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Acute Toxicity and Efficacy of Nanomaterial based Decontamination Formulation Developed for Personal Decontamination against Chemical Warfare Agents 用于个人净化化学战剂的纳米材料净化配方的急性毒性和功效
Q3 Medicine Pub Date : 2019-09-30 DOI: 10.2174/1875318301909010040
A. Gautam, G. K. Prasad, Deeksha Singh, R. Vijayaraghavan
This study addresses the efficacy of nanomaterials based formulation developed for personal decontamination application against chemical warfare agents and used in Personal Decontamination Kit (PDK). It has the potential to decontaminate the skin of an individual, protective equipment, and small arms contaminated with chemical warfare agents. As this formulation has been developed for personal decontamination, risk of nanomaterial toxicity would always be there while sprinkling or applying to the affected area. It may get into the body through various routes specifically through the inhalation route. The aim of this study was to evaluate in vivo decontamination efficiency of the formulation and acute inhalation, intratracheal, intranasal, oral, dermal, and intraperitoneal toxicity of the formulation. 14 days survival was recorded for the evaluation of decontamination efficiency of this formulation. Various endpoints were considered while assessing the toxicity of Nanomaterial Decontamination Formulation which include Organ Body Weight Index (OBWI), serum biochemical parameters, and respiratory variables like tidal volume, respiratory rate, time of inspiration, time of expiration, etc. LD50 of the formulation were also determined for various routes. As skin is the primary organ to come in contact with the decontaminant, its primary skin irritation response has also been determined in this study. It was found that there is no gross acute toxicity observed at different doses. Though there were some changes in the initial respiratory pattern, they were all later recovered. The preliminary histological evaluation did not show any adverse effect on various organs after exposure with NDF.
本研究探讨了为个人去污应用开发的纳米材料配方对化学战剂的功效,并在个人去污试剂盒(PDK)中使用。它有可能净化个人皮肤、防护设备和被化学战剂污染的小武器。由于该配方是为个人去污而开发的,在喷洒或应用于受影响区域时,纳米材料毒性的风险始终存在。它可能通过各种途径进入人体,特别是通过吸入途径。本研究的目的是评估该制剂的体内去污效率以及该制剂的急性吸入、气管内、鼻内、口服、皮肤和腹膜内毒性。记录14天的存活率以评估该制剂的去污效率。在评估纳米材料去污制剂的毒性时,考虑了各种终点,包括器官体重指数(OBWI)、血清生化参数和呼吸变量,如潮气量、呼吸频率、吸气时间、呼气时间等。还确定了各种途径的制剂LD50。由于皮肤是接触去污剂的主要器官,本研究还确定了其主要的皮肤刺激反应。研究发现,在不同剂量下没有观察到严重急性毒性。尽管最初的呼吸模式有一些变化,但后来都恢复了。初步组织学评估未显示NDF暴露后对各种器官有任何不良影响。
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引用次数: 0
Protective Efficacy of Vitamin F against Acrylamide Induced Toxicity: Studies on Oxidative Stress Biomarkers 维生素F对丙烯酰胺毒性的保护作用:氧化应激生物标志物的研究
Q3 Medicine Pub Date : 2019-09-30 DOI: 10.2174/1875318301909010062
S. Shrivastava, S. Nirala, Mohd Salim Reshi, S. Shukla, Anjali Sharma, C. Uthra
Vitamin F is also known as Linoleic Acid (LA), is an Essential Fatty Acid (EFA) which is not produced in humans. It can be modified to form essential precursors such as arachidonic acid which is used to make prostaglandins, thromboxanes, and leukotrienes. It is found in abundance in several vegetable oils such as sunflower, poppy seed, safflower and corn oils. LA has shown diverse beneficial effects against diseases such as cancer, skin permeability, insulin resistance, depression and cardiovascular diseases. Acrylamide (AA) is a well known neurotoxic, carcinogenic and genotoxic compound. It is used universally in the industrial process and recently found in various food products which are cooked at a temperature above 120˚C such as potato crisps, bread, cookies and french fries. Over exposure of humans and laboratory animals to monomer AA causes damages to the central and peripheral nervous system.To investigate the therapeutic effect of linoleic acid against acrylamide toxicity.AA was given at 38.27 mg/kg dose for 10 days and therapy with different doses of linoleic acid for three days (11-13 days) to female albino rats.Signs and symptoms of acrylamide toxicity occur, they include significant body weight reduction, hair loss, splaying of hindlimbs, dragging of back legs and skin irritation. A significant decline was observed in hemoglobin level and GSH, whereas significant enhancement in LPO was noted, as compared to the control group after AA exposure. The activity of acetylcholinesterase was decreased in the brain after AA administration. AA significantly reduced the superoxide dismutase and catalase activities in liver, kidney and brain but activities of serum transaminases, bilirubin, creatinine, urea and lipid profile increased in serum. Biochemical studies were also strengthened by histopathological observations.Study has shown that linoleic acid promotes defense against AA toxicity.
