The Sienna™ 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.
- Easy to use and authorized by the FDA under an EUA for use in point of care settings
- No additional equipment or training required
- Results in just 10 minutes
- Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
- Each kit contains one positive and one negative control swab
- Individual buffer vials and sterile swabs allow multiple individuals to be tested simultaneously
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. This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories.
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. 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 performance of this test was established based on the evaluation of a limited number of clinical specimens. Clinical performance has not been established with all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
Caution: For professional in vitro diagnostic use only.
