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11.
目的探讨电化学发光法与放射免疫法检测血清甲状腺激素的效果差异,为临床甲状腺激素检测提供参考。方法选择我院普外科及内分泌科住院甲状腺疾病患者血清标本340份,分别采用电化学发光法及放射免疫法进行检测,比较两种方法检测血清TSH、FT3、FT4线性范围,相关性及精密度。结果电化学发光法检测血清TSH、FT3、FT4线性范围宽于放射免疫法,两种检测方法检测血清TSH、FT3、FT4具有良好的相关性,电化学发光法检测血清TSH、FT3、FT4精密度高于放射免疫法。结论电化学发光法与放射免疫法检测血清甲状腺激素能够取得相同的检测效果,电化学发光法检测方法简单,线性范围较宽,可重复性较好,更适合临床采用。  相似文献   
12.
目的探讨标本不同程度溶血对电化学发光免疫法(ECLIA)测定结果的影响。方法将血液标本人为干预成不同程度的溶血标本,使用ECLIA检测各组标本中的甲状腺功能、肿瘤标志物、内分泌激素等共28项指标的浓度并做分析。结果标本溶血可使胰岛素(INS)浓度降低,使叶酸(FA)、神经元特异性烯醇化酶(NSE)浓度升高,重度溶血有使铁蛋白测定结果偏高的趋势,但差异无统计学意义,其余指标测定结果不受溶血的影响。结论除某些项目外大部分溶血标本的ECLIA测定结果没有受到影响。测定INS、FA、NSE时应绝对避免使用溶血标本,以确保结果准确。  相似文献   
13.

Background

Two electrochemiluminescence (ECL) assays were developed which, together, can simultaneously measure serum antibodies against pneumococcal capsular polysaccharides (PnPS) for 17 serotypes. The assays were validated for the 13 PnPS included in the 13-valent pneumococcal conjugate vaccine (PCV13). As recommended by the World Health Organization (WHO), we compared the ECL assays with the WHO reference enzyme-linked immunosorbent assay (ELISA) and derived a threshold corresponding to the 0.35?µg/mL threshold established for the WHO reference ELISA for the non-inferiority comparison and licensure of new PCVs against invasive pneumococcal disease.

Methods

A panel of 452 serum samples from children vaccinated with one of the three licensed PCVs was assessed with the ECL assays and the WHO reference ELISA. The ECL assay threshold for the aggregated seven PnPS included in the 7-valent PCV (PCV7) and serotype-specific thresholds were determined using a receiver operating characteristics (ROC) curve-based approach and Deming regression. To evaluate concordance between the ECL assays and the WHO reference ELISA, serostatus agreement rates between both assays and geometric means of the ratios (GMRs) of concentrations obtained with both assays were calculated.

Results

The thresholds for the seven aggregated PCV7 serotypes obtained with the ROC curve-based approach and Deming regression approximated 0.35?µg/mL (0.38 and 0.34?µg/mL, respectively). Individual thresholds for the PCV13 serotypes ranged between 0.24 and 0.51?µg/mL across both approaches. Serostatus agreement rates using a 0.35?µg/mL threshold for both assays were ≥86.9% for all PCV13 serotypes. GMRs ranged between 0.85 and 1.25 for 11/13 serotypes and were <1.29 for the two remaining serotypes.

