【摘要】 目的探讨自配HCV-RNA质控品稳定性及对其临床应用价值进行评估。方法第1组实验:配备HCVRNA阳性质控品,分装并随机分为4组,分别为A组:-20℃组,B组:-70℃组,C组:-20℃蛋白酶K组,D组:-70℃蛋白酶K组,定期用实时荧光PCR技术定量检测;第2组实验:将HCV-RNA阳性新鲜血清、HCV-RNA阴性新鲜血清和稳定剂按适当比例混合,分装并随机分成3组,分别为E组:-20℃静置保存,F组:干冰包装邮寄组,G组:模拟卫生部邮寄室间质控品的常温邮寄包装,F和G组经历共2 d邮寄运送后-20℃保存,定期用实时荧光定量PCR技术定量,统计分析,绘制质控图。结果 A、B、C和D组28周前病毒载量对数分别为(5.39±0.11)、(5.44±0.11)、(5.40±0.10)、(5.46±0.12),变异系数为2.00%、2.00%、1.85%、2.20%,差异均无统计学意义(P>0.05),SD和CV均小于临床允许误差,Z-score质控图显示28周前4组测定结果均在可控范围。E、F、G组24周前病毒载量对数分别为(5.22±0.09)、(5.19±0.07)、(5.08±0.15),变异系数为1.72%、1.35%、2.95%;3组均值两两比较,E和G组之间差异有统计学意义(P=0.02);L-J质控图显示E、F组病毒载量均匀分布在均值两侧和±2SD范围内,G组于第12周连续超出-2SD,于16周和20周超出-3SD控制线。结论在自配HCV-RNA质控品中加入蛋白酶K不能有效延长质控品的有效期;自配HCV-RNA质控品在-20℃保存稳定期至少7个月(28周),满足临床室内质量控制的需要;常温邮寄过程可明显缩短HCV-RNA时效性,自配HCV-RNA无需经历运送过程,在稳定性上存在明显优势。更多还原

【Abstract】 Objective To investigate the stability of self-preparing internal quality control materials of HCV-RNA stored under several conditions,and observe the long-term effect of transport on the HCV-RNA viral load in plasma with stabilizing solution. Methods IQC materials of HCV-RNA were prepared,sub-packaged and randomly divided into groups.Samples were subjected to the following conditions. Group A : storage at-20℃;Group B: storage at-70℃; Group C:treatment with Proteinase K and storage at-20℃; Group D: treatment with Proteinase K and storage at-70℃. And group E to G were treated with stabilizing solution and two-day transport under the respective conditions as following :E:nontransport as control;F: transport packaged with dry ice;G: transport at ambient temperature. Quantification of HCV-RNA was performed regularly by real-time FQ-PCR. Results Comparison among four groups(group A to D), there was no significant difference(P >0.05),and all data points of groups above distributed in control on the Z-score graph during 28 weeks.There were also no statistical differences of SD and CV. A significant degradation in group G were observed after12 th week on the Levey-Jennings graph,whereas group E and group F in control.There was also significant difference of mean value between group G and group E. Conclusion Self-preparing internal quality control materials of HCV-RNA is quite stable within 7 months when stored at-20℃, and might be more applicable to clinical laboratory than commercial control material given that transport at ambient temperature can reduce the stability of HCV-RNA control materials.更多还原