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.

WHAT ARE ANTIBODY TESTS

A test that detects antibodies specific to the coronavirus. Antibodies begin to appear in the blood about a week after the coronavirus has infected the body.

Sienna COVID-19 Antibody IgG/IgM Rapid Test Kits 

Emblemworks Health is please to introduce the FDA EUA authorized Sienna-Clarity 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 is 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.

SIENNA ANTIBODY TEST KIT SPECS:

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 neede to administer the test.

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. Because of the potential for relaxing physical distancing measures for those who have recovered, several governments and large employers are currently exploring the possible use of what has been termed “immunity certificates,” to release recovered people from physical distancing measures. 

Serology tests will be an important tool for public health workers to estimate the prevalence of disease. These tests will be in high demand by individuals who hope to assess their risks of immunity to SARS-CoV-2. Serology testing, among other nonpharmaceutical interventions, can help to bridge the time before a vaccine is available (4/22/20, The Johns Hopkins Center for Health Security).

Emblemworks Health is proud to be Sienna authorized agent and is currently accepting orders. Please let us know if you have any questions, email us at sienna [at] emblemworkshealth.com

DISCLAIMER:

This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved.

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.

Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This product is intended for professional use and not for home use.

Not for the screening of donated blood.