Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

Completed

• Conditions: Dengue Fever

• Registration Number: NCT01917422
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-28
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-07
• Study First Submitted QC: 2013-08-04
• Last Update Submitted: 2013-08-04
• Study First Posted: 2013-08-06
• Last Update Posted: 2013-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical specimens testing program of dengue antigen detection reagents	one year	Calculate two products of the dengue immune detection accuracy, sensitivity, specificity, false positive, false negative.

Trial Locations

Locations (1)

Kaoshing Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaoshiung, Taiwan