Practical Laboratory Medicine最新文献_第7页

Indirect reference intervals for TSH in a sample of lebanese pregnant women 黎巴嫩孕妇样本中TSH的间接参考间隔

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-03-08 DOI: 10.1016/j.plabm.2025.e00460

Dollen Eid , Nizar El Bcherawi , Georges Abi Tayeh , Nada El Ghorayeb , Marie-Hélène Gannagé-Yared

Background

Thyroid dysfunction in pregnant women can lead to fetal complications. Thyroid-stimulating hormone (TSH) is the key hormone for diagnosis of thyroid dysfunction. No previous study has established reference intervals (RI) for TSH in Lebanese pregnant women. The objective of this study is to define the TSH RIs for each trimester of pregnancy in healthy Lebanese pregnant women using an indirect method.

Materials and methods

This retrospective study included 287 pregnancies selected from the records of an obstetric clinic at Hôtel-Dieu de France University Hospital from January 2021 to May 2023. A control group of 103 non-pregnant women was also included in the study. The collected TSH values were stratified by trimester (first and second) of pregnancy and postpartum. After applying the exclusion criteria, a total of 458 TSH values were included in the analysis.

Results

The respective medians and RIs for TSH during the first, second pregnancy trimesters and postpartum are 1.57 (0.43–3.20 mIU/L), 1.84 (0.56–4.41 mIU/L), and 1.38 (0.30–3.60 mIU/L), while for the control group it is 1.66 (0.64–4.24 mIU/L). There is a significant correlation between TSH values in the first trimester and those in the second trimester and postpartum (p ≤ 0.001 and p = 0.002 respectively). No significant correlation was observed between age and TSH levels in the first and second trimesters and as well as in postpartum.

Conclusion

Our RIs are close to the revised American Thyroid Association (ATA) recommendations. Further research is needed to understand the mechanisms and clinical impact of these differences.

背景：孕妇甲状腺功能障碍可导致胎儿并发症。促甲状腺激素（TSH）是诊断甲状腺功能障碍的关键激素。以前没有研究确定黎巴嫩孕妇TSH的参考区间（RI）。本研究的目的是使用间接方法确定健康黎巴嫩孕妇妊娠每个孕期的TSH RIs水平。材料和方法本回顾性研究选取了2021年1月至2023年5月期间Hôtel-Dieu法兰西大学医院产科门诊287例妊娠病例。研究还包括103名未怀孕妇女作为对照组。收集的TSH值按妊娠初、中期和产后进行分层。应用排除标准后，共有458个TSH值被纳入分析。结果妊娠1、2期及产后TSH的中位值和RIs分别为1.57 （0.43 ~ 3.20 mIU/L）、1.84 （0.56 ~ 4.41 mIU/L）、1.38 (0.30 ~ 3.60 mIU/L)，对照组为1.66 （0.64 ~ 4.24 mIU/L）。妊娠早期TSH值与妊娠中期及产后TSH值有显著相关性（p≤0.001,p = 0.002）。在妊娠早期和中期以及产后，年龄和TSH水平之间没有明显的相关性。结论：我们的ri接近修订后的美国甲状腺协会（ATA）推荐值。需要进一步的研究来了解这些差异的机制和临床影响。

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引用次数: 0

Biogenic amine testing in the South African public health care system 南非公共卫生保健系统中的生物胺检测

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-28 DOI: 10.1016/j.plabm.2025.e00457

D. Legg-E’Silva , E.M. Cave , T. Snyman, S. Currin, N. Kone, K.L. Prigge

Background

Phaeochromocytoma, paraganglioma and neuroblastoma are catecholamine secreting neuroendocrine tumours. Biochemical screening for suspected cases of these tumours involves the measurement of catecholamines and their metabolites in either urine or plasma. The South African National Health Laboratory service (NHLS) measures urine fractionated metanephrines (UMF) and normetanephrines (UNF), urine vanillylmandelic acid (UVMA) and urine homovanillic acid (UHVA).

Objectives

To analyse the demographic, biochemical and testing patterns of patients’ UMF, UNF, UVMA and UHVA in the NHLS.

