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

孙梅; 谈国蕾; 王建芳; 吴旭平

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

DOI: 10.3969/j.issn.1001-5256.2014.12.020

东南大学附属第二医院肝病研究室

基金项目:

南京市医学科技发展资金资助(YKK13151,QRX11236)；

详细信息

中图分类号: R512.63
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出版历程
- 收稿日期: 2014-06-24
- 出版日期: 2014-12-20

Evaluation of two generations of HCV RNA quantitative kits: a comparative study of 556 cases of hepatitis C

Research Center of Hepatology, The Second Affiliated Hospital of Southeast University

Research funding:

摘要

摘要: 目的评估两代HCV核酸定量检测试剂的临床应用。方法收集南京市第二医院住院和门诊HCV感染者556例,采用罗氏COBAS HCV核酸定量一代和二代检测试剂检测其标本,其中HCV RNA阴性血浆93份;HCV RNA阳性血浆350份;血清血浆配对标本52份;干扰样本61份。将阳性血浆样本分为3组,低浓度（3次方及以下）61例、中浓度（4、5次方组）191例和高浓度89例（6次方及以上）。采用线性分析法,计算相关系数和回归方程,比较各组之间的关系。结果总体分析2种HCV RNA定量检测试剂的结果具有相关性（r=0.948,P<0.05）。低浓度组的线性回归方程y=0.9809x+0.1359,r2=0.8047,P>0.05;中浓度组的线性回归方程y=0.8130x+1.0727,r2=0.6956,P<0.01;高浓度组的线性回归方程y=0.6746x+1.8914,r2=0.3088,P<0.01。血清血浆有效对比检测结果的相关性良好（r2=0.9698,P<0.05）,线性回归方程y=0.9368x+0.4469。结论两代HCV RNA定量检测试剂符合程度...
- 肝炎,丙型 /
- RNA,病毒 /
- 聚合酶链反应 /
- 试剂盒,诊断
Abstract: Objective To evaluate the clinical application of two generations of HCV nucleic acid quantitative kits: COBASAmpli Prep /COBASTaq Man HCV, v2. 0 and COBASAmpli Prep / COBASTaq Man HCV Test. Methods HCV RNA levels in 556 samples that were collected in our hospital were measured using the COBASAmpli Prep / COBASTaq Man HCV, v2. 0 and COBASAmpli Prep / COBASTaq Man 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 61 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. Results 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. 9809 x + 0. 1359, r = 0. 8047, P > 0. 06) was higher than that in the medium-concentration group (y = 0. 8130 x + 1. 0727, r = 0. 6956, P < 0. 01) and that in the high-concentration group (y = 0. 6746 x + 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. 9368 x + 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.
- hepatitis C /
- RNA, viral /
- polymerase chain reaction /
- reagent kits, diagnostic

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参考文献(12)

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