一种新型甲型H1N1流感核酸双检诊断试剂盒的验证评价  

The verification of a new DNA double-detection diagnostic kit for identifying novel influenza A （H1N1）

作　　者：王薇 刘立明[2] 郭桐生[2] 王海滨[2] 李永利[2] 王大刚[2] 李波[2] 李伯安[2] 毛远丽[2] 

机构地区：[1]第四人民医院检验科,四川成都610016 [2]解放军第三0二医院临检中心

出　　处：《中华实验和临床病毒学杂志》2011年第1期14-16,共3页Chinese Journal of Experimental and Clinical Virology

摘　　要：目的验证一种“甲型流感通用型及H1N1型病毒核酸双检试剂盒（PCR-荧光探针法）”。方法连续收集流感样患者咽拭子标本150例，提取RNA后，以北京市CDC配发的“甲型H1N1流感病毒Real—timePCR诊断试剂盒”为对照，同时用待评价的双检试剂盒平行扩增，对结果进行Kappa一致性检验和McNemar x2差异性检验以及计算两种方法的检测一致率。结果待验证的双检试剂盒与北京市CDC配发的Real—timePCR诊断试剂盒的一致率，通用引物M为97．33％，H1N1为98．67％。经Kappa一致性检验和MeNemarX。差异性检验，两种方法诊断试剂盒有较高的一致性（分别为Z=10．6466，P〈0．0001和Z=11．3402，P〈0．0001），且待验证双检试剂盒相对于CDC配发试剂的“假阴性率”和“假阳性率”很低（分别为P=0．3173〉0．05和P=1．000〉0．05）。结论上海科华生物工程股份有限公司生产的“甲型流感通用型及H1N1型病毒核酸双检试剂盒（PCR．荧光探针法）”对于甲型流感通用型和H1N1型的诊断均有良好的诊断特性。Objective To verify a new kit of ＂ universal and novel influenza A （H1N1） virus nucleic acid double-detection methods （PCR-fluorescence probe）＂. Methods 150 cases of throat swab specimens were collected consecutively. After RNA was extracted, the specimens were detected by the verified kit. At the same time, the same specimens were detected by Real-time PCR diagnostic kit from Beijing CDC as the control. The data were analysed by the Kappa in agreement and by McNemar X2 in difference test. Results The consistency rate of the verified kit and the Beijing CDC kit was universal primer M 97.33% , H1N1 98.67% respectively. The Kappa test and McNemar X2 test showed that two methods had a higher consistency. Compared to the CDC kit, the ＂false negative rate＂ and ＂false-positive rate＇of double-check kit were lower. Conclusion The kit of ＂universal and novel influenza A （H1N1） virus nucleic acid double-detection methods （PCR-fluorescence probe ）＂ from Shanghai Kehua Bio- Engineering Co. ,Ltd can be used to detect influenza A and novel influenza A（H1N1）.

关 键 词：流感病毒A型 人 试剂盒 诊断 

分 类 号：R446.6[医药卫生—诊断学]