NCT06175611

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: EDAN Instruments Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of: 1. ClariLight Influenza A/B \& SARS-CoV-2 test kits and 2. ClariLight Influenza A/B \& RSV test kits, for the qualitative detection and differential diagnosis of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) present in anterior nasal and oropharyngeal swab, in combination with an automated molecular diagnostic analyzer and sample collection tube by comparing them against a CE marked, in-vitro diagnostic device, used in the standard of care.

Detailed description

Prospective, non-randomized, observational, post-market, multicenter, clinical performance study using anterior nasal and oropharyngeal swabs from subjects suspected of respiratory infection for evaluating the clinical performance of ClariLight Influenza A/B \& SARS-CoV-2 Cartridge and the ClariLight Influenza A/B \& RSV Cartridge by comparing them against a reference standard of care, CE marked, comparator device. This clinical performance study has been designed to minimize any possible, discomfort, or other foreseeable risks to the participants. This clinical performance study: 1. Does not involve surgically invasive sample-taking 2. Is not interventional as test results will not influence patient management decisions neither they will be used to guide treatment 3. There are no additional invasive procedures or other risks for the subjects. The device is being used within the scope of its CE marked intended purpose and for the specimen types claimed which include standard of care specimen collection procedures. No specific follow-up of subjects providing swabs is required following termination, temporary suspension or early termination of the study, or withdrawal of the subject's informed consent. The participation of each subject for the total duration of the study will amount to 1 hour, finishing the participation in day 1. Subjects will be provided with the Investigator's contact information and be instructed to contact the Investigator if they experience any complications from the specimen collection procedures within twenty-four (24) hours of the visit".

Conditions

• SARS-CoV2 Infection
• Influenza A
• Influenza B
• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-10
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-12-19
• Last updated: 2024-01-11

Locations

3 sites across 1 country: Spain