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

VernacularTitle:一种新型甲型H1N1流感核酸双检诊断试剂盒的验证评价
Author: Wei WANG ¹ ; Li-Ming LIU ; Tong-Sheng GUO ; Hai-Bin WANG ; Yong-Li LI ; Da-Gang WANG ; Bo LI ; Bo-An LI ; Yuan-Li MAO
Author Information

1. 第四人民医院检验科
Keywords: Influenza A virus,human; Reagent kits,diagnostic
From: Chinese Journal of Experimental and Clinical Virology 2011;25(1):14-16
CountryChina
Language:Chinese
Abstract: 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 BioEngineering Co. ,Ltd can be used to detect influenza A and novel influenza A( H1N1 ).