临床肝胆病杂志Issue(12):1315-1318,4.DOI:10.3969/j.issn.1001-5256.2014.12.020
罗氏COBAS HCV RNA定量一代和二代检测试剂对556例丙型肝炎患者HCV RNA定量检测结果的比较
Evaluation of two generations of HCV RNA quantitative kits:a comparative study of 556 cases of hepatitis C
摘要
Abstract
Objective To evaluate the clinical application of two generations of HCV nucleic acid quantitative kits:COBAS AmpliPrep/COBAS TaqMan HCV,v2.0 and COBAS AmpliPrep/COBAS TaqMan HCV Test.Methods HCV RNA levels in 556 samples that were collected in our hospital were measured using the COBAS AmpliPrep/COBAS TaqMan HCV,v2.0 and COBAS AmpliPrep/CO-BAS TaqMan HCV Test.The samples included 93 ones that were HCV RNA negative,350 ones that were HCV RNA positive,52 paired plasma and serum samples,and 6 1 ones with previous interferon therapy.HCV RNA-positive samples were divided into low-concentration group (≤103,61 cases),medium-concentration group (104 -105,191 cases),and high-concentration group (≥106,89 cases). Comparison between groups was made by linear analysis to compute the correlation coefficient (r)and establish the regression equation.Re-sults There was a significant correlation between the two generations of HCV nucleic acid quantitative kits (r=0.948,P<0.05 ).The correlation between the two kits in the low-concentration group (y=0.9809x+0.1359,r=0.8047,P>0.06)was higher than that in the medium-concentration group (y=0.8130x+1.0727,r=0.6956,P<0.01)and that in the high-concentration group (y=0.6746x+1.8914,r=0.3088,P<0.01).A high correlation between the two kits in paired serum and plasma samples was observed (y=0.9368x+0.4469,r=0.9698,P>0.05).Conclusion The two generations of HCV RNA quantitative kits produce consistent results.A stronger correlation was shown in the low-concentration group,suggesting that the quantitative kits are more sensitive in detecting low level of HCV RNA in the clinical setting.关键词
肝炎,丙型/RNA,病毒/聚合酶链反应/试剂盒,诊断Key words
hepatitis C/RNA,viral/polymerase chain reaction/reagent kits,diagnostic分类
医药卫生引用本文复制引用
孙梅,谈国蕾,王建芳,吴旭平..罗氏COBAS HCV RNA定量一代和二代检测试剂对556例丙型肝炎患者HCV RNA定量检测结果的比较[J].临床肝胆病杂志,2014,(12):1315-1318,4.基金项目
南京市医学科技发展资金资助 ()