Clinical biochemistry最新文献_第5页

Comparison of three different cystatin C measurement procedures in a pediatric chronic kidney disease cohort: Calibration for longitudinal measurements and implications for clinical estimation of GFR 儿童慢性肾病队列中三种不同胱抑素C测量方法的比较：纵向测量的校准及其对GFR临床估计的影响

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-12-24 DOI: 10.1016/j.clinbiochem.2024.110869

Derek K. Ng , George J. Schwartz , Bradley A. Warady , Susan L. Furth , Jesse C. Seegmiller , for the CKiD Study Investigators

Introduction

Serum cystatin C (CysC) is used to estimate glomerular filtration rate (eGFR), including in the Chronic Kidney Disease in Children (CKiD) Under 25 years (U25eGFR) equations. Several CysC measurement procedures available from diagnostic vendors include reference material for calibration, but the extent of heterogeneity across manufacturers is unclear. Since heterogeneity may have clinical and research implications for eGFR, we evaluated three CysC procedures in samples from the CKiD study representing a wide spectrum of kidney function.

Materials and Methods

The three CysC measurement procedures evaluated were: Siemens BN II N Latex CystatinC Assay; Gentian CystatinC Immunoassay; and Roche Tina-quant CystatinC Gen.2. Bland-Altman quantified agreement with Siemens as reference because that method was used for longitudinal CKiD samples from 2003 to 2023. We present derivation of the interquartile range (IQR) of U25eGFR as a measure of precision and describe differences outside this range.

Results

From 53 samples from 44 participants, Gentian measurements were 7 % higher than Siemens (95 %CI: +5.6 %,+8.5 %), while Roche measurements were 4.8 % lower on average (95 %CI: −6.2 %,-3.3 %). Both had very high correlation: 0.9926 and 0.9906, respectively. There was strong agreement across procedures, but a simple correction factor of 7 % reduction applied to Gentian yielded unbiased estimates (+0.03 %, 95 %CI: −1.3 %,+1.4 %) and strong performance in Deming regression. For precision, 98 % of U25eGFR values based on Gentian and Roche CysC were each within the IQR of the Siemens-based estimates.

Conclusions

Despite reference material calibration, heterogeneity across CysC measurement procedures was observed. Procedure variability was within the limits of U25eGFR estimates indicating that practically, all procedures are appropriate for clinical use. Clinicians may consider calculating IQR of U25eGFR estimates for pediatric chronic kidney disease management.

血清胱抑素C （CysC）用于估计肾小球滤过率（eGFR），包括在25岁以下儿童慢性肾病（CKiD） 年（U25eGFR）方程中。诊断供应商提供的几种CysC测量程序包括用于校准的参考材料，但各制造商之间的异质性程度尚不清楚。由于异质性可能对eGFR具有临床和研究意义，我们评估了CKiD研究样本中的三种CysC程序，代表了广泛的肾功能。材料和方法：评估的三种CysC测量方法为：Siemens BN II N Latex CystatinC Assay；龙胆CystatinC免疫测定；和罗氏Tina-quant CystatinC Gen.2。Bland-Altman量化了Siemens的一致性作为参考，因为该方法用于2003年至2023年的纵向CKiD样本。我们提出了U25eGFR的四分位数范围（IQR）的推导，作为精度的度量，并描述了该范围之外的差异。结果：在44名参与者的53份样本中，龙胆草的测量值比西门子高7 %(95 %CI: +5.6 %,+8.5 %)，而罗氏的测量值平均低4.8 %（95 %CI: -6.2 %,-3.3 %）。两者的相关性都非常高，分别为0.9926和0.9906。在整个过程中有很强的一致性，但对龙胆草进行简单的校正因子7 %的减少产生了无偏估计（+0.03 %,95 %CI: -1.3 %,+1.4 %），并且在Deming回归中表现良好。为了精确起见，98 %基于龙胆草和罗氏CysC的U25eGFR值都在基于西门子的估计的IQR内。结论：尽管进行了标准物质校准，但在CysC测量过程中观察到异质性。手术的可变性在U25eGFR估计的范围内，这表明实际上，所有手术都适合临床使用。临床医生可以考虑计算IQR的U25eGFR估计儿童慢性肾脏疾病的管理。

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引用次数: 0

Re-evaluating the utility of iron indices in hereditary hemochromatosis genotyping: A retrospective study 重新评价铁指标在遗传性血色素沉着病基因分型中的应用：一项回顾性研究

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-29 DOI: 10.1016/j.clinbiochem.2024.110860

