Clarity Diagnostics Covid-19 Visual Antigen Rapid Test
$152.25
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.
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