Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05580731 |
| Other study ID # |
FE006B |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 31, 2022 |
| Est. completion date |
June 28, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Foundation for Innovative New Diagnostics, Switzerland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
