Clinical biochemistry最新文献_第5页

A large-scale survey on the knowledge, attitude, and practice of patient-based real-time quality control in China 中国基于患者的实时质量控制知识、态度和实践的大规模调查。

IF 2.1 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2025-11-10 DOI: 10.1016/j.clinbiochem.2025.111044

Dong Leng , Mengxue Lyu , Li Wei , Xueling Shang , Xia Lou , Minglong Zhang , Yali Zhou , Tony Badrick , Rui Zhou , On behalf of the APFCB Working Group on Patient-based Real-Time Quality Control

Objectives

Patient-based real-time quality control (PBRTQC) plays a promising role in monitoring the quality of medical laboratory testing processes worldwide. In contrast with traditional quality control, PBRTQC demonstrates numerous advantages, but the application status remains unclear. This study was conducted to assess the awareness and intention to apply PBRTQC in laboratories through a survey, providing a basis for subsequent research and promotion.

Design & Methods

A questionnaire was constructed and extended on the basis of Badrick’s fifteen core questions in 2023, which were distributed via the Star questionnaire platform to collect general information on relevant personnel, their cognition, attitude and practice of PBRTQC as well as their willingness to implement it. This survey was carried out in different kinds of clinical laboratories throughout the mainland area of China.

Results

A total of 1,844 valid questionnaires were collected. The survey showed that the average awareness rate of basic knowledge of PBRTQC among laboratory staff was above 50%, and their confidence in establishing and applying PBRTQC in their laboratories was relatively low. However, they recognized the role of PBRTQC in improving quality management. Among the existing PBRTQC related practices, reading literature was the most common. The main concerns for promoting PBRTQC included professional implementation guidelines and policy support, reliable commercial evaluations, software and hardware support, and usage training.

Conclusions

The results of our study demonstrate that laboratory staff recognize the value of PBRTQC and have a generally positive attitude towards its application. In the future, efforts should be made to strengthen the formulation of standardized documents, improve evaluation methods, develop software and hardware, popularize knowledge, and provide technical training to promote the application of PBRTQC.

目的：基于患者的实时质量控制（PBRTQC）在监测全球医学实验室检测过程的质量方面发挥着重要作用。与传统的质量控制相比，PBRTQC具有诸多优势，但其应用现状尚不明朗。本研究通过问卷调查的方式，评估实验室应用PBRTQC的认知度和意愿，为后续的研究和推广提供依据。设计与方法：以Badrick在2023年提出的15个核心问题为基础，构建并扩展问卷，通过Star问卷平台进行发放，收集相关人员的总体情况、对PBRTQC的认知、态度和实践情况以及实施意愿。这项调查是在中国大陆地区不同类型的临床实验室进行的。结果：共回收有效问卷1844份。调查显示，实验室工作人员对PBRTQC基础知识的平均知晓率在50%以上，对在实验室建立和应用PBRTQC的信心较低。然而，他们认识到PBRTQC在改善质量管理方面的作用。在现有的与PBRTQC相关的实践中，阅读文献是最常见的。促进PBRTQC的主要关注点包括专业的实施指南和政策支持、可靠的商业评估、软件和硬件支持以及使用培训。结论：本研究结果表明，实验室工作人员普遍认可PBRTQC的价值，并对其应用持普遍积极的态度。今后应加强标准化文件的制定、完善评价方法、软硬件开发、知识普及、技术培训等工作，促进PBRTQC的应用。

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引用次数: 0

A novel Gasdermin D C-terminal neo-epitope as a biomarker for pyroptosis in sepsis 一种新的Gasdermin D c末端新表位作为脓毒症中焦亡的生物标志物

IF 2.1 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2025-11-10 DOI: 10.1016/j.clinbiochem.2025.111045

Jun Li , Yunyun Luo , Ying Liu , Shujing Cui , Lixin Zhao , Haoxiang Kang , Lijing Huo , Xu Wang , Erling Jin , Sufang Mao , Yu Cao , Jianxia Wang

Background

Gasdermin D (GSDMD)-mediated pyroptosis, a critical component of the innate immune response, is triggered by pathogenic microbial infections and plays a key role in host defense mechanisms. This process involves the cleavage of GSDMD by inflammatory caspases, releasing carboxy-terminal fragments (GSDMD-CT). Monitoring GSDMD-CT levels represents a promising approach for inflammatory diseases, including sepsis and systemic inflammatory response syndrome (SIRS).

