Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection

RecruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

December 10, 2023

Primary Completion Date

April 30, 2024

Study Completion Date

April 30, 2024

Conditions
SARS-CoV2 InfectionInfluenza AInfluenza BRespiratory Syncytial Virus (RSV)
Interventions
DEVICE

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."

Trial Locations (3)

28108

NOT_YET_RECRUITING

Laboratorio Central Health Diagnostics Quirónsalud, Madrid

28905

NOT_YET_RECRUITING

Hospital Universitario de Getafe, Madrid

03010

RECRUITING

Hospital General Universitario Dr. Balmis de Alicante, Alicante

Sponsors
All Listed Sponsors
lead

EDAN Instruments Inc.

INDUSTRY