POINT-OF-CARE

The Avidium 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.

 
 
 

COVID-19 IgG/IgM Rapid Test Kits 

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Emblemworks Health is please to introduce the Avidium Labs/NXT Group COVID-19 IgG/IgM antibody test kit for SARS-CoV-2 also known as COVID-19. The serology test can identify people whose bodies have some degree of immune response to the SARS-CoV-2 virus. Our test kit is CE certified and has a pending FDA Emergency Use Authorization application and is manufactured in an ISO-9001 facility.

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The Avidium Labs test kit is one a few serology test kits with independent validation from CLIA-certified laboratories in both New York and California. One of these laboratories that has validated the Avidium test kit SUNY Downstate Health Science Hospital in collaboration with Mirimus Laboratory. SUNY Downstate is one of busiest COVID-19 only faciliites in the United State located in the heart of pandemic epicenter New York. The validation was performed on moderate to severe hospitalized patients under the directorship of Dr. Prem Premsrirut and Dr. Rachelle Mendoza, Dr. Allen Norin, and Dr. Jenny Libien. Avidium Lab’s results verified by the laboratories demonstrate a high efficacy in detecting IgG/IgM antibodies against SARS-CoV-2 in serum, plasma, or whole blood samples.

In addition, Avidium Labs’ international partners conducted a comparative study of the rapid IgG/IgM antibody test kit for SARS-CoV-2 against other commercially available SARS-CoV-2 IgG/IgM detection test kits that show a positive coincidence rate of 97.92% and a negative coincidence rate of 100%.

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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 Avidium Labs authorized distributor and is currently accepting orders.

Note: Updated FDA guidance issued on May 4, 2020, allows the distribution of this product for use in laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing.

DISCLAIMER:

  • This test has not been reviewed by FDA

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

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

  • 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.