Methods

We developed an immunoassay to measure plasma GSDMD-CT concentrations in 109 healthy individuals, 137 patients with SIRS, and 100 patients with sepsis. The diagnostic utility of GSDMD-CT in distinguishing sepsis from SIRS or healthy controls was assessed using receiver operating characteristic (ROC) analysis, alongside correlations with procalcitonin (PCT), and C-reactive protein (CRP).

Results

Plasma GSDMD-CT levels were significantly elevated in patients with sepsis compared to healthy control and SIRS groups. ROC analysis demonstrated an area under the curve of 0.870, with a sensitivity of 91.0% and specificity of 60.6% for differentiating sepsis from healthy controls. Comparable performance was observed in distinguishing SIRS from healthy controls. Diagnostic accuracy was further enhanced when GSDMD-CT was combined with CRP. Strikingly, GSDMD-CT mirrored the kinetic profile of PCT in antibiotic-treated patients with bacterial infections.

Conclusion

The GSDMD-CT assay demonstrates high sensitivity as a biomarker, offering potential for early and differential diagnosis of sepsis across diverse pathogens.

gasdermin D （GSDMD）介导的焦亡是先天免疫反应的一个重要组成部分，它是由病原微生物感染引发的，在宿主防御机制中起关键作用。该过程涉及炎性半胱天冬酶裂解GSDMD，释放羧基末端片段（GSDMD- ct）。监测GSDMD-CT水平是一种很有希望的炎症性疾病治疗方法，包括败血症和全身炎症反应综合征（SIRS）。方法采用免疫分析法对109名健康人、137名SIRS患者和100名败血症患者的血浆GSDMD-CT浓度进行测定。通过受试者工作特征（ROC）分析，以及降钙素原（PCT）和c反应蛋白（CRP）的相关性，评估GSDMD-CT在区分脓毒症与SIRS或健康对照中的诊断效用。结果与健康对照组和SIRS组相比，败血症患者血浆GSDMD-CT水平显著升高。ROC分析显示，曲线下面积为0.870，区分脓毒症与健康对照的敏感性为91.0%，特异性为60.6%。在区分SIRS与健康对照方面观察到相当的性能。GSDMD-CT联合CRP可进一步提高诊断准确率。引人注目的是，GSDMD-CT反映了抗生素治疗的细菌感染患者的PCT动力学特征。结论GSDMD-CT检测作为一种生物标志物具有很高的敏感性，为不同病原体的脓毒症的早期和鉴别诊断提供了潜力。

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引用次数: 0

The hemopexin-apolipoprotein B product: a novel biomarker integrating oxidative stress and lipid metabolism for coronary artery disease risk stratification 血凝素-载脂蛋白B产物：一种整合氧化应激和脂质代谢的新型生物标志物，用于冠状动脉疾病风险分层。

IF 2.1 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2025-11-09 DOI: 10.1016/j.clinbiochem.2025.111043

Yinsheng Jin , Kun Chen , Qunxiong Fan

Objective

We hypothesized that the Hemopexin-Apolipoprotein B product (Hpx·apoB), a composite biomarker integrating lipid dysregulation and oxidative stress pathways, would improve coronary artery disease (CAD) diagnosis and risk stratification.

Methods

This single-center cross-sectional study included 460 participants (350 CAD patients, 110 non-significant CAD controls). Plasma hemopexin (Hpx) was measured by liquid chromatography – tandem mass spectrometry, and the Hpx·apoB product was calculated. Multivariate logistic regression analyzed its CAD association, while area under the curve (AUC), net reclassification index (NRI), and integrated discrimination improvement (IDI) assessed its incremental predictive value over conventional risk factors and established models (Framingham, SCORE2).