维生素F也被称为亚油酸(LA),是一种人体不能产生的必需脂肪酸(EFA)。它可以被修饰成必需的前体,如花生四烯酸,它被用来制造前列腺素、血栓烷和白三烯。它大量存在于几种植物油中,如葵花籽油、罂粟籽油、红花油和玉米油。LA对癌症、皮肤渗透性、胰岛素抵抗、抑郁症和心血管疾病等疾病显示出多种有益作用。丙烯酰胺(AA)是一种众所周知的神经毒性、致癌性和遗传毒性化合物。它广泛应用于工业生产过程中,最近在薯片、面包、饼干和炸薯条等温度超过120˚C的食品中也发现了它的存在。人类和实验动物过度暴露于单体AA会对中枢和周围神经系统造成损害。探讨亚油酸对丙烯酰胺毒性的治疗作用。雌性白化大鼠按38.27 mg/kg剂量给予AA,连续10 d,并用不同剂量亚油酸治疗3 d (11 ~ 13 d)。丙烯酰胺中毒的体征和症状包括体重明显减轻、脱发、后肢张开、后腿拖拽和皮肤刺激。与对照组相比,AA暴露后血红蛋白水平和GSH显著下降,而LPO显著增强。AA给药后大鼠脑内乙酰胆碱酯酶活性降低。AA显著降低了肝、肾和脑超氧化物歧化酶和过氧化氢酶活性,升高了血清转氨酶、胆红素、肌酐、尿素和血脂活性。组织病理学观察也加强了生化研究。研究表明,亚油酸促进防御AA毒性。
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引用次数: 3
Biomarkers are the Need of the Present Era 生物标志物是当今时代的需要
Q3 Medicine Pub Date : 2019-09-30 DOI: 10.2174/1875318301909010038
C. Sharma, Monika Sharma
The advancements in medicine and public health measures have made possible, the worldwide decline in the incidence and prevalence of infectious liver diseases (i.e., viral, bacterial, fungal, parasitic etc.) However, with the changing pattern of lifestyle, most of the diseases are now associated with the lifestyle and the chemical-induced diseases are increasing paradoxically in recent years to become a major health problem in the near future. So this thematic issue was conceptualized in view to give comprehensive latest information related to the biomarkers used in the medical sciences.
医学和公共卫生措施的进步使传染性肝病(即病毒性、细菌性、真菌性、寄生性等)的发病率和流行率在世界范围内下降成为可能。然而,随着生活方式的改变,大多数疾病现在都与生活方式有关,而化学品引起的疾病近年来自相矛盾地增加,在不久的将来将成为一个主要的健康问题。因此,这个主题问题的概念,以提供有关生物标志物在医学科学中使用的全面的最新信息。
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引用次数: 0
Evaluation of Fucosylated Haptoglobin as a Diagnostic Biomarker for Hepatocellular Carcinoma in Egypt 岩藻糖基结合珠蛋白作为埃及肝细胞癌诊断生物标志物的评价
Q3 Medicine Pub Date : 2019-06-30 DOI: 10.2174/1875318301909010031
Nahla M. Shalably, R. Badawi, N. Hawash, S. Abd-Elsalam, W. ElKhalawany, Amal Hameed, Galal El-Din Alkassas.
