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

Autor: Takuya Murao, Daizou Fukae, Ritsuko Kubota-Koketsu, Kazuyoshi Ikuta, Mieko Kosaka, Akira Kawakami, Shinichi Iwamoto, Yuta Kanai, Tatsuo Hagihara, Yuko Mitsubayashi, Yasuo Uehara, Masahiro Nakamura, Eiichi Nagata, Masafumi Ohno, Kazuo Sawami, Tadahiro Sasaki, Takashi Fukukawa, Michihiro Takei
Rok vydání: 2012
Předmět:
Male
Viral Diseases
Time Factors
medicine.disease_cause
Chromatography
Affinity
Madin Darby Canine Kidney Cells
law.invention
Influenza A Virus
H1N1 Subtype
law
Pandemic
Influenza A virus
Child
Polymerase chain reaction
Aged
80 and over
Multidisciplinary
Middle Aged
Infectious Diseases
Child
Preschool
Predictive value of tests
Medicine
Female
Research Article
Test Evaluation
Adult
Adolescent
Point-of-Care Systems
Science
Point-of-care testing
Immunology
Immunoglobulins
Antiviral Agents
Drug Prescriptions
Virus
Young Adult
Dogs
Diagnostic Medicine
Predictive Value of Tests
Influenza
Human
medicine
Animals
Humans
Immunoassays
Biology
Pandemics
Aged
business.industry
Infant
Newborn
Pandemic influenza
Infant
Reproducibility of Results
Virology
Influenza
Reverse transcriptase
Immunologic Techniques
Clinical Immunology
business
Zdroj: PLoS ONE, Vol 7, Iss 11, p e50670 (2012)
PLoS ONE
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0050670
Popis: 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.
Databáze: OpenAIRE
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