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Time to Results
Visual Read
UNSPSC Code
Nasopharyngeal Swab Sample
Cassette Format
Lateral Flow Immunoassay
Covid-19 Antigen
Antigen Detection
5 Minute Results
41116205
Features
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