COVID-19 rapid test 502090

IgGIgMcoronavirus

The test is limited in the US to distribution to laboratories certified by CLIA to perform high complexity testing. This test has not been reviewed by the FDA. Negative results do not preclude acute SARS-CoV-2 infection. 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. They can also identify whether they have previously been infected with the SARS-CoV-2 virus and have recovered.This test is only authorized to detect SARS-CoV-2 specific IgM and IgG antibodies.IgG and lgM antibodies to 2019 Novel Coronavirus can be detected with 2-3 weeks after exposure. Negative results do not preclude 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. lgG remains positive, but the antibody level drops overtime. It is not applicable to any other viruses or pathogens, and the results should not be used to diagnose or rule out SARS-CoV infection or inform the status of infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. INTENDED USE TheStrongStep® SARS-CoV-2 IgM/IgG Test is a rapid immuno-chromatographic assay for the simultaneous detection of IgM and IgG antibodies to SARS-CoV-2 virus in human whole blood, serum or plasma. The assay is used as an aid in the diagnosis of COVID-19.