- This test has not yet been approved by the FDA.
- This IgG/IgM antibody detection test is a rapid visual immunochromatographic assay for the qualitative detection of IgG and IgM antibodies from human whole blood or serum and provides a result in less than 15 minutes.
- Results from this test should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Rapid Result Tests are intended for point of care application - not for home use.
- Positive results may be due to past or present infection with non-SARS-CoV-2 corona virus strains (coHKU1,NL63,OC43,or229E). Consider follow up testing with molecular diagnostic testing to rule out infection in these individuals.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Results from one antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- To report adverse events please email email@example.com
- Validation studies, factsheets, and supplemental information are available upon request. Please email inquiries and requests to firstname.lastname@example.org