- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01388049
e- Ab Sensor - Based Real-time Diagnosis of Enterovirus Type 71
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Taipei, Taiwan, 10051
- Rekruttering
- National Taiwan University Hospital
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Kontakt:
- Luan-Yin Chang, MD,PhD
- Telefonnummer: 71528 886-2-2312-3456
- E-mail: lychang@ntu.edu.tw
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Ledende efterforsker:
- Luan-Yin Chang, MD/PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: virus detection
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The performance of e- Ab sensor
Tidsramme: 1 Day
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In comparison with results from direct sequencing of EV71, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.
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1 Day
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Luan-Yin Chang, MD,PhD, National Taiwan University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201007053R
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Kliniske forsøg med EV71
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Sinovac Biotech Co., LtdAfsluttet
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Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDAfsluttetEV71-associeret sygdomKina
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Cancer Institute and Hospital, Chinese Academy...Beijing Chaoyang District Centre for Disease Control and Prevention; Neimenggu...UkendtSikkerhed ved inaktiveret EV71-vaccine | Immunisering af inaktiveret EV71-vaccineKina
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Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDAfsluttetSystembiologi | Tidlig Gene | EV71-vaccineKina
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Institute of Medical Biology, Chinese Academy of...Guangxi Center for Disease Control and PreventionAfsluttetEffekten af inaktiveret EV71-vaccine (KMB17) mod HFMD hos kinesiske børn og spædbørnKina
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Jiangsu Province Centers for Disease Control and...AfsluttetHånd-, mund- og klovsyge | Anti-EV71 | Anti-CVA16Kina
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Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDAfsluttetHånd-, mund- og klovsyge | Herpangina | Andre EV71-associerede sygdommeKina
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Institute of Medical Biology, Chinese Academy of...Guangxi Center for Disease Control and PreventionAfsluttetUndersøgelsen fokuserede på sikkerheden ved inaktiveret EV71-vaccine (human diploid celle) mod hånd-, mund- og klovsyge hos kinesiske børn og spædbørnKina
Kliniske forsøg med Electrosensing antibody probing system (e- Ab sensor)
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National Taiwan University HospitalUkendt