Article: Differential diagnosis of pandemic (H1N1) 2009 infection by detection of haemagglutinin with an enzyme-linked immunoassay

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TitleDifferential diagnosis of pandemic (H1N1) 2009 infection by detection of haemagglutinin with an enzyme-linked immunoassay
AuthorsYuan, Q1
Cheng, XD3
Yang, BC1
Zheng, QB1
Chen, YX1
Chen, QR1
Zeng, F1
Zhang, R3
Ge, SX1
Hao, XK3
Chen, H2
Zhang, J1
Xia, NS1
KeywordsHaemagglutinin
Immunoassay
Influenza A virus
Influenza diagnosis
Pandemic (H1N1) 2009 virus
Issue Date2011
PublisherBlackwell Publishing Ltd. The Journal's web site is located at http://www.blackwellpublishing.com/journals/CLM
CitationClinical Microbiology And Infection, 2011, v. 17 n. 10, p. 1574-1580 [How to Cite?]
DOI: http://dx.doi.org/10.1111/j.1469-0691.2010.03413.x
AbstractA sensitive and convenient immunoassay that can directly differentiate pandemic (H1N1) 2009 (pH1N1) virus from seasonal influenza virus can play an important role in the clinic. In the presented study, a double-sandwich ELISA (pH1N1 ELISA), based on two monoclonal antibodies against haemagglutinin (HA) of the pH1N1 virus, was developed. After laboratory determination of the sensitivity and specificity characteristics, the performance of this assay was evaluated in a cohort of 904 patients with influenza-like illness. All seven strains of pH1N1 virus tested were positive by pH1N1 ELISA, with an average lower detection limit of 10 3.0±0.4 tissue culture infective dose (TCID) 50/mL (or 0.009±0.005HA titre). Cross-reaction of the assay with seasonal influenza virus and other common respiratory pathogens was rare. In pH1N1-infected patients, the sensitivity of the pH1N1 ELISA was 92.3% (84/91, 95% CI 84.8-96.9%), which is significantly higher than that of the BD Directigen EZ Flu A+B test (70.3%, p<0.01). The specificity of pH1N1 ELISA in seasonal influenza A patients was 100.0% (171/171, 95% CI 97.9-100.0%), similar to that in non-influenza A patients (640/642, 99.7%, 95% CI 98.9-100.0%). The positive predictive value for pH1N1 ELISA was 97.7% and the negative predictive value was 99.1% in this study population with a pH1N1 prevalence of 10.1%. In conclusion, detection of HA of pH1N1 virus by immunoassay appears to be a convenient and reliable method for the differential diagnosis of pH1N1 from other respiratory pathogens, including seasonal influenza virus. © 2011 The Authors. Clinical Microbiology and Infection © 2011 European Society of Clinical Microbiology and Infectious Diseases.
ISSN1198-743X
2011 Impact Factor: 4.54
2011 SCImago Journal Rankings: 0.320
DOIhttp://dx.doi.org/10.1111/j.1469-0691.2010.03413.x
ReferencesReferences in Scopus
DC Field
Value
dc.contributor.authorYuan, Q
dc.contributor.authorCheng, XD
dc.contributor.authorYang, BC
dc.contributor.authorZheng, QB
dc.contributor.authorChen, YX
dc.contributor.authorChen, QR
dc.contributor.authorZeng, F
dc.contributor.authorZhang, R
dc.contributor.authorGe, SX
dc.contributor.authorHao, XK
dc.contributor.authorChen, H
dc.contributor.authorZhang, J
dc.contributor.authorXia, NS
dc.date.accessioned2011-10-28T02:45:38Z
dc.date.available2011-10-28T02:45:38Z
dc.date.issued2011
dc.description.abstractA sensitive and convenient immunoassay that can directly differentiate pandemic (H1N1) 2009 (pH1N1) virus from seasonal influenza virus can play an important role in the clinic. In the presented study, a double-sandwich ELISA (pH1N1 ELISA), based on two monoclonal antibodies against haemagglutinin (HA) of the pH1N1 virus, was developed. After laboratory determination of the sensitivity and specificity characteristics, the performance of this assay was evaluated in a cohort of 904 patients with influenza-like illness. All seven strains of pH1N1 virus tested were positive by pH1N1 ELISA, with an average lower detection limit of 10 3.0±0.4 tissue culture infective dose (TCID) 50/mL (or 0.009±0.005HA titre). Cross-reaction of the assay with seasonal influenza virus and other common respiratory pathogens was rare. In pH1N1-infected patients, the sensitivity of the pH1N1 ELISA was 92.3% (84/91, 95% CI 84.8-96.9%), which is significantly higher than that of the BD Directigen EZ Flu A+B test (70.3%, p<0.01). The specificity of pH1N1 ELISA in seasonal influenza A patients was 100.0% (171/171, 95% CI 97.9-100.0%), similar to that in non-influenza A patients (640/642, 99.7%, 95% CI 98.9-100.0%). The positive predictive value for pH1N1 ELISA was 97.7% and the negative predictive value was 99.1% in this study population with a pH1N1 prevalence of 10.1%. In conclusion, detection of HA of pH1N1 virus by immunoassay appears to be a convenient and reliable method for the differential diagnosis of pH1N1 from other respiratory pathogens, including seasonal influenza virus. © 2011 The Authors. Clinical Microbiology and Infection © 2011 European Society of Clinical Microbiology and Infectious Diseases.
dc.description.naturelink_to_OA_fulltext
dc.identifier.citationClinical Microbiology And Infection, 2011, v. 17 n. 10, p. 1574-1580 [How to Cite?]
DOI: http://dx.doi.org/10.1111/j.1469-0691.2010.03413.x
dc.identifier.doihttp://dx.doi.org/10.1111/j.1469-0691.2010.03413.x
dc.identifier.epage1580
dc.identifier.hkuros197236
dc.identifier.isiWOS:000295086100023
Funding AgencyGrant Number
Key Special Subjects of Infectious Diseases2008ZX10004-006
Key Project of Science & Technology of Fujian Province2008Y0059
National High Technology Research and Development Program2010AA022801
Funding Information:

This work was supported by grants from Key Special Subjects of Infectious Diseases (2008ZX10004-006), the Key Project of Science & Technology of Fujian Province (2008Y0059) and the National High Technology Research and Development Program (2010AA022801).

dc.identifier.issn1198-743X
2011 Impact Factor: 4.54
2011 SCImago Journal Rankings: 0.320
dc.identifier.issue10
dc.identifier.pmid21054661
dc.identifier.scopuseid_2-s2.0-79959740973
dc.identifier.spage1574
dc.identifier.urihttp://hdl.handle.net/10722/142420
dc.identifier.volume17
dc.languageeng
dc.publisherBlackwell Publishing Ltd. The Journal's web site is located at http://www.blackwellpublishing.com/journals/CLM
dc.publisher.placeUnited Kingdom
dc.relation.ispartofClinical Microbiology and Infection
dc.relation.referencesReferences in Scopus
dc.rightsThe definitive version is available at www.blackwell-synergy.com
dc.subject.meshAntibodies, Viral - immunology
dc.subject.meshHemagglutinin Glycoproteins, Influenza Virus - diagnostic use - immunology
dc.subject.meshInfluenza A Virus, H1N1 Subtype - immunology - pathogenicity
dc.subject.meshInfluenza, Human - diagnosis - epidemiology - immunology - virology
dc.subject.meshPandemics
dc.subjectHaemagglutinin
dc.subjectImmunoassay
dc.subjectInfluenza A virus
dc.subjectInfluenza diagnosis
dc.subjectPandemic (H1N1) 2009 virus
dc.titleDifferential diagnosis of pandemic (H1N1) 2009 infection by detection of haemagglutinin with an enzyme-linked immunoassay
dc.typeArticle
Author Affiliations
  1. Xiamen University
  2. The University of Hong Kong
  3. The Fourth Military Medical University