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1.
化学发光法检测血清甲胎蛋白的方法学评价   总被引:3,自引:0,他引:3  
目的对化学发光免疫分析法(CUA)测定甲胎蛋白(AFP)进行方法学评价。方法用CLIA测定178例血清的AFP值,同时也用酶联免疫吸附试验(ELISA)对AFP进行测定。结果CLIA测定AFP的灵敏度为1.3ng/mL,低、中、高浓度的批内CV分别为4.2%、2.3%、1.6%;批间CV分别为4.8%、3.2%、2.5%。回收率为96%~104%,理论值与实测值的回归方程为Y=0.1427+0.9992X,相关系数r=0.9900(P〈0.001)。ROC曲线显示CLIA测定的敏感性和特异性均在90%以上,曲线下面积为0.992,显著高于ELISA法(P〈0.01)。结论CLIA是目前测定AFP较好的方法,适用于临床对AFP进行检测,可对原发性肝癌进行明确诊断。  相似文献   

2.
目的 建立尿中性肽内切酶 (NEP)检测的ELISA法 ,明确用ELISA法检测尿NEP在诊断肾小管损伤中的意义。方法 建立尿NEP检测的ELISA法 ,并与荧光法比较 ;分别用两法检测患者组和对照组尿NEP。结果 ELISA法检测NEP ,浓度在 2 0~ 2 0 0 μg/L时 ,浓度的对数与吸光度间有良好的线性关系 (r >0 .99,P <0 .0 1)。取 10次标准曲线 ,计算线性范围内各浓度的变异系数 (CV)为 2 .0 6 %~ 4 .17% ,平均 2 .98%。所有标准曲线相关系数 (r)均 >0 .99(P <0 .0 0 1)。ELISA法回收率为 93.6 %~ 10 7.3% ,平均为 10 1.7%。该法批内CV为 4 .15 %、5 .4 6 % ,批间CV为 6 .2 4 %、6 .39%。检测限值为 2 .2 0 μg/L。患者组两法测得尿NEP均低于正常对照组 (P <0 .0 1)。各组两法结果无差异 (P均 >0 .0 5 )。结论 检测尿NEP可以帮助判断近端肾小管损伤。ELISA法与传统荧光法相比更简便 ,不需特殊仪器 ,却有良好的精确度和重复性 ,可以作为评价肾小管损伤的较好方法。  相似文献   

3.
目的探讨化学发光法(CLIA)检测肺炎衣原体(CP)IgG和IgM抗体的性能。方法选择2015年1月至2017年12月在该院呼吸内科确诊的200例肺炎支原体(MP)患者作为观察组,选择同期在该院体检中心接受体检的200例体检健康者作为对照组,分别采用CLIA、酶联免疫吸附测定(ELISA)以及间接免疫荧光(IIF)检测CPIgG和IgM抗体。评估CLIA检测CPIgG和抗体的最低检出限、批内精密度、批间精密度、线性范围、临床符合率以及与ELISA和IIF的一致性。结果 CLIA对于CPIgG抗体的最低检测限为0.01AU/mL;线性范围为3.0~200.0AU/mL;CLSI具有2.15%~6.47%的批内CV和3.17%~6.18%的批间CV。相关性研究显示CLIA与ELISA检测CPIgG和IgM抗体的结果非常一致(Kappa分别为0.900和0.903,均P0.001),一致百分比分别为85.0%和85.5%。CLIA与IIF法的Kappa=0.905(P0.001),总体匹配率为80.0%。结论 CLIA检测CP抗体的各项指标符合临床要求,具有操作简便、精密度高等优点,临床上可以替代ELISA和IIF用于CP抗体的检测。  相似文献   

4.
目的通过对日常献血者标本(3 031份)和血清盘的平行检测,评估化学发光(CLIA)和酶免(ELISA)2个检测系统检测HBsAg各项性能指标。方法分别采用ELISA(国产A试剂)、ELISA(进口B试剂)和CLIA(国产)对3 031份日常献血者标本进行HBsAg的检测,将阳性标本送卫生部临检中心进行确认实验;分别采用ELISA2种厂家试剂和CLIA(国产)对HBsAg血清盘进行平行检测,将上述数据汇总整理分析,比较ELISA和CLIA2种检测体系的灵敏度、特异性、阳性预期值、批内与批间精密度以及不同血清型标本和突变株的检出能力等指标。结果 ELISA与CLIA平行检测日常献血者标本(3 031份)复检符合率CLIA(国产)为83.33%、ELISA(进口B试剂)为33.33%、ELISA(国产A试剂)为14.28%,CLIA高于ELISA(2种试剂)且P0.01。ELISA和CLIA平行检测HBsAg血清盘情况:CLIA本中心实验室与其它实验室整体检测的灵敏度、特异性、阳性预期值,P0.05。ELISA(国产A)和CLIA(国产)的灵敏度分别为77.39%和89.17%,P0.05,阳性预期值和特异性,P0.05;ELISA(进口B)和CLIA(国产)的灵敏度、特异性、阳性预期值,P0.05。A盘弱阳性质控批内CV:CLIA(4.869%)A(7.269%)B(8.428%);H盘弱阳性质控批内CV:CLIA(4.949%)B(7.157%)A(13.712%);H盘强阳性质控批内CV:CLIA(4.486%)B(11.543%)A(46.454%)。弱阳性质控批间CV:CLIA(8.108%)B(15.288%)A(33.585%);强阳性质控批间CV:CLIA(6.410%)A(10.285%)B(12.673%)。血清盘HBV 3种血清型ayw1、adw2和adrq+的检出下限分别为:CLIA(国产)0.09 IU/mL、0.05 IU/mL、0.05 IU/mL;ELISA(进口B试剂)均为0.05 IU/mL;ELISA(国产A试剂)为0.18 IU/mL、0.09 IU/mL、0.05 IU/mL。针对HBsAg突变类型的检测能力多家血站整体数据显示,应用进口试剂的ELISA检测系统要优于应用国产试剂的CLIA检测系统。结论对于HBsAg的检测虽然从方法学上化学发光要优于酶联免疫,但是从我们的评估情况看其各项性能指标的检测水平2种检测系统却各有优劣,由此可见我们认为针对HBsAg的检测,各实验室应通过综合分析选择最适合自己的筛查策略。  相似文献   

5.
目的比较化学发光免疫分析(CLIA)和酶联免疫吸附试验(ELISA)检测血清HBsAg及HBsAb的结果。方法采用CLIA法和ELISA法测定定值血清中的HBsAg和HBsAb,并对两种结果进行比较和分析。结果测定HBsAg时,ELISA法的批内CV:1IU/ml为9.6%,2IU/ml为7.3%,批间CV:1IU/ml为17.8%,2IU/ml为15.1%,灵敏度为0.25IU/ml,CLIA法的批内CV:1IU/ml为2.33%,2IU/ml为1.07%,批间CV:1IU/ml为6.57%,2IU/ml为3.78%,灵敏度为0.063IU/ml。HBsAb测定时,ELISA法的批内CV:10mIU/ml为11.8%,20mIU/ml为8.7%,批间CV:10mIU/ml为18.6%,20mIU/ml为15.9%,灵敏度为10mIU/ml,CLIA法的批内CV:10mIU/ml为4.79%,20mIU/ml为3.52%,批间CV:10mIU/ml为7.58%,20mIU/ml为6.13%,灵敏度为2.5mIU/ml。结论 ELISA法敏感度相对低,精密度差;CLIA法灵敏度高,精密度好,且自动化程度高,检测更快速,更适合于临床。  相似文献   

6.
目的对酶联免疫吸附试验(ELISA)和化学发光免疫分析法(CLIA)检测乙型肝炎5项血清标志物的结果和重复性进行比较和分析。方法分别用ELISA和CLIA检测了500份临床血清标本,其中HBsAg、HBsAb、HBeAg、HBeAb、HBcAb各100例,对两种方法的阳性率和符合率进行了统计分析,对CLIA与ELISA结果不符的标本用第三种方法进行了复测;另用60例HBsAb标本对两种方法的重复性进行了比较。结果 CLIA检测HBsAg和HBcAb的阳性率高于ELISA的检测结果,差异有统计学意义(χ~2=4.308、5.637,P0.05);而HBsAb、HBeAg、HBeAb的阳性率与ELISA的检测结果相比差异无统计学意义(χ~2=0.361、0.785、0.180,P0.05)。重复性试验表明CLIA的批内CV(1.04%~2.8%)、批间CV(4.19%~8.19%)都明显优于ELISA的批内CV(3.81%~12.56%)、批间CV(10.31%~18.90%)。结论 CLIA检测乙型肝炎5项血清标志物比ELISA重复性好,HBsAg和HBcAb项目的灵敏度更高,总体结果更准确。  相似文献   

7.
本文比较儿童传染性单核细胞增多症 (infectiousmononucleosisIM)常用的几种重要的方法优缺点及其它们在IM诊断中的价值及临床意义。结果 异形淋巴细胞阳性率(≥ 0 .1)为 80 .2 % (6 5 / 81例 ) ,EBV IgG、EBV IgM阳性率分别为 74 .1% (6 0 / 81例 )、6 4 .2 % (5 2 / 81例 ) ,而嗜异性凝集反应(HA)阳性率高达 91.4 % (74 / 81例 )。三者相比HA阳性率分别高于前两者 ,差异显著 (χ2 =4 .10~ 18.3,P <0 .0 5~ 0 .0 1)。由于IM临床表现复杂 ,易于误诊 ,因此特异而敏感的实验室检查尤为重要 ,异形淋巴细胞、EBV IgG、EBV IgM、…  相似文献   

8.
目的:评价流式荧光法在血清胃蛋白酶原(PG)Ⅰ/Ⅱ检测中的临床应用价值。方法评价流式荧光法检测 PGⅠ/Ⅱ的精密度,通过检测临床血清标本与酶联免疫吸附试验(ELISA)试剂盒进行方法学比对,初步建立健康人群 PGⅠ、PGⅠ/PGⅡ比值的参考值范围,并应用流式荧光法检测浅表性胃炎、萎缩性胃炎、胃癌患者血清。结果PGⅠ检测批内变异系数(CV批内)为4.26%~5.35%,批间变异系数(CV批间)为6.73%~7.75%。PGⅡ检测 CV批内为5.48%~6.42%,CV批间为8.46%~8.85%。与 ELISA 方法进行方法学比对存在线性关系,线性方程分别为 PGⅠ:Y =0.911X -22.635(r =0.966,P <0.05);PGⅡ:Y =0.892X -0.548(r=0.980,P <0.05)。PGⅠ和 PGⅠ/PGⅠ比值的参考区间下限分别为32.77 ng/mL、4.16。萎缩性胃炎和胃癌患者血清 PGⅠ水平和 PGⅠ/PGⅡ比值明显低于浅表性胃炎患者,差异均有统计学意义(P <0.05)。结论流式荧光法可以实现PGⅠ、PGⅡ的并行测试,方法学性能良好,可以提高检测效率,流式荧光法对血清 PGⅠ和 PGⅡ的测定可以为早期胃癌和萎缩性胃炎的筛查及诊断提供实验室依据。  相似文献   

9.
向龙  毛萌  付雪梅 《华西医学》2003,18(3):372-372
目的 :探讨血清EB病毒抗体IgM在小儿传染性单核细胞增多症 (IM)诊断中的临床应用价值。方法 :临床诊断IM组 4 6例 ,同期急性上呼吸道感染 30例。采用酶联免疫吸附法 (ELISA)检测血清抗EB病毒衣壳抗原 (VCA)的抗体IgM (EBV -VCA -IgM)。结果 :IM组EBV -VCA -IgM4 1例阳性 ,阳性率 91 3% ,显著高于对照组P <0 0 1。结论 :血清EBV -VCA -IgM是IM急性期的重要实验室诊断指标 ,其敏感性和特异性强 ,检测方法简单 ,值得推广  相似文献   

10.
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   

11.
BACKGROUND: Infectious mononucleosis is the common clinical manifestation of primary Epstein-Barr virus (EBV) infection in young children. We evaluated a chemiluminescent immunoassay method for the determination of serum anti-viral capsid antigen IgM antibody and its clinical value in the diagnosis of infectious mononucleosis. METHODS: Concentrations of the antibody in serum samples from 187 children measured by chemiluminescent immunoassay were compared with those measured by ELISA. RESULTS: Assessment of technologic quality (methodology) in diagnostic tests demonstrated that sensitivity of CLIA was 0.64 U/ml and the functional sensitivity was <0.9 U/ml. The within-assay and the between-assay imprecisions of different concentrations were all <5%. Recoveries were all in 93-107%. The linear regression equation between expected values and measured values was y=0.0967+1.0093x, correlation coefficient was 0.9996 (p<0.0001). The ROC curve showed that the sensitivity and specificity of the CLIA both were >90%. The area under the curve was 0.992, which was significantly higher than that of ELISA (p<0.05). CONCLUSION: The CLIA was the excellent method for EBV-VCA IgM measurement at present and can improve the clinical diagnosis of infectious mononucleosis.  相似文献   

12.
We evaluated a method for determination of human cytomegalovirus (hCMV) immunoglobulin M (IgM) by CLIA, and analyzed its clinical value in patients with infectious mononucleosis. Serum samples from 407 participants were measured on an automatic CLIA analyzer. At the same time the serum samples were measured by enzyme-linked immunosorbent assay (ELISA). An assessment of technological quality (methodology) in diagnostic tests demonstrated that the sensitivity of CLIA was 1.0 AU/mL and the functional sensitivity was <1.6 AU/mL. The within- and between-assay imprecision values for different concentrations were all under 5%. Recoveries for both methods were 96-110%. The linear regression equation between expected values and measured values was y=0.644+0.986x, and correlation coefficient was 0.9991 (P<0.0001). The receiver operating characteristic (ROC) curve showed that both the sensitivity and specificity of CLIA surpassed 90%. The area under the curve (AUC) was 0.990, which was significantly higher than that of ELISA (P<0.05). The results indicate that CLIA is an excellent method for hCMV IgM measurement, and thus may be useful for clinical diagnoses.  相似文献   

13.
目的探讨EB病毒(EBV)抗体阳性儿童患者流行病学和临床特征。 方法收集2014年1月至2016年12月于重庆市第九人民医院儿童呼吸科就诊的2 073例住院患儿,依据EBV壳抗原(EBV-VCA)抗体情况分为4组:EBV-VCA IgM(+)/IgG(+)(n=68)、EBV-VCA IgM(+)/IgG(-)(n=133)、EBV-VCA IgM(-)/IgG(+)(n=692)、EBV-VCA IgM(-)/IgG(-)(n=1 180),收集患儿的临床资料并做回顾性分析。 结果2 073例患儿EBV-VCA总体阳性率为43.08%(893/2 073)。不同EBV-VCA抗体阳性组间的年龄、性别、季节分布,均差异有统计学意义(χ2=70.69,12.22,17.39;均P<0.05)。本研究中EBV抗体阳性患儿临床表现以发热(75.70%,676/893)、咳嗽(59.35%,530/893)、咽峡炎(48.26%,431/893)等症状多见。819例患儿进行肝功能检查,有12.58%(103/819)患儿血清丙氨酸氨基转移酶(ALT)水平升高,30.40%(249/819)患儿血清天门冬氨酸氨基转移酶(AST)水平升高;747例患儿进行血清肌酸激酶同工酶(CK-MB)检查,其中388例(51.94%)水平升高。在EBV-VCA IgM和IgG均阳性与仅EBV-VCA IgM阳性两组中,具备典型传染性单核细胞增多症(IM)表现患儿比例分别为61.76%(42/68)、65.41%(87/133),与仅EBV-VCA IgG阳性组(35.40%,245/692)比较,均差异有统计学意义(χ2=18.31,47.78;均P<0.01)。 结论EBV感染在各年龄阶段、各季节均可发生,且临床表现无特异性,因此,EBV感染应引起家长及医疗工作者的重视。  相似文献   

14.
Urease conjugated enzyme linked immunosorbent assays (ELISA) were developed for the detection of human IgM and IgG antibodies against Mycoplasma pneumoniae. Results obtained by ELISA were compared with complement fixation test (CFT); which showed that of the 214 serum specimens tested, 80 were found to have antibody against M. pneumoniae. ELISA revealed that 70 of these specimens were IgG antibody, and 27 of them also contain IgM antibody. CFT failed to detect the presence of antibody against M. pneumoniae in five serum specimens tested. However, by using ELISA, three of them were found to have IgG and IgM antibodies. and the other two sera have IgG antibody only. Four out of the five specimens tested were the first serum specimens collected from patients with clinical and serological evidence of M. pneumoniae infection. In addition, 28 serum specimens, including 10 sera containing IgM rheumatoid factors and sera known to contain IgM antibody to other infectious organisms, were also tested for IgM antibody against M. pneumoniae by ELISA. None of these specimens showed a nonspecific reaction. ELISA had a sensitivity of 87.5% and a specificity of 96.3% when compared with CFT. Thus, ELISA developed in our laboratory is a specific test, and the results indicated that IgM ELISA might be used as a rapid diagnosis for M. pneumoniae infection.  相似文献   

15.
The serological diagnosis of parvovirus B19 (PVB19) was performed by radioimmunoassay or enzyme-linked immunosorbent assay (ELISA), using plasma-derived antigen, in view of the difficulties in obtaining the virus. Since the development of recombinant proteins, a number of commercial kits for detecting both specific immunoglobulin G (IgG) and IgM have become available. We evaluated seven methods, including indirect- and μ-chain-capture ELISA, indirect immunofluorescence and Western blot, in an effort to identify PVB19 IgM. In acute samples of erythema infectiosum, the sensitivity ranged from 37% to 91%; in all samples from primary PVB19 infections, including acute and convalescent samples of erythema infectiosum, and from other primary infections in adults, the sensitivity varied from 31% to 79%. When samples from rubella, measles, infectious mononucleosis and healthy pregnant women were tested, specificity ranged from 67% to 100%. Not all the kits evaluated can be used to diagnose PVB19 infections in view of the limitations of some kits with respect to sensitivity and, more importantly, specificity.  相似文献   

16.
张鹏  马永能  刘慧玲  杨自立 《检验医学与临床》2009,6(24):2087-2088,2090
目的分别用时间分辨荧光免疫分析(TRFIA)和化学发光免疫分析(CLIA)法检测血清甲胎蛋白(AFP)浓度,比较两种检测方法对原发性肝癌(PHC)诊断的临床应用价值。方法选择门诊和住院期闻确诊的PHC患者114例和肝良性病变患者126例,分别用TRFIA和CLIA法检测受试者血清AFP浓度,并进行工作特征(receiver operating characteristic curves,ROC)曲线分析。结果以健康对照组95%可信区间为医学正常值范围,TRFIA法和CLIA法诊断肝癌的临床界限值分别为7.31ng/mL和24,17ng/mL。TRFIA诊断肝癌的灵敏度为46.9%,特异性为93.4%,诊断准确率为79.2%。CLIA法的灵敏度为41.2%,特异性为91.6%,诊断准确率为65.8%。两种检测方法ROC曲线下面积分别为0.761(TRFIA)和0.682(CLIA)。结论TRFIA和CLIA法都可以满足临床AFP检测需要,但TRFIA法优于CLIA法。  相似文献   

