Status:
UNKNOWN
Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection
Lead Sponsor:
EDAN Instruments Inc.
Conditions:
SARS-CoV2 Infection
Influenza A
Eligibility:
All Genders
Brief Summary
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 Influen...
Detailed Description
Prospective, non-randomized, observational, post-market, multicenter, clinical performance study using anterior nasal and oropharyngeal swabs from subjects suspected of respiratory infection for evalu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06175611
Start Date
December 10 2023
End Date
April 1 2024
Last Update
January 11 2024
Active Locations (3)
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1
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Spain, 03010
2
Laboratorio Central Health Diagnostics Quirónsalud
Madrid, Spain, 28108
3
Hospital Universitario de Getafe
Madrid, Spain, 28905