Reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.
Reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.
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DOI：
10.1371/journal.pone.0050670
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发表时间：
2012
期刊：
影响因子：
3.7
通讯作者：
Ikuta K
中科院分区：
文献类型：
--
作者：
Sasaki T;Kubota-Koketsu R;Takei M;Hagihara T;Iwamoto S;Murao T;Sawami K;Fukae D;Nakamura M;Nagata E;Kawakami A;Mitsubayashi Y;Ohno M;Uehara Y;Fukukawa T;Kanai Y;Kosaka M;Ikuta K
对于季节性流感的诊断，临床医生依赖于使用针对季节性流感病毒开发的市售试剂盒的即时检测（POCT）。然而，POCT尚未建立用于诊断甲型流感病毒（H1N1 pdm）感染，因为现有的H1N1 pdm试剂盒灵敏度较低。基于抗H1N1 pdm的单克隆抗体开发了免疫层析（IC）检测试剂盒，该抗体与季节性流感A或B病毒不发生交叉反应。将该试剂盒（PDM-IC试剂盒）用于诊断H1N1 pdm感染的有效性与现有用于检测季节性流感病毒的试剂盒（SEA-IC试剂盒）进行比较。鼻拭子（n = 542）来自2010/2011年冬季日本大坂13家诊所的流感样综合征患者。 在542份样本中，随机选择332份样本通过逆转录聚合酶链反应（RT-PCR）进一步评估病毒存在。PDM-IC试剂盒与SEA-IC试剂盒对H1N1 pdm显示出更高的灵敏度和特异性，尽管两种试剂盒之间或试剂盒与RT-PCR之间存在一些不一致。因此，当使用SEA-IC试剂盒时，记录了更多的假阴性和假阳性病例。在个体诊所观察到两种试剂盒之间的灵敏度、特异性和阴性预测值的显著相关系数，表明结果可能受到临床相关的采样和试剂盒处理技术的影响。重要的是，许多患者（尤其是流感阴性病例）的处方抗流感药物与其病情不一致，这主要是由于医生偏好患者对问卷调查和患者病理学的反应，而不是实际的病毒存在。同时使用SEA-IC和PDM-IC试剂盒增加了正确诊断流感的可能性。提高POCT的可信度预计将减少抗流感药物的不适当分配，从而最大限度地减少耐药H1N1 pdm菌株的出现。
For the diagnosis of seasonal influenza, clinicians rely on point-of-care testing (POCT) using commercially available kits developed against seasonal influenza viruses. However, POCT has not yet been established for the diagnosis of pandemic influenza A virus (H1N1pdm) infection due to the low sensitivity of the existing kits for H1N1pdm. An immunochromatography (IC) test kit was developed based on a monoclonal antibody against H1N1pdm, which does not cross-react with seasonal influenza A or B viruses. The efficacy of this kit (PDM-IC kit) for the diagnosis of H1N1pdm infection was compared with that of an existing kit for the detection of seasonal influenza viruses (SEA-IC kit). Nasal swabs (n = 542) were obtained from patients with flu-like syndrome at 13 clinics in Osaka, Japan during the winter of 2010/2011. Among the 542 samples, randomly selected 332 were further evaluated for viral presence by reverse transcriptase polymerase chain reaction (RT-PCR). The PDM-IC kit versus the SEA-IC kit showed higher sensitivity to and specificity for H1N1pdm, despite several inconsistencies between the two kits or between the kits and RT-PCR. Consequently, greater numbers of false-negative and false-positive cases were documented when the SEA-IC kit was employed. Significant correlation coefficients for sensitivity, specificity, and negative prediction values between the two kits were observed at individual clinics, indicating that the results could be affected by clinic-related techniques for sampling and kit handling. Importantly, many patients (especially influenza-negative cases) were prescribed anti-influenza drugs that were incongruous with their condition, largely due to physician preference for patient responses to questionnaires and patient symptomology, as opposed to actual viral presence. Concomitant use of SEA-IC and PDM-IC kits increased the likelihood of correct influenza diagnosis. Increasing the credibility of POCT is anticipated to decrease the inappropriate dispensing of anti-influenza drugs, thereby minimizing the emergence of drug-resistant H1N1pdm strains.
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