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Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01277380
First received: January 12, 2011
Last updated: January 13, 2011
Last verified: January 2011

January 12, 2011
January 13, 2011
August 2010
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Complete list of historical versions of study NCT01277380 on ClinicalTrials.gov Archive Site
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Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR
Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR

The first outbreak of a new H1N1 influenza pandemic originated in the North America in April 2009. As of July 1, 2009, a total of 77,201 cases were accumulated in 103 countries around the world and the mortality rate of was about 0.43%. Alignment and analysis on gene sequences of the new H1N1 influenza virus found that it contains extremely homologous gene composition with that of the swine influenza viruses (swine flu) identified in Europe and North America in last century. Thus the virus strain was later renamed as a novel influenza H1N1. In general, the symptoms caused by the new influenza H1N1 infection was very similar to those resulted from seasonal influenza viral infection. Thus, it is difficult to distinguish the various influenza strains responsible for the infections only by clinical appearance. To compare the accuracy, specificity and sensitivity and speed in identifying the new influenza H1N1 in suspected cases, the investigators extracted RNA from influenza A-positive reactive specimens identified by a Influenza Rapid Test, for a Real-time PCR method to further detect the presence of swine H1 gene. In addition, the titer of H1N1 virus, the color development on the test stripe and clinical symptoms in patients were significantly associated. Finally, Real-time PCR products were subjected to sequence determination to explore potential new influenza pathogenicity, transmissibility and drug usage.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

H1N1 Influenza

H1N1 Influenza Virus
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  • Experimental Group
  • Control Group
  • Negative control group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
August 2011
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Inclusion Criteria:

  • Influenza Rapid Test Influenza A(+) B(-)
  • Influenza Rapid Test Influenza A(+) B(+)
  • Influenza Rapid Test Influenza A(-) B(-) was negative control

Exclusion Criteria:

  • Influenza Rapid Test Influenza A(-) B(+)
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01277380
99029
No
Giueng-Chueng Wang, Laboratory Medicine, Wanfang Hospital
Taipei Medical University WanFang Hospital
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Principal Investigator: Giueng-Chueng Wang Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP