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Clinical Trials/NCT02009735
NCT02009735
Unknown
Not Applicable

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

National Taiwan University Hospital1 site in 1 country600 target enrollmentJune 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Enterovirus 71 and Influenza Virus
Sponsor
National Taiwan University Hospital
Enrollment
600
Locations
1
Primary Endpoint
Influenza virus or Enterovirus 71 detection
Last Updated
12 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
October 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Study Sites (1)

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