Ad Sensor-based Real-time Diagnosis of Adenovirus

Not Applicable

• Conditions: Adenovirus
• Interventions: Device: Ad sensor

• Registration Number: NCT02008812
• Lead Sponsor: National Taiwan University Hospital

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

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

Study Timeline

• Study Start: 2011-08
• Status Verified: 2013-12
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-16
• Primary Completion: 2015-08
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

A: The patients with confirmed or suspected infection. B: The healthy person without disease.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ad sensor	Ad sensor	virus detection

Primary Outcome Measures

Name	Time	Method
The performance of Ad sensor	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan