一种诺如病毒快检试剂盒的评价

Systematic evaluation on a quick test kit for norovirus

目的系统评价一种诺如病毒快检试剂盒的检测性能。方法收集130份非轮状病毒感染的腹泻样本,分别采用德国拜发公司生产的RIDA快速检测试剂盒和检验检疫行业标准中推荐的RT-PCR方法平行检测诺如病毒,统计分析两种方法的检测结果 ,并用RT-PCR测定快检试剂盒的最低检测下限。结果在130例腹泻样本中,快检试剂盒检出21例诺如病毒阳性,检出率为16.2%,RT-PCR检出24例诺如病毒阳性,检出率为18.5%。两种检测方法的符合率为97.7%(127/130),两种方法的检测结果差异无统计学意义(P=0.25),快检试剂盒的最低检测下限可达到1 000拷贝数。结论基于固相膜免疫测定的诺如病毒快检试剂盒具有较高的特异性和灵敏度,可以用于临床病毒性腹泻样本的快速筛检和国境口岸的应急检测。

Objective To evaluate a norovirus quick test kit systematically. Methods RIDA Quick test kit produced by R-Biopharm AG and reverse transcription polymerase chain reaction （RT-PCR） method recommended in the inspection and quarantine industry standards were used in parallel to detect the norovirus in 130 diarrhea samples that excluded rotavirus infection. Statistical analysis was conducted to compare the results of these two methods. Moreover, fluorescence quantitative RT-PCR method was used to determine the minimum detection limit of the quick test kit. Results Among 130 diarrhea specimens, 21 （16.2%） were diagnosed to be norovirus positive by quick test kit while 24（18.5%） were positive in RT-PCR test, in which 21 specimens were double positive. The coincidence rate of the two detection methods is 97.7% （127/130）. Statistical analysis showed that there were no significant differences between these two methods （P=0.25）. The minimum detection limit of the quick test kit was determined to be 1 000 copies. Conclusion The solid phase based RIDA QUIK Norovirus Test kit shows high specificity and sensitivity, which is suitable for rapid screening of clinical viral diarrhea samples and for emergency detection at frontier port.