Shimizu H, Watanabe S, Kawakami C, Hirai Y, Kimura K, Sugaya N, Imai M
Kawasaki City Institute of Public Health.
Kansenshogaku Zasshi. 1998 Aug;72(8):827-33. doi: 10.11150/kansenshogakuzasshi1970.72.827.
A rapid enzyme immunoassay membrane test, Directigen Flu A (Becton Dickinson, USA), was evaluated by using virus isolates and clinical specimens. The reference laboratory diagnosis was based on the results of virus isolation. Directigen Flu A was reactive for all subtypes of human influenza A viruses, including reference strains of H1N1, H2N2 and H3N2. Moreover, H5N1 (Hongkong/156/97) was also detected by this kit. No cross reactivity was detected with other respiratory viruses. Directigen Flu A showed positive reaction with the solution containing influenza A virus of 2.4 x 10(3) pfu/assay. The rapid test demonstrated 77.9% sensitivity and 98.4% specificity for testing of throat swabs from children with respiratory symptoms. It showed higher sensitivity and specificity (92.1% and 100%) for testing of nasopharyngeal aspirates. Directigen Flu A should be useful for the rapid diagnosis of influenza A virus infection.
采用病毒分离株和临床标本对一种快速酶免疫测定膜试验——Directigen Flu A（美国BD公司）进行了评估。参考实验室诊断基于病毒分离结果。Directigen Flu A对所有人类甲型流感病毒亚型均有反应，包括H1N1、H2N2和H3N2的参考毒株。此外，该试剂盒还检测到了H5N1（香港/156/97）。未检测到与其他呼吸道病毒的交叉反应。Directigen Flu A对每检测孔含2.4×10(3) 蚀斑形成单位的甲型流感病毒溶液呈阳性反应。该快速试验对有呼吸道症状儿童的咽拭子检测显示出77.9%的敏感性和98.4%的特异性。对鼻咽抽吸物检测显示出更高的敏感性和特异性（分别为92.1%和100%）。Directigen Flu A应有助于甲型流感病毒感染的快速诊断。
