Intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results will not preclude SARS-CoV-2 infection, and they cannot be used as the sole basis for treatment or other management decisions. The test is not intended to be used as a donor screening test for SARS-CoV-2.
An in vitro diagnostic rapid test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, venous and fingerstick whole blood.