共查询到19条相似文献,搜索用时 93 毫秒
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目的评估化学发光法(CLIA)测HIV抗体在血液筛查中的应用情况。方法采用酶联免疫吸附法(ELISA)、化学发光法(CLIA)及核酸检测(NAT)分别检测献血员HIV12558例,阳性样本送省CDC进行免疫印迹法(WB)确证,统计分析两种方法学检测HIV抗体结果的差异。结果 12558例献血样本,有1例样本经确证为真阳性,有16例样本CLIA与ELISA检测结果不一致,NAT均为阴性,WB结果有3例为不确定,13例为阴性。其中有2例样本ELISA1单独有反应性,NAT及WB均为阴性;有2例样本ELISA2和CLIA均有反应性,NAT均为阴性,WB结果 1例为阴性,1例为不确定;有3例样本ELISA2单独有反应性,NAT及WB均为阴性;有9例样本CLIA单独有反应性,NAT均为阴性,WB结果 4例为不确定,5例为阴性。结论 12558例样本的评估结果显示,化学发光试剂表现出较好的灵敏度和特异性,可以在血液筛查中加以推广,并且化学发光试剂配套的全自动仪器具有自动化程度高,出结果快,操作简便等优势,可以在一定程度上解放劳动力,提高工作效率,同时减少人为操作失误导致的异常检测结果。 相似文献
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目的比较贝克曼Access 2Immunoassay System化学发光免疫分析系统及罗氏COBAS E 411电化学发光免疫分析系统对皮质醇的分析性能与检测结果相关性。方法按照ISO15189中方法评估贝克曼及罗氏分析系统对皮质醇检测的精密度、功能灵敏度、参考范围、方法学、阳性符合率、阴性符合率。结果贝克曼与罗氏分析系统在皮质醇检测中精密度良好,功能灵敏度符合各自厂商设定的临床检测的下限,实验室自建参考范围后,将两分析系统对皮质醇的测定值进行线性回归分析,二者间相关性良好,线性回归系数r~2=0.977,阳性符合率、阴性符合率均为100%。结论两分析系统对于皮质醇的分析性能优异,均可满足临床检验需求。经过方法学比对,二者相关性良好,能够通过回归方程对二者间测定值进行引证。 相似文献
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目的分析电化学发光免疫分析法(ECLIA)与酶联免疫吸附法(ELISA)在献血者HBsAg检测结果的一致性,探讨ECLIA常规应用于献血者血液检测的效果。方法对2016年12月~2017年11月本站献血者血液标本,使用2种不同厂家ELISAHBsAg(试剂A和试剂B)和ECLIA(试剂C)进行检测,对部分ELISAHBsAg无反应性而核酸检测(NAT)HBV DNA有反应性的标本再进行ECLIA检测。以ELISA检测0≤S/CO0.3、0.3≤S/CO0.9和S/CO≥0.9进行分类统计ECLIA阳性数,并分析ECLIA与ELISA结果的一致性;以ECLIA为参考方法分析2种ELISA试剂的灵敏度和特异性。结果 HBsAg共检测11127人份,试剂A、B、C检测的阳性率分别为2.642%、3.020%和2.894%,差异无统计学意义(P0.05);ECLIA与2种ELISA试剂结果一致性均极高(К_(试剂A)=0.927、К_(试剂B)=0.900); ELISA检测无反应性的标本中,"0.3≤S/CO0.9"段ECLIA阳性率0.35%高于"0≤S/CO0.3"段的0.11%(P 0.05);以试剂C为参考方法,试剂A的灵敏度88.82%低于试剂B的灵敏度92.24%,试剂A的特异性99.93%略高于试剂B的99.64%;78例ELISAHBsAg无反应性而NAT反应性的标本ECLIA检测阳性有16例,阳性率15.5%。结论 2遍ELISA血清学方法检测HBsAg阴性的标本仍有漏检几率,ECLIA能缩短ELISA检测的"窗口期",且与ELISA结果一致性高;现有血液检测方法增加一遍ECLIA可进一步提高血液安全。 相似文献
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《中国输血杂志》2019,(7)
目的与酶联免疫吸附试验(ELISA)检测相比较,探讨化学发光法(CLIA)在血液初筛中的应用。方法采用1种CLIA和2种ELISA的乙肝表面抗原(HBs Ag)试剂平行检测日常献血者血样3 000份及卫生部临检中心收集的血清盘标本792份。任1种试剂有反应性的献血者标本和所有的血清盘标本由卫生部临检中心进行确认实验,分析比较结果。结果 3 000份献血者标本中11例有反应性,其中7份CLIA、ELISA和确认实验均为阳性; 4份为ELISA双试剂阴性CLIA单阳性,而确认结果均为阴性。792份血清盘标本中587份确认阳性,197份确认阴性,8份不确定。CLIA的HBs Ag最低检出浓度0. 05 IU/m L低于ELISA法的0. 09 IU/m L。CLIA对变异性抗原的检出率84. 62%明显高于ELISA B试剂42. 31%(P <0. 05)。CLIA的灵敏度89. 10%、特异性97. 97%明显高于2种ELISA法。重复性试验中,CLIA法的批内批间变异系数(CV)明显小于ELISA方法。结论 3 000份献血者血样经HBs Ag胶体金快速检测合格后抗原阳性率低,而792份血清盘由收集于不同血站的献血者标本组成,阳性率高,且标本的分组与设计合理有针对性。结合其检测结果,CLIA相比ELISA对HBs Ag的初筛有着较高的灵敏度、特异性和较好的精密度,且变异性抗原检出率较高,对防止不合格血样漏检,保证血液质量安全有较好的应用价值。 相似文献
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光激化学发光法检测甲胎蛋白实验性能评价 总被引:3,自引:1,他引:2