Conclusion

The ECL assays were comparable to the WHO reference ELISA and offer a sensitive, time- and serum volume-saving method to quantify serotype-specific anti-PnPS antibodies in pediatric sera. A 0.35?µg/mL threshold will be used for each PCV13 serotype to assess PCV immunogenicity in clinical trials.  相似文献   
14.
目的建立永康市正常孕妇妊娠各期甲状腺功能指标的参考值。方法收集2017年6月-12月在永康市妇幼保健院产检妊娠妇女为研究对象,经过筛选共纳入449例。采用全自动电化学发光免疫分析方法进行甲状腺功能7个项目的测定,并依测定数据统计分析得到各个项目的双侧95%医学参考值范围。结果研究获得本院正常妊娠妇女各孕期甲状腺激素的参考值如下:早孕期,TSH:0.04μIU/ml^4.14μIU/ml,FT4:1.01 ng/dl^1.78 ng/dl,FT3:2.52 pg/ml^4.31 pg/ml;中孕期,TSH:0.02μIU/ml^4.77μIU/ml,FT4:0.85 ng/dl^1.71 ng/dl,FT3:2.34 pg/ml^4.39 pg/ml;晚孕期,TSH:0.24μIU/ml^5.63μIU/ml,FT4:0.74 ng/dl^1.30 ng/dl,FT3:2.11 pg/ml^3.58 pg/ml。年龄对妊娠妇女甲状腺功能影响并不大。根据美国甲状腺协会推荐标准和本研究的参考值诊断本院妊娠妇女亚临床甲状腺功能减退的患病率分别为17.59%和2.23%。结论甲状腺激素在妊娠各期之间的差异有统计学意义,不同地区妊娠妇女甲状腺激素参考值也存在差异,建立适合本地区的特异性甲状腺激素参考值有助于妊娠期甲状腺疾病的诊疗。  相似文献   
15.
目的 探讨糖类抗原125(CA125)、细胞角蛋白21-1(CYFRA21-1)、神经元特异性烯醇化酶(NSE)、癌胚抗原(CEA)联合检测对肺癌的诊断价值.方法 应用检测灵敏度高和线性范围宽的电化学发光技术对68例肺癌、41例肺良性疾病及33例健康体检者血清进行检测.结果 肺癌组血清CA125、CYFRA21-1、NSE和CEA含量均显著高于健康对照组和肺良性疾病组(P〈0.01).单项肿瘤指标对肺癌检测敏感性分别为73.5%、75.0%、79.4%、82.4%,联合检测可提高检测敏感性达97.1%;如以任何三项以上阳性作为肺癌的诊断依据,则敏感性为75.0%,而对照组无1例阳性.结论 CA125、CYFRA21-1、NSE和CEA联合检测可显著提高肺癌诊断的敏感性,在肺癌的早期诊断方面可为临床提供有价值的资料.  相似文献   
16.
目的:比较电化学发光免疫测定(ECLIA)法与酶联免疫吸附试验(ELISA)法检测抗环瓜氨酸肽(抗CCP)抗体的价值。方法:采用ECLIA法和ELISA法分别检测192例类风湿关节炎(RA)患者、56例其他风湿性疾病患者及100名健康对照者血清中的抗CCP抗体,观察ECLIA法检测抗CCP抗体的精密度、回收率、诊断灵敏度、诊断特异度,并分析ECLIA法与ELISA法间的相关性。结果:ECLIA法检测抗CCP抗体的批内、批间变异系数分别为0.9%~1.8%、1.7%~2.4%,明显低于ELISA法(5.8%~8.6%,6.7%~9.8%)(P<0.01)。ECLIA法检测抗CCP抗体的回收率为96.7%~98.6%,灵敏度和特异度分别为72.9%、98.7%,与ELISA法检测结果的一致率达96.7%。结论:ECLIA法检测抗CCP抗体的精密度较高,且对RA诊断的灵敏度、特异度与ELISA法具有较好的一致性。  相似文献   
17.
A method of ionic liquid-based hollow fiber liquid-phase microextraction enhanced electrically was successfully developed and applied to the extraction and determination of neutral red (NR) dye, which was selected as the model analyte. A room temperature ionic liquid, 1-octyl-3-methylimidazolium hexafluorophosphate ([C8mim][PF6]), was placed in the pores of a polytetrafluoethylene hollow fiber, which acts as a liquid membrane and the acceptor solution. The extraction parameters affecting the enrichment factor of NR, such as pH, extraction time, elution time, stirring rate, and the voltage were optimized. In addition, UV–Visible (UV–Vis) or electrochemiluminescence spectra were also determined. The extraction rate and capacity of NR could be improved significantly by cathodic polarization. Under the optimized extraction conditions (organic liquid microextraction phase [C8mim][PF6], pH 7, stirring rate 300 rpm, extraction time 20 minutes, ultrasonic-assisted elution time 3 minutes, voltage −70 V), the detection limit of 0.38 μg/L and linear correlation coefficient of r > 0.99 were obtained. The established method was successfully applied to the analysis of three soft drink samples, which were spiked with NR standards at the concentrations of 0.1, 1.0, and 5.0 mg/L, and satisfactory results were obtained.  相似文献   
18.
目的:探讨ECLIA与RIA测定血清C肽结果出现差异的原因。方法:采用ECLIA和RIA测定40例健康体检者及8例门诊病人空腹及餐后2小时血清C肽的含量;统一C肽标准品后,用这两种方法测定上述96份血清C肽。结果:当标准品不同时,两法测定结果差异有统计学意义(P<0.05),但相关性良好;当统一标准品后,两法测定结果差异无统计学意义(P>0.05),并具有良好的相关性。结论:对于血清C肽的测定,ECLIA与RIA方法学没有差异,只要标准品统一,两法结果可比,且具有高度相关性。  相似文献   
19.
BACKGROUNDTo achieve the elimination of hepatitis B and C, there is an urgent need to develop alternative strategies to increase the access of diagnosis, particularly among key populations such as people living with human immunodeficiency virus (HIV), individuals with coagulopathies and chronic kidney disease (CKD) patients. AIMTo evaluate the use of dried blood spot (DBS) in the detection of hepatitis B virus (HBV) and hepatitis C virus (HCV) markers. METHODSA total of 430 individuals comprised of people living with HIV, coagulopathies and CKD provided paired serum and DBS samples. HBsAg, anti-HBc and anti-HCV were tested in those samples using a commercial electrochemiluminescence. Demographic and selected behavioral variables were evaluated to assess possible association with HBV and HCV positivity. RESULTSUsing DBS, HBsAg prevalence varied from 3.9% to 22.1%, anti-HBc rates varied from 25.5% to 45.6% and anti-HCV positivity ranged from 15.9% to 41.2% in key populations. Specificities of HBV and HCV tests using DBS varied from 88.9% to 100%. The HBsAg assay demonstrated the best performance in CKD and coagulopathy individuals and the anti-HCV test had a sensitivity and specificity of 100% in people living with HIV. Accuracy of HBV and HCV detection in DBS varied from 90.2% to 100%. In the CKD group, HBsAg positivity was associated with infrequent use of condoms, and anti-HBc positivity was associated with sharing nail cutters/razors/toothbrushes. Anti-HCV reactivity was positively associated with a history of transplantation and length of time using hemodialysis in both specimens. In people living with HIV, only the male gender was associated with anti-HBc positivity in serum and DBS.CONCLUSIONDBS with electrochemiluminescence are useful tools for the diagnosis and prevalence studies of hepatitis B and C among key populations and may increase the opportunity to foster prevention and treatment.  相似文献   
20.
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