Ad Sensor-based Real-time Diagnosis of Adenovirus

National Taiwan University

Status: Unknown

Conditions: Adenovirus

Treatments: Device: Ad sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT02008812

201108029RD

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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200 participants in 1 patient group

Ad sensor

Experimental group

Description:

virus detection

Treatment:

Device: Ad sensor