{"product_id":"clarity-rapid-test-kit-antigen-detection-covid-19-antigen-nasopharyngeal-swab-sample-clia-waived-for-point-of-care-25-box-cla-cov19ag-vis","title":"Clarity Rapid Test Kit, Antigen Detection, Covid-19 Antigen, Nasopharyngeal Swab Sample, CLIA Waived for Point of Care, 25\/Box, CLA-COV19AG-VIS","description":"\u003ch1\u003eClarity Rapid Test Kit, Antigen Detection, Covid-19 Antigen, Nasopharyngeal Swab Sample, CLIA Waived for Point of Care, 25\/Box\u003c\/h1\u003e\u003cbr\u003e\u003cbr\u003e\u003cstrong\u003eFeatures\u003c\/strong\u003e\u003cbr\u003e\u003cli\u003eThe 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\u003c\/li\u003e\u003cli\u003eThis 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\u003c\/li\u003e\u003cli\u003eTesting 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\u003c\/li\u003e\u003cli\u003eThe 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\u003c\/li\u003e\u003cli\u003eLaboratories within the United States and its territories are required to report all results to the appropriate public health laboratories\u003c\/li\u003e\u003cli\u003eFor prescription use only\u003c\/li\u003e\u003cli\u003ePositive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status\u003c\/li\u003e\u003cli\u003ePositive results do not rule out bacterial infection or co-infection with other viruses\u003c\/li\u003e\u003cli\u003eThe agent detected may not be the definite cause of disease\u003c\/li\u003e\u003cli\u003eNegative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed\u003c\/li\u003e\u003cli\u003eNegative 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\u003c\/li\u003e\u003cli\u003eNegative 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\u003c\/li\u003e\u003cli\u003eThe Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is intended for use by trained clinical laboratory personnel and individuals trained in point of care\u003c\/li\u003e\u003cli\u003eRelative Sensitivity 87.5%\u003c\/li\u003e\u003cli\u003eRelative Specificity: \u0026gt;98.9%\u003c\/li\u003e\u003cli\u003eFast and Easy - Positive results as fast as 5 minutes\u003c\/li\u003e\u003cli\u003e25\/box\u003cbr\u003e\u003cbr\u003e\n\u003c\/li\u003e","brand":"Clarity Diagnostics","offers":[{"title":"Default Title","offer_id":43517456547876,"sku":"CLA-COV19AG-VIS","price":199.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0744\/8910\/2372\/files\/CLA-COV19AG-VIS.jpg?v=1770709835","url":"https:\/\/www.lexiconsupply.com\/products\/clarity-rapid-test-kit-antigen-detection-covid-19-antigen-nasopharyngeal-swab-sample-clia-waived-for-point-of-care-25-box-cla-cov19ag-vis","provider":"Lexicon Medical Supply","version":"1.0","type":"link"}