Methods

Data from January 2015 to December 2016 for all patients undergoing UMF, UNF, UVMA and UHVA testing was extracted from the NHLS central data warehouse. Neuroendocrine tumours were biochemically diagnosed when results were >2x multiples of the upper reference limits. Multiple testing was defined as ≥2 tests within a 14-day period. Ethnicity was determined through hot-deck imputation.

Results

Biochemically abnormal test results were identified by UMF/UNF measurements in 98.2 % of cases. In 1.8 % of cases, the addition of UVMA resulted in a previously unidentified biochemical positive. Adult white and coloured populations have significantly less biochemically positive UMF results compared to the African population. Multiple testing resulted in discordant results for 12.8 % of UMF and 13.1 % of UNF testing.

Conclusion

UVMA testing for phaeochromocytoma and paraganglioma offers little benefit over testing with UMF alone. Requesting consecutive multiple samples is preferred, however, a single 24-h fractionated UMF/UNF is efficient and cost-effective for phaeochromocytoma and paraganglioma screening, with further testing recommended when clinically indicated. African individuals are more likely to have raised catecholamines and requires further investigation.

背景嗜铬细胞瘤、副神经节瘤和神经母细胞瘤是分泌儿茶酚胺的神经内分泌肿瘤。对这些肿瘤疑似病例的生化筛查包括测量尿液或血浆中的儿茶酚胺及其代谢物。南非国家卫生实验室服务（NHLS）测量尿分离肾上腺素（UMF）和去甲肾上腺素（UNF）、尿香草酸（UVMA）和尿同型香草酸（UHVA）。目的分析国家健康保险系统患者UMF、UNF、UVMA和UHVA的人口学、生化和检测模式。方法从NHLS中央数据仓库中提取2015年1月至2016年12月所有接受UMF、UNF、UVMA和UHVA检测的患者的数据。当结果为参考上限的2倍时，生物化学诊断神经内分泌肿瘤。多次检测定义为14天内≥2次检测。种族是通过热甲板归罪法确定的。结果98.2%的病例通过UMF/UNF检测发现生化异常。在1.8%的病例中，UVMA的加入导致了先前未知的生化阳性。与非洲人口相比，成年白人和有色人种的生物化学阳性UMF结果明显较少。多重测试导致12.8%的UMF和13.1%的UNF测试结果不一致。结论uvma检测对嗜铬细胞瘤和副神经节瘤的检测效果与单独使用UMF检测相比效果不大。然而，对于嗜铬细胞瘤和副神经节瘤筛查而言，单个24小时分离UMF/UNF是高效且经济的，临床需要时建议进行进一步检测。非洲人更有可能产生儿茶酚胺，这需要进一步的调查。

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引用次数: 0

Preparation of recombinant myoglobin and investigation of the liquid antigen stability for quality control materials 重组肌红蛋白的制备及液抗原稳定性的研究

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-28 DOI: 10.1016/j.plabm.2025.e00456

Yu-Hui Wang, Xi-Feng Sun, Chun-Xin Xu, Feng-Qiang Sun, Rong-Rong Wang, Xiao-Kun Bian, Zhan-Zhao Wang, Qiang Wu

Myoglobin (Mb) has been used as a biomarker for acute myocardial infarction. This study aimed to evaluate the stability of liquid Mb as quality control materials for Mb determination. Mb protein was expressed in Escherichia coli system and purified using Ni²⁺ chelate affinity chromatography. The purity of purified recombinant Mb reached to 95 %. The immunoreactivity of Mb was investigated using Mb assay kits. The coefficient of determination (R²) of the curve fitted with dilution ratio and Mb concentration as variables was greater than 0.95, which indicated that Mb had good immunoreactivity. The concentrations per gradient measured using different kits had no significant difference (p-value>0.05), which indicated that the reactivity between the Mb antigen and Mb antibodies with different epitopes was good. The effects of different storage buffer, storage temperature and storage times on the stability of liquid Mb were investigated by detecting the concentration changes. At 2–8 °C for two months, Mb concentration in buffer B (Tris-HCl, pH 7.8, containing 1 % BSA and 0.05 % NaN₃) decreased within 10 % compared with the initial concentration. The long-term storage stability was investigated by the thermal acceleration experiment. At 37 °C for one week, Mb concentration decreased by less than 15 %, indicating that the Mb had good long-term storage stability. The prepared liquid Mb had good immunoreactivity and stability, avoiding storage in freeze-dried powder. It was a promising alternative as the quality control material for Mb detection.

