Clinical Trial: Ad Sensor-based Real-time Diagnosis of Adenovirus

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Ad Sensor-based Real-time Diagnosis of Adenovirus

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 Summary:

  1. 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.
  2. 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.
  3. Gold standard: viral isolation and RT-PCR

Sponsor: National Taiwan University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Taiwan University Hospital

Dates:
Date Received: December 6, 2013
Date Started: August 2011
Date Completion: December 2015
Last Updated: December 12, 2013
Last Verified: December 2013