Practical Laboratory Medicine最新文献_第7页

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。

{"title":"Impact of hemolysis on the levels of proteins associated with aging and age-related neurodegenerative diseases in a multicentric clinical research","authors":"Masroor Anwar , Km Renu , Abhinay Kumar Singh , Abhilasha Nayal , Bharat Thyagarajan , Peifeng Hu , Jinkook Lee , Sharmistha Dey , A.B. Dey","doi":"10.1016/j.plabm.2025.e00455","DOIUrl":"10.1016/j.plabm.2025.e00455","url":null,"abstract":"<div><h3>Introduction</h3><div>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).</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00455"},"PeriodicalIF":1.7,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143140814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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。

{"title":"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","authors":"Guoxiang Xie , Kejun Zhou , Wenting Sun , Fengjie Huang , Lu Wang , Zhangbao Zhou , Wei Jia","doi":"10.1016/j.plabm.2025.e00454","DOIUrl":"10.1016/j.plabm.2025.e00454","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00454"},"PeriodicalIF":1.7,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788763/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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。

{"title":"Impact of using cross-over CV and mean for two different lots of assay control on implementation of Westgard rules in chemical diagnostic tests","authors":"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","doi":"10.1016/j.plabm.2025.e00449","DOIUrl":"10.1016/j.plabm.2025.e00449","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00449"},"PeriodicalIF":1.7,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123434","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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

{"title":"Complete blood count in neonatal Intensive care Unit (NICU): Performance comparison between POCT Sight OLO® and Sysmex XN-9100™ hematology analyzers","authors":"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","doi":"10.1016/j.plabm.2025.e00453","DOIUrl":"10.1016/j.plabm.2025.e00453","url":null,"abstract":"<div><h3>Background and aims</h3><div>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.</div><div>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).</div></div><div><h3>Material and methods</h3><div>The two analyzers were compared through Passing-Bablok regression analysis and Bland-Altman plot.</div></div><div><h3>Results</h3><div>We analyzed 65 blood samples, in detail 38 from adults and 27 from newborns.</div><div>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.</div><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00453"},"PeriodicalIF":1.7,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11787615/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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。

{"title":"Observational assessment of the utilization of donated point of care tests and glycemic control at free and charitable clinics across the United States","authors":"Sonak D. Pastakia , Heidi Schutz , Tena Tiruneh , Ariana Gordillo De Vivero , Lindsey Dodds","doi":"10.1016/j.plabm.2025.e00450","DOIUrl":"10.1016/j.plabm.2025.e00450","url":null,"abstract":"<div><h3>Introduction</h3><div>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.</div></div><div><h3>Methods</h3><div>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 <em>t</em>-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.</div></div><div><h3>Results</h3><div>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 %, <em>p</em> < 0.01, -10 mmol/mol [95 % CI, -6 mmol/mol - -14 mmol/mol]).</div></div><div><h3>Discussion</h3><div>The provision of POC labs helped support the care populations experiencing poverty received at free and charitable clinics, especially for chronic diseases like diabetes.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00450"},"PeriodicalIF":1.7,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11782993/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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。

{"title":"Development of an accurate and sensitive assay for 2-methoxyestradiol using derivatization and liquid chromatography-tandem mass spectrometry","authors":"Koji Takahashi , Masaki Takiwaki , Seketsu Fukuzawa , Yoshikuni Kikutani , Kentaro Abe , Tatsuya Higashi , Hironori Kobayashi","doi":"10.1016/j.plabm.2024.e00447","DOIUrl":"10.1016/j.plabm.2024.e00447","url":null,"abstract":"<div><div>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-<em>O</em>-methyl 2-hydroxyestradiol, and 3-<em>O</em>-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.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00447"},"PeriodicalIF":1.7,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11772991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Molecular diagnosis of visceral leishmaniasis from blood samples using different genetic markers: A simple, sensitive and less invasive diagnostic approach 利用不同遗传标记从血液样本中进行内脏利什曼病的分子诊断：一种简单、敏感和侵入性较小的诊断方法。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-09 DOI: 10.1016/j.plabm.2025.e00448

Harish Kumar Shah , K.R. Rajesh , P.A. Fathima , R.S. Aiswarya , P.M. Ajithlal , Prasanta Saini

