Sienna COVID-19 Antigen Rapid Test

The Sienna Antigen test is good for all variants of Covid-19 Sars 2:
Covid-19, Alpha, Delta, Delta+ since it detects an integral part of the Nucleocapsid That is Common to all Covid-19 Variants

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 antigen 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.

Sienna™ COVID-19 Antigen Rapid Test Features:

• 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

About the Rapid Antigen Test:

The Sienna Antigen Rapid test is the number one supported Rapid Antigen test from the WHO. This test has full Approval from the Government for sale in over 80 Countries, which includes all of Europe, Mexico, Canada, Asia, Africa, the Middle East, and also South America. It’s the second largest selling test for SARS-CoV-2 Antigen in Germany, which has one of the most difficult approval processes in the world. DNA Analytical Services is currently selling Sienna products in the United States, UK, Africa, The Middle East, South America & Europe. With the Sienna test, in less than 15 minutes, a positive or negative Covid-19 result is displayed clearly, along with a control result , which allows the tester to know the specimen was accurately collected via the nasal swab.

Reliable & Accurate Results:

• Relative Sensitivity: 93.8%
• Relative Specificity: 99.2%
• Relative Accuracy: 98.7%

Added Convenience:

• 10-15 Minute Results
• Easy to Read Visual Instructions
• Simple to Interpret Results
• Pool Multiple Vials at Once

Product Capabilities:

• 1.2 million per Week Production Capacity with an Estimated Delivery of 7 Business Days
• Manufactured in Finland (ISO Certified For Medical Device Manufactures)
• USA Manufacturing Facility Set to Open in the Fall will allow for Double Capacity

Package Includes:

• Instruction for use
• Quick User Guide
• Individually Pouched Test Cassettes (25)
• Extraction Buffers (25)
• Sterile Nasopharyngeal swabs (25)
• Workstation
• Positive Control swab (1)
• Negative Control swab (1)

Resources

Sienna Instructions for use