The IgM rapid Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibodies in human serum to Rheumatoid Factor (RF) antigen. It is intended to be used as ascreening test and as an aid in the diagnosis of rheumatoid arthritis. Any reactive specimen with the RF IgM Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.