We'd like to share an exciting paper with you!
This establishes the use of Epitope’s Novel Coronavirus COVID-19 IgM (Cat# KT-1033) and IgG (Cat# KT-1032) ELISA tests used as reference methods. The paper is peer reviewed and has been published in the Clinica Chimica Acta journal.
In summary, this study illustrates a 94% detection rate for our IgM and 100% detection rate for our IgG COVID-19 ELISA tests. The study shows that the compared Elecsys® Anti-SARS-CoV-2 total antibody test does not differentiate the sub type (IgG vs IgM or IgA) of the antibodies, which may lead to an unclear immune response status for use in clinical practice.
We are in communication with the U.S. FDA and hope to get the EUA granted very soon. If you would like to be added to a list of distributors to receive an email upon our approval, please respond to this email.
Thank you for your continued support!
Please feel free to reach out with any further questions.
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