COVID-19 MP Biomedicals SARS-CoV-2 Ag OTC: Clinical Evaluation
SARS-CoV2 Infection, COVID-19
About this trial
This is an interventional diagnostic trial for SARS-CoV2 Infection
Eligibility Criteria
Inclusion Criteria:
- The study population will include subjects from 2 years old to greater than 65 years old.
- Lay subjects who perform the test on themselves must be able to read, write, speak, and understand English.
Exclusion Criteria:
- Subjects less than 2 years old will be excluded.
- Participants who regularly use home diagnostic tests, such as glucose meters, or are trained medical or laboratory professionals will be excluded.
- Persons under 14 years of age will be excluded from performing the Rapid SARS-CoV-2 Antigen Test on themselves.
- Persons under 2 years of age will be excluded from participation.
- Persons under 18 years of age will be excluded from performing the Rapid SARS-CoV-2 Antigen Test on another qualified participant.
Sites / Locations
- Accel Research
- Daniel Sarkis
- Accel Research Site St. Petersburg
- EDP Biotech Corporation
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Subject 14-65+ years of age
At least 30 children between 2 and 13 years of age
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 Rapid SARS-CoV-2 Antigen 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 Rapid SARS-CoV-2 Antigen Test.
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 Rapid SARS-CoV-2 Antigen Test. The parent or legal guardian of the child will collect an anterior nasal swab sample from the child and perform the Rapid SARS-CoV-2 Antigen Test.