Amy Lou , Manal O. Elnenaei , Julie Zhu , Kevork Peltekian , Eric Liu , Jennifer A. Jamieson , Hammam Said , Bassam A. Nassar

Introduction

Hereditary hemochromatosis (HH), associated with C282Y or H63D mutations in the HFE gene, is the commonest genetic disorder in Canada. The majority of HH cases are attributable to C282Y homozygosity which can precipitate iron overload and organ damage, but with low penetrance. Elevated transferrin saturation (TSat) and ferritin levels are key biochemical indicators of iron overload in C282Y homozygotes. This retrospective study examined TSat and ferritin levels as predictors of C282Y homozygosity in genotyped patients.

Methods

This study included 23,432 individuals from Maritime provinces who underwent HFE genotyping from 2009 to 2022. Those with available biomarkers (TSat, ferritin, ALT) were included in the study sample. C282Y and H63D variants were identified based on HFE genotying. Median values for each biomarker were compared across genotypes and their diagnostic performance in predicting C282Y homozygosity evaluated using ROC analysis.

Results

1241 individuals (5.3 %) showed C282Y homozygosity, marking the largest North American study cohort. C282Y homozygotes showed significantly higher median TSat and ferritin levels than wildtypes. TSat showed the best diagnostic performance in detecting C282Y homozygosity (AUC = 0.82, 95 % CI: 0.78–0.85), outperforming ferritin (AUC = 0.54, 95 % CI: 0.50–0.58) and ALT (AUC = 0.59, 95 % CI: 0.56–0.63). TSat thresholds of 32 % (females) and 35 % (males) had a 90 % sensitivity for C282Y homozygosity. Using thresholds of TSat ≤46 % and ferritin ≤370 µg/L (females), and TSat ≤49 % and ferritin ≤703 µg/L (males) reduced the need for genotyping by up to 50 % without missing significant biochemical iron overload cases. Implementing this strategy across 23,432 tests could save $1,701,163 and potentially reduce unnecessary downstream management.

Conclusion

Our study suggests significant efficiency savings by implementing an algorithm to reduce unnecessary HFE genotyping and alleviate unwarranted genetic testing anxiety.

遗传性血色素沉着症（HH）与HFE基因的C282Y或H63D突变相关，是加拿大最常见的遗传性疾病。大多数HH病例可归因于C282Y纯合性，可导致铁超载和器官损伤，但外显率低。转铁蛋白饱和度（TSat）和铁蛋白水平升高是C282Y纯合子铁超载的关键生化指标。本回顾性研究检验了TSat和铁蛋白水平作为基因型患者C282Y纯合性的预测因子。方法本研究纳入2009 - 2022年来自沿海省份的23,432例HFE基因分型患者。具有可用生物标志物（TSat、铁蛋白、ALT）者纳入研究样本。通过HFE基因测序鉴定C282Y和H63D变异。比较各基因型生物标志物的中位数，并使用ROC分析评估其预测C282Y纯合性的诊断性能。结果1241例（5.3%）个体显示C282Y纯合性，是北美最大的研究队列。C282Y纯合子的TSat和铁蛋白水平中位数明显高于野生型。TSat对C282Y纯合性的诊断效果最好（AUC = 0.82, 95% CI: 0.78 ~ 0.85），优于铁蛋白（AUC = 0.54, 95% CI: 0.50 ~ 0.58）和ALT （AUC = 0.59, 95% CI: 0.56 ~ 0.63）。TSat阈值为32%（女性）和35%（男性），对C282Y纯合性的敏感性为90%。使用TSat≤46%和铁蛋白≤370µg/L（女性）以及TSat≤49%和铁蛋白≤703µg/L（男性）的阈值，在不遗漏显著生化铁超载病例的情况下，减少了高达50%的基因分型需求。在23,432个测试中实施该策略可以节省1,701,163美元，并可能减少不必要的下游管理。结论本研究表明，通过实施一种算法来减少不必要的HFE基因分型和减轻不必要的基因检测焦虑，可以显著节省效率。

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引用次数: 0

Longitudinal changes in plasma Cystatin C and all-cause mortality risk among the middle-aged and elderly Chinese population 中国中老年人群血浆胱抑素 C 与全因死亡风险的纵向变化

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-23 DOI: 10.1016/j.clinbiochem.2024.110858

Ying Zhang , Ling Zhang , Jie Xing , Yujie Weng , Wangquan Xu , Liping Zhi , Min Yuan

Objective

Elevated plasma Cystatin C levels are associated with an increased mortality risk among middle-aged and elderly Chinese individuals. This study explores whether tracking the longitudinal changes in Cystatin C can improve the prediction of mortality risk and allow better risk stratification, jointly with baseline measurements.