Most Hepatocellular Carcinomas (HCCs) are diagnosed at an advanced stage. Therefore, there is citation-type an urgent need for better methods of detection and surveillance of patients at risk of HCC. Alpha-fetoprotein (AFP) has a suboptimal diagnostic performance for HCC surveillance, so novel and reliable diagnostic biomarkers are required. The aim of this work is to evaluate fucosylated haptoglobin as a diagnostic biomarker for hepatocellular carcinoma in Egyptian patients. This case-control study was carried out on 60 patients classified into 3 groups (20 patients on each); group I (HCC group), group II (Cirrhotic group) and group III (Control group). Diagnosis of liver cirrhosis was done by clinical, biochemical and ultrasound (US), whereas the diagnosis of HCC was done by percutaneous biopsy or radiological (by US and triphasic Computerized Tomography (CT) based on the guidelines of the American-Association for the Study of Liver Diseases. HCC stage was clinically defined according to the Barcelona Clinic Liver Cancer (BCLC) staging system. AFP & fucosylated haptoglobin levels were estimated in all groups. There was a statistically significant positive correlation between serum fucosylated haptoglobin and tumor size in the HCC group. Serum fucosylated haptoglobin (at 116 U/ ml) showed sensitivity 80%, specificity 65%, positive predictive value 53% and negative predictive value 87% with AUC 0.786. Combination of serum fucosylated haptoglobin and serum AFP at (200 ng/ ml) increased sensitivity that reached 95%. Serum fucosylated haptoglobin may serve as a novel diagnostic biomarker for the detection of HCC with higher sensitivity than AFP.
大多数肝细胞癌(hcc)在晚期才被诊断出来。因此,迫切需要更好的方法来检测和监测有HCC风险的患者。甲胎蛋白(AFP)在HCC监测中的诊断性能不理想,因此需要新颖可靠的诊断生物标志物。这项工作的目的是评估集中的触珠蛋白作为埃及患者肝细胞癌的诊断生物标志物。本病例对照研究将60例患者分为3组(每组20例);ⅰ组(HCC组)、ⅱ组(肝硬化组)、ⅲ组(对照组)。肝硬化的诊断是通过临床、生化和超声(US)来完成的,而HCC的诊断是根据美国肝病研究协会的指南通过经皮活检或放射学(US和三相计算机断层扫描(CT))来完成的。HCC分期根据巴塞罗那临床肝癌(BCLC)分期系统进行临床定义。估计所有组的AFP和集中的触珠蛋白水平。在HCC组中,血清聚集性接触珠蛋白与肿瘤大小有统计学意义的正相关。血清聚焦型触珠蛋白(116 U/ ml)敏感性80%,特异性65%,阳性预测值53%,阴性预测值87%,AUC为0.786。血清集中的触珠蛋白和血清AFP (200 ng/ ml)联合使用可使敏感性提高95%。血清聚焦型触珠蛋白可能作为一种新的HCC诊断生物标志物,具有比AFP更高的敏感性。
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引用次数: 3
Matrix Metalloproteinases 2 and 9 are CAD More Relevant Biomarkers Than -1, -8, and -12 to Separate CAD from Non-CAD Patients 基质金属蛋白酶2和9是比-1、-8和-12更能区分CAD和非CAD患者的生物标志物
Q3 Medicine Pub Date : 2019-06-30 DOI: 10.2174/1875318301909010022
Álvaro Luís Müller da Fonseca, Rogério Jorge B. de Oliveira, Júlio Cezar de Abreu Santos, L. Cardoso, F. D. Couto, Fernanda Washington de Mendonça Lima, M. Castilho, Y. Maor, Raul D. Santos, R. Couto
Atherosclerotic Carotid Artery Disease (CAD) is a frequent cause of mortality worldwide. The discovery of biomarkers that evidenced CAD progression would help with cardiovascular risk reduction. Extracellular Matrix Metalloproteinases (MMPs) have been associated with plaque progression, lesion aggravation, and rupture. This study evaluated that MMPs serum optical-densities and digestive gel-activity are associated with CAD. This cross-sectional study evaluated 65 outpatients presenting CAD (n=31) or not (n=34). The