COVID-19 iCura SARS-CoV-2 Ag OTC: Clinical Evaluation
SARS-CoV-2 Infection, COVID-19
About this trial
This is an interventional diagnostic trial for SARS-CoV-2 Infection
Eligibility Criteria
Inclusion Criteria:
- Lay subjects greater than 2 years old that do not know their current COVID-19 status and can complete the consent/assent process in both written and spoken English may be included in the study.
Exclusion Criteria:
- Subjects less than 2 years old will be excluded.
- Participants that are or were medial and/or laboratory professionals will be excluded.
- Participants that cannot read and understand English will be excluded.
- High risk individuals will not be excluded unless they are too young or have prior training or experience that would exclude them.
- Participants who refuse to sign the informed consent/assent form(s) will be excluded.
Sites / Locations
- Paragon
- EDP Biotech
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
At least 30 children between 2 and 13 years of age
Subject 14-65+ years of age
Participants 2-13 years of age will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the iCura SARS-CoV-2 Antigen Rapid Home Test. The parent or legal guardian of the child will collect an anterior nasal swab sample from the child and perform the iCura SARS-CoV-2 Antigen Rapid Home Test.
Participants will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the iCura SARS-CoV-2 Antigen Rapid Home Test. The participant will then self-collect or, if both are over 18, collect from another study participant an anterior nasal swab sample and test using the iCura SARS-CoV-2 Antigen Rapid Home Test.