Clarity COVID-19 Antigen Rapid Test Kits, Includes 25 Tests, 25 NP Swabs, 25 Buffers, Package Insert, QSG, 1 Negative Control, and 1 Positive Control per kt

Features

• The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is only for use under the Food and Drug Administration's Emergency Use Authorization: In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for 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