[Source: PLoS ONE, full text: (LINK). Abstract, edited.]
Reliability of a Newly-Developed Immunochromatography Diagnostic Kit for Pandemic Influenza A/H1N1pdm Virus: Implications for Drug Administration
Tadahiro Sasaki1*, Ritsuko Kubota-Koketsu1, Michihiro Takei2, Tatsuo Hagihara2, Shinichi Iwamoto2, Takuya Murao2, Kazuo Sawami2, Daizou Fukae2, Masahiro Nakamura2, Eiichi Nagata2, Akira Kawakami2, Yuko Mitsubayashi2, Masafumi Ohno2, Yasuo Uehara2, Takashi Fukukawa2, Yuta Kanai1, Mieko Kosaka3, Kazuyoshi Ikuta1
1 Department of Virology, Research Institute for Microbial Diseases, Osaka University, Suita, Osaka, Japan, 2 Osaka Higashinari-ku Medical Association, Higashinari-ku, Osaka, Japan, 3 Alfresa Pharma Corporation, Ibaraki, Osaka, Japan
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.
Citation: Sasaki T, Kubota-Koketsu R, Takei M, Hagihara T, Iwamoto S, et al. (2012) Reliability of a Newly-Developed Immunochromatography Diagnostic Kit for Pandemic Influenza A/H1N1pdm Virus: Implications for Drug Administration. PLoS ONE 7(11): e50670. doi:10.1371/journal.pone.0050670
Editor: Jianqing Xu, Fudan University, China
Received: June 1, 2012; Accepted: October 23, 2012; Published: November 30, 2012
Copyright: © 2012 Sasaki et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This work was supported in part by a Grant-in-Aid for Scientific Research (B) (Overseas Academic Research) from the Japan Society for the Promotion of Science to K.I. Also, this work was partly supported by funding from Alfresa Phama Corporation to Osaka University to perform a collaborative research. The funders had no role in study design, data collection or analysis, decision to publish, or preparation of the manuscript. No additional external funding was received for this study.
Competing interests: Tadahiro Sasaki is responsible for recognizing and disclosing on behalf of all authors any competing interest that could be perceived to bias their work, acknowledging all financial support and any other relevant financial or competing interests. Mieko Kosaka is employed by Alfresa Pharma Corporation. Funding for collaboration research was from this company only to Osaka University under the contract between Alfresa Pharma Corporation and Osaka University, but not to the authors. Also, immunochromatography kits, products of this company, were supported by this company for this study. The authors declare that they have no affiliations to this company, along with any other relevant declarations relating to employment, consultancy, patents, products, products in development or marketed products. This does not alter the authors’ adherence to all the PLOS One policies on sharing data and materials.
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