CAJ | 학술논문

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 AmpliPrep/TaqMan 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（107数量级）或HCV RNA（105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105和102数量级，均分装数管，以罗氏COBAS AmpliPrep/TaqMan 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 AmpliPrep/TaqMan 48超敏PCR检测系统的“即刻法”室内质控。
목적：제비함유불동농도적을형간염병독（HBV）DNA혹병형간염병독（HCV）RNA적혈장표본，용우라씨COBAS AmpliPrep/TaqMan 48초민PCR검측계통정량측정HBV DNA급HCV RNA적실내질공품，평개기림상가행성。방법장함유고농도HBV DNA（107수량급）혹HCV RNA（105수량급）적림상혈장표본용건강지원자혈적림상혈장표본희석지105화102수량급，균분장수관，이라씨COBAS AmpliPrep/TaqMan 48초민PCR검측계통분별대질공혈장중HBV DNA화HCV RNA정량측정20차，채용“즉각법”질공방법，계산매비차적리산지수（SI）상한화하한치，진행실내질공동태감측。결과 HBV DNA급HCV RNA실내질공혈장매비차검측SI상한화하한치균재공， HBV DNA저농도화고농도20차검측결과적균치（대수치）분별위2.24화5.72，표준차균위0.12，비간CV치분별위5.41%화2.17%；HCV RNA실내질공혈장검측결과적균치（대수치）분별위2.26，표준차위0.13，비간CV치위5.80%。결론함HBV DNA、HCV RNA혈장표본제비간단，단차제비량대、은정성호，가용우라씨COBAS AmpliPrep/TaqMan 48초민PCR검측계통적“즉각법”실내질공。
Objective To prepare and evaluate internal quality control (IQC) plasma for the quantiifcation 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 (107 magnitude) or HCV RNA level (105 magnitude) were diluted by the HBV and HCV-free 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 quantiifed 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 (105 and 102 magnitude) were 2.24 and 5.72, respectively. The standard deviations (SD) were both 0.12. The coefifcients of variation (CVs) were 5.41%and 2.17%, respectively. The mean value (log), SD and CV values of HCV IQCs (102 magnitude) were 2.26, 0.13 and 5.80%, respectively. Conclusions The self-prepared internal quality control plasma is suitable and applicable for the quantiifcation of HBV DNA and HCV RNA by the COBAS AmpliPrep/TaqMan 48 detection system.