Design & Methods

This analysis includes 3,195 participants from the China Health and Retirement Longitudinal Study who completed plasma Cystatin C measurements in two waves (2011 and 2015) and were followed through 2020. To evaluate the association between Cystatin C levels/changes and mortality risk, multivariate Cox proportional hazard models were employed, adjusting for potential confounders. Survival probabilities were compared using Kaplan-Meier curves and log-rank tests, while restricted cubic splines were utilized to illustrate any nonlinear relationships between Cystatin C levels and hazard ratios.

Results

Participants in the highest quartile of baseline Cystatin C show an increased risk of mortality compared to those in the lowest quartile (hazard ratio (HR): 1.51, 95 % CI: 1.02–2.24, p = 0.04). Including longitudinal changes in Cystatin C further strengthens this association (HR: 1.81, 95 % CI: 1.20–2.74, p < 0.001). Kaplan-Meier plots show that baseline levels effectively stratify both the entire cohort and gender-specific subgroups (p < 0.001). Moreover, integrating baseline levels with the longitudinal changes in Cystatin C levels provides additional stratification benefits. The predictive performance significantly improves by including longitudinal changes in Cystatin C in baseline-only models, with the concordance index increasing from 0.745 to 0.839 and the area under the receiver operator characteristic curve rising from 0.751 to 0.845. Additionally, significant nonlinear relationships between changes in Cystatin C and HR are observed in the entire population, the males and the females (p = 0.003, 0.018, 0.025).

Conclusions

Dynamic monitoring of changes in Cystatin C could enhance the prediction of mortality risk among middle-aged and elderly individuals.

目的血浆胱抑素 C 水平升高与中国中老年人死亡风险增加有关。本研究探讨了追踪胱抑素 C 的纵向变化是否能改善对死亡风险的预测，并结合基线测量结果更好地进行风险分层。为了评估胱抑素 C 水平/变化与死亡风险之间的关系，我们采用了多变量 Cox 比例危险模型，并对潜在的混杂因素进行了调整。使用卡普兰-梅耶曲线和对数秩检验比较生存概率，同时使用限制性三次样条来说明胱抑素 C 水平与危险比之间的非线性关系。结果与基线胱抑素 C 最高四分位数的参与者相比，基线胱抑素 C 最低四分位数的参与者的死亡风险更高（危险比 (HR)：1.51，95 % CI：1.02-2.24，p = 0.04）。胱抑素 C 的纵向变化进一步加强了这种关联（HR：1.81，95 % CI：1.20-2.74，p = 0.001）。Kaplan-Meier 图显示，基线水平有效地对整个队列和特定性别的亚组进行了分层（p < 0.001）。此外，将基线水平与胱抑素 C 水平的纵向变化结合起来还能带来额外的分层优势。将胱抑素 C 的纵向变化纳入纯基线模型后，预测性能明显提高，一致性指数从 0.745 提高到 0.839，接收者运算特征曲线下面积从 0.751 提高到 0.845。结论动态监测胱抑素 C 的变化可提高对中老年人死亡风险的预测能力。

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引用次数: 0

Cardiac biomarkers and CT coronary angiography for the assessment of coronary heart disease 用于评估冠心病的心脏生物标记物和 CT 冠状动脉造影。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-23 DOI: 10.1016/j.clinbiochem.2024.110857

Gard Mikael Sæle Myrmel , Ryan Wereski , Iman Karaji , Nasir Saeed , Kristin Moberg Aakre , Nicholas L. Mills , Eva Ringdal Pedersen

Over the last 30 years, the widespread use of cardiac biomarkers has transformed the diagnostic evaluation of patients with coronary heart disease. Cardiac troponin is integral to the definition of acute myocardial infarction. High-sensitivity cardiac troponin (hs-cTn) assays can improve risk stratification to facilitate both the rapid rule out of myocardial infarction and prediction of future cardiovascular events. Numerous circulating biomarkers representing different pathological pathways improve prediction of atherosclerotic cardiovascular disease (ACVD) and coronary artery disease (CAD). In parallel, coronary computed tomography angiography (CCTA) has become the most widely used imaging modality for the evaluation of patients with possible angina. CCTA now allows for the quantification of coronary calcification, atherosclerotic plaque volume and different plaque characteristics, enabling the identification high-risk features and inflammation. In the future, the use of CCTA is likely to extend to risk stratification for the prevention of ACVD. As such, how to integrate these diagnostic and prognostic circulating and imaging biomarkers is a topic of considerable interest. This review aims to describe current status and future possibilities for the integration of CCTA and cardiac biomarker testing to improve the identification and treatment of individuals with coronary heart disease and heightened cardiovascular risk.