Carotid disease was evidenced by Doppler echography. ELISA and SDS-PAGE zymography were performed to determine MMPs serum optical-densities and proteolytic-activity. Principal Component Analysis (PCA) was performed to identify the most relevant MMPs (MMP-1, 2, 8, 9 and 12). MMP-2 and MMP-9 showed lower serum optical-densities in CAD (MMP-2, p = 0.0246; and MMP-9, p < 0.0001), but higher digestive enzymatic activity when compared to non-CAD samples (p < 0.0001). PCA analysis strengthens the singling out of those individual MMPs as predictors of choice to differentiate CAD from non-CAD patients as opposed to others MMPs. Analysis of the loadings showed MMP-2 and MMP-9 as the most important independent variables to separate CAD from non-CAD patients. MMP-2 and MMP-9 are more relevant biomarkers for CAD than the other MMPs analyzed.
动脉粥样硬化性颈动脉疾病(CAD)是世界范围内常见的死亡原因。发现证明CAD进展的生物标志物将有助于降低心血管风险。细胞外基质金属蛋白酶(MMPs)与斑块进展、病变加重和破裂有关。本研究评估MMPs血清光密度和消化凝胶活性与CAD相关。这项横断面研究评估了65名门诊患者是否患有CAD(n=31)(n=34)。颈动脉疾病可通过多普勒超声检查证实。ELISA和SDS-PAGE酶谱测定MMPs血清光密度和蛋白水解活性。进行主成分分析(PCA)以确定最相关的MMP(MMP-1、2、8、9和12)。与非CAD样本相比,MMP-2和MMP-9在CAD中显示出较低的血清光密度(MMP-2,p=0.0246;MMP-9,<0.0001),但具有较高的消化酶活性(p<0.0001)。主成分分析加强了对这些个体MMP的筛选,将其作为区分CAD和非CAD患者的预测因素,而不是其他MMP。负荷分析显示MMP-2和MMP-9是区分CAD和非CAD患者的最重要的自变量。与所分析的其他MMP相比,MMP-2和MMP-9是CAD的更相关的生物标志物。
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引用次数: 1
Investigating Micronucleus Changes in Mouse Lymphocytes Due to Exposure to Silica Dust 暴露于二氧化硅粉尘后小鼠淋巴细胞微核变化的研究
Q3 Medicine Pub Date : 2019-03-22 DOI: 10.2174/1875318301909010017
F. Golbabaei, A. Gholami, Gholamheidar Teimori-Boghsani, M. Kianmehr, M. Yaseri
Occupational exposure to silica dust has multiple consequences, including genetic complications. One of the genetic complications is Micronucleus (MN) changes; therefore, this study aims to evaluate the rate of MN formation in mouse lymphocyte cells due to exposure to silica dust.Totally 72 male mice BALB/c were selected and categorized into five exposure groups with 12 mice in exposure to the concentrations of 1.3, 3, 8, 12, and 17 mg/m3of 99% pure silica dust and a control group. The mice were exposed to silica dust in which they were exposed for 8 hours a day, 6 days a week, and for 1, 2, 3, and 4 months. Then, blood samples were taken from the mice and the rate of MN formation in their lymphocyte cells was evaluated. The results were analyzed via SPSS software version 21 (P<0.05).Maximum and minimum averages of dust concentration, related to boxes 1 and 5, were 17 mg/m3and 1.3 mg/m3, respectively. Maximum rate of MN formation was observed in the fourth month of exposure and in group 1 with the value of 21.6±1.15, and minimum rate of MN formation was observed in the third month of exposure and in control group with the value of 3±1. Average of MN frequencies in each of the exposure month was significant related to the control group (P=0.001). There was a direct and significant correlation between exposure concentrations of exposed group and average rate of MN formation (r=0.679).More than 3 months exposure to silica dust may lead to significant MN formation in lymphocytes of mice BALB/c in comparison with the control group.
职业接触二氧化硅粉尘有多种后果,包括遗传并发症。遗传并发症之一是微核(MN)改变;因此,本研究旨在评估暴露于二氧化硅粉尘的小鼠淋巴细胞中MN的形成率。选取BALB/c雄性小鼠72只,分为5个暴露组,其中12只小鼠分别暴露于浓度为1.3、3、8、12、17 mg/m3的99%纯硅尘和对照组。这些小鼠被暴露在硅尘中,每天8小时,每周6天,持续1、2、3和4个月。然后,从小鼠身上采集血液样本,并评估其淋巴细胞中MN的形成率。采用SPSS软件21版对结果进行分析(P<0.05)。与框1和框5相关的最大和最小平均粉尘浓度分别为17 mg/m3和1.3 mg/m3。暴露第4个月和第1组MN形成率最高,为21.6±1.15;暴露第3个月和对照组MN形成率最低,为3±1。每个暴露月的MN平均频率与对照组显著相关(P=0.001)。暴露组暴露浓度与MN平均形成率存在显著的直接相关(r=0.679)。与对照组相比,暴露于硅尘3个月以上可导致小鼠BALB/c淋巴细胞明显形成MN。
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引用次数: 0
Effect of Sample Processing Delays on the Values of Serum Based Biomarkers of Brain Injury Collected from the Umbilical Cord Blood of Neonates 样本处理延迟对新生儿脐带血脑损伤血清生物标志物价值的影响
Q3 Medicine Pub Date : 2019-02-15 DOI: 10.2174/1875318301909010021
M. Weiss, N. Bliznyuk, Candace Rossignol, Livia Sura, Melissa Huene, N. Copenhaver, Olena Y. Glushakova, R. Hayes
When a neonate is born with suspected brain injury, blood samples are often obtained from the umbilical cord blood but are not always processed immediately. Test the accuracy of brain injury biomarker assays on samples that experienced delayed processing. Healthy neonates who did not have risk factors for brain injury provided cord blood samples. Group 1 blood samples were centrifuged immediately, and the serum was removed and frozen at baseline, 4, and 8 hours. Group 2 had a baseline sample processed immediately and then blood samples remained in contact with the clotted portion until 4, and 8 hours and then were centrifuged. Enzyme-linked immunosorbent assays determined the concentrations of Ubiquitin C-Terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP). Group 1’s average concentrations of GFAP were 62±47 pg/ml at 0 hours (n=32) with a mean increase of 3±14% and a decrease of 0.2±9% at 4 and 8 hours, respectively. UCH-L1 average concentrations were 3306±3093 pg/ml at 0 hours (n=37) with a mean increase of 3±10% at 4 hours and a mean decrease of 0.6±11% at 8 hours. Group 2’s average GFAP concentrations were 104±111 pg/ml at 0 hours (n=9) with a mean decrease of 5±9% and 7±7% at 4 and 8 hours, respectively. UCH-L1 average concentrations were 3448±2456 pg/ml at 0 hour (n=8) with a mean increase of 9±6% and 6±18% at 4 and 8 hours, respectively. Delays in processing up to 8 hours did not significantly affect the concentration of UCH-L1 or GFAP.
