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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01388062
Enrollment
100
Registered
2011-07-06
Start date
2010-08-31
Completion date
2013-10-31
Last updated
2012-12-27

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

Conditions

Influenza Caused by Unspecified Influenza Virus

Keywords

influenza virus

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.

Interventions

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.

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
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.

Design outcomes

Primary

MeasureTime frameDescription
The performance of e- Ab sensor1 DayIn comparison with results from direct sequencing of influenza virus, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.

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