Sienna™ COVID-19 Rapid Antigen Test Kits FDA-EUA (Carton)
FDA-Emergency Use Authorized (EUA)
Nasopharyngeal Swab
RAPID RESULTS: 10 – 15 MINUTES
- For PRESCRIPTION use only
- For in-vitro diagnostic use only
The COVID-19 Rapid Antigen Test Cassette (Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of the N protein of SARS-CoV-2 in Nasopharyngeal swab. In this test, an antibody specific to the N protein of SARS-CoV-2 is separately coated on the test line regions of the test cassette. During testing, the extracted specimen reacts with the antibody to N protein of SARS-CoV-2 that is coated onto particles. The mixture migrates up the membrane to react with the antibody to N protein of SARS-CoV-2 on the membrane and generate one colored line in the test regions. The presence of this colored line of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.
DEPENDABLE ACCURATE RESULTS
- Sensitivity 93.8%
- Specificity 99.2%*
- Accuracy 98.7%
UNMATCHED CONVENIENCE
- Individual Buffer Vials
(Helping multiple operators at the same time) - Visual Results Easy to Interpret
- 15 Minute Test Time
EACH CARTON CONTAINS 49 BOXES of 25 TEST KITS PER BOX
- 1,225 test kits including:
- 1,225 Individually Pouched Test Cassettes
- 1,225 Extraction Buffer Tubes
- 1,225 Sterile Swabs,
- and 49 Instruction Sheet Inserts (1 per box).
