一种A型流感病毒NP抗原快速检测试剂的建立

Development of a rapid test kit for detection of influenza A virus specific nucleoproteins

目的建立一种适合现场检测需要的A型流感快速诊断试剂。方法以自制的抗A型流感（Flu A）病毒核蛋白（NP）单抗为原料，建立快速检测A型流感病毒的双抗体夹心酶免疫渗滤试验，并对其灵敏度和特异性进行了初步评价。结果该试剂对不同地区流行的各种亚型的A型流感病毒株均有较高的反应性，而对非Flu A病毒株无交叉反应。比较该试剂与BD公司的两种流感快速诊断试剂，发现该试剂对随机选取的3株Flu A病毒的检测分析灵敏度高出Directigen EZ FluA试剂5～125倍，对2株Flu A病毒的分析灵敏度高出Directigen Flu A试剂约20倍。另外，用该试剂对57份含漱液标本和170份动物拭子标本进行检测，结果显示：本试剂的灵敏度（〉85％）和特异性（〉95％）均优于当前主流的商品化A型流感快速诊断试剂。结论利用抗Flu A NP单抗为原料建立了A型流感快速诊断试剂，该试剂的应用无需任何专用仪器，操作简便快速，可满足现场检测需要。

A rapid test kit for influenza A based on detection of viral nucleoprotein（NP） was developed by using enzyme immuno-filtration assay. This kit has been demonstrated to have high reactivity with a range of influenza A strains from different areas and have no cross reactivity with non-influenza A viruses. In comparison with analytical sensitivity of this kit, Directigen EZ Flu AA-B and Directigen Flu A, the results showed that limits of detection of influenza A viruses by this kit were 5-125 fold higher than Directigen EZ Flu AA-B for the detection of three influenza A viruses strains, and about 20 fold higher than Di- rectigen Flu A for another two influenza A viruses. Both 57 specimens from Flu patients and 170 trachea swabs from chickens were performed by this kit. The results showed that this kit had a high sensitivity（〉85 %） and specificity（〉95 %）. Furthermore, this kit is easy to use and can produce results rapidly without the use of special test instruments.