e- Ab Sensor - Based Real-time Diagnosis of Influenza Virus

NCT01388062 | Unknown

• 1 other identifier: 201007054R
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor for influenza virus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of influenza virus, the investigators evaluate the performance of e- Ab sensor, 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 influenza virus patients early treatment to reduce the complications and case-fatality rate.

Conditions

Influenza Caused by Unspecified Influenza Virus

Keywords

influenza virus

Outcome Measures

Primary Outcomes (1)

• The performance of e- Ab sensor

  In comparison with results from direct sequencing of influenza virus, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.

  1 Day

Study Arms (1)

virus detection

EXPERIMENTAL

Device: Electrosensing antibody probing system (e- Ab sensor)

Interventions

Electrosensing antibody probing system (e- Ab sensor) DEVICE

Electrosensing antibody probing system (e- Ab sensor), which was developed for the rapid and sensitive detection of hapten, proteins, or viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti- influenza virus antibody and its antigen (influenza virus) present in patients. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through (eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe, which specifically and selectively binds targeted molecules (influenza virus) in the test specimens. From assessment of the electric signature of semiconductive anti- influenza virus antibodies, the eABprobe could offer sensitive detection and precise quantification of EV71.

virus detection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A: The patients with confirmed or suspected infection.
• B: The patients without disease.

You may not qualify if:

• Patients will be excluded if they couldn't sign the consent.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10051, Taiwan

RECRUITING

Study Officials

• Luan-Yin Chang, MD,PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiming Lin, PhD

CONTACT

886-2-23123456; til@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 6, 2011
• Study Start: August 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 27, 2012

Record last verified: 2012-11

Locations

TW (1)