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)log10copies/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B90.4%、56.3%,试剂C77.0%、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。
Objective 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. Methods Serum 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. Results The 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 eopies/mL, respectively （ P 〈 0.05）. And the HBV- DNA level determined by A was higher than either of the lather two （ P 〈 0.05）, while that by B and C were comparable （ P 〉 0.05）. The correlative co-efficieney 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 sam- pies 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. Conclusion Both 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.
出处
《山东大学学报（医学版）》
CAS
北大核心
2009年第4期62-64,共3页
Journal of Shandong University:Health Sciences
关键词
肝炎病毒
乙型
荧光定量PCR
灵敏性
特异性
Hepatitis B virus
Fluorescence quantitative PCR
Sensitivity
Specificity
