Development of Two Types of Rapid Diagnostic Test Kits To Detect the Hemagglutinin or Nucleoprotein of the Swine-Origin Pandemic Influenza A Virus H1N1

Mizuike, Rika; Sasaki, Tadahiro; Baba, Koichi; Iwamoto, Hisahiko; Shibai, Yusuke; Kosaka, Mieko; Kubota‐Koketsu, Ritsuko; Yang, Cheng-Song; Du, Anariwa; Sakudo, Akikazu; Tsujikawa, Masato; Yunoki, Mikihiro; Ikuta, Kazuyoshi

doi:10.1128/cvi.00269-10

Cited by 19 publications

(24 citation statements)

References 26 publications

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“…Similar approaches to the diagnosis of A(H1N1)pdm09 virus based on the development of viral-specific mAbs have also been reported [MiyoshiAkiyama et al, 2010;Mizuike et al, 2011].…”

Section: Introductionmentioning

confidence: 82%

“…With this pandemic virus of mixed-origin, increased anxiety levels resulted worldwide, accompanied by CDC guidelines suggesting prompt antiviral treatment and implementation of specific infection control precautions for hospitalized and high-risk patients [CDC, 2009a,c;Mizuike et al, 2011]. Under these circumstances, rapid diagnosis was pivotal for the initiation of treatment with antiviral drugs and management of infection control measures.…”

Section: Introductionmentioning

confidence: 99%

“…An RIDT utilizing immuno-chromatography is one type of test that satisfies this requirement. An RIDT can be performed in a variety of clinical settings because it yields rapid results and is simple to undertake; both are attributes required for the point-of-care strategy of pandemic viral infection [Gavin and Thomson, 2003;Landry, 2011;Mizuike et al, 2011].…”

Section: Introductionmentioning

confidence: 99%

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Impact of influenza virus escape‐mutations on influenza detection by the rapid influenza diagnostic test

Kim

et al. 2013

Journal of Medical Virology

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During the influenza pandemic of 2009-2010, rapid influenza diagnostic tests (RIDTs) were used to detect influenza viral infections because they are quick and simple to use. However, retrospective studies showed that RIDTs performed poorly when used to diagnose pandemic viral infections. Determining how amino acid sequence changes in pandemic or epidemic influenza viral antigens impact clinical value of RIDTs has not been possible, because the viral epitopes recognized by RIDTs have been not mapped. In this study, the effect of escape-variations or mutations in influenza viral antigens upon the sensitivity and specificity of an RIDT was investigated by characterizing the immunological properties of the antibodies used in the RIDT. Escape-mutants were generated by cultivating A/Korea/01/2009 in the presence of an excess of the same antibodies used in the RIDT. Escape-mutants not recognized by the RIDT were selected. Epitopes recognized by the RIDT were mapped by comparing the sequence and immunological analysis of the escape-variants and wild-type isolates. The RIDT antibodies recognized epitopes on the Sa antigenic site and in the F subdomain in hemagglutinin. Variants bearing mutations in these epitopes were not detected by the RIDT. The frequency of escape-variants emerging since the 2009-2010 pandemic was calculated as 1.27% using in silico surveillance of influenza sequence databases. These results suggest that mapping the relevant epitopes of RIDTs and making such information available to clinics would be helpful for determining whether RIDTs match newly emergent strains and subtypes prior to retrospective re-evaluation of the RIDTs using clinical specimens.

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“…Similar approaches to the diagnosis of A(H1N1)pdm09 virus based on the development of viral-specific mAbs have also been reported [MiyoshiAkiyama et al, 2010;Mizuike et al, 2011].…”

Section: Introductionmentioning

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Impact of influenza virus escape‐mutations on influenza detection by the rapid influenza diagnostic test

Kim

et al. 2013

Journal of Medical Virology

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“…Mizuike et al developed an RIDT containing two mAbs specific to the HA and NP of H1N1pdm09 for the detection of H1N1pdm09 (Mizuike et al, 2011). Samuel et al (2011) generated mAbs to the HA1 of the H1N1pdm09 viral HA for the serodiagnosis of H1N1-pdm09 infections.…”

Section: Discussionmentioning

confidence: 99%

Immunological characterization of monoclonal antibodies used in rapid influenza diagnostic test for detection of the 2009 pandemic influenza A(H1N1)pdm09 infection

Lee

et al. 2015

J Microbiol.

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Since the 2009 pandemic, monoclonal antibodies (mAbs) for rapid influenza diagnostic tests (RIDT) have been developed for specific diagnostics of pandemic viral infection. Most of the mAbs were poorly characterized because of urgency during the pandemic. Further characterization of the mAbs for RIDTs would be beneficial for understanding the immunological properties of the pandemic virus and utilizing the mAbs for other research purposes. In this study, it was confirmed that two mAbs (I38 and D383) in an RIDT for H1N1pdm09 diagnostics were able to detect H1N1pdm09 virus through enzyme-linked immunosorbent assay (ELISA) and immunofluorescence assay (IFA). Also, the two mAbs exhibited reactivity to hemagglutinins (HAs) of both the H1N1pdm09 and 1918 H1N1 viruses; therefore, the RIDT using the mAbs could detect HAs of H1N1pdm09 and also HAs of 1918 H1N1-like strains. In an extension to our previous study, the epitopes (Sa antigenic site and the interface area of F' and vestigial esterase subdomains on the HA1 domain of HA of H1N1pdm09) recognized by the mAbs were corroborated in depth by IFA with escape-mutants from the mAbs and mapping of the epitopes on the crystal structure of human H1N1 viral HAs. Collectively, these results imply that the mAbs for the RIDT may be suitable for use in studying the immunological properties of H1N1pdm09 viruses and that the Sa antigenic site and the interface area between F' and vestigial esterase subdomains on influenza viral HA recognized by the mAbs are immunologically conserved regions between H1N1pdm09 and 1918 H1N1.

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“…Consequently, we developed murine monoclonal antibodies that were specific for H1N1pdm, which exhibited no cross-reactivity with seasonal influenza A (H1N1 or H3N2) or seasonal influenza B viruses. These monoclonal antibodies were then employed to develop a new IC test kit for the high-sensitivity detection of H1N1pdm [27].…”

Section: Introductionmentioning

confidence: 99%

Reliability of a Newly-Developed Immunochromatography Diagnostic Kit for Pandemic Influenza A/H1N1pdm Virus: Implications for Drug Administration

Sasaki

Kubota‐Koketsu

Takei³

et al. 2012

PLoS ONE

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BackgroundFor 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.Methodology/Principal FindingsAn 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.Conclusions/SignificanceConcomitant 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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Development of Two Types of Rapid Diagnostic Test Kits To Detect the Hemagglutinin or Nucleoprotein of the Swine-Origin Pandemic Influenza A Virus H1N1

Cited by 19 publications

References 26 publications

Impact of influenza virus escape‐mutations on influenza detection by the rapid influenza diagnostic test

Impact of influenza virus escape‐mutations on influenza detection by the rapid influenza diagnostic test

Immunological characterization of monoclonal antibodies used in rapid influenza diagnostic test for detection of the 2009 pandemic influenza A(H1N1)pdm09 infection

Reliability of a Newly-Developed Immunochromatography Diagnostic Kit for Pandemic Influenza A/H1N1pdm Virus: Implications for Drug Administration

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