SKU: 95415379836

Clarity Rapid Test Kit, Antigen Detection, Covid-19 Antigen, Nasopharyngeal Swab Sample, CLIA Waived for Point of Care, 25/Box, CLA-COV19AG-VIS

Name: Clarity Rapid Test Kit, Antigen Detection, Covid-19 Antigen, Nasopharyngeal Swab Sample, CLIA Waived for Point of Care, 25/Box, CLA-COV19AG-VIS
Brand: 2pierres.com
SKU: 95415379836
Price: 199.99 USD
Availability: InStock
Rating: 4.1089 (10 reviews)

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Description

Clarity Rapid Test Kit, Antigen Detection, Covid-19 Antigen, Nasopharyngeal Swab Sample, CLIA Waived for Point of Care, 25/Box, CLA-COV19AG-VISClarity Rapid Test Kit, Antigen Detection, Covid 19 Antigen, Nasopharyngeal Swab Sample, CLIA Waived for Point of Care, 25 Box 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

Clarity Rapid Test Kit, Antigen Detection, Covid-19 Antigen, Nasopharyngeal Swab Sample, CLIA Waived for Point of Care, 25/Box

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

25/box

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