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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01277380
Enrollment
100
Registered
2011-01-14
Start date
2010-08-31
Completion date
2011-08-31
Last updated
2011-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H1N1 Influenza Virus

Keywords

H1N1 Influenza virus, swine flu, Real Time RT-PCR

Brief summary

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.

Interventions

None listed

Sponsors

Taipei Medical University WanFang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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(+)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026