Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection
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.
⁃ Subjects must meet ALL the inclusion criteria described below to be eligible for this clinical performance study.
• Subjects with suspected respiratory infection who have physical signs/symptoms, such as chills, fever, headache, myalgia, fatigue, nasal congestion, sore throat, and other symptoms.
• Subjects able to provide anterior nasal swabs and oropharyngeal swabs for testing on the study device according to the instructions for use of that device.
• Subjects able to provide comparator samples according to the instructions for use of the comparator device.
• Subjects able to provide study and comparator samples within 24 hours to allow for a valid comparison.
• Subjects or their legal guardians willing and able to provide written informed consent.