17.
An enzyme-linked immunosorbent assay (ELISA) that detects IgM antibody to a peptide component of the Epstein-Barr virus (EBV) nuclear antigen (EBNA-1) was compared with a conventional rapid heterophil antibody method for the rapid diagnosis of infectious mononucleosis. Discrepancies between the two methods were further analyzed using an indirect immunofluorescence assay to detect antibodies to EBV antigens. We evaluated 298 cases of suspected infectious mononucleosis. The ELISA was very sensitive (98.7%) and able to detect some cases (seven (9%) of 75 confirmed positives) that were negative by the rapid heterophil antibody test, but confirmed by immunofluorescence. However, approximately 17% of all positive tests could not be confirmed by EBV-specific immunofluorescence; thus, the overall positive predictive value was 83%; negative predictive value was 99.5%; and specificity was 93%. The high rate of false-positive tests makes this rapid ELISA unsuitable for the diagnosis of infectious mononucleosis.  相似文献   

18.
目的比较化学发光法(TP-CLIA)、酶联免疫吸附试验(TP-ELlSA)和梅毒螺旋体明胶颗粒凝聚试验(TPPA)对梅毒螺旋体特异性抗体(TP-Ab)检测的意义。方法分别用CLIA、ELISA和TPPA检测患者的1797份血清样本,收集CLIA/ELISA/TPPA/法检测均阳性但临床未明确诊断的标本及结果不一致标本以重组免疫印迹法(RIBA)最终确认。结果三种方法共筛选69例阳性及可疑血清标本。CIIA/EIISA/TPPA法均阳性标本63例,其中52例有临床明确诊断。另11例3种方法检测均阳性但未明确诊断标本和6例检测结果不一致标本用RIBA确证。CLIA法确认阳性66例,阳性率3.67;ELISA法确认阳性65例,阳性率3.62;TPPA法法确认阳性61例,阳性率3.39;CLIA、ELISA及TPPA法敏感性分别为98.51%、97.02%和91.05%;特异性均为99.88;诊断效率分别99.83%、99.78和99.66%。结论CLIA法和ELISA法敏感性均高于TPPA法,不管用何种方法检测对于临床诊断不符的标本均应慎重,必要时用RIBA法补充确认,以排除假阳性。  相似文献   

19.
目的 探讨咽拭子荧光定量聚合酶链反应(FQ-PCR)法检测非洲淋巴细胞瘤病毒脱氧核糖核(EBV—DNA)在早期诊断EBV感染中的应用价值。方法对于疑诊EBV感染的患儿在疾病初期分别采用咽拭子PCR法检测EBV—DNA,同时用酶联免疫吸附测定(ELISA)法检测静脉血EBV—VCA—IgM和(或)IgG,对于前者阳性而后者阴性的病例在1周后复查EBV—VCAIgM和IgG,比较两者在早期诊断EBV感染中的价值。同期检测健康儿童50例作为对照组。结果①共检测疑诊病例985例,其中EBV—DNA阳性344例,阳性率34.9%,EBV—VCA—IgM和(或)IgG阳性164例,阳性率16.6%;健康对照组检测50例,仅1例EBVDNA阳性,所有病例EBV—VCA—IgM和(或)IgG均阴性。②在纳入研究病例中,诊断为传染性单核细胞增多症者38例,其中EBV—DNA37例阳性、EBV—VCAIgM和(或)IgG27例阳性(P〈0.05)。诊断为非典型EBV感染的312例,其中EBVDNA阳性307例,阳性率98.4%,EBV—VCA—IgM和(或)IgG阳性137例,阳性率43.9%(P〈0.01)。结论咽拭子PCR法检测EBV—DNA敏感度高,特异度强,且取材简单,方法无创,家长易于接受,与检测EBV-VCA—IgM、IgG相比,在早期诊断EBV感染性疾病,尤其是非典型EBV感染很有应用价值。  相似文献   

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