title: Reliability of a newly-developed immunochromatography diagnostic kit for pandemic influenza A/H1N1pdm virus: implications for drug administration.
abstract: BACKGROUND
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Virology, Research Institute for Microbial Diseases, Osaka University, Suita, Osaka, Japan. sasatada@biken.osaka-u.ac.jp
authors.forename: Tadahiro
authors.initials: T
authors.lastname: Sasaki
authors.forename: Ritsuko
authors.initials: R
authors.lastname: Kubota-Koketsu
authors.forename: Michihiro
authors.initials: M
authors.lastname: Takei
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Hagihara
authors.forename: Shinichi
authors.initials: S
authors.lastname: Iwamoto
authors.forename: Takuya
authors.initials: T
authors.lastname: Murao
authors.forename: Kazuo
authors.initials: K
authors.lastname: Sawami
authors.forename: Daizou
authors.initials: D
authors.lastname: Fukae
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nakamura
authors.forename: Eiichi
authors.initials: E
authors.lastname: Nagata
authors.forename: Akira
authors.initials: A
authors.lastname: Kawakami
authors.forename: Yuko
authors.initials: Y
authors.lastname: Mitsubayashi
authors.forename: Masafumi
authors.initials: M
authors.lastname: Ohno
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Uehara
authors.forename: Takashi
authors.initials: T
authors.lastname: Fukukawa
authors.forename: Yuta
authors.initials: Y
authors.lastname: Kanai
authors.forename: Mieko
authors.initials: M
authors.lastname: Kosaka
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Ikuta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D000998:Antiviral Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002846:Chromatography, Affinity / Q000379:methods*; D004285:Dogs; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D053118:Influenza A Virus, H1N1 Subtype / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification* / Q000502:physiology*; D007251:Influenza, Human / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology*; D061985:Madin Darby Canine Kidney Cells; D008297:Male; D008875:Middle Aged; D058873:Pandemics; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D013997:Time Factors; D055815:Young Adult
chemical_list: D000998:Antiviral Agents