Clarity Covid-19 Antigen Test

The Clarity COVID-19 Antigen Rapid Test has been granted a shelf-life extension to 21 months! All products now have an expiration date that is 9 months beyond the expiration date printed on the product label. For additional information, please view the attached letter: Shelf-life Extension of the Clarity COVID-19 Antigen Rapid Test Cassettes Letter 6102022 with FDA letter

The Clarity COVID-19 Antigen Rapid Test is EUA, CLIA WAIVED, and POCT APPROVED!

FDA Emergency Use Authorized, CLIA Waived and POCT approved.
Relative Sensitivity 87.5%
Relative Specificity: >98.9%
Fast and Easy – Positive results as fast as 5 minutes
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.

CLA-COV19AG-VIS (25/box)
- 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.

Important Information

This test is not approved for OTC use or At-Home use.
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 onset.
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 a CLIA 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