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Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus

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ClinicalTrials.gov Identifier: NCT02009735
Recruitment Status : Unknown
Verified December 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 12, 2013
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
To develop a real-time diagnostic technique with Virosensor for Enterovirus 71 and Influenza Virus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Enterovirus 71 and Influenza Virus, the investigators evaluate the performance of virosensor , including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. With such technique, the investigators hope to make early diagnosis and give Enterovirus 71 and Influenza Virus patients early treatment to reduce the complications and case-fatality rate.

Condition or disease Intervention/treatment Phase
Enterovirus 71 and Influenza Virus Device: virosensor Not Applicable

Detailed Description:
  1. Sample acquirement： At National Taiwan University Hospital in Taiwan, we will enroll patients who have influenza-like illness or enterovirus infection . We will take three throat swabs for each patient: one for viral isolation, one for RT-PCR and the last for the Virosensor - based real-time diagnosis.
  2. Virosensor diagnosis： Virosensor (structural chip-based optosensing virus probing system), which is for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-influenza-virus (or anti-Enterovirus 71-virus) and its influenza virus antigen (or Enterovirus 71 antigen) present in patients'and normal samples.
  3. Gold standard： viral isolation and RT-PCR
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus
Study Start Date : June 2012
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: virosensor
virus detection
 Device: virosensor

virosensor, which was developed for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-influenza-virus (or anti-EV71-virus) and its influenza virus antigen (or EV71 antigen) present in patients and normal samples.

The system incorporates the use of chip formats. In antibody probing, antibodies are bound as a suitable probe, which specifically and selectively binds targeted molecules (virus antigen) in the test specimens.


Outcome Measures
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Primary Outcome Measures :
  1. Influenza virus or Enterovirus 71 detection [ Time Frame: 1 Day ]
    In comparison with results from viral isolation and RT-PCR of influenza virus or Enterovirus 71 , we evaluate the performance of virosensor, including sensitivity, specificity, cross-reaction and reproducibility.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The patients with confirmed or suspected infection.
  • The healthy person without disease.

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009735


Contacts
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Contact: Shiming Lin, PhD 886-2-23123456 ext 88458 til@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10051
Contact: Luan-Yin Chang, MD,PhD    886-2-2312-3456 ext 71528    lychang@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02009735    
Other Study ID Numbers: 201203067RIC
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013
Keywords provided by National Taiwan University Hospital:
Enterovirus 71 and Influenza Virus
Additional relevant MeSH terms:
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Influenza, Human
Enterovirus Infections
Virus Diseases
Infections
Respiratory Tract Infections
 Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Picornaviridae Infections