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

Not Applicable

• Conditions: Enterovirus 71 and Influenza Virus
• Interventions: Device: virosensor

• Registration Number: NCT02009735
• Lead Sponsor: National Taiwan University Hospital

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

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-12-26
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-16
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
virosensor	virosensor	virus detection

Primary Outcome Measures

Name	Time	Method
Influenza virus or Enterovirus 71 detection	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan