- The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests
- The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset
- Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories
- For prescription use only
- Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease
- Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed
- Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
- Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19
- The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is intended for use by trained clinical laboratory personnel and individuals trained in point of care
- Relative Sensitivity 87.5%
- Relative Specificity: >98.9%
- Fast and Easy - Positive results as fast as 5 minutes
Product Specifications
| Manufacturer # | CLA-COV19AG-VIS |
| Brand | Clarity |
| Manufacturer | Clarity Diagnostics |
| Application | Rapid Test Kit |
| CLIA Classification | CLIA Waived for Point of Care |
| Contents | (25) Test Cassettes , (25) Sterile Naso-Pharyngeal Swabs , (25) Buffers, Package Insert, QSG, Negative Control Swab, Positive Control Swab |
| Number of Tests | 25 Tests |
| Reading Type | Visual Read |
| Sample Type | Nasopharyngeal Swab Sample |
| Test Format | Cassette Format |
| Test Method | Lateral Flow Immunoassay |
| Test Name | Covid-19 Antigen |
| Test Type | Antigen Detection |
| Time to Results | 5 Minute Results |
