Ad Sensor-based Real-time Diagnosis of Adenovirus
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|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||Phase|
|Adenovirus||Device: Ad sensor||Not Applicable|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|