两种HBV-DNA荧光定量PCR检测试剂比较  

Comparison between two HBV-DNA fluorescence quantitative polymerase chain reaction reagents

作　　者：王敏玲[1] 梁晓燕[2] 郭海波[1] 吴晓蔓[1] 

机构地区：[1]广州医学院第二附属医院检验科,510260 [2]广州医学院检验系,510182

出　　处：《广州医药》2009年第3期52-55,共4页Guangzhou Medical Journal

摘　　要：目的比较及评价两种HBV-DNA荧光定量PCR试剂特异性、灵敏度、重复性及检测结果的相关性。方法用深圳匹基生物工程有限公司生产的两种HBV-DNA荧光定量PCR试剂(试剂A,试剂B)对已知结果的质控血清、标准品及本院154份HBsAg阳性的临床标本进行平行检测,比较两种试剂检测结果的特异性、灵敏度、重复性及结果的相关性。结果试剂A与试剂B的特异性均为100%,灵敏度分别为90.91%和95.45%,符合率分别为93.33%和96.67%;对强阳性、临界阳性标本,试剂A重复性试验批内CV值为3.16%、5.61%,批间为3.18%、6.32%,试剂B批内CV值为2.11%、5.36%,批间CV为3.58%、4.59%;两种试剂对临床标本的检测结果相关性良好(r=0.93、P<0.01),但试剂A检测的灵敏度和符合率均低于试剂B(P<0.01)。结论试剂B总体性能优于试剂A,适于临床使用;试剂A有待校准及(或)改进。实验室必须选择质量好且符合自己实验室要求、与本实验室仪器相匹配的试剂以保证检验质量。Objective To compare and evaluate the specinficity, sensitivity, repeatability and correlation with the test results of clinical samples of the two HBV-DNA fluorescence quantitative polymerase chain reaction reagents. Methods Detected the HBV-DNA of the known quality control serum, standards and 154 serum samples of HBsAg-positive clinical patients bv the two HBV-DNA fluorescence quantitative polymerase chain reaction reagents （reagent A, reagent B） produced by The Shenzhen PG Biotech Company. Results The specificities of reagent A and reagent B were both t00%, the sensitivities were 90. 91% and 95.45% respectively, correspondences were 93. 33% and 96. 67% respectively. The results of reproducibility test of reagent A showed the intra-assav coefficient of variation was 3. 16% to strong positive samples and 5.61% to borderline positive samples, and the inter-assay coefficient of variation was 3. 18% to intensive positive samples and 6. 32% to borderline positive samples. The results of reproducibility test of reagents B showed the intra-assay coefficient of variation was 2. 11% to strong positive samples and 5.36% to borderline positive samples, and the inter-assay coefficinent of variation was 3.58% to intensive positive samples and 4. 59% to borderline positive samples. The results of clinical samples of two reagents had good correlation （r =0. 93, P 〈0. 01 ）, but the sensitivity and the correspondence of reagent A were lower than reagent B （ P 〈 0.01 ） . Conclusion The overall performanee of reagent B was better than reagent A. The reagent B is suitable for clinical administration. The reagent A need to be calibrated and improved. The laboratory should choose a reagent with good quality, can fulfill its requirements and match its own equipment to ensure the quality of analysis.

关 键 词：乙型肝炎病毒 DNA 荧光定量聚合酶链反应 试剂 

分 类 号：R450[医药卫生—治疗学]