ANTIBODY (IgG/IgM) TEST
The Healgen COVID-19 Antibody IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test device is a diagnostic test that utilizes lateral flow technology for the qualitative and differential detection for the presence of IgM and IgG antibodies against SARS-CoV-2 (COVID-19) using while blood, serum or plasma, delivering reliable test results in 10 – 15 minutes.
The Healgen Covid-19 Antibody IgG/IgM Rapid test can be run remotely, without the use of laboratory equipment. Test results are easy to read and differentiates between the presence of IgG or IgM.
In general, the IgM antibodies can be detected as early as 8 days following point of infection with IgM detection about 8-10 days thereafter. Sensitivity for IgM is 100% and delivers 100% specificity. IgG detection confirming the IgG antibody presence has a sensitivity of 96.7% and with specificity of 100%.
The COVID-19 IgG/IgM test is intended to screen patients for COVID-19 antibodies and a positive test can detect a current or previous infection.
HEALGEN IgG/IgM
The Healgen COVID-19 IgG/IgM test has received the U.S. Food and
Drug Administration Emergency Use Authorization (EUA), with high
sensitivity and specificity confirmed by the U.S. National Institutes of
Health.
It also carries the European Union CE mark and is available for shipment
throughout the United States as well as internationally.
In the United States under the current EUA, the Healgen COVID-19
IgG/IgM Rapid Antibody Test can only be sold to medium to high
complexity, CLIA approved labs.
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This product is intended for professional use and not for home use.
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Warning
​ This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
​ This product has been authorized only for detecting the presence of IgG and IgM antibodies to 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.​
​This product is intended for professional use and not for home use.
​Not for the screening of donated blood.
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