Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus

National Taiwan University

Status: Unknown

Conditions: Enterovirus 71 and Influenza Virus

Treatments: Device: virosensor

Study type: Interventional

Funder types: Other

Identifiers

NCT02009735

201203067RIC

Details and patient eligibility

About

To develop a real-time diagnostic technique with Virosensor for Enterovirus 71 and Influenza Virus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Enterovirus 71 and Influenza Virus, the investigators evaluate the performance of virosensor , 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 Enterovirus 71 and Influenza Virus 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 influenza-like illness or enterovirus infection . We will take three throat swabs for each patient: one for viral isolation, one for RT-PCR and the last for the Virosensor - based real-time diagnosis.
2. Virosensor diagnosis： Virosensor (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-influenza-virus (or anti-Enterovirus 71-virus) and its influenza virus antigen (or Enterovirus 71 antigen) present in patients'and normal samples.
3. Gold standard： viral isolation and RT-PCR

Enrollment: 600 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The patients with confirmed or suspected infection.
• The healthy person without disease.

Exclusion criteria

• None

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

---

600 participants in 1 patient group

virosensor

Experimental group

Description:

virus detection

Treatment:

Device: virosensor