中文摘要：

目的制备含有不同浓度的乙型肝炎病毒（HBV）DNA或丙型肝炎病毒（HCV）RNA的血浆标本,用于罗氏COBAS Ampli Prep/Taq Man 48超敏PCR检测系统定量测定HBV DNA及HCV RNA的室内质控品,评价其临床可行性。方法将含有高浓度HBV DNA（10^7数量级）或HCV RNA（10^5数量级）的临床血浆标本用健康志愿者血的临床血浆标本稀释至10^5和10^2数量级,均分装数管,以罗氏COBAS Ampli Prep/Taq Man 48超敏PCR检测系统分别对质控血浆中HBV DNA和HCV RNA定量测定20次,采用＂即刻法＂质控方法,计算每批次的离散指数（SI）上限和下限值,进行室内质控动态监测。结果 HBV DNA及HCV RNA室内质控血浆每批次检测SI上限和下限值均在控,HBV DNA低浓度和高浓度20次检测结果的均值（对数值）分别为2.24和5.72,标准差均为0.12,批间CV值分别为5.41%和2.17%;HCV RNA室内质控血浆检测结果的均值（对数值）分别为2.26,标准差为0.13,批间CV值为5.80%。结论含HBV DNA、HCV RNA血浆标本制备简单,单次制备量大、稳定性好,可用于罗氏COBAS Ampli Prep/Taq Man 48超敏PCR检测系统的＂即刻法＂室内质控。

英文摘要：

Objective To prepare and evaluate internal quality control （IQC） plasma for the quantification of hepatitis B virus （HBV） DNA and hepatitis C virus （HCV） RNA by the COBAS AmpliPrep/TaqMan 48 detection system. Methods The plasma samples with high HBV DNA level （10^7 magnitude） or HCV RNA level （10^5 magnitude） were diluted by the HBV and HCV-frec plasma from a healthy volunteer and subpackaged into several tubes as internal quality controls （IQCs）. The HBV DNA or HCV RNA concentrations of IQCs were quantified 20 times by the COBAS AmpliPrep/TaqMan 48 detection system. After each quantitative detection, the separation index （SI） values were calculated for the IQC analysis by the instant method. Results The SI values of IQCs were all under control. The mean values （log） of IQCs with low and high HBV DNA levels （10^5 and 10^2 magnitude） were 2.24 and 5.72, respectively. The standard deviations （SD） were both 0.12. The coefficients of variation （CVs） were 5.41% and 2.17%, respectively. The mean value （log）, SD and CV values of HCV IQCs （10^2 magnitude） were 2.26, 0.13 and 5.80%, respectively. Conclusions The self-prepared internal quality control plasma is suitable and applicable for the quantification ofHBV DNA and HCV RNA by the COBAS AmpliPrep/TaqMan 48 detection system.