Visceral leishmaniasis (VL), or kala-azar, is a deadly disease with high fatality rates if diagnosis and treatment are delayed. Diagnosis is often delayed due to symptoms that mimic other conditions. Sample isolation and diagnostic procedures are labor-intensive and time-consuming. Rapid immunochromatographic tests cannot differentiate active cases from past infections. In the present study we investigated the utility of peripheral blood samples for molecular diagnosis of VL. Whole genomic DNA from the erythrocyte fraction of blood from VL and cutaneous leishmaniasis (CL) suspected patients was used for PCR using multiple markers (k-DNA, ITS-Ⅰ, and 18s rRNA). PCR amplification of k-DNA, ITS-Ⅰ, and 18s rRNA genes yielded positive results in VL symptomatic patients. However, the same PCR approach with peripheral blood samples from CL patients was not significant. Hence, peripheral blood samples can effectively distinguish active VL cases through PCR using multiple markers, offering a less invasive and labor-intensive diagnostic alternative.

内脏利什曼病（VL），或黑热病，是一种致命的疾病，如果诊断和治疗延迟，死亡率很高。由于症状类似于其他疾病，诊断常常被推迟。样品分离和诊断程序是劳动密集型和耗时的。快速免疫层析试验不能区分活动性病例和既往感染病例。在本研究中，我们探讨了外周血样本在VL分子诊断中的应用。采用多种标记物（k-DNA、ITS-Ⅰ和18s rRNA）对VL和皮肤利什曼病疑似患者血液中红细胞部分的全基因组DNA进行PCR检测。VL症状患者k-DNA、ITS-Ⅰ和18s rRNA基因的PCR扩增结果为阳性。然而，同样的PCR方法对CL患者外周血样本没有显著意义。因此，外周血样本可以通过多重标记物的PCR有效区分活动性VL病例，提供了一种侵入性和劳动强度较小的诊断选择。

{"title":"Molecular diagnosis of visceral leishmaniasis from blood samples using different genetic markers: A simple, sensitive and less invasive diagnostic approach","authors":"Harish Kumar Shah , K.R. Rajesh , P.A. Fathima , R.S. Aiswarya , P.M. Ajithlal , Prasanta Saini","doi":"10.1016/j.plabm.2025.e00448","DOIUrl":"10.1016/j.plabm.2025.e00448","url":null,"abstract":"<div><div>Visceral leishmaniasis (VL), or kala-azar, is a deadly disease with high fatality rates if diagnosis and treatment are delayed. Diagnosis is often delayed due to symptoms that mimic other conditions. Sample isolation and diagnostic procedures are labor-intensive and time-consuming. Rapid immunochromatographic tests cannot differentiate active cases from past infections. In the present study we investigated the utility of peripheral blood samples for molecular diagnosis of VL. Whole genomic DNA from the erythrocyte fraction of blood from VL and cutaneous leishmaniasis (CL) suspected patients was used for PCR using multiple markers (k-DNA, ITS-Ⅰ, and 18s rRNA). PCR amplification of k-DNA, ITS-Ⅰ, and 18s rRNA genes yielded positive results in VL symptomatic patients. However, the same PCR approach with peripheral blood samples from CL patients was not significant. Hence, peripheral blood samples can effectively distinguish active VL cases through PCR using multiple markers, offering a less invasive and labor-intensive diagnostic alternative.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"44 ","pages":"Article e00448"},"PeriodicalIF":1.7,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11786688/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of the accuracy of procalcitonin, neutrophil CD64, and C-reactive protein for the diagnosis and prognosis of septic patients after antibiotic therapy 降钙素原、中性粒细胞CD64、c反应蛋白对脓毒症患者抗生素治疗后诊断及预后准确性的比较

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-01 DOI: 10.1016/j.plabm.2024.e00444

Qingteng Zhu , Hui Wang , Liang Chen , Yang Yu , Miao Chen

Background

The performance of the inflammatory biomarkers in the management of septic patients who received antimicrobial therapies is largely neglected. This study aimed to compare the accuracy of procalcitonin (PCT), neutrophil CD64 (CD64), and C-reactive protein (CRP) for the diagnosis and prognosis of septic patients after antimicrobial therapy.

Methods

This study prospectively recruited consecutive patients without infection and those diagnosed with infection but had received initial antimicrobial therapies. Sepsis was diagnosed according to sepsis-3 criteria. Serum PCT, CD64 and CRP levels were measured upon entry to the ICU. We also collected each patient's baseline characteristics. The diagnostic and prognostic performance of these parameters was evaluated from the area under the receiver operator characteristic curve (AUC).

Results

A total of 635 consecutive ICU patients were screened for eligible and 289 (45.5 %) patients were diagnosed with sepsis upon entry to the ICU. The area under the curve (AUC) for PCT, CD64 and CRP in the identification of sepsis is 0.726, 0.692 and 0.719, respectively. Neither PCT (p = 0.587) nor CD64 (p = 0.373) is superior to CRP in the diagnosis of septic patients who received antimicrobial therapies. The AUC for PCT, CD64 and CRP in the prediction of ICU mortality in these sepsis patients is 0.702, 0.637 and 0.593, respectively. The prognostic performance of PCT (p = 0.006) rather than CD64 (p = 0.509) is better than CRP.

Conclusions

Both PCT and CD64 are not superior to CRP in the identification of septic patients who received antimicrobial therapies. However, PCT instead of CD64 has a better prognostic accuracy than CRP for the prediction of ICU mortality of these septic patients.

背景：炎症生物标志物在接受抗菌药物治疗的脓毒症患者管理中的表现在很大程度上被忽视。本研究旨在比较降钙素原（PCT）、中性粒细胞CD64 （CD64）和c反应蛋白（CRP）对脓毒症患者抗菌治疗后诊断和预后的准确性。方法：本研究前瞻性地招募了未感染的连续患者和诊断为感染但已接受初始抗菌药物治疗的患者。根据脓毒症-3标准诊断脓毒症。在进入ICU时测定血清PCT、CD64和CRP水平。我们还收集了每位患者的基线特征。这些参数的诊断和预后性能从接受者操作者特征曲线（AUC）下的面积来评估。结果：共筛选了635例符合条件的ICU患者，289例（45.5%）患者在进入ICU时被诊断为败血症。PCT、CD64、CRP在脓毒症诊断中的曲线下面积（AUC）分别为0.726、0.692、0.719。PCT （p = 0.587）和CD64 （p = 0.373）对接受抗菌药物治疗的脓毒症患者的诊断均不优于CRP。PCT、CD64、CRP预测脓毒症患者ICU死亡率的AUC分别为0.702、0.637、0.593。PCT （p = 0.006）的预后优于CD64 （p = 0.509）。结论：PCT和CD64在鉴别接受抗菌药物治疗的脓毒症患者方面并不优于CRP。然而，PCT代替CD64在预测这些脓毒症患者ICU死亡率方面比CRP具有更好的预后准确性。

{"title":"Comparison of the accuracy of procalcitonin, neutrophil CD64, and C-reactive protein for the diagnosis and prognosis of septic patients after antibiotic therapy","authors":"Qingteng Zhu , Hui Wang , Liang Chen , Yang Yu , Miao Chen","doi":"10.1016/j.plabm.2024.e00444","DOIUrl":"10.1016/j.plabm.2024.e00444","url":null,"abstract":"<div><h3>Background</h3><div>The performance of the inflammatory biomarkers in the management of septic patients who received antimicrobial therapies is largely neglected. This study aimed to compare the accuracy of procalcitonin (PCT), neutrophil CD64 (CD64), and C-reactive protein (CRP) for the diagnosis and prognosis of septic patients after antimicrobial therapy.</div></div><div><h3>Methods</h3><div>This study prospectively recruited consecutive patients without infection and those diagnosed with infection but had received initial antimicrobial therapies. Sepsis was diagnosed according to sepsis-3 criteria. Serum PCT, CD64 and CRP levels were measured upon entry to the ICU. We also collected each patient's baseline characteristics. The diagnostic and prognostic performance of these parameters was evaluated from the area under the receiver operator characteristic curve (AUC).</div></div><div><h3>Results</h3><div>A total of 635 consecutive ICU patients were screened for eligible and 289 (45.5 %) patients were diagnosed with sepsis upon entry to the ICU. The area under the curve (AUC) for PCT, CD64 and CRP in the identification of sepsis is 0.726, 0.692 and 0.719, respectively. Neither PCT (p = 0.587) nor CD64 (p = 0.373) is superior to CRP in the diagnosis of septic patients who received antimicrobial therapies. The AUC for PCT, CD64 and CRP in the prediction of ICU mortality in these sepsis patients is 0.702, 0.637 and 0.593, respectively. The prognostic performance of PCT (p = 0.006) rather than CD64 (p = 0.509) is better than CRP.</div></div><div><h3>Conclusions</h3><div>Both PCT and CD64 are not superior to CRP in the identification of septic patients who received antimicrobial therapies. However, PCT instead of CD64 has a better prognostic accuracy than CRP for the prediction of ICU mortality of these septic patients.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"43 ","pages":"Article e00444"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Liquid biopsy in cancer management: Integrating diagnostics and clinical applications 液体活检在癌症管理：整合诊断和临床应用。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-01 DOI: 10.1016/j.plabm.2024.e00446