在过去的 30 年中，心脏生物标记物的广泛应用改变了对冠心病患者的诊断评估。心肌肌钙蛋白是定义急性心肌梗死不可或缺的指标。高灵敏度心肌肌钙蛋白（hs-cTn）测定可改善风险分层，有助于快速排除心肌梗死并预测未来的心血管事件。代表不同病理途径的大量循环生物标记物可改善对动脉粥样硬化性心血管疾病（ACVD）和冠状动脉疾病（CAD）的预测。与此同时，冠状动脉计算机断层扫描血管造影术（CCTA）已成为评估可能患有心绞痛的患者最广泛使用的成像方式。目前，冠状动脉计算机断层扫描可量化冠状动脉钙化、动脉粥样硬化斑块的体积和不同斑块的特征，从而识别高危特征和炎症。未来，CCTA 的应用可能会扩展到预防心血管疾病的风险分层。因此，如何整合这些诊断和预后的循环和成像生物标志物是一个颇受关注的话题。本综述旨在描述整合 CCTA 和心脏生物标志物检测的现状和未来可能性，以改进对冠心病和心血管风险增高患者的识别和治疗。

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引用次数: 0

Biochemical exploration of cholestasis: interpretation, traps and interferences 胆汁淤积症的生化探索：解读、陷阱和干扰。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-22 DOI: 10.1016/j.clinbiochem.2024.110852

Nicolas Stojkoski , Maylis Bertrand , Khaled Messaoudi , Claude Bendavid , Redwan Al-Shami , Caroline Moreau

We described the case of a 33-year-old patient who presented to the emergency department with non-febrile jaundice associated with epigastric pain. He suffered from acute non-severe alcoholic hepatitis and cholestasis. Biochemical investigations highlighted a huge elevation of the alpha-1-globulins fraction with an unexpected peak in the alpha-1-globulins area in serum protein electrophoresis, a severe hypercholesterolemia without xanthelasmas nor cholesterolomas. Investigations revealed an abnormal lipoprotein, Lipoprotein X (LpX) that can be responsible for the hypercholesterolemia, but also interferes with biochemical tests like direct low-density lipoprotein cholesterol, albumin, and serum electrolytes assays. LpX is an abnormal lipoprotein, which can be present in patients with liver dysfunction, notably in cholestasis-related conditions where the metabolism of plasma lipoproteins is altered. Cholestasis prevents the normal formation of bile acids, leading to the formation of LpX, which is rich in phospholipids and unesterified cholesterol, but poor in esterified cholesterol, triglycerides and proteins. The accumulation of LpX can lead to severe hypercholesterolemia, but this remains uncommon and data regarding the pathophysiology and incidence of this disease is scarce. The laboratory investigation of patients with suspected Lpx can be challenging, due to the lack of available methods for measurement of LpX. In conclusion, LpX-induced hyperlipidemia must be identified to prevent interference in results for a number of biochemical tests, and additionally to improve patient care.

我们描述了一例 33 岁患者的病例，他因非发热性黄疸伴上腹疼痛到急诊科就诊。他患有急性非重度酒精性肝炎和胆汁淤积症。生化检查结果显示，α-1-球蛋白部分显著升高，血清蛋白电泳中α-1-球蛋白区域出现意外峰值，严重高胆固醇血症，但无黄疽或胆固醇瘤。检查发现了一种异常脂蛋白--脂蛋白 X（LpX），它可能是导致高胆固醇血症的原因，但也会干扰生化检测，如直接低密度脂蛋白胆固醇、白蛋白和血清电解质检测。LpX 是一种异常脂蛋白，可出现在肝功能异常的患者中，尤其是在胆汁淤积相关疾病中，因为在这些疾病中，血浆脂蛋白的代谢会发生改变。胆汁淤积会阻碍胆汁酸的正常形成，从而形成 LpX，它富含磷脂和未酯化胆固醇，但酯化胆固醇、甘油三酯和蛋白质含量较低。LpX 的积累可导致严重的高胆固醇血症，但这种情况并不常见，有关这种疾病的病理生理学和发病率的数据也很少。由于缺乏测量 LpX 的可用方法，对疑似 Lpx 患者进行实验室检查具有挑战性。总之，必须识别由 LpX 引起的高脂血症，以防止一些生化检验结果受到干扰，并改善对患者的护理。

