HEALGEN SCIENTIFIC FDA/EUA ANTIBODY TEST

HEALGEN SCIENTIFIC DATA

COVID-19 IgG/IgM Rapid Test Cassette

HealGen

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anti-coagulated blood (Li+ heparin, K2EDTA and sodium citrate), or serum. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.

Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

The sensitivity of COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) early after infection in unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False positive results for COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Recipient Fact Sheet
Instructions for Healthcare Providers
Instructions for Use
FDA/EUA Letter

Healgen-Product-Review

This test has not been FDA cleared or approved; · This test has been authorized by FDA under an EUA for use by authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests. · 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; and · 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.