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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
Clinical biochemistry
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。
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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
Clinical biochemistry
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
Clinical biochemistry
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
Clinical biochemistry
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
Clinical biochemistry
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。
{"title":"Comparison of mean platelet component and mean platelet mass in immune thrombocytopenia versus hypoproductive thrombocytopenias","authors":"Hrvoje Melinscak ,&nbsp;Tahir Mirzoyev ,&nbsp;Yu-Tong Hong ,&nbsp;Mala Varma","doi":"10.1016/j.clinbiochem.2025.111070","DOIUrl":"10.1016/j.clinbiochem.2025.111070","url":null,"abstract":"<div><h3>Introduction</h3><div>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.</div></div><div><h3>Methods</h3><div>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 <em>t</em>-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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"141 ","pages":"Article 111070"},"PeriodicalIF":2.1,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145827171","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
Simple lithium measurement in capillary dried plasma microsamples collected with the HealthID PSD device 用HealthID PSD设备收集的毛细管干燥等离子体微样品中的简单锂测量
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Clinical biochemistry
Pub Date : 2025-12-19 DOI: 10.1016/j.clinbiochem.2025.111069
Eduarda Milena Reichert , Carolina Weber Ferrareze , Mayara Bernardes , Giovana Piva Peteffi , Amanda Pachedo Bondan , Mariele Feiffer Charão , Rafael Linden

Background

Monitoring serum lithium concentrations is essential during bipolar disorder treatment. This study aimed to develop and validate a simple approach for estimating serum lithium concentrations using dried plasma spots (DPS) obtained from the HealthID PSD device after application of capillary blood.

Methods

Lithium was extracted using BSA solution and quantified with a colorimetric assay on an automated clinical analyzer. A chloride-based correction factor was applied to account for variable plasma volumes in DPS extracts. Analytical validation included linearity, extraction yield, imprecision, hematocrit and volume effects, chromatographic uniformity during plasma migration, and stability at different temperatures. A clinical comparison study was performed using paired serum samples and DPS from 40 patients undergoing lithium therapy. Serum-equivalent lithium concentrations were calculated by applying a multiplication factor derived from the serum-to-DPS ratio. Agreement was assessed by Passing–Bablok regression, Bland–Altman analysis, median percentage predictive error (MPPE), median absolute percentage error (MAPE), and total error (TE).

Results

Linearity was demonstrated from 0.1–2.5 mmol/L. Extraction yields were 93.2–95.7 %, and chloride correction significantly improved imprecision. Hematocrit (30–50 %) and applied volume (160–240 µL) showed minimal influence on corrected concentrations. Lithium remained stable for 21 days. Serum-equivalent DPS lithium showed strong correlation with serum (r = 0.984), no proportional or systematic bias, MPPE 0.91 %, MAPE 6.7 %, and TE 11.9 %.

