POINT-OF-CARE

The Sienna IgG IgM 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

Results from the antibody tests can identify who has been infected and developed antibodies that may protect from future infection as well as identify those still at risk. These results can provide crucial data to help control the virus at a school or workplace.

 
 
 

Sienna COVID-19 IgG/IgM Rapid Test Kits 

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Emblemworks Health is please to introduce the FDA EUA authorized Sienna COVID-19 IgG/IgM antibody test kit for SARS-CoV-2. The Sienna rapid test kit delivers a result in ten mminutes and meets the minimum FDA performance thresholds for serology test kits. The Sienna test kit was independently validated at the Frederick National Laboratory for Cancer Research, a federally funded research and development center sponsored by the National Cancer Institute.

The Sienna test kit was 100% manufacturered in Finland (with no components sourced from China) by a leading European in vitro diagnostics company called Salofa Oy. With a capacity of 1.2M 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, easy to interpret results and comes complete with everything neede to administer the test.

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The Sienna IgG/IgM rapid test can help determine whether you have been infected in the past with Covid-19. The serology test can identify people whose bodies have some degree of immune response to the SARS-CoV-2 virus.

Rapid test kits are easy to use and can enable more effective and efficient decentralized screening among suspected patients entering a hospital, COVID-19 quarantine facility or any border entry point. In addition, rapid test kits could be used to clear employees to go back to work.

Emblemworks Health is proud to be Sienna authorized agent and is currently accepting orders.

DISCLAIMER:

  • This test has not been FDA cleared or approved;

  • This test has been authorized by FDA under an EUA for use by authorized laboratories;

  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;

  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

    Negative results do not rule out SARS-CoV-2 infection. If acute infection is suspected, molecular testing for SARS-CoV-2 is necessary.

  • Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2.