肌红蛋白（Mb）已被用作急性心肌梗死的生物标志物。本研究旨在评价液态微量元素作为微量元素测定的质量控制材料的稳定性。Mb蛋白在大肠杆菌体系中表达，采用Ni2+螯合亲和层析纯化。重组Mb的纯度可达95%。采用Mb检测试剂盒检测Mb的免疫反应性。以稀释比和Mb浓度为变量拟合曲线的决定系数R2均大于0.95，表明Mb具有良好的免疫反应性。不同试剂盒测定的每梯度浓度无显著差异（p值>；0.05），说明不同表位的Mb抗原与Mb抗体的反应性较好。通过检测其浓度变化，考察了不同储存缓冲液、储存温度和储存时间对液态Mb稳定性的影响。在2-8°C条件下，缓冲液B （Tris-HCl, pH 7.8，含1% BSA和0.05% NaN3）中Mb浓度较初始浓度下降10%以内。通过热加速实验考察了其长期贮存稳定性。在37℃下放置一周，Mb浓度下降幅度小于15%，表明Mb具有良好的长期储存稳定性。制备的Mb液具有良好的免疫反应性和稳定性，可避免冻干粉储存。作为Mb检测的质控材料，是一种很有前途的选择。

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引用次数: 0

Impact of hemolysis on the levels of proteins associated with aging and age-related neurodegenerative diseases in a multicentric clinical research 一项多中心临床研究中溶血对与衰老和年龄相关的神经退行性疾病相关蛋白水平的影响

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-20 DOI: 10.1016/j.plabm.2025.e00455

Masroor Anwar , Km Renu , Abhinay Kumar Singh , Abhilasha Nayal , Bharat Thyagarajan , Peifeng Hu , Jinkook Lee , Sharmistha Dey , A.B. Dey

Introduction

Hemolysis is a known interference factor that has been found to show erroneous effect. Present study analyzes the impact of hemolysis on the concentrations of protein biomarkers of Alzheimer's disease (Aβ42, t-Tau, p-Tau181) along with novel proteins which are currently under investigation (SIRT1,SIRT2,SIRT6,FOXO3A, NFL, Aβ40, GFAP).

Methods

Plasma samples were grouped into two categories: hemolyzed and non-hemolyzed groups. Degree of hemolysis (in percentage) was separately analyzed using Single molecule array (SIMOA) technology. Quantitative analysis for hemolyzed and non-hemolyzed samples were done using surface plasmon resonance (SPR) technology.

Results

The SIMOA analysis indicated that at high levels of hemolysis (1000 mg/dL) there was an increase in NFL protein level up to approximately 30 % whereas p-Tau181 did not show much interference even at higher hemolysate concentration. Aβ40, Aβ42 and GFAP showed modest effect up to hemolysis of 250mg/dL-500 mg/dL. SPR analysis of total Tau (t-Tau), p-Tau181, SIRT1, SIRT6 showed the consistency in the result and there was no significant difference in hemolyzed plasma compared to non-hemolyzed samples. Aβ42 and FOXO3A showed decline in hemolyzed plasma compared to non-hemolyzed samples (4.34 ± 0.18ng/ul; 4.95 ± 0.19ng/ul) and (3.83 ± 0.34ng/ul; 5.12 ± 0.46ng/ul), respectively whereas, a significant increase in the concentration was observed for SIRT2; 2.4 ± 0.10ng/ul in hemolyzed compared to 1.30 ± 0.22ng/ul in non-hemolyzed group.

Conclusions

High grade hemolysis leads to altered protein concentration associated with neurodegeneration. Present study emphasizes the need to have pre-analytical inspection for hemolysis detection especially in a multicentric biomarker study.

溶血是一种已知的干扰因素，已被发现显示出错误的效果。本研究分析了溶血对阿尔茨海默病蛋白生物标志物（a - β42、t-Tau、p-Tau181）以及目前正在研究的新蛋白（SIRT1、SIRT2、SIRT6、FOXO3A、NFL、a - β40、GFAP）浓度的影响。方法将血浆分为溶血组和非溶血组。采用单分子阵列（SIMOA）技术分别分析溶血程度（百分比）。采用表面等离子体共振（SPR）技术对溶血和非溶血样品进行定量分析。结果SIMOA分析表明，在高溶血水平（1000 mg/dL）下，NFL蛋白水平增加约30%，而p-Tau181即使在高溶血浓度下也没有表现出太大的干扰。a - β40、a - β42和GFAP在溶血剂量为250mg/dL- 500mg /dL时，溶血效果一般。总Tau蛋白（t-Tau）、p-Tau181、SIRT1、SIRT6的SPR分析结果一致，溶血血浆与非溶血血浆无显著差异。溶血血浆中Aβ42和FOXO3A较未溶血血浆下降(4.34±0.18ng/ul；4.95±0.19ng/ul)和（3.83±0.34ng/ul）；5.12±0.46ng/ul)，而SIRT2的浓度显著增加；溶血组为2.4±0.10ng/ul，非溶血组为1.30±0.22ng/ul。结论高度溶血导致蛋白浓度改变与神经退行性变有关。目前的研究强调需要有溶血检测的分析前检查，特别是在一个多中心的生物标志物研究。

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引用次数: 0

D-dimers or more? Assessing the role of laboratory factors in predicting and confirming pulmonary embolism in high-risk orthopedic patients d -二聚体还是更多？评估实验室因素在预测和确认高危骨科患者肺栓塞中的作用

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-20 DOI: 10.1016/j.plabm.2025.e00452

Bartosz Borowski , Mateusz Haratym , Piotr Piech , Jaromir Jarecki , Grzegorz Staśkiewicz

引用次数: 0

Analytical validation of a LC-MS/MS based in vitro diagnostic kit for the quantification of L-tyrosine and taurocholic acid for liver fibrosis diagnosis 基于LC-MS/MS的l -酪氨酸和牛磺胆酸体外诊断试剂盒用于肝纤维化诊断的分析验证。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-16 DOI: 10.1016/j.plabm.2025.e00454

Guoxiang Xie , Kejun Zhou , Wenting Sun , Fengjie Huang , Lu Wang , Zhangbao Zhou , Wei Jia

Background

FibraChek is a newly developed mass spectrometry (MS) assay kit approved by the National Medical Products Administration (NMPA) of China for quantifying L-tyrosine (Tyr) and taurocholic acid (TCA) in serum, aiding liver fibrosis diagnosis. This study aimed to assess its analytical performance.

Methods

The analytical performance was investigated based on NMPA and CLSI guidelines. Method suitability in the clinical context was tested by analyzing clinical samples from liver fibrosis patients confirmed via liver biopsy.

Results

The assay enables simultaneous determination of Tyr and TCA, demonstrating compliance with performance parameters such as linearity, dynamic range, limit of detection (LOD), limit of quantification (LOQ), recovery, repeatability, reproducibility, and stability. It validated a linear range of 20–1000 μmol/L for Tyr and 10.3–618 ng/ml for TCA, maintaining stability after 5 freeze-thaw cycles for 14 months. Components remained stable for up to 7 days at room temperature and 30 days at 2–8 °C. TCA and Tyr were stable for up to 36 months at −20 °C or −80 °C. The method effectively quantified Tyr and TCA in serum from liver fibrosis patients and healthy controls.

Conclusions

This is the first MS-based assay for non-invasive liver fibrosis detection validated for clinical use, providing a rapid and reliable analytical protocol suitable for routine analysis.

