Status:
COMPLETED
Clinical Specimens Testing Program of Dengue Antigen Detection Reagents
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Conditions:
Dengue Fever
Eligibility:
All Genders
Brief Summary
Dengue virus serological reagent, included antigen and antiserum, is a serum test for identification of serum antibodies to dengue virus.
Detailed Description
The developed assay helps to diagnose diseases caused by this virus and to provide information on disease epidemiology. This virus is mainly transmitted by mosquito bites to people and will make flu-l...
Eligibility Criteria
Inclusion
- A total of 95 cases and 100 controls (suspected cases(\>50 %) and normal subjects) are expected to enroll.
- Case group: adults having a medical visit or admission due to dengue / dengue hemorrhagic fever / dengue shock syndrome, and medical care of by (defined by CDC). Any of the following positive test results for the case of 100 adults.
- clinical specimens (blood) isolated and identified dengue virus.
- clinical specimens positive for molecular detection of nucleic acids.
- serological antigen (referring to non-structural proteins of dengue virus non-structural protein 1, NS1) testing positive (based on the test of Bio-Rad DENGUE NS1 Ag STRIP).
- paired serum (restored period and acute phase), the dengue virus specific immunoglobulin M or immunoglobulin G antibodies or negative or ≧ 4 times increase.
- Suspected cases: adults having medical visits or admissions due to infectious disease, but their NS1 (based on the test of Bio-Rad DENGUE NS1 Ag STRIP), immunoglobulin G,immunoglobulin M, real time-Polymerase chain reaction testing were negative.
- Control group: adults without having medical visits or admissions due to Fever. -
Exclusion
- non-adult case -
Key Trial Info
Start Date :
July 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT01917422
Start Date
July 1 2012
End Date
June 1 2013
Last Update
August 6 2013
Active Locations (1)
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1
Kaoshing Medical University Chung-Ho Memorial Hospital
Kaoshiung, Taiwan