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Prognostic value of human serum alpha-klotho concentrations in patients with heart failure with reduced ejection fraction 人血清α -克洛索浓度对心力衰竭伴射血分数降低患者的预后价值。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-19 DOI: 10.1016/j.clinbiochem.2026.111086
Ajay Mahenthiran , Silvio Augusto Nunes Jr , Chia-Feng Liu , Steven Leon , Jennifer Wilcox , W.H. Wilson Tang

Objective

Heart Failure (HF) is a major health problem with high prevalence and mortality. Identifying new biomarkers involved in controlling heart failure progression has become particularly important. This study evaluated the association between serum α-klotho concentrations and long-term all-cause mortality in patients with stable HF.

Design and methods

We analyzed serum α-klotho levels in 230 adults (135 patients with HF with reduced ejection fraction and 95 age and sex-matched healthy controls). A classification and regression tree analysis was used to stratify patients by α-klotho concentration, using all-cause mortality within a 5-year follow-up as the primary endpoint. Differences in log-NT-proBNP levels across α-klotho groups were assessed using the Kruskal-Wallis test with Dunn’s post-hoc comparisons. Kaplan-Meier survival analysis evaluated the association between α-klotho stratified groups and 5-year all-cause mortality.

Results

Patients with higher serum α-klotho levels had significantly lower mortality and lower log NT-proBNP across α-klotho groups (χ2(2) = 8.05, p = 0.018) when compared to lower α-klotho concentration levels. Kaplan-Meier curves show the significant difference in survival across α-klotho stratification (log-rank p < 0.01).

Conclusion

Patients with higher serum α-klotho concentrations were associated with lower log-NT-proBNP levels and better 5-year survival in all patients as well as in patients with heart failure, compared to those with lower. These findings support the role of α-klotho as a promising cardioprotective biomarker for risk stratification in patients with HF.
目的:心力衰竭(HF)是一种发病率高、死亡率高的主要健康问题。识别与控制心力衰竭进展相关的新生物标志物变得尤为重要。本研究评估了稳定型心衰患者血清α-克洛索浓度与长期全因死亡率之间的关系。设计和方法:我们分析了230名成人(135名伴有射血分数降低的心衰患者和95名年龄和性别匹配的健康对照)的血清α-klotho水平。采用分类和回归树分析,以5年随访期间的全因死亡率为主要终点,按α-克洛索浓度对患者进行分层。α-klotho组间log-NT-proBNP水平的差异采用Kruskal-Wallis测试和Dunn’s事后比较进行评估。Kaplan-Meier生存分析评估α-klotho分层组与5年全因死亡率之间的关系。结果:血清α-klotho水平较高的患者死亡率显著低于α-klotho水平较低的患者(χ2(2) = 8.05,p = 0.018),α-klotho水平组的NT-proBNP对数显著低于α-klotho水平组。Kaplan-Meier曲线显示不同α-klotho浓度患者的生存率有显著差异(log-rank p )结论:血清α-klotho浓度较高的患者与所有患者以及心力衰竭患者的log-NT-proBNP水平较低相关,且与较低的患者相比,其5年生存率更高。这些发现支持α-klotho作为心衰患者危险分层的有希望的心脏保护生物标志物的作用。
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引用次数: 0
Advantages and application of a decision tree algorithm combined with the Harris-Boyd criterion in the construction of dynamic reference intervals for coagulation indicators during pregnancy 决策树算法结合Harris-Boyd准则在构建妊娠凝血指标动态参考区间中的优势及应用
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-19 DOI: 10.1016/j.clinbiochem.2026.111087
Xiaosong Lin , Zhi Lin , Liangjie Xu , Feng Zhao , Yuying Weng

Introduction

Reference intervals (RIs) based on fixed gestationals may not accurately reflect the dynamic changes of the hypercoagulable state. This study aimed to evaluate the rationality of integrating a decision tree algorithm (DTA) with the Harris-Boyd criterion (DTAHBC) to establish dynamic RIs for coagulation indicators during pregnancy.

Materials and methods

Dynamic data of prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (Fib), D-dimer (D-d), and fibrin degradation product (FDP) were retrospectively analyzed in 4,698 healthy pregnant women. Scatter plots were drawn to observe changes regarding each indicator during pregnancy. DTAs were used to identify dynamic inflection points, which were validated using the Harris-Boyd criterion. Moreover, 2.5th and 97.5th percentiles and their 90% confidence intervals were calculated. New RIs were compared to traditional trimester-based RIs and validated by coincidence rates within the cohort.

Results

The study showed that PT, INR, APTT, and TT values were stable across gestation weeks. However, Fib, D-d, and FDP values increased rapidly. The DTA analysis found inflection points misaligned with traditional trimester-based nodes. Compared to traditional methods, the new method identified the initial stage of coagulation activation in the second trimester (FDP exceeding non-pregnant ranges at 14–21 weeks) and the aggravation stage of hypercoagulability in the late trimester (median FDP exceeding non-pregnant upper limits at 34–40 weeks). Validation in the same cohort revealed compliance rates >90% for new RIs, whereas traditional TT (82.11%) and D-d (87.89%) measurements obtained at 14–27 weeks failed validation.

Conclusion

DTAHBC-based RIs do not follow the traditional trimester division, can effectively reflect dynamic changes in coagulation indicators, and provide a new solution for coagulation-function evaluation during pregnancy.
基于固定胎位的参考间隔(RIs)可能不能准确反映高凝状态的动态变化。本研究旨在评价将决策树算法(DTA)与Harris-Boyd准则(DTAHBC)相结合建立妊娠凝血指标动态RIs的合理性。材料与方法:回顾性分析4698例健康孕妇凝血酶原时间(PT)、国际标准化比值(INR)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(Fib)、d -二聚体(D-d)、纤维蛋白降解产物(FDP)的动态数据。绘制散点图,观察妊娠期间各指标的变化。dta用于识别动态拐点,并使用Harris-Boyd准则进行验证。计算2.5和97.5%百分位及其90%置信区间。将新的RIs与传统的基于妊娠期的RIs进行比较,并通过队列内的符合率进行验证。结果:PT、INR、APTT、TT值在妊娠周内稳定。Fib、D-d、FDP值增加较快。DTA分析发现拐点与传统的妊娠期节点不一致。与传统方法相比,新方法确定了妊娠中期凝血激活的初始阶段(FDP在14-21 周超过非妊娠范围)和妊娠晚期高凝性加重阶段(FDP中位数在34-40 周超过非妊娠上限)。在同一队列中的验证显示,新RIs的依从率为bb90 %,而在14-27 周获得的传统TT(82.11%)和D-d(87.89%)测量未能验证。结论:基于dtahbc的RIs不遵循传统的孕期划分,能有效反映凝血指标的动态变化,为妊娠期凝血功能评价提供新的解决方案。
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引用次数: 0
Hemoglobin Chapel Hill masquerading as hemoglobin S in newborn sickle cell screening: A case study 在新生儿镰状细胞筛查中,教堂山血红蛋白伪装成血红蛋白S:一个案例研究。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-18 DOI: 10.1016/j.clinbiochem.2026.111081
Natalia Volodko , Michelle L. Parker , Ross Ridsdale , Lauren MacNeil , Iveta Sosova , Mathew P. Estey , Dustin Proctor , Lily Olayinka , Ashley Newbigging , Pierre Bordeleau , Maggie Powell , Victoria Higgins

Background

Newborn screening for hemoglobinopathies is an effective tool for the early detection of clinically significant conditions, such as sickle cell disease. High-performance liquid chromatography (HPLC) is broadly used as it enables high-throughput automation and detection of clinically significant variants using minimal sample volumes. However, it may misidentify hemoglobin variants due to overlapping retention times.

Case report

Abnormal sickle cell screening results in a newborn female, including a peak in the hemoglobin S window, prompted hemoglobinopathy investigation. Capillary electrophoresis results suggested a possible alpha chain variant. Genetic testing revealed four distinct alterations, including a hemizygous HBA2 c.224A > G (p.Asp75Gly) variant, known as Hb Chapel Hill, and a 3.7 kb alpha-globin gene deletion consistent with an alpha-thalassemia silent carrier state.

Conclusion

This case represents the first documented occurrence of Hb Chapel Hill in an infant. Gamma globin production alongside Hb Chapel Hill results in a HbS zone peak on both HPLC and capillary electrophoresis, posing an interpretive challenge. Considering the complete pattern of peaks observed in hemoglobin fractionation methods can help distinguish clinically relevant conditions from likely benign profiles. Molecular analysis in complex cases is essential for confirmation of the suspected diagnosis.
背景:新生儿血红蛋白病筛查是早期发现镰状细胞病等临床重要疾病的有效工具。高效液相色谱(HPLC)被广泛使用,因为它可以使用最小的样本量实现高通量自动化和临床重要变异的检测。然而,由于保留时间重叠,它可能会错误地识别血红蛋白变体。病例报告:新生儿镰状细胞筛查结果异常,包括血红蛋白S窗口峰值,提示血红蛋白病调查。毛细管电泳结果显示可能存在α链变异。基因检测显示了四种不同的改变,包括半合子HBA2 c.224A > G (p.Asp75Gly)变异,称为Hb Chapel Hill,以及3.7 kb的α -珠蛋白基因缺失,与α -地中海贫血沉默携带者状态一致。结论:该病例是第一例记录在案的婴儿发生教堂山Hb。在Hb Chapel Hill附近产生的γ珠蛋白在HPLC和毛细管电泳上都产生了HbS带峰,这对解释提出了挑战。考虑到血红蛋白分离方法中观察到的峰的完整模式,可以帮助区分临床相关的疾病和可能的良性特征。复杂病例的分子分析对于确认疑似诊断至关重要。
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引用次数: 0
Fibrinogen-like protein 1 as a novel biomarker of rheumatoid arthritis and diagnostic basis for disease activity: a diagnostic test study 纤维蛋白原样蛋白1作为类风湿关节炎的新生物标志物和疾病活动性的诊断基础:一项诊断试验研究
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-18 DOI: 10.1016/j.clinbiochem.2026.111084
Xuan Wang , Guoqing Wang , Jiayu Su , Yan Lu , Lu Lu , Lin Zhu , Boqian Chen , Wanjian Gu , Shijia Liu

Background

Early, accurate diagnosis of Rheumatoid Arthritis (RA) is essential for timely intervention, yet a simple and precise method for assessing disease activity remains a challenge. Biomarkers offer a promising solution for disease prediction and monitoring. Consequently, the discovery of novel biomarkers for RA diagnosis and disease activity evaluation is imperative.

Objective

This study seeks to elucidate the diagnostic utility of fibrinogen-like protein 1 (FGL1, also referred to as HFREP1) in rheumatoid arthritis.

Methods

A total of 237 RA patients and 236 non-RA control subjects were enrolled in this clinical trial. Serum levels of rheumatoid factor (RF), anti-cyclic citrullinated peptide (CCP) antibodies, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were measured and compared against HFREP1 concentrations quantified via enzyme-linked immunosorbent assay (ELISA).

Results

Consistent with the established diagnostic gold standard, HFREP1 demonstrated higher sensitivity and negative predictive value compared to CRP and ESR. The area under the receiver operating characteristic curve (AUC) for HFREP1 was comparable to those of CRP and ESR. The combination of HFREP1, CCP antibody, and ESR yielded an AUC of 0.987, which indicates that HFREP1 does not enhance the diagnostic accuracy of the combination of CCP antibody and ESR. The mean serum concentration of HFREP1 was 71.87 ng/mL in patients with remission or low disease activity, compared to 175.47 ng/mL in those with moderate to high disease activity.

Conclusion

HFREP1 demonstrates diagnostic potential for RA and the capability to assess disease activity. It has greater sensitivity than CRP and ESR and can better evaluate disease activity than RF and CCP. These findings support the potential use of HFREP1 as a diagnostic marker for the diagnosis and assessment of RA.
This trial is registered with the Chinese Clinical Trial Registry (Registration No.: ChiCTR2400082686; Date: 2024/04/03).
背景:类风湿关节炎(RA)的早期、准确诊断对于及时干预至关重要,然而一种简单而精确的评估疾病活动性的方法仍然是一个挑战。生物标志物为疾病预测和监测提供了一个很有前途的解决方案。因此,发现新的RA诊断和疾病活动性评估的生物标志物是必要的。目的:本研究旨在阐明纤维蛋白原样蛋白1 (FGL1,也称为HFREP1)在类风湿关节炎中的诊断价值。方法:237例RA患者和236例非RA对照者参加本临床试验。测定血清类风湿因子(RF)、抗环瓜氨酸肽(CCP)抗体、红细胞沉降率(ESR)和c反应蛋白(CRP)水平,并与酶联免疫吸附试验(ELISA)测定的HFREP1浓度进行比较。结果:与建立的诊断金标准一致,与CRP和ESR相比,HFREP1具有更高的敏感性和阴性预测值。HFREP1的受试者工作特征曲线下面积(AUC)与CRP和ESR相当。HFREP1、CCP抗体和ESR联合使用的AUC为0.987,说明HFREP1不能提高CCP抗体和ESR联合使用的诊断准确性。在疾病缓解或低活动性患者中,HFREP1的平均血清浓度为71.87 ng/mL,而在疾病中高活动性患者中,HFREP1的平均血清浓度为175.47 ng/mL。结论:HFREP1具有诊断RA的潜力和评估疾病活动性的能力。它比CRP和ESR更敏感,比RF和CCP更能评价疾病活动性。这些发现支持HFREP1作为RA诊断和评估的诊断标记物的潜在应用。本试验已在中国临床试验注册中心注册(注册号:: ChiCTR2400082686;日期:2024/04/03)。
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引用次数: 0
Unresolved issues of multiple citrulline similar-motif antigen in diagnosing rheumatoid arthritis: from specificity to clinical practice 多瓜氨酸相似基序抗原诊断类风湿关节炎的未解决问题:从特异性到临床实践。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-16 DOI: 10.1016/j.clinbiochem.2026.111083
Nayan Chen
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引用次数: 0
AMH levels and diagnosis in PCOS phenotype D D型PCOS患者AMH水平与诊断
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-08 DOI: 10.1016/j.clinbiochem.2026.111080
Xiaofang Xuan , Minxia Zhang , Yaqi Fang , Liyun Su , Ke Xu

Objectives

To evaluate the diagnostic performance of serum anti-Müllerian hormone (AMH) for polycystic ovary syndrome (PCOS) phenotype D, to define overall and age-specific AMH cut-off values, and to explore the associations between AMH and other reproductive hormones.

Design & Methods

In this cross-sectional study, serum AMH levels were measured in 169 women with PCOS phenotype D and 224 age-matched healthy controls using a magnetic microparticle acridinium ester chemiluminescence immunoassay. Follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone were assessed with immunoluminescence assays. Correlations between AMH and other hormones were analyzed, and receiver operating characteristic (ROC) curves were used to evaluate diagnostic performance and derive cut-off values, including age-stratified thresholds.

Results

Serum AMH, testosterone, and the LH/FSH ratio were significantly higher in the PCOS phenotype D group than in controls (p < 0.0001). AMH was positively correlated with testosterone (r = 0.233, p = 0.002) but not with the LH/FSH ratio. AMH discriminated phenotype D from controls with an area under the ROC curve of 0.779 (95 % CI 0.734–0.825); the optimal overall cut-off was 43.16 pmol/L (sensitivity 71.93 %, specificity 70.67 %). Age-stratified analyses showed robust diagnostic performance across reproductive ages, with cut-off values declining progressively (e.g., 54.16 pmol/L for ≤ 25 years; 35.59 pmol/L for 31–35 years).

Conclusions

Serum AMH is a valuable biomarker for diagnosing PCOS phenotype D. The use of age-specific AMH cut-off values may improve diagnostic accuracy and facilitate earlier recognition of this frequently underdiagnosed PCOS subtype.
目的评价血清抗勒氏杆菌激素(AMH)对D型多囊卵巢综合征(PCOS)的诊断价值,确定AMH的总体临界值和年龄特异性临界值,并探讨AMH与其他生殖激素的关系。设计与方法在这项横断面研究中,使用磁性微粒吖啶酯化学发光免疫分析法测量了169名表型D型PCOS女性和224名年龄匹配的健康对照者的血清AMH水平。促卵泡激素(FSH)、促黄体生成素(LH)和睾酮用免疫发光法测定。分析AMH与其他激素之间的相关性,并使用受试者工作特征(ROC)曲线评估诊断表现并得出截止值,包括年龄分层阈值。结果PCOS表型D组血清AMH、睾酮和LH/FSH比值显著高于对照组(p < 0.0001)。AMH与睾酮呈正相关(r = 0.233, p = 0.002),但与LH/FSH比值无关。AMH区分D型与对照的ROC曲线下面积为0.779 (95% CI 0.734-0.825);最佳总体临界值为43.16 pmol/L(敏感性71.93%,特异性70.67%)。年龄分层分析显示,整个生育年龄的诊断性能都很好,临界值逐渐下降(例如,≤25岁为54.16 pmol/L; 31-35岁为35.59 pmol/L)。结论血清AMH是诊断PCOS表型d的一种有价值的生物标志物,使用年龄特异性AMH临界值可提高诊断准确性,并有助于早期识别这一常被误诊的PCOS亚型。
{"title":"AMH levels and diagnosis in PCOS phenotype D","authors":"Xiaofang Xuan ,&nbsp;Minxia Zhang ,&nbsp;Yaqi Fang ,&nbsp;Liyun Su ,&nbsp;Ke Xu","doi":"10.1016/j.clinbiochem.2026.111080","DOIUrl":"10.1016/j.clinbiochem.2026.111080","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate the diagnostic performance of serum anti-Müllerian hormone (AMH) for polycystic ovary syndrome (PCOS) phenotype D, to define overall and age-specific AMH cut-off values, and to explore the associations between AMH and other reproductive hormones.</div></div><div><h3>Design &amp; Methods</h3><div>In this cross-sectional study, serum AMH levels were measured in 169 women with PCOS phenotype D and 224 age-matched healthy controls using a magnetic microparticle acridinium ester chemiluminescence immunoassay. Follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone were assessed with immunoluminescence assays. Correlations between AMH and other hormones were analyzed, and receiver operating characteristic (ROC) curves were used to evaluate diagnostic performance and derive cut-off values, including age-stratified thresholds.</div></div><div><h3>Results</h3><div>Serum AMH, testosterone, and the LH/FSH ratio were significantly higher in the PCOS phenotype D group than in controls (p &lt; 0.0001). AMH was positively correlated with testosterone (r = 0.233, p = 0.002) but not with the LH/FSH ratio. AMH discriminated phenotype D from controls with an area under the ROC curve of 0.779 (95 % CI 0.734–0.825); the optimal overall cut-off was 43.16 pmol/L (sensitivity 71.93 %, specificity 70.67 %). Age-stratified analyses showed robust diagnostic performance across reproductive ages, with cut-off values declining progressively (e.g., 54.16 pmol/L for ≤ 25 years; 35.59 pmol/L for 31–35 years).</div></div><div><h3>Conclusions</h3><div>Serum AMH is a valuable biomarker for diagnosing PCOS phenotype D. The use of age-specific AMH cut-off values may improve diagnostic accuracy and facilitate earlier recognition of this frequently underdiagnosed PCOS subtype.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111080"},"PeriodicalIF":2.1,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145941396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Laboratory medicine and sustainability: towards a green lab. 检验医学与可持续性:迈向绿色实验室。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-05 DOI: 10.1016/j.clinbiochem.2025.111072
Andre Mattman, Janet Simons

This article introduces the special issue of Clinical Biochemistry that focuses on sustainability in laboratory medicine.

本文介绍了《临床生物化学》的特刊,重点介绍了检验医学的可持续性。
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引用次数: 0
Impact of the implementation of the Sampson-NIH equation for the calculation of LDL-C in a large community cohort of adult and pediatric patients in Ontario 在安大略省的成人和儿科患者的大型社区队列中,实施Sampson-NIH方程计算LDL-C的影响。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.clinbiochem.2025.111071
Nicole White-Al Habeeb , Terence Agbor , Difei Sun , Adam Wan , Michelle Seaton , Peter Catomeris , Danijela Konforte

Introduction

Low-density lipoprotein cholesterol (LDL-C), a known risk factor for cardiovascular disease, is commonly estimated using the Friedewald equation. Although the Sampson-NIH equation has been recommended by the Canadian Society of Clinical Chemists for its improved accuracy, particularly in cases of high triglyceride and low LDL-C concentration, its adoption across Canada has been limited.

Objective

Assess the impact of implementation of the Sampson-NIH equation for the calculation of LDL-C in a large community population in Ontario, including reporting frequency, reclassification and agreement with non-HDL-C.

Methods

Results for total cholesterol, HDL-C, non-HDL cholesterol and triglycerides were obtained from Dynacare and LifeLabs community samples (n = 474,911). LDL-C was calculated using Friedewald and Sampson-NIH equations, followed by regression and clinical impact analysis.

Results

Samples with triglycerides ≤ 4.52 mmol/L, showed excellent comparison between Friedewald and Sampson-NIH calculated results (R2 = 0.995, y = 1.00x + 0.08, both cohorts). Samples with triglycerides 4.53–9.04 mmol/L, showed worsening agreement between the two equations (R2 = 0.994, y = 0.81x + 0.79, both cohorts). The comparison results were similar when analyzed across ages (pediatric and adults) and fasting status. Implementation of the Sampson-NIH equation allowed reporting of an additional 1.49% patients (n = 7055). Minor reclassification was observed based on pediatric and adult LDL-C decision thresholds. The Sampson-NIH calculated LDL-C showed better agreement with non-HDL-C than Friedewald calculated LDL-C (86.0 % vs 84.2 %).

Conclusion

There is excellent agreement between Sampson-NIH equation and Friedewald equations, resulting in reclassification of only a small proportion of patients. This study demonstrated the impact of the Sampson-NIH equation for LDL-C in a large pediatric and adult Canadian community population.
低密度脂蛋白胆固醇(LDL-C)是已知的心血管疾病的危险因素,通常使用弗里德瓦尔德方程进行估计。尽管加拿大临床化学家协会推荐了Sampson-NIH方程,因为它提高了准确性,特别是在高甘油三酯和低LDL-C浓度的情况下,但它在加拿大的采用受到限制。目的:评估在安大略省大型社区人群中实施Sampson-NIH公式计算LDL-C的影响,包括报告频率、重新分类以及与非hdl - c的一致性。方法:从Dynacare和LifeLabs社区样本(n = 474,911)中获取总胆固醇、HDL-C、非hdl胆固醇和甘油三酯的检测结果。采用Friedewald和Sampson-NIH方程计算LDL-C,然后进行回归和临床影响分析。结果:样品与甘油三酯 ≤4.52  更易与L,展示优秀的比较Friedewald和Sampson-NIH计算结果(R2 = 0.995,y = 1.00 x + 0.08,两组)。甘油三酯为4.53-9.04 mmol/L的样品,两组方程的一致性变差(R2 = 0.994,y = 0.81x + 0.79,两个队列)。当样本在不同年龄(儿童和成人)和禁食状态下进行分析时,比较结果是相同的。实施Sampson-NIH方程允许报告额外的1.49 %的患者(n = 7055),并增加了根据儿童和成人LDL-C决策阈值重新分类的患者总数。samson - nih计算的LDL-C与非hdl - c的一致性优于Friedewald计算的LDL-C(86.0 % vs 84.2 %)。结论:Sampson-NIH方程与Friedewald方程吻合良好,仅一小部分患者被重新分类。这项研究证明了Sampson-NIH等式对加拿大大量儿童和成人社区人口LDL-C的影响。
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引用次数: 0
Effect of microcollection tube fill volume on common acute care tests 微收集管填充量对常见急症护理试验的影响。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.clinbiochem.2025.111066
Fangze Cai , Isolde Seiden-Long , Allison A. Venner , Heather Paul , Jessica L. Gifford , Tariq Roshan , Lawrence de Koning

Background

Microcollection tubes are frequently used in pediatric phlebotomy. We performed a pilot study to determine what clinical biochemistry and hematology tests can be reported on different microcollection tube fill volumes.

Methods

Blood was collected from 11 volunteers into Becton Dickinson (BD) Vacutainers® and microcollection tubes (BD Microtainers® and the Sarstedt Microvette® 300 FH) at different fill volumes (Filled: top line; Intermediate: second line; Short: third line. If there was no second or third line, 200 µL was used for short fills) for 36 clinical biochemistry tests and the complete blood count (CBC) with differential (23 components). At each fill volume, tests were strong candidates to report if they did not have statistically significant biases compared to results in Vacutainers®. Potential candidates had statistically significant biases that were small (median absolute bias < 25 % of total allowable error and less than desirable bias from biological variation). Tests were not candidates if biases were significant and large (median absolute bias ≥ 25 % of TEa or ≥ desirable bias). Biases that increased or decreased across concentration ranges invalidated reporting candidacy.

Results

Twenty four clinical biochemistry tests were strong or potential candidates to report on all fill volumes, 7 were strong or potential candidates to report on some fill volumes and 5 were not candidates to report on any fill volumes. Seventeen CBC components were strong or potential candidates to report on all fill volumes, 2 were strong or potential candidates to report on some fill volumes and 4 were not candidates to report on any fill volumes.

Conclusions

While most tests were valid to report on different fill volumes, some were not. We encourage laboratories to perform their own studies on fill volumes.
背景:微采集管用于儿科静脉切开术。我们进行了一项初步研究,以确定在微收集管填充体积上可以报告哪些临床生化和血液学测试。方法:将11名志愿者的血液采集到不同填充体积的Becton Dickinson (BD) Vacutainers®和Microvette®300 FH (BD Microtainers®和Sarstedt Microvette®300 FH)中(填充:顶行;中间:第二行;短:第三行)。如果没有第二或第三条线,则使用200 µL(短填充)进行36项临床生化检查和全血细胞计数(CBC)差异(23组分)。与Vacutainers®的结果相比,在每一卷中,如果没有统计学上显著的偏差,则测试是强有力的候选报告。潜在的候选物有统计学上显著的小偏差(绝对偏倚中位数 )结果:24项临床生化试验对所有填充量都有很强或潜在的候选报告,6项对某些填充量有很强或潜在的候选报告,6项对任何填充量都没有候选报告。17个CBC组成部分是报告所有填充量的强候选或潜在候选,2个是报告某些填充量的强候选或潜在候选,4个不是报告任何填充量的候选。结论:虽然大多数测试对不同填充体积的报告是有效的,但有些不是。我们鼓励实验室对填充体积进行自己的研究。
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引用次数: 0
Comparison of mean platelet component and mean platelet mass in immune thrombocytopenia versus hypoproductive thrombocytopenias 免疫性血小板减少症与低生成性血小板减少症平均血小板成分和平均血小板质量的比较。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-12-22 DOI: 10.1016/j.clinbiochem.2025.111070
Hrvoje Melinscak , Tahir Mirzoyev , Yu-Tong Hong , Mala Varma

Introduction

The Siemens (Bayer) ADVIA 120 has the capacity to calculate the mean platelet component (MPC), a measure of platelet density, and the mean platelet mass (MPM). In September 2013, we initiated a prospective study to determine if the MPC and MPM are significantly higher in immune thrombocytopenia than in hypoproductive thrombocytopenias.

Methods

Lavender tri-potassium EDTA tubes were filled and analyzed on the Siemens (Bayer) ADVIA 120 within a period not exceeding two hours from their collection. The student’s t-test was used to compare these parameters in the patient groups. Coefficients of variation were used to study intra-individual variability and inter-individual variability.

Results

Twenty patients with immune thrombocytopenia and 20 patients with hypoproductive thrombocytopenias were enrolled. The MPC and MPM were significantly higher in immune thrombocytopenia than in hypoproductive thrombocytopenias. A unique patient was studied when he had immune thrombocytopenia and then when he had chemotherapy-induced thrombocytopenia during treatment of lymphoma. His MPC and MPM were significantly higher during immune thrombocytopenia than during chemotherapy-induced thrombocytopenia. Intra-individual variability and inter-individual variability were low in this study.

Conclusion

A strength of our study is that the MPC and MPM assays were measured within 2 h of collection, since the MPC decreases over time. Our results attest to the clinical utility of MPC and MPM toward distinguishing immune thrombocytopenia from hypoproductive thrombocytopenias.
西门子(拜耳)ADVIA 120具有计算平均血小板成分(MPC),血小板密度的测量和平均血小板质量(MPM)的能力。2013年9月,我们启动了一项前瞻性研究,以确定MPC和MPM在免疫性血小板减少症中是否明显高于低生成性血小板减少症。方法:收集薰衣草三钾EDTA管后,在不超过2小时的时间内,在Siemens (Bayer) ADVIA 120上进行填充和分析。使用学生t检验来比较患者组中的这些参数。变异系数用于研究个体内变异和个体间变异。结果:共纳入20例免疫性血小板减少症患者和20例低增殖性血小板减少症患者。免疫性血小板减少症患者MPC和MPM明显高于低生成性血小板减少症患者。我们研究了一个独特的病人,当他有免疫性血小板减少症,然后当他在治疗淋巴瘤期间化疗引起的血小板减少症。他的MPC和MPM在免疫性血小板减少时明显高于化疗引起的血小板减少。本研究的个体内变异性和个体间变异性较低。结论:我们研究的一个优势是MPC和MPM检测在收集后2 h内测量,因为MPC随着时间的推移而降低。我们的结果证明了MPC和MPM在区分免疫性血小板减少症和低生成性血小板减少症方面的临床应用。
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Clinical biochemistry
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