Ad Sensor-based Real-time Diagnosis of Adenovirus

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Adenovirus

Intervention / Treatment
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* Device: Ad sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A: The patients with confirmed or suspected infection. B: The healthy person without disease. Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ad sensor<br>virus detection | Device: Ad sensor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The performance of Ad sensor | 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. | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenovirus