Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT05618561
Eligibility Criteria:
Inclusion Criteria:
1. Specimens from subjects over 12 years old agreeing to participate in the study and with a legal representative able to provide informed consent, OR;
2. Specimens from subjects over 18 years old able to provide informed consent.
3. Specimens collected with nasopharyngeal swabs, OR;
4. Combined nasal mid-turbinate and throat specimen collection.
Exclusion Criteria:
1. Specimens and testing methods that are not deemed to be in line with gold-standard RT-PCR standards.
2. Specimens stored for over 2 hours at 2-8 ºC temperature between collection and testing with EuGeni SARS-CoV-2 Ag RDT.
3. Specimens stored for over 5 days at -20ºC between collection and testing with RT-PCR.
4. Specimens stored for over 24h at 4ºC between collection and testing with RT-PCR.
5. Contamination and/or deterioration of the specimen which, in the opinion of the investigator, may affect its handling and/or analysis.
6. The subject is deemed unsuitable to participate in the study by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05618561
Study Brief:
Protocol Section:
NCT05618561