Shashwat Pandey , Preeti Yadav

Liquid biopsy is an innovative, minimally invasive diagnostic tool revolutionizing cancer management by enabling the detection and analysis of cancer-related biomarkers from bodily fluids such as blood, urine, or cerebrospinal fluid. Unlike traditional tissue biopsies, which require invasive procedures, liquid biopsy offers a more accessible and repeatable method for tracking cancer progression, detecting early-stage cancers, and monitoring therapeutic responses. The technology primarily focuses on analyzing circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and other cancer-derived genetic materials. These biomarkers provide critical information on tumor heterogeneity, mutation profiles, and potential drug resistance. In clinical practice, liquid biopsy has demonstrated its utility in identifying actionable mutations, guiding personalized treatment strategies, and assessing minimal residual disease (MRD). While liquid biopsy holds immense promise, challenges related to its sensitivity, specificity, and standardization remain. Efforts to optimize pre-analytical and analytical processes, along with the establishment of robust regulatory frameworks, are crucial for its widespread clinical adoption. This abstract highlights the transformative potential of liquid biopsy in cancer diagnosis, prognosis, and treatment monitoring, emphasizing its role in advancing personalized oncology. Further research, clinical trials, and regulatory harmonization will be vital in realizing its full potential in precision cancer care.

液体活检是一种创新的微创诊断工具，通过检测和分析血液、尿液或脑脊液等体液中与癌症相关的生物标志物，彻底改变了癌症管理。与传统的组织活检不同，液体活检提供了一种更容易获得和可重复的方法来跟踪癌症进展，检测早期癌症，并监测治疗反应。该技术主要侧重于分析循环肿瘤细胞（CTCs）、循环肿瘤DNA （ctDNA）和其他癌症来源的遗传物质。这些生物标志物提供了肿瘤异质性、突变谱和潜在耐药性的关键信息。在临床实践中，液体活检已经证明了它在识别可操作的突变、指导个性化治疗策略和评估最小残留病（MRD）方面的效用。虽然液体活检具有巨大的前景，但其敏感性、特异性和标准化方面的挑战仍然存在。优化分析前和分析过程的努力，以及建立健全的监管框架，对于其广泛的临床应用至关重要。本摘要强调液体活检在癌症诊断、预后和治疗监测方面的变革潜力，强调其在推进个性化肿瘤学中的作用。进一步的研究、临床试验和监管协调对于实现其在精确癌症治疗中的全部潜力至关重要。

{"title":"Liquid biopsy in cancer management: Integrating diagnostics and clinical applications","authors":"Shashwat Pandey , Preeti Yadav","doi":"10.1016/j.plabm.2024.e00446","DOIUrl":"10.1016/j.plabm.2024.e00446","url":null,"abstract":"<div><div>Liquid biopsy is an innovative, minimally invasive diagnostic tool revolutionizing cancer management by enabling the detection and analysis of cancer-related biomarkers from bodily fluids such as blood, urine, or cerebrospinal fluid. Unlike traditional tissue biopsies, which require invasive procedures, liquid biopsy offers a more accessible and repeatable method for tracking cancer progression, detecting early-stage cancers, and monitoring therapeutic responses. The technology primarily focuses on analyzing circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and other cancer-derived genetic materials. These biomarkers provide critical information on tumor heterogeneity, mutation profiles, and potential drug resistance. In clinical practice, liquid biopsy has demonstrated its utility in identifying actionable mutations, guiding personalized treatment strategies, and assessing minimal residual disease (MRD). While liquid biopsy holds immense promise, challenges related to its sensitivity, specificity, and standardization remain. Efforts to optimize pre-analytical and analytical processes, along with the establishment of robust regulatory frameworks, are crucial for its widespread clinical adoption. This abstract highlights the transformative potential of liquid biopsy in cancer diagnosis, prognosis, and treatment monitoring, emphasizing its role in advancing personalized oncology. Further research, clinical trials, and regulatory harmonization will be vital in realizing its full potential in precision cancer care.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"43 ","pages":"Article e00446"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11743551/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143010566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0