Results

The Hpx·apoB product was significantly elevated in CAD patients compared to controls (median [IQR]: 2.35 [1.80–3.15] vs. 1.72 [1.30–2.25] mg²/L², p < 0.001). After adjusting for traditional cardiovascular risk factors, Hpx·apoB remained an independent predictor of CAD (Odds Ratio [OR] = 2.61, 95 % Confidence Interval [CI]: 1.48–4.60, p = 0.001). Adding Hpx·apoB to a baseline model with conventional risk factors (hs-CRP + LDL-C) significantly improved the AUC from 0.75 (95 % CI: 0.70–0.80) to 0.83 (95 % CI: 0.79–0.87; p for ΔAUC < 0.001), with a continuous NRI of 0.352 (p < 0.001) and an IDI of 0.098 (p < 0.001). Furthermore, integrating Hpx·apoB into the Framingham and SCORE2 models also yielded significant improvements in risk reclassification (NRI = 29.5 % and 39.8 %, respectively; both p < 0.001).

Conclusion

The Hpx·apoB biomarker, combining oxidative stress and lipid metabolism, independently predicts CAD presence and severity while improving existing risk models’ accuracy, enhancing clinical risk stratification.

目的：我们假设血凝素-载脂蛋白B产物（Hpx·apoB）是一种整合脂质失调和氧化应激途径的复合生物标志物，可以改善冠状动脉疾病（CAD）的诊断和风险分层。方法：这项单中心横断面研究包括460名参与者（350名CAD患者，110名非显著CAD对照组）。采用液相色谱-串联质谱法测定血浆血红素（Hpx），计算Hpx·apoB产物。多变量logistic回归分析了其与CAD的相关性，而曲线下面积（AUC）、净重分类指数（NRI）和综合判别改善（IDI）评估了其相对于传统危险因素和已建立模型的增量预测价值（Framingham, SCORE2）。结果：与对照组相比，冠心病患者Hpx·apoB产物显著升高(中位[IQR]: 2.35 [1.80-3.15] vs. 1.72 [1.30-2.25] mg2/L2， p 结论：Hpx·apoB生物标志物结合氧化应激和脂质代谢，可独立预测冠心病的存在和严重程度，同时提高现有风险模型的准确性，增强临床风险分层。

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引用次数: 0

Decoding the interference: How therapeutic monoclonal antibodies challenge serum protein electrophoresis and immunofixation 解码干扰：治疗性单克隆抗体如何挑战血清蛋白电泳和免疫固定

IF 2.1 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2025-11-05 DOI: 10.1016/j.clinbiochem.2025.111038

Julie Milandri , Marine Jaillard , Mariette Laffineur , Magali Dechomet , Marie N. Kolopp-Sarda

Introduction

Serum protein electrophoresis and immunofixation electrophoresis are routinely used to diagnose and monitor monoclonal gammopathies. However, several therapeutic monoclonal antibodies are detectable by these techniques and may mimic a pathological monoclonal protein, leading to diagnostic confusion. This study aimed to evaluate potential interferences caused by these treatments and to characterize their electrophoretic migration profiles and detection thresholds.

Materials and methods

Seven therapeutic monoclonal antibodies (daratumumab, isatuximab, rituximab, elranatamab, teclistamab, eculizumab, and ravulizumab) were assessed using an overloaded hypogammaglobulinemic serum model. Each antibody was tested at seven decreasing concentrations, from one point five grams per liter to zero point one gram per liter. All dilutions were analyzed by capillary electrophoresis and immunofixation electrophoresis.

Results

Validation was performed using daratumumab, for which interference is well documented. Rituximab and elranatamab consistently generated a discrete peak in the slow-gamma region on serum protein electrophoresis, associated with an IgG kappa band on immunofixation electrophoresis. Teclistamab migrated in the mid-gamma region and produced an IgG lambda band, detectable down to zero point fifteen gram per liter on serum protein electrophoresis and zero point zero two gram per liter on immunofixation electrophoresis. Ravulizumab, an IgG kappa antibody migrating in the beta-two region, remained detectable down to zero point five gram per liter and zero point one gram per liter, respectively.

