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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 Pub Date : 2026-01-01 Epub 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
Pre-analytical considerations in the simultaneous quantification of ketone bodies, lactate, pyruvate and TCA cycle intermediates 同时定量酮体、乳酸、丙酮酸和TCA循环中间体的分析前考虑。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01 Epub Date: 2025-11-13 DOI: 10.1016/j.clinbiochem.2025.111056
Kaitlyn Berchier , Chiara Nyffeler , Stephen Bruce , Clothilde Roux , Jean-Marc Nuoffer , Matthias Gautschi , Alexander Laemmle , Déborah Mathis

Background

Accurate quantification of small metabolites such as ketone bodies (KB: β-hydroxybutyrate (BHB), acetoacetate (AcAc)), pyruvate (Pyr), lactate (Lac) and tricarboxylic acid (TCA) cycle intermediates is essential for diagnostics, therapy monitoring and metabolic research. These metabolites serve as energy substrates and signaling molecules, with their interpretation often relying on physiologically meaningful ratios (Lac/Pyr, BHB/AcAc). However, their chemical instability and susceptibility to rapid post-collection metabolism pose significant pre-analytical challenges.

Method

We developed an LC-MS/MS method for the simultaneous quantification of KB, Pyr, Lac and TCA cycle intermediates, and systematically evaluated pre-analytical factors affecting their stability and accuracy. We compared lithium-heparin (LH), ethylenediaminetetraacetic acid (EDTA), sodium fluoride/EDTA (NaF/EDTA) and sodium citrate (NaCit) collection tubes and deproteinized whole blood (depWB) using perchloric acid. Stability was assessed in whole blood at RT over 24 h, as well as in LH and depWB at various temperatures (RT, 4 °C, –20 °C) over 7 days.

Results

Pyr, Lac, AcAc and fumarate were most labile, while BHB and citrate were stable across matrices. LH-plasma with prompt centrifugation showed minimal metabolic alterations, while NaF/EDTA effectively stabilized Lac but compromised Pyr and TCA cycle intermediates. DepWB improved Lac/Pyr ratio reliability but introduced higher variability and matrix effects. NaCit induced unexpected metabolic shifts, suggesting in-vitro TCA cycle activity.

Conclusions

Our findings highlight the critical impact of anticoagulants and processing conditions on metabolite stability. LH-plasma provides the best compromise for quantifying KB, Pyr and TCA cycle intermediates when processed rapidly, while depWB remains preferable for accurate Lac/Pyr ratio determination despite its higher variability.
背景:小代谢产物如酮体(KB: β-羟基丁酸酯(BHB),乙酰乙酸酯(AcAc)),丙酮酸酯(Pyr),乳酸酯(Lac)和三羧酸(TCA)循环中间体)的准确定量对诊断,治疗监测和代谢研究至关重要。这些代谢物作为能量底物和信号分子,它们的解释通常依赖于生理上有意义的比率(Lac/Pyr, BHB/AcAc)。然而,它们的化学不稳定性和对采集后快速代谢的敏感性给分析前带来了重大挑战。方法:建立同时定量KB、Pyr、Lac和TCA循环中间体的LC-MS/MS方法,并对影响其稳定性和准确性的分析前因素进行系统评价。我们比较了锂-肝素(LH)、乙二胺四乙酸(EDTA)、氟化钠/EDTA (NaF/EDTA)和柠檬酸钠(NaCit)采集管和高氯酸去蛋白全血(depWB)。在RT超过24 h的血浆中,以及在不同温度(RT, 4 °C, -20 °C)超过7 天的LH和depWB中,评估稳定性。结果:Pyr、Lac、AcAc和富马酸酯在基质中最不稳定,BHB和柠檬酸盐在基质中最稳定。及时离心的lh血浆代谢变化最小,而NaF/EDTA有效地稳定了Lac,但损害了Pyr和TCA循环中间体。DepWB提高了Lac/Pyr比的可靠性,但引入了更高的变异性和矩阵效应。NaCit诱导了意想不到的代谢变化,提示体外TCA循环活性。结论:我们的研究结果强调了抗凝剂和处理条件对代谢物稳定性的关键影响。在快速处理时,lh -血浆提供了定量KB、Pyr和TCA循环中间体的最佳折衷方案,而depWB尽管变异性较高,但仍更适合用于准确测定Lac/Pyr比率。
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引用次数: 0
Novel and known fibrinogen gene mutations in Chinese pediatric patients with congenital dysfibrinogenemia: genetic and functional characterization 中国儿童先天性纤维蛋白异常血症患者中新的和已知的纤维蛋白原基因突变:遗传和功能特征。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01 Epub Date: 2025-12-02 DOI: 10.1016/j.clinbiochem.2025.111064
Juan Huang , Duocai Wang , Ying Wang , Yongqiang Yang , Dong Peng , Meizhu Luo , Xiaoying Fu

Objectives

Congenital dysfibrinogenemia (CD) is a rare inherited disorder caused by qualitative abnormalities in fibrinogen, leading to discordance between functional and antigenic fibrinogen levels. Genetic testing plays a pivotal role in confirming diagnosis and elucidating phenotypic heterogeneity. This study aims to emphasize the diagnostic value of combining coagulation assays with genetic testing and underscore the clinical heterogeneity of CD through clinical cases of novel mutations.

