is not approved for OTC use or At-Home use.
FDA Emergency Use Authorized, CLIA
Waived and POCT approved.
Relative Sensitivity 87.5%Relative Specificity:
Fast and Easy – Positive results as fast as 5
Test Naso-Pharyngeal Swab immediately, or store
at room temperature and test within 1 hour.
Naso-Pharyngeal Swab stored in a dry tube at
2-8c can be tested within 24 hours.
Contains: 25 Individually pouched test
cassettes, 25 Sterile Naso-Pharyngeal Swabs, 25 Buffer
Tubes, 1 Negative Control Swab, 1 Positive
Control Swab, 1 Work Station, 1 Package Insert, 1 Quick Start Guide.
The Clarity COVID-19 Antigen test can be used to
test directly collected naso-pharyngeal swab specimens.
The Clarity COVID-19 Antigen test should be
ordered for the detection of COVID-19 antigen in individuals who are suspected
of COVID-19 by their healthcare provider and who are within six days of symptom
The Clarity COVID-19 Antigen test is authorized
for use in laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform
high complexity, moderate complexity, or waived tests. This test is authorized
for use at the Point of Care (POC), i.e., patient care settings operating under
Certificate of Waiver, Certificate of Compliance, or Certificate of
Accreditation. Our CLIA
Waiver can be found on the FDA’s website at the following link: https://www.fda.gov/media/149056/download