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引用次数: 0

A survey of Canadian neurologists’ perspectives and preferences for laboratory reporting of CSF oligoclonal banding 加拿大神经科医生对实验室报告 CSF 少克隆条带的观点和偏好调查。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-21 DOI: 10.1016/j.clinbiochem.2024.110855

Victoria Higgins , Michelle L. Parker , Daniel R. Beriault , Ahmed Mostafa , Mathew P. Estey , Terence Agbor , Ola Z. Ismail

Introduction

Cerebrospinal fluid (CSF) oligoclonal banding (OCB) analysis aids in the diagnosis of multiple sclerosis (MS). Despite its clinical importance, there is profound variation in processes, reporting, and interpretation of CSF OCB and associated tests/indices across Canadian laboratories. This is likely due to the lack of clear, evidence-based recommendations on CSF OCB analysis processes and reporting. Here, we assessed the CSF OCB reporting needs and preferences of Canadian neurologists as a first step in clinical stakeholder engagement to aid in the development of CSF OCB reporting recommendations.

Methods

A 16-question survey was sent to neurologists across Canada in January 2022, and it closed in March 2022. The survey included questions regarding location and length of clinical practice; preferred maximum time limit for paired CSF and serum samples; reporting preferences for CSF-specific OCB, banding patterns, and associated tests/indices; as well as the clinical utility of CSF OCB and associated tests/indices.

Results

Twenty-two neurologists from nine provinces participated, with a median practice length of 13 years. Most (64 %) preferred a 24-hour limit for paired serum and CSF sample collection. The majority (73 %) favored a cutoff of ≥ 2 CSF-specific bands for positivity, aligning with the 2017 McDonald criteria. Opinions varied on reporting the number of bands and listing specific conditions in the interpretive comments. Some highlighted the need for further research on band count interpretation and its clinical implications. All respondents found CSF OCB results useful, with 64 % valuing it more than other CSF tests for MS evaluation.

Conclusions

Our survey reveals diverse preferences among Canadian neurologists for CSF OCB reporting. Stakeholder engagement and further research are crucial for standardized, improved MS diagnostic practices.

简介：脑脊液（CSF）寡克隆带（OCB）分析有助于诊断多发性硬化症（MS）。尽管其临床重要性不言而喻，但加拿大各实验室在脑脊液寡克隆带分析及相关检测/指标的流程、报告和解释方面却存在很大差异。这可能是由于缺乏关于 CSF OCB 分析流程和报告的明确循证建议。在此，我们对加拿大神经科医生的 CSF OCB 报告需求和偏好进行了评估，作为临床利益相关者参与的第一步，以帮助制定 CSF OCB 报告建议：方法： 2022 年 1 月，我们向加拿大各地的神经科医生发送了一份包含 16 个问题的调查问卷，并于 2022 年 3 月结束。调查内容包括临床实践的地点和时间长短；CSF 和血清样本配对的首选最长时限；CSF 特异性 OCB、分带模式和相关检验/指标的报告偏好；以及 CSF OCB 和相关检验/指标的临床实用性：来自 9 个省的 22 名神经科医生参加了此次调查，他们的执业年限中位数为 13 年。大多数医生（64%）倾向于将血清和脑脊液样本的采集时间限制为 24 小时。大多数人（73%）赞成 CSF 特异性条带阳性的临界值≥ 2，这与 2017 年麦克唐纳标准一致。对于在解释性意见中报告条带数和列出具体条件，意见不一。一些人强调需要进一步研究条带数解释及其临床意义。所有受访者都认为 CSF OCB 结果有用，64% 的受访者认为 CSF OCB 比其他 MS 评估 CSF 检测更有价值：我们的调查揭示了加拿大神经科医生对 CSF OCB 报告的不同偏好。利益相关者的参与和进一步的研究对于标准化和改进 MS 诊断实践至关重要。

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引用次数: 0

Discordance between creatinine and cystatin C-based estimation of glomerular filtration rate (eGFR) in solid organ transplant recipients 基于肌酐和胱抑素 C 的实体器官移植患者肾小球滤过率（eGFR）估算结果不一致。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-20 DOI: 10.1016/j.clinbiochem.2024.110853

Mary Kathryn Bohn , Meshach Asare-Werehene , Felix Leung , Davor Brinc , Rajeevan Selvaratnam

Background

Estimation of glomerular filtration rate is a critical component of assessing kidney function post-solid organ transplantation and in monitoring risk of acute injury. Our objective was to evaluate estimated glomerular filtration rate (eGFR) as derived from creatinine (eGFR_cr), cystatin C (eGFR_cys), and both (eGFR_cr-cys) in a cohort of transplant recipients.

