The SIENNA™ COVID-19 Antigen test is a lateral flow immunochromatographic assay for the qualitative detection of SARS-CoV-2 viral proteins in respiratory secretions. The assay is designed to detect protein antigens from replicating virus detectable in respiratory secretions. The test can be used for screening in patients exposed to SARS-CoV-2 or for confirmation in symptomatic patients or when isolation of the virus has been established.
The SIENNA™ COVID-19 Antigen test offers excellent analytical performances, providing the accuracy and sensitivity needed to detect SARS-CoV-2. Sienna COVID-19 Antigen Rapid Test Kits, Includes: (25) Tests, (25) NP Swabs, (25) Buffers, Package Insert, QSG, (1) Negative Control, and (1) Positive Control/kt. Rapid Results in 10-15 minutes and CLIA Waived.
Approved July 13, 2020 - only 1 of 15 serology rapid tests approved in the United States.
Absolutely no components from China, no trade embargo risk, ISO certified for medical device manufacturers.
Meets FDA performance thresholds for accuracy, independently tested at the Frederick National Laboratory for Cancer Research.
Easy to use and easy to read results. Each kit comes with an individual beffer solution, lancet, capillary dropper and alcohol swab.
1.2 million units a week capacity. Average order delivery 7 business days. Capacity will double in Fall with USA Manufacturing facility.