Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

N/ACompletedNCT01917422

Kaohsiung Medical University Chung-Ho Memorial Hospital195 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

195

Conditions

Dengue Fever

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria:A total of 95 cases and 100 controls (suspected cases(\>50 %) and normal subjects) are expected to enroll. 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. 3. Control group: adults without having medical visits or admissions due to Fever. - Exclusion Criteria:non-adult case -

Locations (1)

Kaoshing Medical University Chung-Ho Memorial Hospital

Kaoshiung, Taiwan

Outcomes

Primary Outcomes

Clinical specimens testing program of dengue antigen detection reagents

Calculate two products of the dengue immune detection accuracy, sensitivity, specificity, false positive, false negative.

Time frame: one year

Data from ClinicalTrials.gov

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