- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01388062
e- Ab Sensor - Based Real-time Diagnosis of Influenza Virus
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taipei, 대만, 10051
- 모병
- National Taiwan University Hospital
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수석 연구원:
- Luan-Yin Chang, MD/PhD
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연락하다:
- Luan-Yin Chang, MD/PhD
- 전화번호: 71528 886-2-2312-3456
- 이메일: lychang@ntu.edu.tw
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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- 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The performance of e- Ab sensor
기간: 1 Day
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In comparison with results from direct sequencing of influenza virus, 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Luan-Yin Chang, MD,PhD, National Taiwan University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 201007054R
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