Ad Sensor-based Real-time Diagnosis of Adenovirus
Primary Purpose
Adenovirus
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ad sensor
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenovirus focused on measuring Adenovirus
Eligibility Criteria
Inclusion Criteria:
A: The patients with confirmed or suspected infection. B: The healthy person without disease.
Exclusion Criteria:
-
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ad sensor
Arm Description
virus detection
Outcomes
Primary Outcome Measures
The performance of Ad sensor
In comparison with results from viral isolation and RT-PCR of Adenovirus , we evaluate the performance of Ad sensor, including sensitivity, specificity, cross-reaction and reproducibility.
Secondary Outcome Measures
Full Information
NCT ID
NCT02008812
First Posted
December 6, 2013
Last Updated
December 12, 2013
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02008812
Brief Title
Ad Sensor-based Real-time Diagnosis of Adenovirus
Official Title
Ad Sensor-based Real-time Diagnosis of Adenovirus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief Summary
To develop a real-time diagnostic technique with Ad sensor for Adenovirus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Adenovirus, the investigators evaluate the performance of Ad 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 Adenovirus patients early treatment to reduce the complications and case-fatality rate.
Detailed Description
Sample acquirement: At National Taiwan University Hospital in Taiwan, we will enroll patients who have Adenovirus infection . We will take three throat swabs for each patient: one for viral isolation, one for RT-PCR and the last for the Ad sensor - based real-time diagnosis.
Ad sensor diagnosis: Ad sensor (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-Adenovirus and its Adenovirus antigen present in patients'and normal samples.
Gold standard: viral isolation and RT-PCR
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenovirus
Keywords
Adenovirus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ad sensor
Arm Type
Experimental
Arm Description
virus detection
Intervention Type
Device
Intervention Name(s)
Ad sensor
Intervention Description
Ad sensor, 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-Adenovirus and its Adenovirus 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.
Primary Outcome Measure Information:
Title
The performance of Ad sensor
Description
In comparison with results from viral isolation and RT-PCR of Adenovirus , we evaluate the performance of Ad sensor, including sensitivity, specificity, cross-reaction and reproducibility.
Time Frame
1 Day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A: The patients with confirmed or suspected infection. B: The healthy person without disease.
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiming Lin, PhD
Phone
886-2-23123456
Ext
88458
Email
til@ntu.edu.tw
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10051
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luan-Yin Chang, MD,PhD
Phone
886-2-2312-3456
Ext
71528
Email
lychang@ntu.edu.tw
12. IPD Sharing Statement
Learn more about this trial
Ad Sensor-based Real-time Diagnosis of Adenovirus
We'll reach out to this number within 24 hrs