HBV DNA和HCV RNA能力验证样品的均匀性和稳定性评价

Evaluation of the homogeneity and stability of HBV DNA and HCV RNA samples used for proficiency testing

目的 评价上海市临床检验中心（以下简称“中心”）制备的乙型肝炎病毒脱氧核糖核酸（hepatitis B virus DNA,HBV DNA）和丙型肝炎病毒核糖核酸（hepatitis C virus RNA,HCV RNA）能力验证样品的均匀性和稳定性。方法 中心在能力验证样品制备完成后,依据中国合格评定国家认可委员会（China National Accreditation Service for Conformity Assessment,CNAS）-GL03“能力验证样品均匀性和稳定性评价指南”文件评价上海地区2013年和2014年发放的2次HBV DNA和HCV RNA能力验证样品的均匀性和稳定性。对所有阳性样品进行均匀性检验,每个样品号随机抽取10支,每支重复检测2次,采用单因子方差分析评价能力验证样品的均匀性检测数据;从每次能力验证样品中随机抽取2个阳性样品号进行稳定性检验,即每个样品号随机抽取6支,置2~8℃1周后,每支检测1次;同时对稳定性检验的2个样品进行同步稳定性检验,即从发放能力验证样品后的剩余样品中,每个样品号随机抽取6支,每支检测1次,采用t检验评价能力验证样品的稳定性检测数据。结果 2013和2014年HBV DNA 2次能力验证样品共有8个批号样品,而HCV RNA 2次能力验证样品共有7个批号样品进行了均一性评价。2次检测HBV DNA项目8个样品间的均匀性差异均无统计学意义（F值分别为0.627 8、0.986 1、2.028 6、1.050 7、0.530 5、0.824 4、1.394 1、1.912 6,P均〉0.05）;2次检测HCV RNA项目7个样品间的均匀性差异也均无统计学意义（F值分别为1.966 4、1.705 7、0.541 8、2.307 6、1.626 0、0.996 5、1.225 2;P均〉0.05）。2013和2014年HBV DNA和HCV RNA 2次能力验证样品各有4个批号的样品进行了稳定性评价。2次检测HBV DNA项目4个样品间的稳定性差异均无统计学意义（稳定性检验的t值分别为1.96、1.56、0.92、0.67,同步稳定性检验的t值分别为1.17、2.07、1.13、0.52;P均〉0.05）;2次检测HCV RNA项目4个样品的稳定性差异均无统计学意义（稳定性检验的t值分别为2.05、1.72、1.63、0.53,同步稳定性检测的t值分别为0.66、1.30、0.66、0.22,P均〉0.05）。结论 中心制备的HBV DNA和HCV RNA项目能力验证样品是均匀和稳定的,适用于HBV DNA和HCV RNA项目的能力验证评价。

Objective To evaluate the homogeneity and stability of the HBV DNA and HCV RNA samples used for proficiency testing prepared by Shanghai Center for clinical laboratory （SCCL）. Methods The experiment was designed according to the Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing （CNAS-GL03） using samples from 2013 and 2014 proficiency testing. The homogeneity was evaluated by detecting 10 aliquots selected randomly from each positive sample. For stability, 6 aliquots of the randomly chosen 2 positive samples from each batch ofproficiency test were analyzed one week after 2-8℃ preservation. Furthermore, synchronous stability was assessed by testing 6 aliquots of the above-mentioned 2 positive samples from the residue after distribution of proficiency testing. One way analysis of variance （ANOVA） and t test were used to analyze homogeneity and stability data, respectively. Results The F values of the 8 batches of HBV DNA samples were 0.627 8, 0.986 1, 2.028 6, 1.050 7, 0.530 5, 0.824 4, 1.394 1, 1.912 6; P〉0.05 respectively. The F values of the 7 batches ofHCV RNA samples were 1.966 4, 1.705 7, 0.541 8, 2.307 6, 1.626 0, 0.996 5, 1.225 2; respectively P〉0.05. The t values of the 4 batches ofHBV DNA samples were 1.96, 1.56, 0.92, 0.67 and were 1.17, 2.07, 1.13, 0.52 in synchronous stability tests respectively. The t values of the 4 batches of HCV RNA samples were 2.05, 1.72, 1.63, 0.53 and were 0.66, 1.30, 0.66, 2.20 in synchronous stability tests respectively （P〉0.05）. Conclusion The HBV DNA and HCV RNA samples prepared by SCCL are both homogeneous and stable, which are suitable for proficiency testing.