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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02009735
Enrollment
600
Registered
2013-12-12
Start date
2012-06-30
Completion date
2015-10-31
Last updated
2013-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enterovirus 71 and Influenza Virus

Keywords

Enterovirus 71 and Influenza Virus

Brief summary

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.

Detailed 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

Interventions

DEVICEvirosensor

virosensor, 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-influenza-virus (or anti-EV71-virus) and its influenza virus antigen (or EV71 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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Influenza virus or Enterovirus 71 detection1 DayIn comparison with results from viral isolation and RT-PCR of influenza virus or Enterovirus 71 , we evaluate the performance of virosensor, including sensitivity, specificity, cross-reaction and reproducibility.

Countries

Taiwan

Contacts

Primary ContactShiming Lin, PhD
til@ntu.edu.tw886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026