COVID-19 IgM-IgG Rapid Test

The BioMedomics Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 is a lateral flow immunoassay intended for the qualitative, differential detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, or whole blood samples (capillary or venous) including samples prepared by commonly-used anticoagulants (K2EDTA, NaCitrate,

Li-Heparin) from individuals with current or prior

COVID-19 infection. The Medomics Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 is intended for use as an aid in identifying patients 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 ifthe presence of antibodies confers protective immunity.

The Medomics Rapid IgM-IgG Combined Antibody Test for SARS- CoV-2 should not be used to diagnose acute SARS-CoV-2 infection.

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. Patients may have detectable virus present for several weeks following seroconversion.

The sensitivity of Medomics Rapid IgM-IgG Combined

Antibody Test for SARS-CoV-2 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 Medomics Rapid IgM-IgG

Combined Antibody Test for SARS-CoV-2 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 a second, different IgG or IgM assay.