Sienna COVID-19 IgG/IgM Rapid Antibody Test

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)

FDA EUA

Yes!

Results

10 minutes

Type

Finger prick

Detection

Detect and differentiate IgM/IgG antibodies specific to SARS-CoV-2

Use

For in vitro diagnostic use only

Sensitivity

The combined sensitivity is 93.3%

Specificity

The combined specificity is 98.8%

Zero cross-reactivity issues

The NCI analysis also showed that the Sienna test had zero cross-reactivity issues

FDA EUA

Authorization Letter

Fact Sheet

For HealthCare Providers

Instruction

for Use

FDA Disclaimer

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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