Sienna COVID-19 Rapid Antigen Point-of-Care Test is a rapid qualitative test that detects SARS-CoV-2 from nasal swab specimens from individuals with signs and symptoms of respiratory infection COVID-19.
| Country of Origin | Finland |
| Application | Rapid Test Kit |
| Contents | (25) Individually Pouched Tests Cassettes, (25) Extraction Reagent Buffer Droppers, (25) Sterile NP Swabs, (1) Package Insert, (1) Quick User Guide, (1) Negative Control Swab, (1) Positive Control, (1) Workstation |
| Number of Tests | 25 Tests |
| Storage | USP Controlled Room Temperature |
| Test Format | Test Device |
| Test Method | Lateral Flow Immunochromatographic Assay |
| Part No. | 102242 |
| Test Type | Rapid Antigen Detection |
| Time to Results | 10 Minute Results |
| Box Packing | 25 Tests |
| Case Packing | 49 Kits (1,225 Tests) |
| Application | Rapid Antigen Test |
| Pallet Packing | 12 Cases (14,700 Tests) |
Sienna COVID-19 Rapid Test
- Sienna COVID-19 Rapid Test has been granted emergency use authorization (EUA) by the FDA for use at the point-of-care setting: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- During the duration of the emergency, this test can be performed in a patient care setting that is operating under a CLIA Waiver, Certificate of Compliance, or Certificate of Accreditation
- Results are for the identification of nucleocapsid antigens of SARS-CoV-2
- The Sienna Antigen test is intended for use by medical professionals and laboratory personnel trained to perform the test
- Nasopharyngeal swab for superior specimen collection and patient comfort
- Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
