POINT-OF-CARE

The Sienna nasal swab test kit is a point-of-care immunodiagnostic test that can be administered anywhere, does not require samples to be sent to a lab and delivers a result in ten minutes.

 

ASSESSMENT TOOL

Rapid antigen tests are commonly used in the diagnosis of respiratory pathogens, including influenza viruses and respiratory syncytial virus (RSV).

 

WHAT ARE ANTIGEN TESTS

Antigen tests detect bits of coronavirus proteins called antigens. Antigen tests are fast, taking as little as five minutes.

 
 

Sienna COVID-19 FDA EUA Antigen Nasal Swab Rapid Test Kits 

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Sienna-Clarity COVID-19 is a antigen rapid test kit for SARS-CoV-2. The test is a is a qualitative, lateral flow immunoassay for the detection of the N protein of SARS-CoV-2 in Nasopharyngeal swab. The point-of-care Sienna rapid test kit delivers a result in ten minutes.

The Sienna test kit is 100% manufactured in Finland (with no components sourced from China) by a leading European in vitro diagnostics company called Salofa Oy. With a capacity of 1.25M kits/week, Salofa Oy is CE, ISO 13485:2016 and EC certified.

Embodying the best of Scandinavian user experience design, the Sienna test kit is easy to use, simple to interpret results and comes complete with everything needed to administer the test.

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The clinical performance of rapid antigen diagnostic tests largely depends on the circumstances in which they are used. Rapid antigen tests perform best when the person is tested in the early stages of infection with SARS-CoV-2 when viral load is generally highest. They also may be informative in diagnostic testing situations in which the person has a known exposure to a confirmed case of COVID-19. Rapid antigen tests can be used for screening testing in high-risk congregate settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission. In this case, there may be value in providing immediate results with antigen tests even though they may have lower sensitivity than RT-PCR tests, especially in settings where a rapid turnaround time is require.

Please let us know if you have any questions, email us at sienna [at] emblemworkshealth.com

DISCLAIMER:

  • This test has not been reviewed by the FDA

  • Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.

  • Use of this test is limited to laboratories certified to perform high complexity testing, including testing at point-of-care when the site is covered by the laboratory's CLIA certificate of high-complexity testing.

  • This test is not for home-use or at-home specimen collection.