The HAV IgM Cassette Rapid Test is a lateral chromatographic immunoassay.
The test cassette consists of: 1) a burgundy colored conjugate pad containing mouse anti- human IgM antibody conjugated with colloidal gold (IgM conjugates) and 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with recombinant HAV antigen, and the C band is pre-coated with goat anti-mouse IgM antibodies. When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. Anti -HAV IgM if present in the specimen will bind to the IgM conjugates. The immuno complex is then captured on the membrane by the pre-coated HAV antigen forming a burgundy colored T line, indicating a HAV IgM positive test result. Absence of the T line suggests a negative result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of goat anti-mouse IgG/IgM-gold conjugate regardless of the color development of the T line. Otherwise, the test result is invalid and the specimen must be retested with another device.