Designed exclusively for use under the FDA's Emergency Use Authorization, the Access SARS-CoV-2 IgM Assay provides reliable detection of IgM antibodies to SARS-CoV-2, indicating recent or prior infection.
Eligible for deployment in CLIA-certified laboratories capable of conducting moderate or high complexity tests, ensuring quality and accuracy in COVID-19 testing.
Utilizes advanced paramagnetic particle and chemiluminescent technology for high sensitivity and specificity in SARS-CoV-2 IgM detection.
Each kit contains materials for 200 tests, optimized for use with Beckman Coulter Access Immunoassay Systems, streamlining laboratory workflow for efficient COVID-19 antibody testing.
Storage requirements: The reagent kit requires refrigeration to maintain stability and ensure long-term usability.