Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-06-30

Brief Summary

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Dengue virus serological reagent, included antigen and antiserum, is a serum test for identification of serum antibodies to dengue virus.

Detailed Description

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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-like symptoms, including fever, fatigue, cough and headache, which can cause severe hemorrhagic dengue.

Conditions

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Dengue Fever

Study Design

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Observational Model Type

CASE_CONTROL

Eligibility Criteria

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Inclusion Criteria

1. 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.

1. clinical specimens (blood) isolated and identified dengue virus.
2. clinical specimens positive for molecular detection of nucleic acids.
3. 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).
4. paired serum (restored period and acute phase), the dengue virus specific immunoglobulin M or immunoglobulin G antibodies or negative or ≧ 4 times increase.
2. 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaoshing Medical University Chung-Ho Memorial Hospital

Kaoshiung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMUHIRB-2012-03-14(II)

Identifier Type: -

Identifier Source: org_study_id