The HEV IgM Cassette Rapid Test is a lateral ow chromatographic immunoassay.
The test cassette consists of: A burgundy colored conjugate pad containing HEV antigens conjugated with colloidal gold (HEV conjugates) and rabbit IgG-gold conjugates, a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with monoclonal anti-human IgM antibody, and the C line is pre-coated with goat anti-rabbit IgG antibody.
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 -HEV IgM if present in the specimen will bind to the HEV conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM forming a burgundy colored T line, indicating a HEV IgM positive test result.
Absence of the test 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-rabbit IgG/rabbit IgG-gold conjugate regardless of color development on the T line. Otherwise, the test result is invalid and the specimen must be retested with another device.