Evaluation Study of Dengue RDTs

NCT05580731 | Completed

• 1 other identifier: FE006B
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Point estimates of sensitivity and specificity of each RDTs to detect acute dengue with 95% confidence intervals using ELISA as reference standard.

  Point estimates of sensitivity and specificity, with 95% confidence intervals based on Wilson's score methods, will be calculated

  7 months

Secondary Outcomes (1)

• Estimates of operational characteristics of different RDTs, based on quantitative assessment including invalid rates

  7 months

Interventions

Diagnostic test: 5 different Rapid diagnostic test and Reference tests DIAGNOSTIC_TEST

Diagnostic test: 5 different Rapid diagnostic test and Reference tests

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be conducted at AKU research laboratory using leftover serum samples, which were archived for further research purposes for previous trial "Comparative study of commercially available typhoid point of care tests to benchmark current and emerging tools" conducted at AKU in 2020-2021. Precisely, the population is represented by children and adults (age 2-65) who presented with fever of 3-7 days duration. All patients from whom these samples were obtained have consented to store their sample at AKU and to use them for research on diagnostic tool for fever management.

You may qualify if:

• Have been obtained from patients presented with fever of \< 1 week who have given consent for sample storage for further research purpose.
• Have minimum sample volume of 1 ml.
• Are non-haemolytic
• Have a limited number of freeze-thaw cycles (\<3)
• Have been stored at or below -200C

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Aga Khan University: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

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

Study Officials

• Rumina Hasan

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: July 31, 2022
• Primary Completion: February 24, 2023
• Study Completion: June 28, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

PA (1)