评价cobas 4800 HPV检测技术在宫颈癌及癌前病变筛查中的可行性及应用价值.方法:对河南省新密市856例年龄>21岁有性生活的妇女进行宫颈癌筛查.每位妇女均接受了cobas 4800 HPV检测、高危型HPV第二代杂交捕获试验(hy?brid capture 2 technology,HC2)检测、ThinPrep液基细胞学和阴道镜检查.阴道镜下在可见病变处直接取活检;任意筛查结果阳性但无可见病变时,于宫颈外口鳞柱交界处行四象限随机活检和宫颈管搔刮术(endocervical curettage,ECC).结果:cobas 4800 HPV检测与HC2检测对宫颈上皮内瘤变(cervical intraepithelial neoplasia,CIN)2级以上(CIN2、CIN3及宫颈癌)患者的灵敏度均为94.4%(34/36),特异度分别为63.2%(516/817)和63.9%(522/817);一致率为83.4%(711/853),两者具有高度一致性(Kappa=0.65).cobas 4800 HPV检测对于液基细胞学检查漏诊的患者具有100%检出率.cobas 4800 HPV16及18分型检测对于CIN2以上患者的阳性预测值21.9%为HC2检测10.3%的2.13倍.妇女感染HPV16及18型患CIN2以上病变的年龄比感染其他类型平均小5.4岁.结论:cobas 4800 HPV检测与HC2检测具有相似的准确性和良好的一致性,比ThinPrep液基细胞学检查更为灵敏,并且能鉴别HPV16及18两种高风险类

Objective:This study aimed to evaluate the feasibility and utility of cobas 4800 human papilloma virus (HPV) test as a primary screening test and a triage tool in cervical cancer screening. Methods:A total of 856 unscreened women subjects over 21 years of age and have engaged in sexual activities were recruited from Henan, China in 2011. All subjects were screened through cobas 4800 HPV, Hybrid Capture 2 (HC2) technology, ThinPrep liquid-based cytology, and colposcopy. Any visible lesion was directly biopsied through colposcopy. Random biopsies in four quadrants at the squamocolumnar junction and endocervical curettage were performed when apparent colposcopic abnormality was not observed, but at least one of the HPV tests was positive. Pathologic diagnosis was used as the golden standard to evaluate the performance of the screening tests. Results:Measured as a primary screening test, the sensitivity and specificity of the cobas 4 800 HPV test in detecting gradeⅡcervical intr

目的：探讨AMPLIPREP-COBAS TAQMAN法（罗氏COBAS法）和北京鑫诺美迪PCR-荧光探针“一管法”检测血清HBV DNA含量的性能差异。方法采用2种方法同步检测175例乙型肝炎患者血清样本，并将黄疸、溶血和脂血标本作为干扰样本，分析2种方法的相关性、一致性和抗干扰性。取一已知定量为2.24×10^9 IU/ml的标本，用阴性血清做1＋9（即1∶10）的稀释，并依次稀释至2.24×10 IU/ml，比较2种方法的线性范围和灵敏性的差异。结果175份均有数值的标本中，2种试剂检测结果比较差异无统计学意义。2种试剂对黄疸、溶血和脂血标本的定量值影响不大。对于HBV DNA＞1.70×10^8 IU/ml的样本，罗氏COBAS法结果只显示＞1.70×10^8 IU/ml，而“一管法”无须稀释仍能准确定量；对于HBV DNA＜1.00×10^2 IU/ml的样本，“一管法”仅能检测到病毒，而罗氏COBAS法的稳定性和线性更好。结论 PCR-荧光探针“一管法”与进口罗氏COBAS法具有良好的一致性，且省时、省力，价格低廉，适合在我国推广应用。

Objective To investigate the performance differences in detecting serum HBV DNA quantification between Roche COBAS TaqMan HBV assay and one-tube nested PCR assay. Methods The serum samples from 175 patients with hepatitis B were detected by Roche COBAS TaqMan HBV assay and one-tube nested PCR assay, with the jaundice, hemolytic and lipemic samples as interference samples, so as to analyze the correlation, consistency and interference performance of the two assays. A known sample with 2.24×109 IU/ml of HBV DNA was diluted by 1∶10 in negative serum in turn, and finally to an HBV DNA level of 2.24×10 IU/ml. The linear range and sensitivity of the two assays were analyzed. Results There was no significant difference in HBV DNA quantification of the 175 samples detected by the two assays. HBV DNA quantification in the jaundice, hemolytic and lipemic samples detected by the two assays was not significantly different. For samples with HBV DNA>1.70 ×108 IU/ml, Roche COBAS TaqMan

探讨罗氏Cobas E411与Cobas E601两台电化学发光免疫分析仪检测结果的可比性。方法:参考美国临床和实验室标准协会(CLSI)EP9-A2文件,以E411为比对方法(X),E601为实验方法(Y),检测患者样本中甲胎蛋白(AFP)、癌胚抗原(CEA)、糖类抗原125(CA125)、糖类抗原199(CA199)的含量,并对实验数据进行比对分析。结果:两系统之间的相关性好,在医学决定水平处的预期偏倚均可接受。结论:使用不同检测系统检测同一项目时,应进行比对分析和偏倚评估,以保证系统间检测结果的可比性。

Objective :To investigate the comparability of test results of two electrochemiluminescence immunoassay analyzer between Roche Cobas E411 and Cobas E601 .Methods :According to United States Clinical and Laboratory Standards Institute (CLSI) EP9-A2 document ,E411 was acted as comparison method (X) and E601 was as the experi-mental method (Y) .Alpha fetoprotein (AFP) ,carcinoembryonic antigen (CEA) ,carbohydrate antigen 125 (CA125) and carbohydrate antigen 199 (CA199) levels of patient samples were tested and the results were analyzed .Results:The correlation between the two systems is good and the bias is acceptable in the medical decision level .Conclusion:The comparative analysis and bias evaluation systems should be carried out to ensure the comparability of test results when the same items are detected with different detection systems .

目的：探讨低水平乙型肝炎病毒表面抗原（HBsAg）的检测方法及其临床意义。方法血清样本为上海科华公司生产的 HBsAg 酶联免疫吸附试验（ELISA）试剂盒或罗氏 cobas E601分析仪免疫发光分析仪初筛为弱阳性的标本；用丽珠 HBsAg中和试剂盒（酶联免疫法）或罗氏 cobas E601进行确认试验，并结合相应样本的肝功能及 HBV-DNA 检测结果进行分析。结果经科华试剂盒初筛为弱阳性的53例样本中，丽珠 HBsAg 中和试剂盒检测为阳性37例、阴性16例；经电化学发光法检测为弱阳性的18例样本中，丽珠 HBsAg 中和试剂盒检测为阳性4例，阴性6例。结论不同检测系统检测低水平 HBsAg 的结果存在差异，低水平 HBsAg 的临床价值有待进一步研究。

Objective To investigate the methods for the detection of serum samples with low-concentration HBsAg and its clin-ical value.Methods Serum samples with HBsAg weak positive were measured by ELISA or using Roch cobas e601 were collected from the clinical laboratory.The samples with low-concentration HBsAg were confirmed by neutralization assay by using Lizhu ELISA reagent Kit or Roch cobas e601 analyzer.at the same time,ALT/AST concentrations and HBV DNA copies were also deter-mined.Results Among 53 samples that showed weak positive reaction by using Kehua reagent kit,37 samples were positive in neu-tralization test,while the other 16 samples were negative.Among 18 samples that showed weak positive reaction tested by using Roch cobas e601 analyzer,13 samples showed positive in neutralization test,and the other 5 samples showed negative.Conclusion The results of HBsAg test varies in different detection System.The clinical significance of samples with low-concentration HBsAg needs further

目的对临床生化内部三种不同检测体系Cobas6000,Hitachi7600及Vitros350(干化学)间相同项目的测定结果进行可比性及偏倚评估分析,为实验室认可及标准化提供实验数据。方法法参考美国临床和实验室标准化委员会(CLSI)的EP9A2文件,以Hitachi7600作为参比方法,Cobas6000和Vitros350作为待评方法,对相同项目结果进行线性回归分析、并计算医学决定水平处的方法间偏差,以美国临床实验室修正法规(CLIA88)规定的室间质评允许误差范围的1/2为标准,判断偏倚的临床可接受性。结果 Cobas6000与Hitachi7600间相同检测项目40项,其中4项:钙、镁、氯和二氧化碳相关系数R20.95,并有7项:ALT、AST、ALP、ADA、β2MG、Phos及Lac方法间偏倚超出允许误差范围;Hitachi7600与Vitros350相同项目16项,其中3项:ALB、Na+、CL+相关系数R20.95,并有5项ALT、AST、ALP、Crea、Ca方法间偏倚超出允许误差范围。结论不同检测体系间存在一定偏差,特别是干化学与湿化学之间主要指标差异显著,相对偏差大于30%。当同一项目在2个或以上的检测系统测试时,应定期进行结果可比性及偏倚评估,判断临床可接受性,必要时分别建立参考值系统,以满足临床需求。

Objective to analyse the comparasity and bias estimation of results among three different biochemistry decetion systems including Cobas6000,Hitachi7600 and Vitros350 ( dry-chemistry ), and to provide experimental data for laboratorys’ standardization and identification. Methods Reference to the file of EP9A2 from National committee for clinical laboratory ( CLSI ), firstwe took Hitachi7600 as a way of comparison so as to evaluate Cobas6000 and Vitros350, then we analysed the results of the same tests by linear regression and to calculate the deviation of medical decision level between different methods, and took 1/2 of allowable error of provision of Clinical Laboratory Improvement Amendment ( CLIA88 ) as standard to estimate the clinical acceptability of bias. Results There were 40 same detections between Cobas6000 and Hitachi7600, for 4 of them ( Calcium, Magnesium, Chlorine and Carbon dioxide ), the correlation coefficient R2﹤0.95, and for 7 of them (ALT、AST、ALP、ADA、