Ad Sensor-based Real-time Diagnosis of Adenovirus
|ClinicalTrials.gov Identifier: NCT02008812|
Recruitment Status : Unknown
Verified December 2013 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : December 11, 2013
Last Update Posted : December 16, 2013
|Condition or disease||Intervention/treatment|
|Adenovirus||Device: Ad sensor|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Ad Sensor-based Real-time Diagnosis of Adenovirus|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||December 2015|
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.
- The performance of Ad sensor [ Time Frame: 1 Day ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008812
|Contact: Shiming Lin, PhD||886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 10051|
|Contact: Luan-Yin Chang , MD,PhD 886-2-2312-3456 ext 71528 email@example.com|