CLINICAL PROVIDER and LAB PURCHASE ONLY
Clarity COVID-19 Antigen Rapid Test Cassette
Contents: 25 Individually Pouched Test Cassettes, 25 Sterile
Nasopharyngeal Swabs, 25 Buffer Tubes, 1 Negative Control Swab,
1 Positive Control Swab, 1 Work Station, 1 Package Insert.
A rapid test for the qualitative detection of Novel Coronavirus SARS-CoV-2 antigen in nasopharyngeal swab.
The 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.
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. 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 Clarity COVID-19 Antigen Rapid Test Cassette does not differentiate between SARS-CoV and SARS-CoV-2 viruses.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasopharyngeal swab specimens during the acute phase of infection. 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. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
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.