Infectious Diseases Clinical Trial
Official title:
Determination of Estimated Specificity of DENV Detect NS1 ELISAs
This study assesses the specificity of DENV Detect™ NS1 ELISA versus standard reference tests
(e.g. PCR or viral culture) for dengue diagnosis in the US.
DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages
of Dengue infection in patients with clinical symptoms consistent with Dengue infection. This
test is intended to be used on sera obtained within the first 7 days of symptoms. DENV
Detect™ NS1 ELISA and rapid test results (positive or negative) must be confirmed by testing
with a reference standard test.
This study will use archived, leftover human serum samples that have been sequentially
collected from areas non-endemic for Dengue infection. Each specimen must have been collected
within the first 7 days of symptoms, and must be accompanied by clinical data demonstrating
that the individual had symptoms consistent with Dengue infection. The samples will have no
personally identifiable information.
ELISAs and reference tests will be performed by different operators who are laboratory staff
members. These staff members, blinded to each other's results, will evaluate the samples from
each method independently.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02763345 -
The Added Value of a Mobile Application of Community Case Management on Pediatric Referral Rates in Malawi
|
N/A | |
| Completed |
NCT00550706 -
Drug Utilization Prevalence in a Pediatric Care Medical Center
|
N/A | |
| Completed |
NCT01033799 -
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
|
N/A | |
| Completed |
NCT00761462 -
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
|
Phase 3 | |
| Completed |
NCT05088421 -
A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00828971 -
A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs
|
Phase 3 | |
| Completed |
NCT05468723 -
Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1
|
||
| Recruiting |
NCT02162966 -
Safety and Efficacy Study of High Dose Colistin
|
Phase 4 | |
| Recruiting |
NCT00001281 -
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
|
||
| Active, not recruiting |
NCT02654210 -
LoewenKIDS - Infections and the Development of the Immune System
|
||
| Completed |
NCT02226263 -
Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics
|
Phase 2 | |
| Terminated |
NCT00211471 -
Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension ( 15 mg.).
|
Phase 2 | |
| Active, not recruiting |
NCT04342702 -
A Study on the Prospective Cohort Library of COVID-19 in Southeran
|
||
| Completed |
NCT02134548 -
Sensitivity Study of Diagnostic for Detection of Chagas Infection
|
N/A | |
| Active, not recruiting |
NCT01611025 -
Hospital Microbial Ecology Follow the Introduction of Ertapenem and Other Newly Introduced Antibiotic Over Time
|
N/A | |
| Completed |
NCT01361997 -
Isopropyl Alcohol Against Chlorhexidine - Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
|
Phase 3 | |
| Completed |
NCT00638677 -
Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
|
Phase 4 | |
| Completed |
NCT02434848 -
A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses
|
Phase 2/Phase 3 | |
| Completed |
NCT02544139 -
Specificity Study of Diagnostic for Chagas Disease
|
N/A | |
| Completed |
NCT00276198 -
Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants
|
Phase 3 |