Conclusions

This work specifies the electrophoretic behavior of several monoclonal antibody therapies, helping distinguish therapy-related peaks from true monoclonal gammopathy. These findings support the systematic use of confirmatory strategies—particularly reflex immunofixation—to ensure accurate interpretation of electrophoresis results in patients receiving monoclonal antibody treatment.

血清蛋白电泳和免疫固定电泳常规用于诊断和监测单克隆伽玛病。然而，一些治疗性单克隆抗体可以通过这些技术检测到，并且可能模仿病理单克隆蛋白，导致诊断混乱。本研究旨在评估这些处理引起的潜在干扰，并表征其电泳迁移谱和检测阈值。材料和方法使用超载低γ球蛋白血症血清模型评估7种治疗性单克隆抗体（daratumumab、isatuximab、rituximab、elranatamab、teclistamab、eculizumab和ravulizumab）。每种抗体以七种递减浓度进行测试，从每升1.5克到每升0.1克。所有稀释液均采用毛细管电泳和免疫固定电泳分析。结果使用daratumumab进行验证，其干扰已被充分记录。利妥昔单抗和埃尔那他单抗在血清蛋白电泳慢伽马区一致产生离散峰，在免疫固定电泳上与IgG kappa带相关。Teclistamab在中伽马区迁移并产生IgG条带，血清蛋白电泳检测到每升0.15克，免疫固定电泳检测到每升0.02克。Ravulizumab，一种在β - 2区域迁移的IgG κ pa抗体，仍然可以检测到，分别降至每升0.05克和每升0.01克。结论本研究明确了几种单克隆抗体疗法的电泳行为，有助于从真正的单克隆伽玛病中区分治疗相关峰。这些发现支持系统地使用验证策略，特别是反射免疫固定，以确保在接受单克隆抗体治疗的患者中准确解释电泳结果。

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引用次数: 0

Corrigendum to “Optimization and validation of the Kairos Amino Acid Kit for plasma amino acid monitoring in inherited metabolic disorder patients” [Clin. Biochem. 138 (2025) 110960] “用于遗传性代谢紊乱患者血浆氨基酸监测的Kairos氨基酸试剂盒的优化和验证”的勘误表[临床]。生物化学，138(2025):110960。

IF 2.1 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2025-11-04 DOI: 10.1016/j.clinbiochem.2025.111036

Kiara Theron , Jeannette Gauthier , Marijn Van Hulle , Murray Potter

引用次数: 0

Assessment of serum sST2 for cardiac involvement in idiopathic inflammatory myopathies 特发性炎性肌病中血清sST2对心脏累及的评估。

IF 2.1 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2025-11-01 DOI: 10.1016/j.clinbiochem.2025.111037

Liubing Li , Ying Yuan , Siting Yi , Tangdan Ding , Hongji Zhu , Qiong Shi , Hongxia Tan , Runzhao Li , Yuheng Liu , Hongxu Xu , Min Liu , Dong Wang , Ruizhi Wang

Objective

To assess the diagnostic performance of soluble growth stimulation-expressed gene 2 (sST2) for cardiac involvement in patients with idiopathic inflammatory myopathies (IIMs).

Methods

From a cohort of 237 patients with IIMs, 86 were finally included and 18 exhibited cardiac involvement. The comparison of demographic, clinical, and laboratory parameters between IIM patients with and without cardiac involvement was conducted. Additionally, independent predictors for cardiac involvement and the diagnostic performance of sST2 were analyzed.

Results

The prevalence of cardiac involvement in IIMs was 20.9 %. The medians (interquartile range, IQR) of sST2 (65.6 [33.7–92.9] vs. 14.5 [7.8–25.4] μg/L) and N-terminal B-type pro-natriuretic peptide (NTproBNP, 120.2 [65.5–324.1] vs. 44.0 [16.8–104.6] ng/L) were significantly elevated in IIM patients with cardiac involvement compared with those without cardiac involvement. Multivariable logistic regression showed elevated levels of sST2 (OR = 3.936, 95 % CI 1.808–8.571, P = 0.001) and NTproBNP (OR = 2.308, 95 % CI 1.302–4.093, P = 0.004) were risk factors for cardiac involvement in IIM patients. The combined receiver operating characteristic (ROC) analysis of sST2 and NTproBNP indicated high diagnostic values in distinguishing IIM patients with cardiac involvement from those without cardiac involvement, with 94.4 % (95 % CI 72.2 %–99.7 %) sensitivity, 87.3 % (95 % CI 76.9 %–93.4 %) specificity, and 0.926 area under the ROC curve (95 % CI 0.840–1.000, P < 0.001).

