DESCRIPTIOIN

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is not intended to screen patients for active COVID-19 infection.

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• The sensitivity of the IgM test is 87.9% and specificity 100% when compared to RT-PCR.

  The sensitivity of the IgG test is 97.2% during the convalescence period, and specificity is 100%.

- Positive results may be detected in as little as 10 minutes

- Detection Window (IgM): 3-5 days after incubation

- Dual band results for simple interpretation

- Multivariable analysis of immunoglobin IgG & IgM

- Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)

- Procedural internal control included

Fact Sheets

- Click here for Fact Sheet for Recipients

- Click her for Fact Sheet for Providers

Warning

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.

Note

• - The Healgen antibody test is not being promoted for Fingerstick use.
• - This product is not available to be purchased online from our website and is not sold “for at home use”.