Antibody Tests are primarily intended for point of care application, they are not yet intended for home use without the oversight of a clinician to interpret the test results, record and report data pertinent to public health, and develop/discuss an appropriate care plan if necessary.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Regular testing is recommended. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains (coHKU1, NL63, OC43, or 229E). Consider follow up testing with molecular diagnostic to rule out infection in these individuals. To mitigate risk of false positive results, consider follow-up testing using a second, different rapid test, i.e., total antibody detection to dual line IgG/IgM assay, etc.
Results from one antibody test should not be used as the sole basis to diagnose or exclude SARS- CoV-2 infection or to inform infection status. Tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Additional information including clinical validation studies, fact sheets, and specific recommendations for asymptomatic testing programs available to healthcare providers upon request.
This test has not yet been reviewed by the FDA.