The Sienna COVID-19 IgG/IgM Rapid Antibody Test are
Rapid Antibody Tests which detect both IgG and IgM antibodies through a patient’s serology (blood) sample.
Antibody tests will identify whether a patient has previously contracted the COVID-19 virus and has antibodies in their blood which indicate a level of immunity to the virus.
Early after infection (usually after the first week), a class of antibodies known as immunoglobulin M (IgM) develops. Later, after the first 2-4 weeks following infection, immunoglobulin G (IgG), a more durable antibody, is produced.
According to the independent evaluation performed by the National Cancer Institute (NCI)
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; the emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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