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.
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.
- No additional equipment or training required
- Results in just 10 minutes
- Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
- Used with nasopharyngeal swab specimen
- Individual buffer vials and sterile swabs allow multiple individuals to be tested simultaneously
Product Documentation
Authorized Laboratories
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.
Safety Information
- For prescription use only
- For professional in vitro diagnostic use only
- For Emergency Use Authorization only
Disclaimers
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.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
For information on the EUA, IFU, and purchase orders please contact your local sales representative or contact us at sales@lochnessmedical.com or 1-888-506-2658.
Product Information
- Product Code: COV-19C25S
- Sample: Nasopharyngeal Swab Specimens
- Format: Cassette
- Time-to-Result: 10 minutes
- Storage Condition: 2 - 30°C / 35.6 - 86°F
- Test Principle: Lateral Flow Chromatographic Immunoassay
Contents
- Instruction for use
- Quick User Guide
- Individually Pouched Test Cassettes
- Extraction Buffers
- Sterile Nasopharyngeal swabs
- Workstation
- Positive Control swab
- Negative Control swab