The StrongStep® SARS-CoV-2 IgM/IgG Antibody Rapid Test kit is used for in vitro qualitative detection and identification of SARS-CoV-2 antibody coronavirus disease COVID-19 in serum/plasma/whole blood samples (including venous blood and finger prick blood) of suspected patients the diagnosis of infection can be used to diagnose symptomatic or asymptomatic individuals with acute infection and molecular testing or clinical information.
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.