Product Details

The BioSys Plus™ COVID-19 IgM/IgG Rapid Screening Device is a lateral flow immunoassay test device for the rapid presumptive qualitative simultaneous detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma. THE TESTS SHALL ONLY BE USED FOR PRELIMINARY SCREENING PURPOSES AND SHALL ONLY BE USED TO DETERMINE IF ADDITIONAL TESTING IS REQUIRED. The test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS‐CoV‐2 infection or to inform infection status. -10 minutes time to result -Capillary finger stick sample (5uL) -Visual Reading: No instrumentation required -For use by clinical laboratories or healthcare professionals at the point-of-care -This screening is not CLIA waived. For the use by clinical laboratories or healthcare workers at the point of care.