当新生儿出生时疑似脑损伤,通常从脐带血中提取血液样本,但并不总是立即处理。测试脑损伤生物标志物分析在经历延迟处理的样本上的准确性。没有脑损伤危险因素的健康新生儿提供了脐带血样本。1组血样立即离心,取血清,分别于基线、4、8小时冷冻。第2组立即处理基线样本,然后血液样本与凝块部分保持接触,直到4、8小时,然后离心。酶联免疫吸附法测定泛素c端水解酶L1 (UCH-L1)和胶质纤维酸性蛋白(GFAP)的浓度。组1在0 h时GFAP平均浓度为62±47 pg/ml (n=32),在4和8 h时平均升高3±14%,下降0.2±9%。0 h时UCH-L1平均浓度为3306±3093 pg/ml (n=37), 4 h时平均升高3±10%,8 h时平均下降0.6±11%。组2在0 h时平均GFAP浓度为104±111 pg/ml (n=9),在4和8 h时平均分别下降5±9%和7±7%。0 h时UCH-L1平均浓度为3448±2456 pg/ml (n=8), 4 h和8 h时平均浓度分别增加9±6%和6±18%。处理延迟8小时对UCH-L1或GFAP的浓度没有显著影响。
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引用次数: 0
Pollution Biomarkers in Environmental and Human Biomonitoring 环境和人类生物监测中的污染生物标志物
Q3 Medicine Pub Date : 2019-01-31 DOI: 10.2174/1875318301909010001
M. Lionetto, R. Caricato, M. Giordano
Environmental pollutants generate harmful conditions for living organisms, including humans. This accounts for the growing interest to early warning tools for detection of adverse biological responses to pollutants in both humans and wildlife. Molecular and cellular biomarkers of pollution meet this requirement. A pollution biomarker is defined as an alteration in a biological response occurring at molecular, cellular or physiological levels which can be related to exposure to or toxic effects of environmental chemicals.Pollution biomarkers have known a growing development in human and environmental biomonitoring representing a valuable tool for early pollutant exposure detection or early effect assessment (exposure/effect biomarkers).The review discusses the recent developments in the use of pollution biomarker in human and environmental biomonitoring and analyzes future perspectives in the application of this tool such as their potentiality for bridging human and environmental issued studies.
环境污染物对包括人类在内的生物产生有害的条件。因此,人们对早期预警工具越来越感兴趣,以发现人类和野生动物对污染物的不良生物反应。污染的分子和细胞生物标志物满足这一要求。污染生物标志物被定义为发生在分子、细胞或生理水平上的生物反应的改变,这可能与环境化学品的暴露或毒性作用有关。污染生物标志物在人类和环境生物监测中得到了越来越多的发展,代表了早期污染物暴露检测或早期影响评估的宝贵工具(暴露/效应生物标志物)。本文讨论了污染生物标志物在人类和环境生物监测中的最新进展,并分析了该工具应用的未来前景,例如它们在连接人类和环境研究方面的潜力。
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引用次数: 40
Pre-Analytical Challenges during RAS Testing: Tissue Quality and the Estimation of Neoplastic Cell Percentage RAS检测中的分析前挑战:组织质量和肿瘤细胞百分比的估计
Q3 Medicine Pub Date : 2019-01-01 DOI: 10.36648/2472-1646.5.2.61
K. Dufraing, C. Keppens, A. Siebers, KafatosG, K. Lowe, Gaston Demonty, Dequeker Emc, J. V. Krieken
Laboratories require customized feedback on improving biomarker testing practices. A workshop was organized for laboratories that participated in a European external quality assessment scheme to resolve issues related to the estimation of neoplastic cell percentage and tissue quality for RAS testing for colorectal cancer. An interactive course about tissue quality took place to stress the importance of the pre-analytical phase. During a microscopic session, five H&E stained tumor tissue slides were discussed and neoplastic cell percentages estimated. Participants included 4 pathologists, 3 molecular biologists, a technologist and a clinical geneticist from 7 laboratories. In six laboratories, tumor contents are checked routinely by visual estimation by the pathologist. The average difference between the lowest and highest estimation was 22%. During the workshop the importance of the pre-analytical phase was stressed and feedback was provided. Such initiatives can contribute in improving biomarker testing standards in Europe
