Status:
COMPLETED
COVID-19 Novel Molecular Point of Care Diagnostics Evaluation
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Conditions:
COVID-19 Respiratory Infection
Eligibility:
All Genders
18+ years
Brief Summary
Point estimates of sensitivity and specificity of molecular POC platforms for SARS-CoV-2, with 95% confidence intervals, using RT-PCR as reference standard.
Detailed Description
The aim of this study is to independently evaluate the performance of novel molecular point-of-care (POC) assays for the direct detection of SARS-CoV-2 nucleic acid (RNA) in comparison to the current ...
Eligibility Criteria
Inclusion
- Participants and specimens are eligible to be included in the study only if all the following inclusion criteria apply:
- Adult individuals (≥18 years of age) with symptoms suggesting plausible COVID-19 infection (as per WHO or national clinical case definitions)
- Individuals who have voluntarily given written consent to participate in this study or who have given their written consent for their specimen to be used for future research studies
- Individuals able to provide the specimens required for the study
Exclusion
- Individuals on oxygen therapy
- Individuals with recent history of excessive nose bleeds
- Individuals with hemodynamic instability as determined by their treating physician
- Individuals already enrolled in other clinical studies, where similar respiratory specimens are collected on the same day.
Key Trial Info
Start Date :
January 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06055218
Start Date
January 30 2023
End Date
August 30 2023
Last Update
October 5 2023
Active Locations (3)
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1
University Hospital of Geneva
Geneva, Switzerland, 1211
2
Central Public Health Laboratories
Kampala, Uganda, 759125
3
Liverpool school of Topical Medicine
Liverpool, United Kingdom, L35QA