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

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。

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

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-DN...