- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02009735
Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- 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.
- 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.
- Gold standard: viral isolation and RT-PCR
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 10051
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Luan-Yin Chang, MD,PhD
- Phone Number: 71528 886-2-2312-3456
- Email: lychang@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patients with confirmed or suspected infection.
- The healthy person without disease.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: virosensor
virus detection
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 Day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201203067RIC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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