Methods

A total of 47 unique post-solid organ transplant patients receiving tacrolimus were included. Residual specimens were assayed for creatinine (Jaffe and enzymatic), cystatin C, and tacrolimus. eGFR was estimated using the 2021 CKD-EPI formulae. Results were compared by Deming regression and bias was assessed using non-parametric cumulative distribution plots. Percent agreement in chronic kidney disease (CKD) by stage was evaluated across equations.

Results

eGFR_c_ys relative to eGFR_c_r estimates demonstrated a median bias of –22 mL/min/1.73 m² and an overall 21.3 % [95 % CI: 12.1, 35.0] agreement in CKD staging. eGFR_cr-cys demonstrated a median bias of −14 mL/min/1.73 m² and overall agreement of 34.0 % [95 % CI: 22.3, 48.4] relative to eGFR_cr (enzymatic). Discordance increased proportionally with eGFR and did not differ by creatinine assay (Jaffe or enzymatic).

Conclusion

Cystatin C incorporation leads to markedly negative biases between eGFR estimates in patients with solid organ transplant, implying lack of applicability of eGFR_cys or GFR_cr-cys in the transplant setting. This highlights the dependency of patient characteristics on equation performance and the need to consider confounding factors in interpretation and utilization of cystatin C based equations.

背景：估算肾小球滤过率是评估实体器官移植后肾功能和监测急性损伤风险的重要组成部分。我们的目的是在一组移植受者中评估根据肌酐（eGFRcr）、胱抑素 C（eGFRcys）和两者（eGFRcr-cys）得出的估计肾小球滤过率（eGFR）：方法：共纳入 47 名接受他克莫司治疗的独特的实体器官移植后患者。采用 2021 年慢性肾脏病 (CKD) -EPI 公式估算 eGFR。通过戴明回归比较结果，并使用非参数累积分布图评估偏差。结果：eGFRcr 相对于 eGFRcys 估计值的中位偏差为 -22 mL/min/1.73 m2，在 CKD 分期中的总体一致性为 21.3% [95 % CI: 12.1, 35.0]。不一致性随 eGFR 成比例增加，但肌酐测定（雅法或酶法）并无差异：结论：胱抑素 C 的加入会导致实体器官移植患者的 eGFR 估计值之间出现明显的负偏差，这意味着胱抑素 C 在移植环境中缺乏适用性。这凸显了患者特征对方程性能的依赖性，以及在解释和使用基于胱抑素 C 的方程时考虑混杂因素的必要性。

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引用次数: 0

Evaluation of the applicability of urine lateral flow immunochromatography tests for the detection of cocaine in plasma samples 评估尿液侧流免疫层析检测法检测血浆样本中可卡因的适用性。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-17 DOI: 10.1016/j.clinbiochem.2024.110854

Isabella Almeida Millan de Souza , Bruno Pereira dos Santos , Sabrina Nunes do Nascimento , Letícia Birk , Viviane Cristina Sebben , Sarah Eller , Tiago Franco de Oliveira

Introduction

Qualitative analysis of cocaine in urine is a common practice in emergency settings. However, positive results from urine screening tests do not necessarily indicate recent exposure. In this context, plasma is considered a more appropriate option due to its shorter detection window and better correlation with symptomatology. Therefore, the availability of rapid tests for this biological matrix is extremely relevant in the clinical and emergency context.

Methods

A lateral flow immunochromatography test designed for analyzing cocaine in urine was evaluated for use with plasma samples. A total of 412 samples from suspected cases of intoxication were processed and tested. Concurrently, the samples were analyzed for cocaine and its metabolites, benzoylecgonine and ecgonine methyl ester, using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Reliability parameters, including sensitivity, specificity, positive predictive value, negative predictive value, and efficiency, were calculated considering different cutoff values.

