e- Ab Sensor - Based Real-time Diagnosis of Enterovirus Type 71
1 other identifier
interventional
72
1 country
1
Brief Summary
To develop a real-time diagnostic technique with e- Ab sensor for Entervirus 71 detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Entervirus 71, 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 EV71 patients early treatment to reduce the complications and case-fatality rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedDecember 27, 2012
November 1, 2011
3 years
July 1, 2011
December 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The performance of e- Ab sensor
In comparison with results from direct sequencing of EV71, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.
1 Day
Study Arms (1)
virus detection
EXPERIMENTALInterventions
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-EV71 antibody and its antigen (EV71) present in patients. The system incorporates the use of engineered semiconducive 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 (EV71) in the test specimens. From assessment of the electric signature of semiconductive anti-EV71 antibodies, the eABprobe could offer sensitive detection and precise quantification of EV71.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 10051, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Luan-Yin Chang, MD,PhD
National Taiwan University Hospital
Central Study Contacts
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
July 1, 2010
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
December 27, 2012
Record last verified: 2011-11