Conclusion

sST2 serves as a valuable biomarker for detecting cardiac involvement in patients with IIMs.

目的：评价可溶性生长刺激表达基因2 （sST2）对特发性炎性肌病（IIMs）患者心脏病变的诊断价值。方法：从237例IIMs患者中，最终纳入86例，其中18例表现为心脏受累。比较有和无心脏受累的IIM患者的人口学、临床和实验室参数。此外，我们还分析了心脏受累的独立预测因素和sST2的诊断性能。结果：IIMs患者心脏受累率为20.9 %。有心脏受累的IIM患者的sST2 （65.6 [33.7-92.9] vs. 14.5 [7.8-25.4] μg/L）和n端b型利钠前肽（NTproBNP, 120.2 [65.5-324.1] vs. 44.0 [16.8-104.6] ng/L）的中位数（四分位间距，IQR）明显高于无心脏受累的IIM患者。多变量逻辑回归显示高浓度的sST2(或 = 3.936,95 %可信区间1.808 - -8.571,P = 0.001)和NTproBNP(或 = 2.308,95 %可信区间1.302 - -4.093,P = 0.004)是心脏介入所分校患者的危险因素。接受者操作特征(ROC)联合分析sST2 NTproBNP表示高诊断值从那些没有区分IIM患者心脏介入心脏介入,以94.4 %(95 %可信区间72.2 % -99.7 %)敏感性,87.3 %(95 %可信区间76.9 % -93.4 %)特异性,和0.926 ROC曲线下面积(95 %可信区间0.840 - -1.000,P 结论:sST2作为有价值的生物标志物检测心脏介入病人所分校。

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引用次数: 0

Diagnosis of patients with IgM monoclonal gammopathy due to analytical interference 分析干扰对IgM单克隆γ病的诊断。

IF 2.1 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2025-11-01 DOI: 10.1016/j.clinbiochem.2025.111033

Ricardo Rubio-Sánchez , Alberto Izquierdo-Martínez , Sara Martínez-Rodríguez , Lucia Mezquita Romero , José Ángel Noval-Padillo , Daniel Fatela-Cantillo , Juan M. Guerrero

Introduction

Blood hyperviscosity is a condition associated, in most cases, with Waldenström’s macroglobulinemia (WM) and other plasma cell dyscrasias, primarily due to the pentameric structure of immunoglobulin (Ig) M. Analytical interference in the determination of alanine aminotransferase with the Abbott Alinity c assay has recently been documented, related to increased blood viscosity as a result of a monoclonal component. The detection of this interference indicates a significant and isolated increase in the concentration of a single immunoglobulin, leading to the diagnosis of a previously unknown monoclonal gammopathy.

Case description

Thanks to the described interference and the expansion of analytical testing by the clinical laboratory, 15 patients with a previously unknown IgM monoclonal component were identified over 7 months. IgM levels ranged from 8.37 g/L, with a monoclonal component of 2.4 g/L, to 82.43 g/L, with a monoclonal component of 40.9 g/L. Ten patients were diagnosed with IgM monoclonal gammopathy of undetermined significance, one with asymptomatic biclonal gammopathy, and one with WM who presented with hyperviscosity syndrome, requiring plasmapheresis and treatment with rituximab-bendamustine.

Discussion

These cases highlight the importance of investigating laboratory test interferences, as they may be related to subclinical pathologies, such as monoclonal gammopathies. Detecting this interference and expanding laboratory testing can detect the pathology even before the appearance of related symptoms. This early identification allows for patient referral to the Hematology Department for appropriate follow-up, improving the prevention of complications and helping to make more timely therapeutic decisions.

简介：在大多数情况下，血液高粘度是一种与Waldenström的巨球蛋白血症（WM）和其他浆细胞异常相关的疾病，主要是由于免疫球蛋白（Ig） m的五聚体结构引起的。最近有文献证明，雅博特Alinity c测定丙氨酸转氨酶的分析干扰与单克隆成分导致的血液粘度增加有关。这种干扰的检测表明单个免疫球蛋白浓度的显著和孤立的增加，导致以前未知的单克隆γ病的诊断。病例描述：由于所描述的干扰和临床实验室分析测试的扩展，在7 个月内确定了15例以前未知的IgM单克隆成分的患者。IgM水平范围为8.37 g/L（单克隆成分为2.4 g/L）至82.43 g/L（单克隆成分为40.9 g/L）。10例患者被诊断为意义不明的IgM单克隆伽玛病，1例无症状双克隆伽玛病，1例WM患者出现高黏度综合征，需要血浆置换和利妥昔单抗-苯达莫司汀治疗。讨论：这些病例强调了调查实验室检测干扰的重要性，因为它们可能与亚临床病理有关，如单克隆伽玛病。发现这种干扰并扩大实验室检测，甚至可以在相关症状出现之前发现病理。这种早期识别允许患者转诊到血液科进行适当的随访，提高并发症的预防，并有助于做出更及时的治疗决定。

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引用次数: 0

A novel 17.9 kb deletion of the beta-globin gene causing beta-thalassemia trait in a Danish male 一个新的17.9 kb的β -珠蛋白基因缺失导致了丹麦男性的β -地中海贫血特征

IF 2.1 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2025-10-30 DOI: 10.1016/j.clinbiochem.2025.111035

Helle Pilgaard Kristiansen , Jesper Petersen , Peter Schou , Peter H. Nissen , Anne Winther-Larsen

Background

Beta-thalassemia is a common monogenic disease, especially in malaria-endemic areas. It is mainly caused by point mutations in the beta-globin gene (HBB) while large deletions are more rarely described. Here, a novel, large deletion encompassing the entire HBB gene causing beta-thalassemia in an ethnically Danish male is described.

Case report

A 60-year-old male with no family history of anemia was admitted to the local Department of Medicine with microcytotic anemia. He had observed fatigue and slight dizziness, but despite this, he felt healthy. His blood tests showed no signs of iron deficiency and a hemoglobinopathy was suspected. Hemoglobin fractionation by ion-exchange high-performance liquid chromatography revealed an elevated HbF of 5.9 % and an increased HbA2 of 8.5 %. GAP-PCR of the alpha-thalassemia HBA1/HBA2 genes and Sanger sequencing of the HBB gene showed none of the common thalassemia-causing variations. Hence, multiplex ligation dependent probe amplification was performed and a deletion variant was identified that resulted in the complete loss of the HBB gene. The exact breakpoints were identified using Sanger sequencing, revealing a novel 17.9 kb deletion (NC000011.10:g.5211831_5229725del) not previously described in the literature or in databases. The deletion was consistent with beta-thalassemia trait in accordance with the patient’s symptoms.

Conclusion

We present a novel large deletion of the HBB gene causing beta-thalassemia trait detected in an ethnically Danish male. Thalassemia must be considered in patients with microcytosis of unknown cause despite a Northern European ethnicity.

背景-地中海贫血是一种常见的单基因疾病，特别是在疟疾流行地区。它主要由-珠蛋白基因（HBB）的点突变引起，而大的缺失则很少被描述。在这里，一个新的，大的缺失包括整个HBB基因导致-地中海贫血在一个民族丹麦男性被描述。病例报告一例60岁男性，无贫血家族史，因小细胞性贫血入院。他观察到疲劳和轻微的头晕，但尽管如此，他觉得很健康。他的血液检查显示没有缺铁的迹象，怀疑有血红蛋白病。离子交换高效液相色谱分离血红蛋白显示HbF升高5.9%，HbA2升高8.5%。α -地中海贫血HBA1/HBA2基因的GAP-PCR和HBB基因的Sanger测序显示没有任何常见的导致地中海贫血的变异。因此，进行了多重连接依赖探针扩增，并确定了导致HBB基因完全丢失的缺失变体。使用Sanger测序确定了确切的断点，揭示了一个新的17.9 kb的缺失（NC000011.10:g.5211831_5229725del），以前没有在文献或数据库中描述过。根据患者的症状，这种缺失符合-地中海贫血的特征。结论我们提出了一种新的大缺失HBB基因导致-地中海贫血的性状检测到一个民族丹麦男性。地中海贫血必须考虑患者的原因不明的小细胞增多症，尽管北欧种族。

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引用次数: 0

The contribution of IL-10 and IL-6 as potential biomarkers for detecting central nervous system involvement in non-Hodgkin lymphomas IL-10和IL-6作为检测非霍奇金淋巴瘤中枢神经系统受累的潜在生物标志物的贡献。

IF 2.1 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2025-10-28 DOI: 10.1016/j.clinbiochem.2025.111034

Elisa Buzzatti , Fabiana Esposito , Maria Morello , Vanessa Rossi , Maria Christina Cox , Ombretta Annibali , Enrico Santinelli , Maria Antonietta Irno-Consalvo , Giovangiacinto Paterno , Lucia Cardillo , Massimiliano Postorino , Adriano Venditti , Maria Ilaria Del Principe

Introduction

A significant clinical challenge in the management of hematologic malignancies is the occurrence of central nervous system (CNS) involvement. In non-Hodgkin lymphoma (NHL), it occurs in varying percentages depending on the subtype and identifying patients is crucial but challenging. Furthermore, a definitive gold standard for diagnosing leptomeningeal involvement is still lacking. Conventional cytology (CC) of cerebrospinal fluid (CSF) has high specificity but low sensitivity. Multiparametric flow cytometry offers superior sensitivity but is limited by CSF cellularity and the need for specialized expertise, a resource not available at every institution. CSF cytokine analysis is emerging as a promising diagnostic approach, with IL-6 and IL-10 showing potential as biomarkers.

Objective

This prospective study investigated the utility of dosing the aforementioned cytokine in serum and CSF samples for diagnosing CNS involvement in non-primary CNS lymphoma patients.

Methods

CSF samples were analyzed using CC and IL-6/IL-10 assays. IL-6 and IL-10 levels were then compared between CC-positive (CC + ) and CC-negative (CC–) patients.

Results

The study cohort included 27 patients, with a median age of 71 years. Six patients (22.2 %) were CC + . In CSF, statistically significant differences were observed for both IL-6 (p = 0.02) and IL-10 (p = 0.04) levels between CC + and CC– patients, with higher levels in CC + patients. Elevated CSF IL-6 and IL-10 levels were also associated with elevated LDH, advanced disease stage, and elevated CSF protein.

Conclusions

This study suggests that CSF IL-6 and IL-10 are potential, widely available biomarkers for early detection of CNS involvement in NHL, offering a complement to traditional cytological analysis in clinical laboratories.

简介：在血液系统恶性肿瘤的管理显著临床挑战是发生中枢神经系统（CNS）受累。在非霍奇金淋巴瘤（NHL）中，根据亚型的不同，其发生率不同，识别患者至关重要，但具有挑战性。此外，诊断脑轻脑膜受累的明确金标准仍然缺乏。常规脑脊液细胞学检查特异性高，敏感性低。多参数流式细胞术提供了优越的灵敏度，但受到脑脊液细胞数量和对专业知识的需求的限制，这是每个机构都无法获得的资源。脑脊液细胞因子分析正在成为一种有前景的诊断方法，其中IL-6和IL-10显示出作为生物标志物的潜力。目的：本前瞻性研究探讨了在非原发性中枢神经系统淋巴瘤患者的血清和脑脊液样本中剂量上述细胞因子对诊断中枢神经系统受累的效用。方法：采用CC法和IL-6/IL-10法对脑脊液样本进行分析。比较CC阳性（ + ）和CC阴性（CC-）患者的IL-6和IL-10水平。结果：研究队列包括27例患者，中位年龄为71 岁。6例（22.2% %）CC + 。脑脊液中IL-6 （p = 0.02）和IL-10 （p = 0.04）水平在CC + 和CC-患者中差异有统计学意义，CC + 患者IL-6和IL-10水平较高。升高的CSF IL-6和IL-10水平也与LDH升高、疾病晚期和CSF蛋白升高相关。结论：本研究提示CSF IL-6和IL-10是潜在的、广泛可用的生物标志物，可用于NHL中中枢神经系统的早期检测，为临床实验室传统的细胞学分析提供补充。