目的评价光激化学发光法(LICA)检测血清甲胎蛋白(AFP)的实验性能。方法利用定标品和质控品对LICA检测AFP的实验性能进行评价;利用358份含不同浓度AFP的血清标本对LICA和罗氏电化学发光免疫法进行方法学对比评价。结果LICA检测AFP的分析敏感性为0.25μg/L,在平均浓度10和500μg/L的检测总变异系数(CV)均〈5%。与参比方法所测AFP浓度差异无统计学意义,2种方法所测结果的对数值呈直线相关(r=0.966,P〈0.001),对标本阴、阳性分类差异无统计学意义(P=0.824),有较好的一致性(Kappa=0.886,P〈0.001)。结论LICA检测AFP具有良好的检测性能;与罗氏电化学发光法具有类似的实验性能。 相似文献
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目的评价光激化学发光法(LICA)检测血清甲胎蛋白(AFP)的实验性能。方法利用定标品和质控品对LICA检测AFP的实验性能进行评价;利用358份含不同浓度AFP的血清标本对LICA和罗氏电化学发光免疫法进行方法学对比评价。结果LICA检测AFP的分析敏感性为0.25μg/L,在平均浓度10和500μg/L的检测总变异系数(CV)均<5%。与参比方法所测AFP浓度差异无统计学意义,2种方法所测结果的对数值呈直线相关(r=0.966,P<0.001),对标本阴、阳性分类差异无统计学意义(P=0.824),有较好的一致性(Kappa=0.886,P<0.001)。结论LICA检测AFP具有良好的检测性能;与罗氏电化学发光法具有类似的实验性能。 相似文献
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目的探讨分析化学发光法检测梅毒特异性抗体进行梅毒筛查的效果。方法对逆向梅毒筛查流程实验室数据进行回顾性分析,通过化学发光法进行抗体筛查试验,初筛阳性标本,实施非梅毒螺旋体抗原血清甲苯胺红不加热试验检测,颗粒凝集试验复测,在不加热试验的同时测定阳性标本的滴度。结果对本次所采集的梅毒标本,使用甲苯胺红不加热试验和化学发光法检测进行检测,化学发光法检出率明显高于甲苯胺红不加热试验法(P<0.05);通过TPPA确认,化学发光法的特异度和敏感性明显优于甲苯胺红不加热试验法(P<0.05)。结论通过化学发光法检测梅毒特异性抗体实施梅毒筛查,给予阳性标本滴度检测,两者不满足则应用TPPA试验,能够明显降低假阴性,提升敏感率,明显优于传统梅毒筛查模式。 相似文献
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Popp C Krams D Beckert C Buenning C Queirós L Piro L Luciani M Roebbecke M Kapprell HP 《Diagnostic microbiology and infectious disease》2011,70(4):479-485
A low initial reactive rate for screening assays is important for time- and cost-effective infectious disease testing. Therefore, the new ARCHITECT HBsAg Qualitative screening assay, in conjunction with the new ARCHITECT HBsAg Qualitative Confirmatory assay, was introduced. As the role of hepatitis B surface antigen (HBsAg) as surrogate marker for HBV resolution and the monitoring of drug effectiveness are becoming increasingly important, the established ARCHITECT HBsAg Quantitative assay remains available on the market. Precision, sensitivity, and specificity of the newly developed screening assay were in the range of established HBsAg assays. Seroconversion sensitivity was slightly superior compared to other commercially available assays. An initial reactive rate of 0.2% (without HBsAg-confirmed positive samples of 0.17%) for the ARCHITECT HBsAg Qualitative assay was observed. As the new screening assay is a 1-step assay format, the "high-dose hook effect" was investigated to assess the risk of false-negative results, but even very high positive HBsAg samples obtained signals clearly above the cutoff. 相似文献
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目的通过对两种多重核酸血液筛查系统临床数据分析比较,为血站系统的使用提供参考。方法汇总2018年1-10月哈尔滨市血液中心采用北京万泰和罗氏多重核酸血液筛查系统进行检测的数据及部分阳性标本跟踪数据,统计分析这两个检测系统的性能差异及原因。结果万泰和罗氏核酸检测系统分别检测86 475份和36 641份标本,万泰系统的乙型肝炎病毒(HBV)假阳性率低于罗氏,罗氏系统的丙型肝炎病毒(HCV)和人类免疫缺陷病毒(HIV)假阳性率低于万泰;两个系统的HBV、HCV和HIV的阳性率基本一致。罗氏系统的无效率高于万泰系统。结论两个多重核酸血液筛查系统各有优劣,具有一定互补性,但均能从ELISA阴性标本中检测出一定数量的核酸阳性标本,检出率基本一致,均能提高输血安全性。 相似文献
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Prostate specific antigen (PSA) is a glycoprotein found in the epithelial cells of the prostatic duct and acini. PSA is elevated in all four stages of prostate cancer as well as in benign prostatic hypertrophy. We evaluated a new chemiluminescent assay for PSA by comparing this assay with the microparticle enzyme immunoassay for PSA (MEIA) on the AxSYM analyzer (Abbott Laboratories, Abbott Park, IL) and a Hybritech Tandem R assay for PSA. The new chemiluminescent assay is recently available from Bayer Diagnostics (Tarrytown, NY) and can be run using the ACS: 180 Plus analyzer. Precision of the new chemiluminescent assay was evaluated using commercially available controls (Bayer Diagnostics). The within-run and total CVs were 6.4 and 8.7% for the low control (mean: 0.43 microg/L), 1.6 and 5.2% for the next level control (mean:1.94 mg/L), 4.3 and 4.9% for the medium control (mean: 2.10 mg/L), 1.2 and 3.9% for the high control 1 (mean: 11.52 mg/L), and finally 3.2 and 6.9% for the high control 2 (mean: 21.52 mg/L). The spike recovery varied from 94.2 to 109.6% for five different specimens we studied. We also observed excellent dilution recoveries. For example, in the specimen supplemented with 3.02 mg/L of PSA, the dilution recoveries were 102. 1, 104.7, and 103.7% for 1:2, 1:4, and 1:8 dilutions, respectively. We analyzed 113 serum specimens from patients with various concentrations of PSA (range 0.5 mg/L-2040 mg/L) using the new chemiluminescent assay and compared our results with the MEIA and Hybridtech (Tandem-R PSA) assays. Using x axis as the PSA concentrations obtained by the Tandem-R assay and the y axis as the PSA values obtained by the new chemiluminescent assay, we observed the following regression equations: y = 1.04 x -0.19 (r = 0.99, n = 112). One specimen with PSA concentrations of 2040 microg/L by the MEIA and 2156 microg/L by the chemiluminescent assay was not used for regression analysis. Similarly using x axis as the PSA concentrations obtained by the MEIA assay and y axis as the PSA concentrations obtained by the chemiluminescent assay, we observed the following regression equation: y = 0.88 + 0.02 (r = 0.99, n = 112). We conclude that the new chemiluminescent assay has excellent precision and the results compared well with the existing assays. 相似文献
