Negative results may not rule-out hepatitis D virus (HDV) infection during the early phase of infection or in immunocompromised patients who have delayed or inadequate immune response.
False-positive results may be due to cross-reactive antibodies from other viral infection or underlying illnesses. Positive result should be correlated with the patient's clinical history, physical examination findings, and risk factors for HDV infection.
Performance characteristics have not been established for the following specimen characteristics:
-Grossly icteric (total bilirubin level of >20 mg/dL)
-Grossly lipemic (triolein level of >3000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Containing particulate matter
-Cadaveric specimens