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OpenTrials
Completed

NCT Number: NCT01917422

Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

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

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Key information

Conditions

Dengue Fever Arbovirus Infections Dengue Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaoshing Medical University Chung-Ho Memorial Hospital

Kaoshiung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 Criteria:non-adult case -

Treatment and study plan

Primary outcomes

  1. Clinical specimens testing program of dengue antigen detection reagents

    Time frame: one year

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

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 6, 2013
Registry last updated
Aug 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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