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Clinical Trials/NCT01388062
NCT01388062
Unknown
Not Applicable

e- Ab Sensor - Based Real-time Diagnosis of Influenza Virus

National Taiwan University Hospital1 site in 1 country100 target enrollmentAugust 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Influenza Caused by Unspecified Influenza Virus
Sponsor
National Taiwan University Hospital
Enrollment
100
Locations
1
Primary Endpoint
The performance of e- Ab sensor
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor for influenza virus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of influenza virus, the investigators evaluate the performance of e- Ab 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 influenza virus patients early treatment to reduce the complications and case-fatality rate.

Detailed Description

Since April 15 and 17, 2009, when the first two cases of novel influenza A (H1N1) infection were identified in two southern California counties, as of 12 March 2010, the virus has spread to more than 213 countries and overseas territories or communities where it has caused the deaths of at least 16713 people. Therefore, a rapid diagnosis is clinically necessary and can provide clinicians the rapid answers and make early treatment possible to reduce the complications and case-fatality rate. In addition, early diagnosis of the patients will alert parents and public health workers to prevent the contacts earlier and to limit the influenza spread. Electrosensing antibody probing system (e- Ab sensing), which was developed for the rapid and sensitive detection of hapten, proteins or viral antigen in medical samples, will be used for analyzing the interaction kinetics between Q.anti-influenza-virus and its influenza virus antigen present in flu patients'and normal samples. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eVchip) or lateral flow through (eVsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds influenza-virus epitope target molecules in the test samples. The investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. e- Ab sensor threshold decisions must maximize its sensitivity. Therefore, the threshold value in the test group is to find the decision could have 90% sensitivity and 90% specificity. With such technique, the investigators hope to make early diagnosis and give influenza patients early treatment to reduce the complications and case-fatality rate.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
October 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Patients will be excluded if they couldn't sign the consent.

Outcomes

Primary Outcomes

The performance of e- Ab sensor

Time Frame: 1 Day

In comparison with results from direct sequencing of influenza virus, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.

Study Sites (1)

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