Clarity Diagnostics Covid-19 Visual Antigen Rapid Test

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Covid Tests

V1001_000057_CLA-COV19AG-VIS_KT

Learn about Clarity Diagnostics Covid-19 Visual Antigen Rapid Test

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
  • Relative Specificity: >98.9%
  • 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
  • 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
  • For prescription use only
  • 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
  • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
  • 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
  • Fast and Easy - Positive results as fast as 5 minutes
  • 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
  • Relative Sensitivity 87.5%
  • Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories
  • 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

Specifications:

Country of Origin Finland
Application Rapid Test Kit
Brand Clarity
HCPCS U0003
Test Type Antigen Detection
UNSPSC Code 41116205
Sample Type Nasopharyngeal Swab Sample
Number of Tests 25 Tests
Test Name Covid-19 Antigen
Time to Results 5 Minute Results
Manufacturer # CLA-COV19AG-VIS
Reading Type Visual Read
Test Method Lateral Flow Immunoassay
CLIA Classification CLIA Waived for Point of Care
Test Format Cassette Format
Manufacturer Clarity Diagnostics LLC
Additional Information:

The Clarity Diagnostics Covid-19 Visual Antigen Rapid Test is a rapid test kit for Covid-19 that includes (25) tests, (25) NP swabs, (25) buffers, a package insert, QSG, (1) negative control, and (1) positive control/kit.