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".