Results

Approximately 8.3 % of the samples tested positive in the immunoassay, while 10.2 % had a concentration greater than 5 ng/mL for at least one analyte in the LC-MS/MS analysis. Using benzoylecgonine as the target analyte with a cutoff of 40 ng/mL yielded the best reliability results, with 96.3 % sensitivity and 97.9 % specificity. Cocaine did not show satisfactory results, whereas ecgonine methyl ester, despite having 92.9 % sensitivity and 94.7 % specificity at its best cutoff (20 ng/mL), had a positive predictive value of only 38.2 %.

Conclusions

The study evaluated the suitability of using rapid urine tests for cocaine detection in plasma, offering a simple and quick drug screening method that is particularly useful in toxicological emergencies.

导言：对尿液中的可卡因进行定性分析是急诊环境中的常见做法。然而，尿液筛查试验的阳性结果并不一定表明最近接触过可卡因。在这种情况下，血浆被认为是更合适的选择，因为它的检测时间更短，与症状的相关性更好。因此，提供这种生物基质的快速检测方法对临床和急救工作极为重要：方法：评估了用于分析尿液中可卡因的侧流免疫层析检测法在血浆样本中的应用。共处理和检测了 412 份疑似中毒病例的样本。同时，利用液相色谱-串联质谱法（LC-MS/MS）对样本中的可卡因及其代谢物苯甲酰可待因和可待因甲酯进行了分析。根据不同的临界值计算了灵敏度、特异性、阳性预测值、阴性预测值和效率等可靠性参数：约 8.3% 的样本在免疫测定中呈阳性，而 10.2% 的样本在 LC-MS/MS 分析中至少有一种分析物的浓度超过 5 纳克/毫升。以苯甲酰可待因为目标分析物，以 40 纳克/毫升为临界值，结果可靠性最佳，灵敏度为 96.3%，特异性为 97.9%。可卡因的结果并不令人满意，而蜕皮激素甲酯尽管在最佳临界值（20 纳克/毫升）下具有 92.9 % 的灵敏度和 94.7 % 的特异性，但其阳性预测值仅为 38.2 %：该研究评估了使用快速尿检检测血浆中可卡因的适用性，提供了一种简单、快速的药物筛查方法，尤其适用于毒理学紧急情况。

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引用次数: 0

The potential of anti-glutamic acid decarboxylase antibodies to support a diagnosis of autoimmune diabetes mellitus 抗谷氨酸脱羧酶抗体支持自身免疫性糖尿病诊断的潜力。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-17 DOI: 10.1016/j.clinbiochem.2024.110842

Maryah Liepert , Shamayel Alhaqqan , Alaa Husain , Heather Lochnan , Ronald A. Booth , Julie Shaw , Cathy J. Sun

Objective

Anti-glutamic acid decarboxylase (anti-GAD) antibodies are a frequently used diagnostic marker for autoimmune forms of diabetes mellitus (DM), namely, type 1 diabetes mellitus (T1DM) and latent autoimmune diabetes in adults (LADA). We sought to provide insight into a unique diagnostic application of anti-GAD antibodies in patients potentially misdiagnosed with type 2 diabetes mellitus (T2DM).

Methods

We present a case series of patients who had a change in diagnosis from T2DM to autoimmune DM that was supported by positive anti-GAD antibodies. Patients were identified via a retrospective chart review of all anti-GAD antibodies tests ordered between 1 January 2020 and 31 December 2021 at a tertiary care academic hospital.

Results

Of the 23 patients with previous diagnosis of T2DM, positive anti-GAD antibodies supported the clinician’s decision to change the diagnosis to autoimmune DM. The prominent clinical reasons for ordering anti-GAD antibodies in patients previously diagnosed as T2DM were patient presentation with diabetic ketoacidosis, features of insulin insufficiency, inadequate effect of oral diabetes mellitus medications, young age at diagnosis, and a family history of autoimmune conditions.

Conclusion

Anti-GAD antibodies’ positivity can support a change in diagnosis from T2DM to autoimmune DM, which has substantial impact on patient care. Timely and reliable clinical laboratory reporting of anti-GAD antibodies is highly recommended.

