e- Ab Sensor - Based Real-time Diagnosis of Enterovirus Type 71

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01388049
First received: July 1, 2011
Last updated: December 26, 2012
Last verified: November 2011

July 1, 2011
December 26, 2012
July 2010
July 2013   (final data collection date for primary outcome measure)
The performance of e- Ab sensor [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
In comparison with results from direct sequencing of EV71, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.
Same as current
Complete list of historical versions of study NCT01388049 on ClinicalTrials.gov Archive Site
Not Provided
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e- Ab Sensor - Based Real-time Diagnosis of Enterovirus Type 71
e- Ab Sensor - Based Real-time Diagnosis of Enterovirus Type 71

To develop a real-time diagnostic technique with e- Ab sensor for Entervirus 71 detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Entervirus 71, 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 EV71 patients early treatment to reduce the complications and case-fatality rate.

Entervirus 71 is one of the most important infectious diseases in children and the important concern in public health. Since 1998, EV71 has become an endemic disease in Taiwan and caused hundreds of severe cases and dozens of fatal cases each year due to lack of EV71 vaccine. Family transmission study also showed that it is highly contagious among households as well as in daycares or kindergartens. 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 EV71 spread.

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 Q.anti-EV71 and its antigen EV71 present in EV71 patients and normal sample. 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 virus probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds EV71 epitope target molecules in the test serum. In comparison with results from direct sequencing of EV71, 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 EV71 patients early treatment to reduce the complications and case-fatality rate.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
EV71
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-EV71 antibody and its antigen (EV71) present in patients. The system incorporates the use of engineered semiconducive 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 (EV71) in the test specimens. From assessment of the electric signature of semiconductive anti-EV71 antibodies, the eABprobe could offer sensitive detection and precise quantification of EV71.
Experimental: virus detection
Intervention: Device: Electrosensing antibody probing system (e- Ab sensor)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Shiming Lin, PhD 886-2-23123456 ext 88458 til@ntu.edu.tw
Taiwan
 
NCT01388049
201007053R
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Luan-Yin Chang, MD,PhD National Taiwan University Hospital
National Taiwan University Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP