Hurt Aeron C, Baas Chantal, Deng Yi-Mo, Roberts Sally, Kelso Anne, Barr Ian G
WHO Collaborating Centre for Reference and Research on Influenza, 10 Wreckyn St, North Melbourne, Victoria, Australia.
Influenza Other Respir Viruses. 2009 Jul;3(4):171-6. doi: 10.1111/j.1750-2659.2009.00086.x.
In April 2009, an A(H1N1) influenza virus of swine lineage was detected in humans in the USA, and in just over a month has infected over 10,000 people in more than 40 countries.
To determine the performance of the Binax Now, BD Directigen EZ, and the Quidel QuickVue influenza rapid point-of-care (POC) tests for the detection of the recently emerged swine lineage A(H1N1) virus.
Swine lineage A(H1N1) and human seasonal influenza strains were cultured and then diluted to specific infectivity titres. Viral dilutions were assayed by the rapid POC tests and by real-time RT-PCR.
All three of the rapid POC tests successfully detected the swine lineage A(H1N1) viruses at levels between 10(3) and 10(5) TCID(50)/ml (tissue culture infectious dose(50)), with the BD Directigen test demonstrating marginally greater sensitivity than the other two tests. Viral infectivity and RNA load data for viruses at the detection limit of the rapid test kits, suggested that both the Quidel and the Binax tests were less sensitive for the detection of swine lineage A(H1N1) viruses than for human seasonal strains. In comparison the BD Directigen demonstrated similar sensitivity when detecting swine lineage A(H1N1) and human seasonal viruses.
The three rapid POC tests all detected the emergent swine lineage A(H1N1) virus when it was present at high virus concentrations. Early diagnosis of infection can assist in the rapid treatment. However the tests are significantly less sensitive than PCR assays and as such, negative results should be verified by a laboratory test.
2009年4月，美国在人类中检测到一种猪源甲型（H1N1）流感病毒，在短短一个多月时间里，已在40多个国家感染了1万多人。
确定Binax Now、BD Directigen EZ和Quidel QuickVue流感快速即时检测（POC）试验检测最近出现的猪源甲型（H1N1）病毒的性能。
培养猪源甲型（H1N1）和人类季节性流感毒株，然后稀释至特定感染滴度。通过快速POC试验和实时逆转录聚合酶链反应检测病毒稀释液。
所有三种快速POC试验均成功检测到浓度在10³至10⁵组织培养感染剂量（50）（TCID₅₀）/毫升之间的猪源甲型（H1N1）病毒，BD Directigen试验的灵敏度略高于其他两种试验。快速检测试剂盒检测限的病毒感染性和RNA载量数据表明，Quidel和Binax试验检测猪源甲型（H1N1）病毒的灵敏度低于检测人类季节性毒株。相比之下，BD Directigen在检测猪源甲型（H1N1）和人类季节性病毒时表现出相似的灵敏度。
三种快速POC试验在高病毒浓度下均能检测到新出现的猪源甲型（H1N1）病毒。感染的早期诊断有助于快速治疗。然而，这些试验的灵敏度明显低于聚合酶链反应检测，因此，阴性结果应通过实验室检测进行验证。
