国产荧光定量PCR与COBAS Amplicor检测HBVDNA的结果比较

山东大学学报(医学版)

国产荧光定量PCR与COBAS Amplicor检测
HBVDNA的结果比较

薛艳¹，王磊¹，徐皖苏²

（1．山东大学第二医院感染病科，济南 250033； 2. 济南市传染病医院检验科，济南 250021）

收稿日期:1900-01-01 修回日期:1900-01-01 发布日期:2009-04-16
通讯作者: 王磊

Domestic fluorescence quantitative PCR reagents and COBAS Amplicor assay in measuring HBVDNA: a comparison study

XUE Yan¹，　WANG Lei¹，　XU Wansu²

(1. Department of Infectious Disease, Second Hospital of Shandong University, Jinan 250033, China;
2. Department of Clinical Laboratory, Jinan Hospital of Infectious Disease, Jinan 250021, China)

Received:1900-01-01 Revised:1900-01-01 Published:2009-04-16
Contact: WANG Lei

摘要/Abstract

摘要： 目的比较国产实时荧光定量PCR（FQPCR）试剂与罗氏COBAS Amplicor方法检测乙型肝炎病毒（HBV）DNA的结果。方法据COBAS Amplicor 的FQPCR试剂（A）的检测结果，抽取151份慢性乙型肝炎（慢乙肝）血清标本，采用两种国产实时FQPCR试剂B、C对血清标本进行HBVDNA平行检测，以分析国产试剂的敏感度、特异度及与试剂A的相关性。结果试剂A、B、C测得的HBVDNA结果分别为（5.87±1.64）、（5.11±1.34）、（4.93±1.35）log10?copies/mL，试剂B、C与试剂A的相关系数分别为0.947、0.937。3种试剂检测结果总体差异有统计学意义（P＜0.05），试剂B、C与试剂A检测结果相比差异有统计学意义（P＜0.05）。低HBV载量标本，试剂B、C与试剂A相关性较低。以试剂A为准，总体灵敏度、特异度分别为试剂B 90.4％、56.3%，试剂C 77.0%、100%。结论试剂B、C与试剂A在检测HBVDNA方面有较好一致性，但在低HBV载量时可靠性较低。试剂B灵敏度高，试剂C特异度高。

关键词: 肝炎病毒,乙型, 荧光定量PCR, 灵敏性, 特异性

Abstract: To compare the efficacy of two domestic real time fluorescence quantitative PCR(FQPCR) diagnostic kits and COBAS Amplicor HBVDNA monitor for HBVDNA determination. MethodsSerum samples from 151 patients with chronic hepatitis B were determined by COBAS Amplicor HBVDNA monitor (A). The serum samples were retested by FQPCR with domestic reagents (B and C). Concordance and correlation of the results were assessed and sensitivity and specificity of B and C were evaluated. ResultsThe serum HBVDNA levels determined by reagent A, B and C were (5.87±1.64)， (5.11±1.34), (4.93±1.35) log10?copies/mL, respectively (P＜0.05). And the HBVDNA level determined by A was higher than either of the latter two (P＜0.05)， while that by B and C were comparable (P＞0.05). The correlative coefficiency between results by A and B, and A and C were 0.947 and 0.937, respectively. Correlation between B, C and A in low virus load samples was not as good as that in high load samples. Overall sensitivity of reagent B and C was 90.4％ and 77.0%, and overall specificity was 56.3% and 100%, respectively. ConclusionBoth of the domestic fluorescence quantitative PCR reagents are fairly good in measuring serum HBVDNA, while they are less reliable in low virus load samples. Regent B is more sensitive and C is more specific.

Key words: Hepatitis B virus, Fluorescence quantitative PCR, Sensitivity, Specificity

中图分类号:

R446.61

薛艳1 ，王磊1 ，徐皖苏2
. 国产荧光定量PCR与COBAS Amplicor检测
HBVDNA的结果比较[J]. 山东大学学报(医学版), 2009, 47(04): 62-64.

XUE Yan¹，　WANG Lei¹，　XU Wansu²
.

Domestic fluorescence quantitative PCR reagents and COBAS Amplicor assay in measuring HBVDNA: a comparison study

[J]. JOURNAL OF SHANDONG UNIVERSITY (HEALTH SCIENCES), 2009, 47(04): 62-64.

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