Conclusions

Lithium can be reliably quantified in DPS generated with the HealthID PSD device using a routine colorimetric assay. The method enables stable, minimally invasive capillary microsampling suitable for clinical monitoring of lithium therapy.
背景：在双相情感障碍治疗过程中监测血清锂浓度是必不可少的。本研究旨在开发和验证一种简单的方法，利用从HealthID PSD装置获得的毛细管血后的干血浆斑点（DPS）来估计血清锂浓度。方法采用牛血清白蛋白溶液提取钪，在全自动临床分析仪上用比色法定量。氯基校正因子用于解释DPS提取物中可变的血浆体积。分析验证包括线性度、提取率、不精密度、红细胞压积和体积效应、等离子体迁移过程中的色谱均匀性和不同温度下的稳定性。对40例接受锂治疗的患者的配对血清样本和DPS进行了临床比较研究。通过应用从血清- dps比率得出的倍增因子来计算血清等效锂浓度。采用Passing-Bablok回归、Bland-Altman分析、中位数百分比预测误差（MPPE）、中位数绝对百分比误差（MAPE）和总误差（TE）评估一致性。结果在0.1 ~ 2.5 mmol/L范围内呈线性关系。提取率为93.2 ~ 95.7%，经氯离子校正可显著改善不精密度。红细胞压积（30 - 50%）和应用体积（160-240µL）对校正浓度的影响最小。锂在21天内保持稳定。血清等效DPS锂与血清有很强的相关性（r = 0.984），无比例偏倚或系统偏倚，MPPE为0.91%，MAPE为6.7%，TE为11.9%。结论采用常规比色法，HealthID PSD装置产生的DPS中可以可靠地定量测定硫。该方法使稳定，微创毛细管微采样适合于锂治疗的临床监测。
{"title":"Simple lithium measurement in capillary dried plasma microsamples collected with the HealthID PSD device","authors":"Eduarda Milena Reichert ,&nbsp;Carolina Weber Ferrareze ,&nbsp;Mayara Bernardes ,&nbsp;Giovana Piva Peteffi ,&nbsp;Amanda Pachedo Bondan ,&nbsp;Mariele Feiffer Charão ,&nbsp;Rafael Linden","doi":"10.1016/j.clinbiochem.2025.111069","DOIUrl":"10.1016/j.clinbiochem.2025.111069","url":null,"abstract":"<div><h3>Background</h3><div>Monitoring serum lithium concentrations is essential during bipolar disorder treatment. This study aimed to develop and validate a simple approach for estimating serum lithium concentrations using dried plasma spots (DPS) obtained from the HealthID PSD device after application of capillary blood.</div></div><div><h3>Methods</h3><div>Lithium was extracted using BSA solution and quantified with a colorimetric assay on an automated clinical analyzer. A chloride-based correction factor was applied to account for variable plasma volumes in DPS extracts. Analytical validation included linearity, extraction yield, imprecision, hematocrit and volume effects, chromatographic uniformity during plasma migration, and stability at different temperatures. A clinical comparison study was performed using paired serum samples and DPS from 40 patients undergoing lithium therapy. Serum-equivalent lithium concentrations were calculated by applying a multiplication factor derived from the serum-to-DPS ratio. Agreement was assessed by Passing–Bablok regression, Bland–Altman analysis, median percentage predictive error (MPPE), median absolute percentage error (MAPE), and total error (TE).</div></div><div><h3>Results</h3><div>Linearity was demonstrated from 0.1–2.5 mmol/L. Extraction yields were 93.2–95.7 %, and chloride correction significantly improved imprecision. Hematocrit (30–50 %) and applied volume (160–240 µL) showed minimal influence on corrected concentrations. Lithium remained stable for 21 days. Serum-equivalent DPS lithium showed strong correlation with serum (<em>r</em> = 0.984), no proportional or systematic bias, MPPE 0.91 %, MAPE 6.7 %, and TE 11.9 %.</div></div><div><h3>Conclusions</h3><div>Lithium can be reliably quantified in DPS generated with the HealthID PSD device using a routine colorimetric assay. The method enables stable, minimally invasive capillary microsampling suitable for clinical monitoring of lithium therapy.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"141 ","pages":"Article 111069"},"PeriodicalIF":2.1,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145786948","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
The influence of kidney function on the prognostic value of cardiac troponin 肾功能对心肌肌钙蛋白预后价值的影响。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Clinical biochemistry
Pub Date : 2025-12-16 DOI: 10.1016/j.clinbiochem.2025.111068
Rasmus Bo Hasselbalch , Martin Schultz , Nicholas Carlson , Nina Strandkjær , Sophie Sander Knudsen , Alexander Holst Kronborg , Kristian H. Kragholm , Mikkel Porsborg Andersen , Henning Bundgaard , Christian Torp-Pedersen , Kristin M. Aakre , Kasper Karmark Iversen

Background

Kidney function influences the concentration of cardiac troponin T (cTnT) and I (cTnI). We investigate how this impacts their prognostic ability.

Methods

This Danish nationwide study included patients from 2013 to 2023 with at least two measurements of Roche hs-cTnT, Abbott hs-cTnI, or Siemens hs-cTnI Vista or Atellica during the index admission. Patients were stratified by estimated glomerular filtration rate (eGFR). We assessed prognostic ability by Cox models and area under the receiver operating characteristics curve (AUC). The primary endpoint was 30-day all-cause mortality.

Results

We included 277,723 patients (median age 69 years, 38.4 % female) of whom 19,565 (7.0 %) died within 30 days. Almost all patients with eGFR <30 ml/min/1.73 m2 had myocardial injury using hs-cTnT (99.4 %) compared to hs-cTnI (85.4 %). Hazard ratios (HRs) for overall myocardial injury were higher than for acute myocardial injury and declined with worsening eGFR, particularly for hs-cTnT: HR 15.58 (95 % CI 12.77–19.00) for eGFR ≥90 ml/min/1.73 m2, while estimation was impossible at eGFR 15–30 ml/min/1.73 m2 due to few normal values. The highest HR for acute myocardial injury at eGFR ≥90 ml/min/1.73 m2 was for hs-cTnI Abbott, HR 3.50 (95 % CI 2.79–4.38). AUC decreased with worsening eGFR across assays, 0.68–0.76 for eGFR ≥90 ml/min/1.73 m2 to 0.59–0.63 for eGFR <15 ml/min/1.73 m2. At eGFR ≥90 ml/min/1.73 m2 the optimal cutoff was 16.5 ng/l for hs-cTnT and below the sex-specific 99th percentile for all hs-cTnI assays, increasing 5–20-fold with lower eGFR for all assays.

Conclusion

Kidney function affects cTn prognostic performance, with reduced predictive ability and higher optimal cutoff concentrations for lower eGFR.
背景：肾功能影响心肌肌钙蛋白T （cTnT）和I （cTnI）的浓度。我们调查这如何影响他们的预后能力。方法：这项丹麦全国范围的研究纳入了2013年至2023年在入院期间至少两次测量罗氏hs-cTnT、雅培hs-cTnI或西门子hs-cTnI Vista或Atellica的患者。通过估计肾小球滤过率（eGFR）对患者进行分层。我们通过Cox模型和受试者工作特征曲线下面积（AUC）评估预后能力。主要终点为30天全因死亡率。结果：我们纳入了277,723例患者（中位年龄69 岁，女性38.4% %），其中19,565例（7.0 %）在30 天内死亡。与使用hs-cTnI（85.4 %）相比，几乎所有的eGFR 2患者使用hs-cTnT（99.4 %）都有心肌损伤。整体心肌损伤的危险比（HR）高于急性心肌损伤，并随着eGFR的恶化而下降，特别是hs-cTnT: eGFR≥90 ml/min/1.73 m2时，HR为15.58(95 % CI 12.77-19.00)，而eGFR 15-30 ml/min/1.73 m2时，由于正常值很少，无法估计。当eGFR≥90 ml/min/1.73 m2时，hs-cTnI Abbott急性心肌损伤的HR最高，HR为3.50（95% % CI 2.79-4.38）。AUC随eGFR的恶化而降低，eGFR≥90时为0.68-0.76 ml/min/1.73 m2， eGFR 2时为0.59-0.63。当eGFR≥90 ml/min/1.73 m2时，hs-cTnT的最佳临界值为16.5 ng/l，所有hs-cTnI检测的最佳临界值均低于性别特异性的第99个百分点，随着eGFR的降低，所有检测的最佳临界值均增加5-20倍。结论：肾功能影响cTn的预后，其预测能力降低，eGFR越低，最佳切断浓度越高。
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引用次数: 0
A novel fluorescent-labeled serum protein electrophoresis method for detection of monoclonal free light chains in serum 荧光标记血清蛋白电泳检测血清中单克隆游离轻链的新方法。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Clinical biochemistry
Pub Date : 2025-12-15 DOI: 10.1016/j.clinbiochem.2025.111067
Gaoyang Pang , Xiaojun Kang , Yan Li , Xiaojuan Zhang , Huijun Ren

Background

Current guidelines recommend a combination of serum protein electrophoresis (SPE), immunofixation electrophoresis (IFE), and serum free light chain (FLC) assays for monoclonal immunoglobulin (M−protein) screening. However, the high cost of this comprehensive panel limits its widespread use. In routine clinical practice in China, SPE alone is commonly employed for general population screening, but it suffers from low sensitivity for detecting monoclonal free light chains (LC-M−proteins), leading to a high rate of missed diagnoses. There is a clear clinical need for a novel method that enhances LC-M−protein detection while preserving the practicality of SPE.

Methods

We established a fluorescent-labeled serum protein electrophoresis (FSPE) technique. The method utilizes 2-(diphenylphosphino)ethylamine (DPEA) to selectively reduce the C-terminal thiols of LC-M−proteins (4 °C, 60 min, dark), followed by specific fluorescent labeling with sulfo-Cyanine5 maleimide (4 °C, 30 min, dark). After agarose gel electrophoresis separation, synchronous identification and quantification of LC-M−proteins and intact M−proteins are achieved via dual-channel (fluorescence and protein staining) imaging.

Results

Method validation demonstrated that DPEA enables efficient and selective reduction. The detection limit of FSPE for LC-M−proteins reached 400 mg/L. Quantitative analysis showed excellent performance (linearity: R2 = 0.9887; total precision: relative standard deviation, RSD = 6.61%). FSPE results were highly correlated with the reference Freelite™ FLC assay (Spearman’s rs = 0.895, p < 0.01), although Bland-Altman analysis revealed quantitative differences between individual samples.

Conclusion

FSPE represents a significant upgrade to conventional SPE, effectively addressing its critical flaw of missing LC-M−proteins while achieving sensitivity comparable to IFE. It retains the key advantages of SPE, namely operational simplicity and low cost. Therefore, FSPE emerges as a potential standalone method for efficient M−protein screening.
背景：目前的指南推荐结合血清蛋白电泳（SPE）、免疫固定电泳（IFE）和血清游离轻链（FLC）检测来筛选单克隆免疫球蛋白（m蛋白）。然而，这种综合面板的高成本限制了它的广泛应用。在中国的常规临床实践中，SPE通常单独用于普通人群筛查，但其检测单克隆游离轻链（lc - m蛋白）的灵敏度较低，导致漏诊率高。显然，临床需要一种新的方法来增强lc - m蛋白检测，同时保持SPE的实用性。方法建立荧光标记血清蛋白电泳（FSPE）技术。该方法利用2-（二苯基膦）乙胺（DPEA）选择性地还原lc - m蛋白的C端硫醇（4 °C, 60 min，暗），然后用磺基氰胺5马来酰亚胺（4 °C, 30 min，暗）进行特异性荧光标记。琼脂糖凝胶电泳分离后，通过双通道（荧光和蛋白染色）成像实现lc - m蛋白和完整m蛋白的同步鉴定和定量。结果：方法验证表明，DPEA具有高效、选择性的还原效果。FSPE对lc - m蛋白的检出限达到400 mg/L。定量分析结果良好（线性关系：R2 = 0.9887；总精密度：相对标准偏差，RSD = 6.61%）。FSPE结果与参考Freelite™FLC分析高度相关（Spearman’s rs = 0.895, p < 0.01），尽管Bland-Altman分析显示个体样品之间存在定量差异。结论：FSPE代表了传统SPE的重大升级，有效地解决了lc - m蛋白缺失的关键缺陷，同时获得了与IFE相当的灵敏度。它保留了SPE的主要优点，即操作简单和成本低。因此，FSPE成为高效m蛋白筛选的潜在独立方法。
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引用次数: 0
Improving the environmental impact paradox of clinical medical laboratories 改善临床医学实验室环境影响悖论。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Clinical biochemistry
Pub Date : 2025-12-15 DOI: 10.1016/j.clinbiochem.2025.111063
Pernilla Sörme, Scott Weitze
The global healthcare system is a substantial contributor to planetary greenhouse gas emissions and the climate crisis. Healthcare also has additional negative effects on the environment through the pollution of water, soil, and air, and the generation of general and regulated biomedical waste. The healthcare system’s lagging sustainability has both direct and indirect consequences for human health, these factors present a paradox. Healthcare Without Harm has estimated that global healthcare systems are emitting two gigatons of carbon dioxide yearly, accounting for 4.4% of total global net emissions. Healthcare systems should address their negative environmental impact, while still treating patients to the highest standards of care.
Laboratories are resource-intensive spaces and should be a principal consideration when addressing the overall sustainability strategy of a healthcare system. Clinical medical laboratories, in particular, have often not optimised operations for sustainability, and have overlooked carbon emissions. The last decade has seen slow adoption of sustainable practices in clinical diagnostic laboratories even though numerous tools and programs are available for implementation, a disappointing result that also suggests an opportunity for rapid and dramatic improvement.
This article will describe:
  • •
    The impact of clinical laboratories on the environment.
  • •
    What actions clinical laboratories can take to reduce the environmental footprint of the healthcare system.
  • •
    How third-party certification standards and established organizations are being utilized by hospitals and diagnostic laboratories.
  • •
    Progress towards expanding the My Green Lab Certification framework to address the unique operational and environmental challenges of clinical laboratories.
全球医疗保健系统是造成全球温室气体排放和气候危机的重要因素。医疗保健还通过污染水、土壤和空气以及产生一般和受管制的生物医学废物对环境产生额外的负面影响。医疗保健系统的滞后可持续性对人类健康有直接和间接的影响，这些因素呈现出一个悖论。“无伤害医疗保健”组织估计，全球医疗保健系统每年排放20亿吨二氧化碳，占全球净排放量的4.4%。卫生保健系统应解决其对环境的负面影响，同时仍以最高的护理标准治疗患者。实验室是资源密集型空间，在解决医疗保健系统的整体可持续性战略时应主要考虑。特别是临床医学实验室，往往没有优化可持续性操作，并且忽视了碳排放。在过去的十年中，尽管有许多工具和程序可供实施，但临床诊断实验室对可持续实践的采用速度缓慢，这一令人失望的结果也表明了快速和显著改善的机会。本文将描述。
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引用次数: 0
Evaluation of three NT-proBNP assays for heart failure 三种NT-proBNP检测心力衰竭的评价。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Clinical biochemistry
Pub Date : 2025-12-06 DOI: 10.1016/j.clinbiochem.2025.111062
Isaiah K. Mensah , Brittany Roemmich , Sydny Lawless , Alexis Wysocki , David Daghfal , Christian J. Hunter , Christopher W. Farnsworth