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目的 对1种新型国产超敏HBsAs试剂在血液筛查中的应用进行评估.方法 用考核试剂WT CLEIA分别检测WHO标准品、HBV阴性的血清、各种HBV亚型及HBsAg突变株标本以及无偿献血者标本,并与参比试剂做比较.结果 WT CLEIA对HBsAg阴性标本的检测特异性为99.81%(95% CI:99.57% ~ 99.93%);对WHO标准品检测的分析灵敏度可达0.012 IU/mL,高于参比试剂Hepanostika HBsAg Ultra的0.05 IU/mL和Abbott Murex V3的0.1 IU/mL;对HBsAg突变株及不同亚型的检出率也高于2种参比试剂;对近5 000份标本的检测结果与参比试剂Abbott Murex V3有高度的符合率(99.60%).结论 该试剂检测性能良好,在血液筛查中有较好的应用前景. 相似文献
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Dasgupta A Chow L Nazareno L Tso G Datta P 《Journal of clinical laboratory analysis》2000,14(5):224-229
Cardiac troponin I is a marker for diagnosis of myocardial damage. Several immunoassays are currently available for determination of concentrations of troponin I in serum. We evaluated a chemiluminescent assay for troponin I using ACS:180 automated analyzer (Bayer Diagnostics). We compared our results with two other immunoassays using the OPUS Magnum (OPUS troponin I assay, Dade Behring) and AxSYM (microparticle enzyme immunoassay, Abbott) analyzers. The within-run and between-run CVs were less than 5% for all three levels of controls. The chemiluminescent assay for troponin I was linear up to a serum troponin I concentration of 50 ng/mL and the detection limit was 0.1 ng/mL of troponin. A good correlation between troponin I concentration measured by the chemiluminescent assay (y axis) and the microparticle enzyme immunoassay (MEIA) (x axis) was observed, although the concentrations of troponin I in individual specimens were approximately four times higher, when measured by the MEIA assay, than those measured by chemiluminescent assay. The correlation coefficient was 0.98 with the regression equation y = 0.22x + 1.125. We also observed a good correlation in troponin I concentrations obtained by the chemiluminescent assay (y axis) and OPUS troponin I assay (x axis). The correlation coefficient was 0.96 and the regression equation was y = 0.79x - 0.52. The correlation coefficient was 0.93 when we compared troponin I concentrations obtained by the OPUS assay (x axis) with the corresponding concentrations obtained by the MEIA assay (y axis). The corresponding regression equation was y = 0.25x + 3.5. We conclude that the chemiluminescent troponin I assay showed good analytical performance. 相似文献
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