Clinical Information

The performance of the assay has not been established for populations of immunocompromised or immunosuppressed patients. Do not test samples from patients who take high doses of biotin. If biotin interference is suspected, minimal 3 days of withdrawing biotin before blood draw or test with an alternative assay that is not affected by biotin interference. For assays employing antibodies, the possibility exists for interference by human anti-animal antibodies (i.e., heterophile antibodies) in the patient sample. Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, (e.g., HAMA), that interfere with immunoassays. This may falsely elevate or falsely decrease the results.