Evaluation of COVID-19 and flu test kits for respiratory infections

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

This study is testing new ClariLight test kits to see if they can accurately detect COVID-19, flu, and RSV in people who might have a respiratory infection.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Sex: All
• Sponsor: EDAN Instruments Inc. (industry)
• Locations: 3 sites (Alicante and 2 other locations)
• Trial ID: NCT06175611 on ClinicalTrials.gov

What this trial studies

This clinical performance study aims to evaluate the effectiveness of ClariLight test kits for detecting SARS-CoV-2, influenza A, influenza B, and RSV in patients suspected of respiratory infections. It involves collecting anterior nasal and oropharyngeal swabs from participants and comparing the results of the test kits against a CE marked standard diagnostic device. The study is observational and non-interventional, meaning it will not influence patient management decisions. Participants will only need to provide samples and will not undergo any invasive procedures.

Who should consider this trial

Good fit: Ideal candidates are individuals showing symptoms of respiratory infections, such as fever, chills, or sore throat.

Not a fit: Patients who do not exhibit symptoms of respiratory infections or have previously undergone nasal or oropharyngeal sampling will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of diagnosing respiratory infections, leading to better patient management.

How similar studies have performed: Other studies have shown success in validating diagnostic tests for respiratory infections, making this approach promising.

Eligibility criteria

Inclusion Criteria:

Subjects must meet ALL the inclusion criteria described below to be eligible for this clinical performance study.

1. Subjects with suspected respiratory infection who have physical signs/symptoms, such as chills, fever, headache, myalgia, fatigue, nasal congestion, sore throat, and other symptoms.
2. 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.
3. Subjects able to provide comparator samples according to the instructions for use of the comparator device.
4. Subjects able to provide study and comparator samples within 24 hours to allow for a valid comparison.
5. 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.

1. 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).
2. Subjects or their legal guardians unwilling and unable to provide informed consent.
3. Subjects who have had a nasal wash or aspirate procedure within the past 24 hours.
4. Women who are pregnant or currently breastfeeding.

Where this trial is running

Alicante and 2 other locations

• Hospital General Universitario Dr. Balmis de Alicante — Alicante, Spain (RECRUITING)
• Laboratorio Central Health Diagnostics Quirónsalud — Madrid, Spain (NOT_YET_RECRUITING)
• Hospital Universitario de Getafe — Madrid, Spain (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: DAVID TOMÉ

Conditions: SARS-CoV2 Infection, Influenza A, Influenza B, Respiratory Syncytial Virus