目的：抗谷氨酸脱羧酶（anti-GAD）抗体是自身免疫性糖尿病（DM），即1型糖尿病（T1DM）和成人潜伏自身免疫性糖尿病（LADA）的常用诊断标志物。我们试图深入了解抗GAD抗体在可能被误诊为2型糖尿病（T2DM）患者中的独特诊断应用：我们展示了一系列病例，这些患者的诊断由T2DM转变为自身免疫性DM，抗GAD抗体阳性支持了诊断结果。我们对一家三级医疗学术医院在 2020 年 1 月 1 日至 2021 年 12 月 31 日期间开具的所有抗 GAD 抗体检测单进行了回顾性病历审查，从而确定了患者：结果：在23名先前诊断为T2DM的患者中，抗GAD抗体阳性支持临床医生将诊断改为自身免疫性DM的决定。先前被诊断为T2DM的患者订购抗-GAD抗体的主要临床原因是患者出现糖尿病酮症酸中毒、胰岛素分泌不足、口服糖尿病药物效果不佳、诊断时年龄较小、有自身免疫性疾病家族史：抗-GAD抗体阳性可支持从T2DM到自身免疫性DM的诊断改变，这对患者护理有重大影响。我们强烈建议临床实验室及时、可靠地报告抗-GAD抗体。

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引用次数: 0

Decreased monocytic HLA-DR in patients with sepsis: Prediction of diagnosis, severity and prognosis 败血症患者单核细胞 HLA-DR 减少：预测诊断、严重程度和预后。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-15 DOI: 10.1016/j.clinbiochem.2024.110851

Juanjuan Cui , Wen Cai , Li Zhang , Yueyuan Wu , Yan Huang , Weifeng Zhao

Objective

Sepsis is characterized by high incidence and mortality rates, making early recognition and risk stratification critical for preventing delayed treatment and overtreatment. This study investigated the potential of monocytic (m) HLA-DR as a diagnostic and prognostic biomarker of sepsis.

Methods

In this prospective study, we collected blood in EDTA-anticoagulated tubes within 48 h from patients diagnosed with sepsis or infection and analyzed the percentage of mHLA-DR in peripheral blood mononuclear cells, C-reactive protein, and procalcitonin within 2 h of collection. We gathered clinical and laboratory data, including sex, age, and comorbidities, calculated the number of dysfunctional organs and sequential organ failure assessment (SOFA) score, and recorded the survival status of patients with sepsis on the 30th day after admission.

Results

mHLA-DR levels were lower in patients with sepsis (median 46.60 [interquartile range 23.86–66.51]%) than infection (75.44 [52.13–91.50]%). mHLA-DR could distinguish sepsis from infection with an area under the curve (AUC) of 0.724 (95 %CI 0.624–0.824). Decreased mHLA-DR levels have been found in septic patients with shock or secondary infections. mHLA-DR expression decreased with an increasing number of dysfunctional organs and higher SOFA score. In 30-day non-survivors, mHLA-DR levels were 26.94 (12.06–44.45)%, significantly lower than in survivors (55.20 [24.83–72.37]%). mHLA-DR predicted sepsis prognosis with an AUC of 0.750 (95 %CI 0.623–0.877). When the cut-off value was <52.29 %, the sensitivity and specificity of mHLA-DR for prognosis were 100 % and 52.83 %, respectively. The 30-day survival rate of septic patients with mHLA-DR ≥ 52.29 % was 6.798 (95 %CI 2.075–22.27) times higher than that of patients with mHLA-DR < 52.29 %.

Conclusion

mHLA-DR negatively correlates with the severity of sepsis and could be used as a diagnostic and prognostic biomarker for sepsis.

目的：败血症具有高发病率和高死亡率的特点，因此早期识别和风险分层对于防止延误治疗和过度治疗至关重要。本研究探讨了单核细胞（m）HLA-DR 作为败血症诊断和预后生物标志物的潜力：在这项前瞻性研究中，我们在 48 小时内用 EDTA 抗凝管采集了确诊为败血症或感染患者的血液，并在采集后 2 小时内分析了外周血单核细胞中 mHLA-DR 的百分比、C 反应蛋白和降钙素原。我们收集了包括性别、年龄和合并症在内的临床和实验室数据，计算了功能障碍器官的数量和序贯器官衰竭评估（SOFA）评分，并记录了脓毒症患者入院后第 30 天的生存状况。结果：与感染（75.44 [52.13-91.50] %）相比，脓毒症患者的 mHLA-DR 水平较低（中位数 46.60 [四分位距 23.86-66.51]%）。随着功能障碍器官数量的增加和 SOFA 评分的提高，mHLA-DR 的表达也会降低。在 30 天内未存活的患者中，mHLA-DR 水平为 26.94 (12.06-44.45)%，明显低于存活者（55.20 [24.83-72.37]%）。mHLA-DR 预测脓毒症预后的 AUC 为 0.750 (95 %CI 0.623-0.877)。结论：mHLA-DR与脓毒症的严重程度呈负相关，可用作脓毒症的诊断和预后生物标志物。

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引用次数: 0