein (HDL) levels and elevated triglycerides, was observed in obese individuals with NAFL. The serum levels of angiopoietin-1 (Ang-1) and vascular endothelial growth factor-165b (VEGF165b) were measured as anti-angiogenic markers, while vascular endothelial growth factor-A (VEGF-A), fibroblast growth factor-2 (FGF-2) and P-selectin were assessed as pro-angiogenic factors. Compared to normal-weight children (5558 ± 674 pg/mL), Ang-1 levels were significantly elevated in all obese subgroups (8861 ± 1026; 8105 ± 615; 7388 ± 924, respectıvely). However, no significant differences in Ang-1 levels were observed among the obese subgroups. Ang-1 and VEGF165b levels were significantly higher in insulin-resistant individuals (7575 ± 747 pg/mL and 293 ± 44.4 pg/mL, respectively) compared to insulin-sensitive subjects (6143 ± 557 pg/mL and 179 ± 31.4 pg/mL, respectively). These findings suggest that insulin resistance in obese children is associated with altered angiogenic signaling. However, no significant differences in the serum levels of angiogenic factors were observed between obese groups with and without NAFL.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"263-268"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080071","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}
引用次数: 0
Validation of cobas® pulse point-of-care testing device for blood glucose monitoring. 用于血糖监测的cobas®脉搏即时检测设备的验证。
IF 1.3 4区 医学
Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-01-01 Epub Date: 2025-05-30 DOI: 10.1080/00365513.2025.2512382
Josefine B H Adelhelm, Charlotte S Jørgensen, Heidi B Hansen, Stine B Østertoft, Mads Nybo, Louise H Jørgensen
{"title":"Validation of cobas<sup>®</sup> pulse point-of-care testing device for blood glucose monitoring.","authors":"Josefine B H Adelhelm, Charlotte S Jørgensen, Heidi B Hansen, Stine B Østertoft, Mads Nybo, Louise H Jørgensen","doi":"10.1080/00365513.2025.2512382","DOIUrl":"10.1080/00365513.2025.2512382","url":null,"abstract":"<p><p>The aim of this study was to validate the blood glucose point-of-care system, cobas<sup>®</sup> pulse (Roche Diagnostics GmbH), which is the successor to the Accu-Chek<sup>®</sup> Inform II system (Roche Diagnostics GmbH). Since the cobas<sup>®</sup> pulse device is intended to replace an existing device from the same manufacturer, we found it highly relevant to perform an industry-independent validation regarding accuracy and comparability with existing glucose measurement systems. From 40 randomly selected, non-fasting adults capillary and venous blood was drawn simultaneously. Correlation and agreement was evaluated by comparing capillary blood glucose on cobas<sup>®</sup> pulse to plasma glucose on cobas<sup>®</sup> 8000 (Roche Diagnostics GmbH) and capillary blood glucose on ABL800 Flex (Radiometer, Denmark), respectively. The cobas<sup>®</sup> pulse generally showed good agreement with both comparison methods, although the agreement between cobas<sup>®</sup> pulse and ABL800 Flex was better (bias -0.01 mmol/L) than between cobas<sup>®</sup> pulse and cobas<sup>®</sup> 8000 (bias 0.61 mmol/L). Differences between measurements of low blood glucose levels (range 0.5 to 4.8 mmol/L) and higher blood glucose levels (range 9.7 to 15.3 mmol/L) when comparing cobas<sup>®</sup> pulse to ABL800 Flex was also within allowable limits. Altogether, the validation study demonstrated a clinically satisfactory performance of the cobas<sup>®</sup> pulse point-of-care device.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"275-280"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144187857","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}
引用次数: 0
Exploratory method comparison analysis with emphasis on graphical illustrations. 探索性方法,以图解为主,比较分析。
IF 1.3 4区 医学
Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2025-01-01 Epub Date: 2025-04-23 DOI: 10.1080/00365513.2025.2494259
Bent Kristensen, Marc Ø Nielsen, Arlinda Ljoki, Bo Zerahn, Lars T Jensen
{"title":"Exploratory method comparison analysis with emphasis on graphical illustrations.","authors":"Bent Kristensen, Marc Ø Nielsen, Arlinda Ljoki, Bo Zerahn, Lars T Jensen","doi":"10.1080/00365513.2025.2494259","DOIUrl":"10.1080/00365513.2025.2494259","url":null,"abstract":"<p><p><b>Objectives:</b> To develop and present simple visual and descriptive summary measures of agreement in method comparison studies with replicated measurements and to discuss detection of drift in method comparison studies. Summary measures may serve as an exploratory data analysis guiding further agreement and decision analysis of two methods using the Bland and Altman method and mixed-effects modeling. <b>Materials and methods:</b> The methodological approach is illustrated using freely available clinical datasets from two published method comparison studies with repeated measurements on each subject. <b>Results:</b> With the use of ellipses and a numerical ideality index as summary measures for each subject with paired measurements from two clinical methods, it is possible to quickly decode a dataset's intra- and interindividual variation, differential and proportional bias, possible drift, and the number of measured subjects in clinically relevant areas for the two methods. <b>Conclusion:</b> Simple and intuitive exploratory method comparison analysis can be performed and interpreted even for relatively large datasets prior to more advanced statistical analysis of method comparisons using data with replicated measurements.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":"85 3","pages":"202-213"},"PeriodicalIF":1.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144009380","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}
引用次数: 0
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