The Clarity Diagnostics COVID-19 Antigen test is FDA Emergency Use Authorized, CLIA Waived, and POCT approved. With a relative sensitivity of 87.5% and relative specificity of >98.9%, this fast and easy test will generate positive results as fast as five minutes.
The kit includes 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, and 1 Quick Start Guide.
Important Information About the Clarity COVID-19 Antigen Test
- 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. The CLIA Waiver for this test can be found on the FDA’s website at the following link: https://www.fda.gov/media/149056/download
For additional information, including the Patient Fact Sheet, please see the product information in the "Downloads" section on this page.
To view a video from the manufacturer on the use of this product, please click here.