- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01388049
e- Ab Sensor - Based Real-time Diagnosis of Enterovirus Type 71
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Taipei, Taiwan, 10051
- Rekrutierung
- 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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Hauptermittler:
- Luan-Yin Chang, MD/PhD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The performance of e- Ab sensor
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Luan-Yin Chang, MD,PhD, National Taiwan University Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 201007053R
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Klinische Studien zur EV71
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Sinovac Biotech Co., LtdAbgeschlossen
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Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDAbgeschlossenEV71-assoziierte KrankheitChina
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Cancer Institute and Hospital, Chinese Academy...Beijing Chaoyang District Centre for Disease Control and Prevention; Neimenggu...UnbekanntSicherheit des inaktivierten EV71-Impfstoffs | Immunisierung des inaktivierten EV71-ImpfstoffsChina
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Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDAbgeschlossenSystembiologie | Frühes Gen | EV71-ImpfstoffChina
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Institute of Medical Biology, Chinese Academy of...Guangxi Center for Disease Control and PreventionAbgeschlossenDie Wirksamkeit des inaktivierten EV71-Impfstoffs (KMB17) gegen HFMD bei chinesischen Kindern und SäuglingenChina
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Jiangsu Province Centers for Disease Control and...AbgeschlossenHand-Fuß-Mund-Krankheit | Anti-EV71 | Anti-CVA16China
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Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDAbgeschlossenHand-Fuß-Mund-Krankheit | Herpangina | Andere EV71-assoziierte KrankheitenChina
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Institute of Medical Biology, Chinese Academy of...Guangxi Center for Disease Control and PreventionAbgeschlossenDie Studie konzentrierte sich auf die Sicherheit des inaktivierten EV71-Impfstoffs (humane diploide Zelle) gegen die Hand-Fuß-Mund-Krankheit bei chinesischen Kindern und SäuglingenChina
Klinische Studien zur Electrosensing antibody probing system (e- Ab sensor)
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National Taiwan University HospitalUnbekannt