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The HEV IgM Cassette Rapid Test is a lateral ïow chromatographic immunoassay.
The test cassette consists of: 1) a burgundy colored conjugate pad containing HEV
antigens conjugated with colloidal gold (HEV conjugates) and rabbit IgG-gold
conjugates, 2) 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
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.