实验室需要改进生物标记物检测实践的定制反馈。为参加欧洲外部质量评估计划的实验室组织了一个讲习班,以解决与估计结直肠癌RAS检测中肿瘤细胞百分比和组织质量有关的问题。一个关于组织质量的互动课程进行了强调分析前阶段的重要性。在显微镜下,我们讨论了5张H&E染色的肿瘤组织切片,并估计了肿瘤细胞的百分比。参与者包括来自7个实验室的4名病理学家、3名分子生物学家、1名技术专家和1名临床遗传学家。在六个实验室中,病理学家通过目测常规检查肿瘤内容物。最低和最高估计之间的平均差异为22%。在讲习班期间,强调了分析前阶段的重要性,并提供了反馈。这些举措有助于提高欧洲的生物标志物检测标准
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引用次数: 1
Estradiol Serum Levels are Crucial to Understand Physiological/Clinical Setting in Both Sexes: Limits of Measurement of Low Estradiol and Evaluation of a Sensitive Immunoassay 血清雌二醇水平对了解两性生理/临床环境至关重要:低雌二醇的测量极限和敏感免疫测定的评估
Q3 Medicine Pub Date : 2019-01-01 DOI: 10.36648/2472-1646.5.2.62
C. Nencetti, M. Sessa, P. Vitti, M. C. Anelli, M. Tonacchera, P. Agretti
Background: Measure of serum 17β-Estradiol is essential to understand physiology, development and health of reproductive processes in both sexes. Commercially immunoassays are not enough sensitive and accurate to assess low concentrations of E2. Purpose of this study was to compare a new sensitive immunoassay for estradiol measurement with respect to method current in our laboratory and to evaluate the performance of the new method. Methods: Four pools of patient sera with E2 concentrations close to clinical decision values were prepared. To test the repeatability of new method the 5x5 protocol was used and CVs were calculated. To evaluate the performance of new method, 50 samples with E2 concentrations covering the whole measurable interval were selected and assayed. Linearity dilution, LoB (Limit of Blank) and LoD (Limit of Detection) were determined. Results: The new assay showed good total repeatability demonstrated by low CV values, and good linear relationship with respect to current method (R=0.9926) as demonstrated by linear regression. Non-parametric regression showed for the new method a slight constant and proportional systematic error that, however, resulted not significant from difference plot analysis, with a general tendency to overestimate results for the current method. Performances of the new method resulted acceptable within the maximum admissible error derived from the literature, and a good linearity over a wide range of dilutions was showed. LoD value confirmed an amelioration in measurement of low estradiol. Conclusion: In conclusion, sensitive assay is suitable to replace the method used in our laboratory with significant improvement in the measurement of low serum estradiol levels.
背景:血清17β-雌二醇的测定对了解两性生殖过程的生理、发育和健康至关重要。商业免疫测定法在评估低浓度E2时不够灵敏和准确。本研究的目的是比较一种新的用于测定雌二醇的灵敏免疫分析法与我们实验室现有的方法,并评价新方法的性能。方法:制备4个E2浓度接近临床判定值的患者血清。为验证新方法的重复性,采用5x5方案并计算cv。为了评价新方法的性能,选择了50个E2浓度覆盖整个测量区间的样品进行了分析。测定线性稀释度、空白限(LoB)和检出限(LoD)。结果:新方法重复性好,CV值低,与现有方法线性关系良好(R=0.9926)。非参数回归表明,新方法有轻微的常数和比例系统误差,但差异图分析结果不显著,普遍倾向于高估现有方法的结果。新方法的性能在文献中得出的最大允许误差范围内是可接受的,并且在广泛的稀释度范围内显示出良好的线性。LoD值证实了低雌二醇测量的改善。结论:本实验室对低血清雌二醇水平的测定有明显改善,敏感性测定法适合替代本实验室使用的方法。
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引用次数: 0
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Open Biomarkers Journal
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