丙型肝炎病毒RNA室内质控品的制备及其临床应用评估

Preparation and clinical application evaluation of internal quality control of hepatitis C virus RNA

目的探讨自制丙型肝炎病毒(hepatitis C Virus,HCV)RNA定量检测室内质控品的可行性,并评估其临床应用价值。方法收集已发过HCV-RNA临床报告的血浆样本,分别将HCV-RNA阴性血浆(<50 IU/mL)、弱阳性血浆(102~103 IU/mL)和强阳性血浆(105~106 IU/mL)混合、离心后,获得阴性质控品(HCV-RNA-N)、弱阳性质控品(HCV-RNA-L)和强阳性质控品(HCV-RNA-H),小量分装后于-80℃冻存。确定靶值后,评价其均一性、重复性、准确性和稳定性。结果自制HCV RNA室内质控品具有良好的均一性、重复性和准确性,可在-80℃保持稳定至少12个月。结论HCV RNA室内质控品制备过程简单,样品均一,重复性好,准确性高,稳定性良好,可用于临床检测HCV-RNA。

Objective To investigate the feasibility of preparation of internal quality control(IQC)for quantitative detection of hepatitis C virus(HCV)-RNA and evaluate its significance in clinical application.Methods Clinical plasma samples,including HCV-RNA negative plasma(<50 IU/mL),weakly positive plasma(102~103 IU/mL)and strong positive plasma(105~106 IU/mL),which have been clinically reported,were collected,pooled respectively and centrifuged to obtain negative quality control(HCV-RNA-N),weak positive quality control(HCV-RNA-L)and strong positive quality control(HCV-RNA-H).All the IQCs were aliquoted and stored in frozen at-80℃.After the target value was confirmed,the IQCs were evaluated for homogeneity,repeatability,accuracy and stability.Results The prepared IQC of HCV-RNA showed good homogeneity,repeatability and accuracy,of which the quality was stable at-80℃for at least 12 months.Conclusion The preparation process of IQC of HCV-RNA was simple,and the IQC samples were homogeneous,repeatable,accurate and stable,which could be used for clinical control of HCV-RNA.