Department of Infectious Diseases, Research Institute, International Medical Center of Japan, 1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan.
J Clin Microbiol. 2010 Mar;48(3):703-8. doi: 10.1128/JCM.02262-09. Epub 2010 Jan 13.
The pandemic caused by a new type of influenza virus, pandemic H1N1 (2009) influenza virus A (AH1pdm), has had a major worldwide impact. Since hemagglutinin (HA) genes are among the most specific genes in the influenza virus genome, AH1pdm can be definitively diagnosed by viral gene analysis targeting the HA genes. This type of analysis, however, cannot be easily performed in clinical settings. While commercially available rapid diagnosis kits (RDKs) based on immunochromatography can be used to detect nucleoproteins (NPs) of influenza A and B viruses in clinical samples, there are no such kits that are specific for AH1pdm. We show here that an RDK using a combination of monoclonal antibodies against NP can be used to specifically detect AH1pdm. The RDK recognized AH1pdm virus isolates but did not recognize seasonal H1N1 and H3N2 and influenza B viruses, indicating that the specificity of the RDK is 100%. A parallel comparison of RDK with a commercial influenza A/B virus kit revealed that both types of kits had equal sensitivities in detecting their respective viruses. Preliminary evaluation of clinical samples from 5 individuals with PCR-confirmed human AH1pdm infection showed that the RDK was positive for all samples, with the same detection intensity as that of a commercial influenza A/B virus kit. This RDK, together with a new vaccine and the stockpiling of anti-influenza drugs, will make aggressive measures to contain AH1pdm infections possible.
新型流感病毒引发的大流行，即甲型 H1N1（2009）流感病毒（AH1pdm），已在全球范围内产生重大影响。由于血凝素（HA）基因是流感病毒基因组中最具特异性的基因之一，因此可以通过针对 HA 基因的病毒基因分析来明确诊断 AH1pdm。然而，这种类型的分析在临床环境中不易进行。虽然市售的基于免疫层析的快速诊断试剂盒（RDK）可用于检测临床样本中的甲型和乙型流感病毒的核蛋白（NP），但尚无针对 AH1pdm 的此类试剂盒。我们在此表明，使用针对 NP 的单克隆抗体组合的 RDK 可用于特异性检测 AH1pdm。该 RDK 可识别 AH1pdm 病毒分离株，但不识别季节性 H1N1 和 H3N2 以及乙型流感病毒，表明该 RDK 的特异性为 100％。对 5 例经 PCR 确诊的人感染 AH1pdm 临床样本的 RDK 与商业流感 A/B 病毒试剂盒的平行比较表明，这两种试剂盒在检测各自病毒时具有相同的灵敏度。对来自 5 例经 PCR 确诊的人感染 AH1pdm 临床样本的初步评估显示，该 RDK 对所有样本均呈阳性，与商业流感 A/B 病毒试剂盒的检测强度相同。这种 RDK 与新型疫苗和抗流感药物的储备将使采取积极措施遏制 AH1pdm 感染成为可能。
