Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01917422

Enrollment

195

Registered

2013-08-06

Start date

2012-07-31

Completion date

2013-06-30

Last updated

2013-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue Fever

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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 -

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Taiwan

Outcome results