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Evaluation Study of Dengue RDTs

NCT05580731 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 430

Last updated 2023-11-21

No results posted yet for this study

Summary

RT-PCR and virus isolation are considered gold standard for diagnosis of Dengue from blood during first few days of infection. Serological methods such as enzyme-linked immunosorbent assays (ELISA), confirms the presence of a recent or past infection with detection of NS1 antigen and anti-dengue antibodies. However, these methods are time-consuming and need significant laboratory infrastructure, including instrumentation, trained personnel and refrigeration for reagents. Hence, in areas where DENV is endemic, have limited resources and inadequate laboratory capacity to perform these tests, rapid diagnostic tests (RDTs) can be used for quick and simple screening. Recently various RDTs which detect Antigen (NS1) and Antibodies (IgM and IgG) in single format are widely available and in use, but the performance data are not available or not consistent from one study to another. Therefore, this study aims to evaluate the sensitivity and specificity of different RDTs that detect antigens and antibodies to Dengue viruses in one cassette during acute febrile stage thereby helping healthcare providers to decide on the best test.

Conditions

  • Dengue Fever

Interventions

DIAGNOSTIC_TEST

Diagnostic test: 5 different Rapid diagnostic test and Reference tests

Diagnostic test: 5 different Rapid diagnostic test and Reference tests

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Rumina Hasan · Aga Khan University

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2023-02-24
Completion
2023-06-28

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580731 on ClinicalTrials.gov