Ad Sensor-based Real-time Diagnosis of Adenovirus
|Study Design:||Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Ad Sensor-based Real-time Diagnosis of Adenovirus|
- The performance of Ad sensor [ Time Frame: 1 Day ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Ad sensor
Device: Ad sensor
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02008812
|Contact: Shiming Lin, PhD||886-2-23123456 ext email@example.com|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 10051|
|Contact: Luan-Yin Chang , MD,PhD 886-2-2312-3456 ext 71528 firstname.lastname@example.org|