背景：FibraChek是中国国家药品监督管理局（NMPA）批准的一种新型质谱（MS）检测试剂盒，用于定量血清中l -酪氨酸（Tyr）和牛磺胆酸（TCA），有助于肝纤维化诊断。本研究旨在评估其分析性能。方法：根据NMPA和CLSI标准考察其分析性能。方法通过分析经肝活检证实的肝纤维化患者的临床样本来检验其在临床环境中的适用性。结果：该方法可同时测定Tyr和TCA，符合线性、动态范围、检出限（LOD）、定量限（LOQ）、回收率、可重复性、重现性和稳定性等性能参数。结果表明，Tyr在20 ~ 1000 μmol/L范围内呈线性，TCA在10.3 ~ 618 ng/ml范围内呈线性，在5次冻融循环后保持稳定，冻融周期为14个月。组件在室温下可保持稳定长达7天，在2-8℃下可保持30天。TCA和Tyr在-20°C或-80°C下稳定达36个月。该方法可有效定量肝纤维化患者和健康对照血清中酪氨酸和TCA的含量。结论：这是首个用于临床验证的无创肝纤维化检测的MS-based分析方法，为常规分析提供了一种快速可靠的分析方案。

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引用次数: 0

Impact of using cross-over CV and mean for two different lots of assay control on implementation of Westgard rules in chemical diagnostic tests 交叉CV和均值对化学诊断试验中韦斯特加德规则实施的影响

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-16 DOI: 10.1016/j.plabm.2025.e00449

Ayman Mohamed Nabil , Hayat Mirza Alsaif , Muneer Ahmad Aljamaan , Abdullah Abdullah H. Algafly , Rashad Hassan aleid , Raji Ali Helal , Zainab Ali Hussain almutawah , Amani Abdulkareem S. Alzayer , Walaa Ali Hussain Almutawah , Badr Abdullah Motlaq AlKhalaf

Background

The main challenges of clinical laboratories concerning quality control include cost-effectiveness, variability in standardized materials, and evolving technologies across various diagnostic fields. While traditional QC practices and automation systems provide for accuracy, gaps exist, especially when applying Westgard rules to control lots for multiple assays. Such gaps result in inconsistent QC outcomes and unaddressed challenges in diagnostic reliability.

Objective

This study aims to assess the effect of the cross-over coefficient of variation (CV) and mean values for different assay control lots on implementing Westgard rules to improve QC practices and enhance the accuracy and reliability of diagnostic tests in molecular laboratories.

Methods

Data from 18 Levy-Jennings charts, with two assay control lots, were analyzed. Statistical comparisons of failure rates before and after setting the actual SD were performed using chi-square or T-tests at p < 0.05.

Results

The analysis of 18 Levy-Jennings charts showed a significant reduction in failure rates after establishing actual mean and SD values compared to cross-over CV. Of the charts, 11 exhibited differences in failure occurrences, particularly rejection failures, highlighting improved QC reliability.

Conclusion

These results emphasize the importance of accurate SD calculation in enhancing the effectiveness of Westgard rules. Therefore, establishing mean and SD values enhances QC reliability, reduces false failures, and ensures accurate Westgard rules application, while ongoing training in QC practices enhances diagnostic accuracy.

背景：临床实验室在质量控制方面面临的主要挑战包括成本效益、标准化材料的可变性以及各种诊断领域不断发展的技术。虽然传统的QC实践和自动化系统提供了准确性，但存在差距，特别是在应用Westgard规则来控制多个检测批次时。这些差距导致质量控制结果不一致，并在诊断可靠性方面面临未解决的挑战。目的：探讨不同对照批次的交叉变异系数（CV）和平均值对实施Westgard规则的影响，以改善分子实验室的质量控制实践，提高诊断检测的准确性和可靠性。方法：对18张Levy-Jennings图的数据进行分析，并附有2个对照批次。结果：对18张Levy-Jennings图的分析显示，与交叉CV相比，建立实际均值和SD值后，故障率显著降低。在图表中，11个显示了故障发生的差异，特别是拒收故障，突出了质量控制可靠性的提高。结论：这些结果强调了准确的SD计算对提高Westgard规则的有效性的重要性。因此，建立均值和标准差值提高了质量控制的可靠性，减少了假故障，并确保了Westgard规则的准确应用，同时持续的质量控制实践培训提高了诊断的准确性。

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引用次数: 0

Complete blood count in neonatal Intensive care Unit (NICU): Performance comparison between POCT Sight OLO® and Sysmex XN-9100™ hematology analyzers 新生儿重症监护病房（NICU）全血细胞计数：POCT Sight OLO®和Sysmex XN-9100™血液学分析仪的性能比较

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-14 DOI: 10.1016/j.plabm.2025.e00453

Francesca Nencini , Alessandro Bonari , Sara Ciullini Mannurita , Alessandra Mongia , Francesca Romano , Maria Garieri , Edda Russo , Silvia Sastrucci , Graziella Marrani , Martina Tonelli , Stefano Salti , Niccola Funel , Amedeo Amedei , Carlo Dani , Alessandra Fanelli

Background and aims

The use of a POCT (Point Of Care Test) could help in reducing the impact of pre-analytical errors in particular in challenging newborn samples.

The study purpose is to compare the POCT Sight OLO® hematology analyzer, validated for >3 months patients, with the reference system Sysmex XN-9100™ in Neonatal Intensive Care Unit (NICU).

Material and methods

The two analyzers were compared through Passing-Bablok regression analysis and Bland-Altman plot.

Results

We analyzed 65 blood samples, in detail 38 from adults and 27 from newborns.

The regression analysis results performed in the newborn and adult patients showed a good agreement between the two instruments. The evaluation of the Bland-Altman plots showed comparable values of bias <10 % for the most of parameters.

The evaluation of sample flags for the presence of distributional and morphological abnormalities showed a partial accordance between the two approaches, but the POCT exhibited good performance compared to the final report revised by the laboratory specialist.

Conclusions

The comparison of the two instruments demonstrated that they provide comparable blood counts, also in patients aged <3 months. The POCT allows having reliable analytical data and faster turning around time, particularly useful in NICU.

背景和目的：使用POCT（护理点测试）可以帮助减少分析前错误的影响，特别是在具有挑战性的新生儿样本中。该研究的目的是比较POCT Sight OLO®血液分析仪，该分析仪已在新生儿重症监护病房（NICU）验证，与参考系统Sysmex XN-9100™进行比较。材料与方法：采用Passing-Bablok回归分析和Bland-Altman图对两种分析仪进行比较。结果：我们分析了65份血液样本，其中成人38份，新生儿27份。在新生儿和成人患者中进行的回归分析结果显示，两种仪器之间的一致性很好。Bland-Altman图的评估显示了可比较的偏倚值。结论：两种仪器的比较表明，它们提供了可比较的血液计数，在老年患者中也是如此

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引用次数: 0

Observational assessment of the utilization of donated point of care tests and glycemic control at free and charitable clinics across the United States 在美国各地的免费和慈善诊所使用捐赠的护理点测试和血糖控制的观察性评估。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-10 DOI: 10.1016/j.plabm.2025.e00450

Sonak D. Pastakia , Heidi Schutz , Tena Tiruneh , Ariana Gordillo De Vivero , Lindsey Dodds

Introduction

Populations experiencing poverty often lack access to convenient lab tests. This analysis assesses trends observed from a national point of care (POC) lab donation program for free and charitable clinics across the United States.

Methods

A total of 16 clinics were selected to receive a comprehensive package of POC lab tests. De-identified data on POC test utilization and results were assessed to descriptively identify trends in utilization (primary objective) and glycemic control (secondary objective). A paired t-test was utilized to identify statistically significant changes in HbA1c from baseline to predefined 90-day time intervals for all people living with diabetes (PLWD) and those with a baseline HbA1c ≥ 9.0 % (75 mmol/mol). The main comparison of interest was the change in HbA1c from baseline to 90–179 days.

Results

A total of 17,563 POC tests were completed for 9658 patients with 3223 tests being HbA1c’s. In the secondary analysis of PLWD with a baseline HbA1c ≥ 9.0 % (75 mmol/mol), patients who completed an HbA1c between 90 and 179 days (n = 188) demonstrated a statistically significant mean reduction from baseline of -1.2 % (95 % CI, -1.6 % to −0.9 %, p < 0.01, -10 mmol/mol [95 % CI, -6 mmol/mol - -14 mmol/mol]).

Discussion

The provision of POC labs helped support the care populations experiencing poverty received at free and charitable clinics, especially for chronic diseases like diabetes.

导言：贫困人口往往无法获得方便的实验室检测。本分析评估了从全国护理点（POC）实验室捐赠计划观察到的趋势，该计划针对美国各地的免费和慈善诊所。方法：选取16家临床诊所，对其进行全面的POC实验室检测。对POC试验使用和结果的去识别数据进行评估，以描述性地确定使用趋势（主要目标）和血糖控制（次要目标）。配对t检验用于确定所有糖尿病患者（PLWD）和基线HbA1c≥9.0% （75 mmol/mol）的HbA1c从基线到预定义的90天时间间隔的统计学显著变化。主要比较感兴趣的是HbA1c从基线到90-179天的变化。结果：9658例患者共完成17563例POC检测，其中3223例为HbA1c检测。在基线HbA1c≥9.0% （75 mmol/mol）的PLWD的二次分析中，在90至179天（n = 188）完成HbA1c的患者显示出统计学上显着的平均较基线降低- 1.2% (95% CI, - 1.6%至- 0.9%)，p讨论：提供POC实验室有助于支持贫困人群在免费和慈善诊所接受治疗，特别是慢性病，如糖尿病。

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引用次数: 0

Development of an accurate and sensitive assay for 2-methoxyestradiol using derivatization and liquid chromatography-tandem mass spectrometry 利用衍生化和液相色谱-串联质谱法建立准确灵敏的2-甲氧基雌二醇测定方法。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-09 DOI: 10.1016/j.plabm.2024.e00447

Koji Takahashi , Masaki Takiwaki , Seketsu Fukuzawa , Yoshikuni Kikutani , Kentaro Abe , Tatsuya Higashi , Hironori Kobayashi

2-Methoxyestradiol (2ME) is involved in the pathogenesis of preeclampsia and antitumor activity. In addition to its low concentration in healthy human serum, presence of isomers makes quantification of 2ME for clinical research and laboratory medicine difficult. The objective of this study was to develop a highly sensitive and accurate method for quantifying 2ME using LC-MS/MS combined with derivatization with 1-(2,4-dinitro-5-fluorophenyl)-4,4-dimethylpiperazinium iodide (MPDNP-F). This approach significantly enhanced the detectability of 2ME in positive electrospray ionization-tandem mass spectrometry (ESI-MS/MS) and enabled the chromatographic separation of 2ME from isomeric metabolites possessing a methoxy group, including 4-methoxyestradiol, 3-O-methyl 2-hydroxyestradiol, and 3-O-methyl 4-hydroxyestradiol (3M4OH). Although the derivatized 2ME and 3M4OH were closely eluted under the optimized LC conditions, the different fragmentation patterns of these isomers during MS/MS allowed their distinction. The lower limit of quantification for 2ME was 2.5 pg/mL, indicating a satisfactory sensitivity. These findings demonstrated that this LC-MS/MS method combined with the MPDNP-F derivatization can provide accurate and highly sensitive quantification of 2ME.

2-甲氧基雌二醇（2ME）参与子痫前期的发病机制和抗肿瘤活性。除了其在健康人血清中的低浓度外，其异构体的存在使得临床研究和实验室医学的2ME定量变得困难。本研究的目的是建立一种高灵敏度、高准确度的液相色谱-质谱联用衍生化1-（2,4-二硝基-5-氟苯基）-4,4-二甲基碘化哌嗪（MPDNP-F）定量2ME的方法。该方法显著提高了2ME在正电喷雾电离串联质谱（ESI-MS/MS）中的可检出性，并能从含有甲氧基的异构体代谢物（包括4-甲氧基雌二醇、3- o -甲基2-羟基雌二醇和3- o -甲基4-羟基雌二醇（3M4OH））中分离出2ME。虽然在优化的液相色谱条件下，衍生的2ME和3M4OH被紧密洗脱，但在质谱/质谱中，这些异构体的不同断裂模式使得它们可以被区分。2ME的定量下限为2.5 pg/mL，灵敏度令人满意。这些结果表明，结合MPDNP-F衍生化的LC-MS/MS方法可以提供准确和高灵敏度的2ME定量。

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