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

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2013 by National Taiwan University Hospital

Sponsor:

Information provided by (Responsible Party):

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT02009735

First received: December 26, 2012

Last updated: December 12, 2013

Last verified: December 2013

History of Changes

Purpose

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	Intervention
Enterovirus 71 and Influenza Virus	Device: virosensor


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

Influenza virus or Enterovirus 71 detection [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	600
Study Start Date:	June 2012
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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

Eligibility


Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009735

Contacts


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

Locations


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

No publications provided


Responsible Party:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT02009735 History of Changes
Other Study ID Numbers:	201203067RIC
Study First Received:	December 26, 2012
Last Updated:	December 12, 2013
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:


Enterovirus 71 and Influenza Virus

Additional relevant MeSH terms:


Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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