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引用次数: 0

Determining the detection of 216 fentanyl analogs and synthetic opioids and predicting epitopes using four commercial immunoassays 测定216种芬太尼类似物和合成阿片类药物的检测，并使用四种商业免疫分析法预测表位

IF 2.1 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2025-10-25 DOI: 10.1016/j.clinbiochem.2025.111032

Carl E. Wolf , Felix I Medrano , Justin L. Poklis , Paul J. Jannetto , Grace R. Williams

Background

The United States continues to face a persistent opioid epidemic, now in its fourth wave, characterized primarily by fentanyl analogs. Detecting fentanyl analogs and synthetic opioids is a critical concern to clinical and forensic laboratories.

Objectives

Evaluate the ability of each assay to detect the opioids at 1, 10, or 100 ng/mL. 216 opioids from the CDC’s TOM Kits® were evaluated using four commercially available fentanyl immunoassays: ARK™ Fentanyl II, Immunalysis Fentanyl Urine HEIA®, Immunalysis Fentanyl Urine SEFRIA® Drug Screening Kit, and the Lin-Zhi International Fentanyl II Enzyme Immunoassay.

Results

The difference in reactivity of the immunoassay’s reagents was evaluated in conjunction with the chemical structure of each opioid. All four immunoassays detected 106 of the 216 opioids at the concentrations tested. Twenty-eight opioids were not detected by any assay and 17 of these were the emerging synthetic opioids. At the lowest concentration tested (1 ng/mL), the ARK™ Fentanyl II assay detected 36 compounds, the Immunalysis SEFRIA® assay detected 74, LZI detected 5, and the Immunalysis HEIA® assay detected 18. The undetected opioids included the surgical anesthetic parent compounds remifentanil and alfentanil, and sufentanil’s metabolite, norsufentanil.

Conclusions

The detectability of fentanyl analogs and synthetic opioids varies by assay, and it may be possible to predict the detection or lack thereof for a particular assay based on a pattern elucidated by the analysis of the TOMs Opioid compound set. This data may be used to evaluate the potential false negative or false positive results of commercially available fentanyl and norfentanyl homogeneous immunoassays and to predict the likely target epitope of each assay.

美国继续面临持续的阿片类药物流行，目前已进入第四波，主要以芬太尼类似物为特征。检测芬太尼类似物和合成阿片类药物是临床和法医实验室的一个关键问题。目的评价各检测方法对1、10、100 ng/mL阿片类药物的检测能力。使用四种市售芬太尼免疫测定试剂盒对来自CDC的TOM试剂盒®的216种阿片类药物进行评估：ARK™芬太尼II， Immunalysis芬太尼尿HEIA®，Immunalysis芬太尼尿SEFRIA®药物筛选试剂盒和Lin-Zhi国际芬太尼II酶免疫测定试剂盒。结果结合阿片类药物的化学结构，评价了免疫测定试剂的反应性差异。所有四种免疫分析法均检测到在所测浓度下216种阿片类药物中的106种。28种阿片类药物未被任何检测到，其中17种是新兴的合成阿片类药物。在最低检测浓度（1 ng/mL）下，ARK™芬太尼II法检测到36种化合物，Immunalysis SEFRIA®法检测到74种，LZI法检测到5种，Immunalysis HEIA®法检测到18种。未检测到的阿片类药物包括手术麻醉剂母体化合物瑞芬太尼和阿芬太尼，以及舒芬太尼的代谢物诺舒芬太尼。结论芬太尼类似物和合成阿片类药物的可检出性因检测方法而异，基于TOMs阿片类化合物组分析所阐明的模式，可以预测特定检测方法的检出或缺失。该数据可用于评估市售芬太尼和去芬太尼均质免疫测定的潜在假阴性或假阳性结果，并预测每种测定的可能靶表位。

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