1,000
Participants
Start Date
December 10, 2023
Primary Completion Date
April 30, 2024
Study Completion Date
April 30, 2024
COVID-19/Flu A/Flu B/RSV Test Kit
"The performance characteristics of EDAN's Test Kit will be evaluated in a prospective, non-randomized, observational, post-market, multicenter, comparison clinical performance study using anterior nasal and oropharyngeal swabs from subjects suspected of respiratory infection.~Samples will be obtained fresh, collected prospectively and will be tested with the study device COVID- 19/Flu A/Flu B/RSV Test Kit. The results will be compared against a reference, CE marked, in-vitro diagnostic device, used in the standard of care.~This clinical performance study has been designed to minimize any possible, discomfort, or other foreseeable risks to the participants."
NOT_YET_RECRUITING
Laboratorio Central Health Diagnostics Quirónsalud, Madrid
NOT_YET_RECRUITING
Hospital Universitario de Getafe, Madrid
RECRUITING
Hospital General Universitario Dr. Balmis de Alicante, Alicante
Lead Sponsor
EDAN Instruments Inc.
INDUSTRY