Influenza Caused by Unspecified Influenza Virus Clinical Trial
Official title:
e- Ab Sensor - Based Real-time Diagnosis of Influenza Virus
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.
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.
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Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic