诺如病毒快速检测试剂的评价

Evaluation of Norovirus rapid detection kit

目的评价德国R—Biopharm公司生产的RIDA QUICK诺如病毒快速检测试剂卡（免疫层析法）的准确性、安全性以及与对照试剂的等效性。方法以上市的IDEA Norovirus检测试剂盒（酶联免疫法）平行测定结果为参考，评价RIDA QUICK诺如病毒快速检测试剂卡（免疫层析法）的灵敏度、特异性及符合率。结果临床检测样本1042份，新型快速检测试剂诺如病毒检测特异性98．4％，灵敏度92．4％，与对照试剂的符合率为97．6％。结论RIDA QUICK诺如病毒快速检测试剂卡对于诺如病毒抗原的检测具有良好的特异性和灵敏度。

Objective Evaluating the accuracy and safety as well as the equivalence compared with the control kit of RIDA QUICK Norovirus detection kit（R-Biopharm, Germany）. Methods Based on the results of commercially available IDEATM Norovirus detection kit （ELISA） , the sensitivity and specificity and accuracy of RIDA QUICK Norovirus detection kit （immunochromatographic assay） were evaluated. Results The sensitivity and specificity of RIDA QUICK Norovirus detection kit were 98.4% and 92.4% , and the accuracy was 97.6% compared with the control kit. Conclusion RIDA QUICK Norovirus detection kit has good sensitivity and specificity for the detection of norovirus antigens.