Design & methods

Five pediatric patients with incidentally identified CD were diagnosed at Shenzhen Children’s Hospital. Peripheral blood samples were analyzed for coagulation parameters, including fibrinogen activity (FIB:C) by the Clauss method, fibrinogen derived from the prothrombin time (PT-dF), as well as activated partial thromboplastin time (aPTT), PT, thrombin time (TT), and thromboelastography (TEG). Sanger sequencing was conducted to assess mutations in FGA, FGB, and FGG genes.

Results

Two unrelated patients harbored a known heterozygous mutation in FGG (c.902G > A; p.Arg301His). Two novel heterozygous mutations were identified: FGA (c.113G > A; p.Arg38Lys) and FGG (c.902G > T; p.Arg301Leu). A homozygous mutation in FGB (c.292G > A; p.Ala98Thr) was detected in another patient; this variant has been reported only twice before in the literature. All patients were asymptomatic. Coagulation testing revealed consistently decreased FIB:C with normal PT-dF, characteristic of CD. TEG analysis showed variable alterations in fibrinogen-related parameters, although no consistent genotype–phenotype correlation was observed.

Conclusion

This study expands the genetic and phenotypic spectrum of CD in children, reporting two novel mutations and documenting the first pediatric cases of these variants in a Chinese cohort. Given the potential long-term risks and diagnostic complexity in asymptomatic pediatric patients, individualized surveillance and management strategies are warranted. Further research is needed to evaluate the functional consequences of novel mutations and their implications for pediatric hemostasis.
目的:先天性纤维蛋白异常血症(CD)是一种罕见的遗传性疾病,由纤维蛋白原质的异常引起,导致功能性和抗原性纤维蛋白原水平不一致。基因检测在确认诊断和阐明表型异质性方面起着关键作用。本研究旨在强调凝血试验与基因检测相结合的诊断价值,并通过新突变的临床病例强调CD的临床异质性。设计与方法:在深圳市儿童医院对5例偶然发现的乳糜泻患儿进行诊断。分析外周血样本的凝血参数,包括纤维蛋白原活性(FIB:C)通过Clauss方法,纤维蛋白原衍生的凝血酶原时间(PT- df),以及活化部分凝血活素时间,PT,凝血酶时间,和血栓弹性图(TEG)。Sanger测序评估FGA、FGB和FGG基因的突变。结果:两名不相关的患者携带已知的FGG杂合突变(c.902G > a; p.Arg301His)。鉴定出两个新的杂合突变:FGA (c.113G > A; p.Arg38Lys)和FGG (c.902G > T; p.Arg301Leu)。在另一名患者中检测到FGB纯合突变(c.292G > A; p.Ala98Thr);这种变异在以前的文献中只报道过两次。所有患者均无症状。凝血试验显示FIB:C持续下降,PT-dF正常,这是CD的特征。TEG分析显示纤维蛋白原相关参数的变化,尽管没有观察到一致的基因型-表型相关性。结论:本研究扩大了儿童CD的遗传和表型谱,报告了两个新的突变,并记录了中国队列中这些突变的第一例儿科病例。鉴于无症状儿童患者的潜在长期风险和诊断复杂性,个性化的监测和管理策略是必要的。需要进一步的研究来评估新突变的功能后果及其对儿童止血的影响。
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引用次数: 0
Constructive critique on the development and validation of a multiplex LC-MS/MS DBS assay 对多重LC-MS/MS DBS分析的开发和验证提出建设性意见。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01 Epub Date: 2025-12-05 DOI: 10.1016/j.clinbiochem.2025.111059
Parth Aphale, Shashank Dokania, Himanshu Shekhar
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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 Epub Date: 2025-12-11 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。
{"title":"Effect of microcollection tube fill volume on common acute care tests","authors":"Fangze Cai ,&nbsp;Isolde Seiden-Long ,&nbsp;Allison A. Venner ,&nbsp;Heather Paul ,&nbsp;Jessica L. Gifford ,&nbsp;Tariq Roshan ,&nbsp;Lawrence de Koning","doi":"10.1016/j.clinbiochem.2025.111066","DOIUrl":"10.1016/j.clinbiochem.2025.111066","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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 &lt; 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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"141 ","pages":"Article 111066"},"PeriodicalIF":2.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145751782","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
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 Pub Date : 2026-01-01 Epub 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
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 Pub Date : 2025-12-01 Epub 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
Optimizing the indeterminate zone for the DiaSorin LIAISON H. Pylori stool antigen test 幽门螺杆菌粪便抗原检测的不确定区优化。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-08 DOI: 10.1016/j.clinbiochem.2025.111027
Natalia Volodko , Mathew P. Estey , Dustin Proctor , Lily Olayinka , Michelle L. Parker , Ashley Newbigging , Victoria Higgins

Introduction

Helicobacter pylori (H. pylori) colonization increases the risk of upper gastrointestinal disorders and can be detected by various tests, including the stool antigen test (HpSAT). DiaSorin recommends an HpSAT equivocal/indeterminate zone of 0.90-<1.10, but high variability observed in our laboratory prompted clinical implementation of a broader zone (0.60-<1.80). This study aimed to define an optimal HpSAT indeterminate zone using molecular as reference and urea breath test (UBT) for confirmation.

Materials and Methods

HpSAT and stool molecular results were available from 379 patients, of which 52 had follow-up UBTs. HpSAT was analyzed by the LIAISON HpSAT assay (DiaSorin), UBT by isotope ratio mass spectrometry, and molecular testing by qPCR targeting H. pylori DNA. Logistic regression modeled HpSAT index values against PCR positivity to define an optimal indeterminate zone, supported by clinical performance and flagging rates analyses.

Results

Logistic regression determined an HpSAT index of 0.79 (95 % CI: 0.34–1.14) had 90 % probability of a negative PCR result, and 4.99 (4.09–6.63) had 90 % probability of a positive result, rounded to an indeterminate zone of 0.80-<5.00. Lower thresholds assessed all had ≤ 2 % false negatives, while upper thresholds exhibited decreased false positive rates (22 % to 6 %) as thresholds increased (1.10 to 5.00), with minimal improvement beyond 3.00 (9 %). A modified zone of 0.80–<3.00 offered high accuracy with 12.9 % indeterminate results (DiaSorin’s threshold: 2.8 %; laboratory’s current threshold: 13.1 %).

Conclusions

Our findings show that DiaSorin’s HpSAT indeterminate zone is too narrow to reliably distinguish true positive and negative results in clinical practice. A modified broader zone (0.80–<3.00), derived via logistic regression using PCR as reference, improves diagnostic accuracy while minimizing indeterminate results.
导读:幽门螺杆菌(h.p ylori)定植增加上消化道疾病的风险,可通过各种测试检测,包括粪便抗原测试(HpSAT)。DiaSorin推荐的HpSAT模棱两可/不确定区域为0.90。材料和方法:379例患者的HpSAT和粪便分子结果可获得,其中52例随访了ubt。HpSAT采用LIAISON HpSAT法(DiaSorin)分析,UBT采用同位素比质谱法分析,qPCR检测H. pylori DNA。在临床表现和标记率分析的支持下,Logistic回归模型对PCR阳性的HpSAT指数值进行了建模,以定义一个最佳的不确定区域。结果:Logistic回归表明,0.79(95 % CI: 0.34-1.14)的HpSAT指数有90 %的概率为PCR阴性结果,4.99(4.09-6.63)有90 %的概率为PCR阳性结果,四合到0.80的不确定区域。结论:我们的研究结果表明,在临床实践中,DiaSorin的HpSAT不确定区域太窄,无法可靠地区分真阳性和阴性结果。修改后的更宽区域(0.80-)
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引用次数: 0
Plasma lipase and hemolysis on Roche Cobas c503 analysers: No evidence of the need to lower the interference threshold 血浆脂肪酶和溶血在罗氏Cobas c503分析仪:没有证据表明需要降低干扰阈值。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-02 DOI: 10.1016/j.clinbiochem.2025.111022
Denis Monneret
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引用次数: 0
Corrigendum to “CA19-9, CEA and PIVKA-II as a novel panel of serum markers for diagnosis of pancreatic cancer” [Clin. Biochem. 137 (2025) 110902] “CA19-9、CEA和PIVKA-II作为诊断胰腺癌的一组新的血清标志物”的勘误表[临床。生物化学,137(2025):110902。
IF 2.1 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-30 DOI: 10.1016/j.clinbiochem.2025.111017
Meifang Wang , Hongying Bu , Weijia Luo , Xi Zeng , Guodong Chen , Yingchun He , Deliang Cao
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引用次数: 0
期刊
Clinical biochemistry
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