e- Ab Sensor - Based Real-time Diagnosis of Influenza Virus
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Influenza Caused by Unspecified Influenza Virus |
Device: Electrosensing antibody probing system (e- Ab sensor) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | e- Ab Sensor - Based Real-time Diagnosis of Influenza Virus |
- The performance of e- Ab sensor [ Time Frame: 1 Day ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: virus detection |
Device: Electrosensing antibody probing system (e- Ab sensor)
Electrosensing antibody probing system (e- Ab sensor), 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 anti- influenza virus antibody and its antigen (influenza virus) present in patients. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through (eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe, which specifically and selectively binds targeted molecules (influenza virus) in the test specimens. From assessment of the electric signature of semiconductive anti- influenza virus antibodies, the eABprobe could offer sensitive detection and precise quantification of EV71.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Shiming Lin, PhD | 886-2-23123456 ext 88458 | til@ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 10051 | |
| Contact: Luan-Yin Chang, MD/PhD 886-2-2312-3456 ext 71528 lychang@ntu.edu.tw | |
| Principal Investigator: Luan-Yin Chang, MD/PhD | |
| Principal Investigator: | Luan-Yin Chang, MD,PhD | National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01388062 History of Changes |
| Other Study ID Numbers: | 201007054R |
| Study First Received: | July 1, 2011 |
| Last Updated: | December 26, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
influenza virus |
Additional relevant MeSH terms:
|
Influenza, Human Virus Diseases Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Infections |
Respiratory Tract Diseases Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013