Reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.

<h4>Background</h4>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)...

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Autores principales: Tadahiro Sasaki, Ritsuko Kubota-Koketsu, Michihiro Takei, Tatsuo Hagihara, Shinichi Iwamoto, Takuya Murao, Kazuo Sawami, Daizou Fukae, Masahiro Nakamura, Eiichi Nagata, Akira Kawakami, Yuko Mitsubayashi, Masafumi Ohno, Yasuo Uehara, Takashi Fukukawa, Yuta Kanai, Mieko Kosaka, Kazuyoshi Ikuta
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spelling oai:doaj.org-article:802d041cbbf44f1fbc7e8b59a1ae06b32021-11-18T08:06:45ZReliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.1932-620310.1371/journal.pone.0050670https://doaj.org/article/802d041cbbf44f1fbc7e8b59a1ae06b32012-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23226350/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>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.<h4>Methodology/principal findings</h4>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.<h4>Conclusions/significance</h4>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.Tadahiro SasakiRitsuko Kubota-KoketsuMichihiro TakeiTatsuo HagiharaShinichi IwamotoTakuya MuraoKazuo SawamiDaizou FukaeMasahiro NakamuraEiichi NagataAkira KawakamiYuko MitsubayashiMasafumi OhnoYasuo UeharaTakashi FukukawaYuta KanaiMieko KosakaKazuyoshi IkutaPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 7, Iss 11, p e50670 (2012)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Tadahiro Sasaki
Ritsuko Kubota-Koketsu
Michihiro Takei
Tatsuo Hagihara
Shinichi Iwamoto
Takuya Murao
Kazuo Sawami
Daizou Fukae
Masahiro Nakamura
Eiichi Nagata
Akira Kawakami
Yuko Mitsubayashi
Masafumi Ohno
Yasuo Uehara
Takashi Fukukawa
Yuta Kanai
Mieko Kosaka
Kazuyoshi Ikuta
Reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.
description <h4>Background</h4>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.<h4>Methodology/principal findings</h4>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.<h4>Conclusions/significance</h4>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.
format article
author Tadahiro Sasaki
Ritsuko Kubota-Koketsu
Michihiro Takei
Tatsuo Hagihara
Shinichi Iwamoto
Takuya Murao
Kazuo Sawami
Daizou Fukae
Masahiro Nakamura
Eiichi Nagata
Akira Kawakami
Yuko Mitsubayashi
Masafumi Ohno
Yasuo Uehara
Takashi Fukukawa
Yuta Kanai
Mieko Kosaka
Kazuyoshi Ikuta
author_facet Tadahiro Sasaki
Ritsuko Kubota-Koketsu
Michihiro Takei
Tatsuo Hagihara
Shinichi Iwamoto
Takuya Murao
Kazuo Sawami
Daizou Fukae
Masahiro Nakamura
Eiichi Nagata
Akira Kawakami
Yuko Mitsubayashi
Masafumi Ohno
Yasuo Uehara
Takashi Fukukawa
Yuta Kanai
Mieko Kosaka
Kazuyoshi Ikuta
author_sort Tadahiro Sasaki
title Reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.
title_short Reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.
title_full Reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.
title_fullStr Reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.
title_full_unstemmed Reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.
title_sort reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza a/h1n1pdm virus: implications for drug administration.
publisher Public Library of Science (PLoS)
publishDate 2012
url https://doaj.org/article/802d041cbbf44f1fbc7e8b59a1ae06b3
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