两种HCV RNA荧光定量试剂盒检测丙型肝炎病毒的比较分析

Comparative Analysis of Two HCV-RNA Fluorescence Quantitative Diagnostic Kits

目的比较分析两种丙型肝炎病毒(HCV)核酸定量检测试剂盒的临床性能。方法随机抽取63例临床血清样本进行平行检测,分别采用HCV磁珠法试剂和对照试剂检测血清中RNA水平。结果对照试剂检测63例临床样本中有22例阳性,41例阴性;磁珠法试剂检测63例样本中有27例阳性,36例阴性,两种试剂的阳性样本具较好的一致性(P=0.000),磁珠法试剂与对照试剂的定量检测结果具有线性相关性(r=0.935,P<0.05)。结论两种试剂都可以应用于HCV临床检测,磁珠法试剂具有更高的灵敏度,是一种比较理想的HCV RNA定量检测试剂。

Objective To evaluate specificity and sensitivity of two hepatitis C viral RNA quantitative fluorescence diagnostic kits. Methods Using the two HCV RNA assays, we detected 63 parallel clinical serum specimens and the difference and the correlation of their analytical results were compared, Results In all of the 63 clinical serum specimens,22 were detected HCV positive, and 41 negative by control reagents; 27 were detected HCV positive and 36 negative by magnetic-bead technology. The results showed a good posi-tive consistency between the two kits （P = 0. 000）. Quantitative test results of the magnetic bead reagent and control reagent have a linear correlation （ r = 0. 935, P 〈 0.05 ）. Conclusion Both kits can be used in clinical labs. Magnetic-bead method is a better one because of its higher sensitivity.