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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: david.tome@medivd.com
• Phone: 34 93 609 62 69

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.