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
  Purpose

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.


Condition
H1N1 Influenza Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Groups/Cohorts
Experimental Group
Control Group
Negative control group

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

H1N1 Influenza

Criteria

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(+)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277380

Locations
Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Giueng-Chueng Wang Taipei Medical University WanFang Hospital
  More Information

No publications provided

Responsible Party: Giueng-Chueng Wang, Laboratory Medicine, Wanfang Hospital
ClinicalTrials.gov Identifier: NCT01277380     History of Changes
Other Study ID Numbers: 99029
Study First Received: January 12, 2011
Last Updated: January 13, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
H1N1 Influenza virus
swine flu
Real Time RT-PCR

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014