Background

N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurement is recommended by guidelines for diagnosing and managing heart failure (HF). Accurate NT-proBNP measurement is critical for timely and effective treatment, but limited studies have compared NT-proBNP results from multiple platforms, and few studies have compared their concordance using commonly used clinical cutpoints.

Methods

The Alinity, PathFast, and Roche NT-proBNP assays were assessed in 276 patient samples, comprising 188 inpatients and 88 outpatients with normal renal function. Correlation and bias among the assays were assessed, and guideline-endorsed clinical cutpoints were used to evaluate concordance.

Results

Passing-Bablok regression revealed a slope of 1.00 (95% CI: 0.99–1.01) for Alinity vs. Roche, 1.14 (1.11–1.16) for PathFast vs. Roche, and 1.11 (1.01–1.13) for PathFast vs. Alinity. Bland-Altman analysis revealed minimal bias among the assays, with the closest agreement observed between PathFast and Alinity (−1.85%, −43.36 to 39.65). On inpatients, the concordance was 0.97 (0.94–0.99) for Alinity vs. Roche, 0.95 (0.92–0.99) for PathFast vs. Roche, and 0.94 (0.91–0.98) for PathFast vs. Alinity. For outpatients, the concordance was 0.92 (0.84–1.00) for Alinity vs. Roche, 0.90 (0.80–1.00) for PathFast vs. Roche, and 0.97 (0.92–1.00) for PathFast vs. Alinity.

Conclusion

Three NT-proBNP assay platforms demonstrated high correlation, minimal bias, and high clinical concordance. The results support the clinical interchangeability of these assays at commonly used and guideline-endorsed cutpoints.
背景：n -末端前b型利钠肽（NT-proBNP）测量被心力衰竭（HF）的诊断和管理指南推荐。准确的NT-proBNP测量对于及时有效的治疗至关重要，但是比较多个平台NT-proBNP结果的研究有限，而且很少有研究使用常用的临床切点比较它们的一致性。方法：对276例患者样本进行Alinity、PathFast和Roche NT-proBNP检测，其中包括188例住院患者和88例门诊正常肾功能患者。评估试验之间的相关性和偏倚，并使用指南认可的临床切点来评估一致性。结果：Passing-Bablok回归显示Alinity与Roche的斜率为1.00 (95% CI: 0.99-1.01)， PathFast与Roche的斜率为1.14 (1.11-1.16)，PathFast与Alinity的斜率为1.11（1.01-1.13）。Bland-Altman分析显示，两种检测方法之间的偏倚最小，PathFast和Alinity的一致性最接近（-1.85%,-43.36至39.65）。在住院患者中，Alinity与Roche的一致性为0.97 (0.94-0.99)，PathFast与Roche的一致性为0.95 (0.92-0.99)，PathFast与Alinity的一致性为0.94（0.91-0.98）。对于门诊患者，Alinity与Roche的一致性为0.92 (0.84-1.00)，PathFast与Roche的一致性为0.90 (0.80-1.00)，PathFast与Alinity的一致性为0.97（0.92-1.00）。结论：三个NT-proBNP检测平台具有高相关性、最小偏倚和高临床一致性。结果支持这些检测在常用和指南认可的切点的临床互换性。
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