Evaluation Study of Dengue RDTs

November 20, 2023 updated by: Foundation for Innovative New Diagnostics, Switzerland

Evaluation Study of Commercially Available Rapid Diagnostic Tests (RDTs) Detecting Antigen and Antibodies Against Dengue Virus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dengue is an emerging infectious disease and is endemic to more than 100 tropical nations. It is a serious public health issue, with an estimated global incidence of > 100 million in 2016, a rise of almost 60% in age-standardized rates since 2006. While rising dengue infection rates affect all major regions of the world, the Asia-Pacific region is disproportionately affected by severe dengue, with rates 18 times higher in Southeast Asia than in the Americas. Climate change and globalization has facilitated the geographic spread of both the mosquito vector and the pathogen to previously unaffected areas, thereby increasing the number of people affected by dengue. Unfortunately, no specific antiviral medication and vaccine exists for Dengue. Hence, an accurate and early diagnosis is essential for proper and timely management and control of the disease in endemic regions. Dengue causes wide spectrum of disease. Primary dengue can range from sub clinical disease to flu-like symptoms. Although less common secondary dengue is associated with increased mortality and morbidity. Accurate, efficient, and rapid diagnosis of dengue in the acute stage is essential as a delay in diagnosis increases the risk of severe dengue and can lead to poor disease outcome. The most commonly used tests to diagnose acute dengue infection are commercial ELISA. Many Dengue RDTs came in rise and flooded the market in the past two decades due to the growing demand for point-of-care diagnostics. RDT is the easiest and most cost-effective method for diagnosis of this virus infection. It is user-friendly, requires no equipment and provide results faster than PCR and ELISA. Different format of Dengue RDTs are available in the market which can detect NS1, IgM and IgG. Detection of NS1, IgM and IgG in single RDT, not only detects primary dengue but also detects past dengue infection and can be helpful in disease prognosis. Many studies have been conducted previously focusing on individual markers of dengue RDTs and not the combined assessment of the test. This has significantly impeded healthcare providers to decide on deciding which overall tests is best to diagnose acute dengue and detects past dengue in a single test format. Hence, this study will aim to perform a head-to-head comparison of Dengue RDTs which detects antigen and antibodies in single test format currently in the market to diagnose acute dengue to help stakeholder decision making more broadly.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Only samples that meet the inclusion criteria listed above will be selected for the study. Therefore, samples in the study site sample archives which do not meet these criteria will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Point estimates of sensitivity and specificity of each RDTs to detect acute dengue with 95% confidence intervals using ELISA as reference standard.
Time Frame: 7 months
Point estimates of sensitivity and specificity, with 95% confidence intervals based on Wilson's score methods, will be calculated
7 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimates of operational characteristics of different RDTs, based on quantitative assessment including invalid rates
Time Frame: 7 months
Rate of invalid runs: Percent of invalid runs per RDTs
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation for Innovative New Diagnostics, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aga Khan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rumina Hasan, Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FE006B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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