The Core COVID-19 IgG/IgM test kits is an in vitro, rapid qualitative immunoassay for the simultaneousdetection and differentiation of IgG and IgM antibodies of Covid-19 in human serum, plasma, or whole blood.
This test has not been reviewed by the FDA.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
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 test is only provided for use in certified high complexity laboratories or by healthcare workers at the point of care as allowed under FDA guidelines.
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