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

Study Overview
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Brief Summary
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The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of: ClariLight Influenza A/B & SARS-CoV-2 test kits and 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
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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: Does not involve surgically invasive sample-taking Is not interventional as test results will not influence patient management decisions neither they will be used to guide treatment 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.

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

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

Intervention / Treatment
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* Device: COVID-19/Flu A/Flu B/RSV Test Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Subjects who meet any of the exclusion criteria described below will NOT be eligible for this clinical performance study. Subjects who have undergone anterior nasal, or oropharyngeal sampling within the past 30 minutes (i.e. a minimum wait of 30 minutes is required before collecting swabs for the study device if previous anterior nasal or oropharyngeal samples were collected from the same subject). Subjects or their legal guardians unwilling and unable to provide informed consent. Subjects who have had a nasal wash or aspirate procedure within the past 24 hours. Women who are pregnant or currently breastfeeding.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Site 1. Laboratorio Central Health Diagnostics Quirónsalud<br>COVID-19/Flu A/Flu B/RSV Test Kit | Device: COVID-19/Flu A/Flu B/RSV Test Kit<br>* 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.<br>|
| SIte 2. Hospital General Universitario Dr. Balmis de Alicante<br>COVID-19/Flu A/Flu B/RSV Test Kit | Device: COVID-19/Flu A/Flu B/RSV Test Kit<br>* 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.<br>|
| Site 3. Hospital Universitario de Getafe<br>COVID-19/Flu A/Flu B/RSV Test Kit | Device: COVID-19/Flu A/Flu B/RSV Test Kit<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective | The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of: ClariLight Influenza A/B & SARS-CoV-2 test kits and 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. The study results are intended to support a regulatory submission to the Notified Body under (EU) IVDR 2017/746 and meet the requirements of the Commission Implementing Regulation (EU) 2022/1107, laying down common specifications for certain class D devices. | 2 hours | 
| Secondary objective | To evaluate the safety of the study device for users and patients. | 2 hours |