Biotin (vitamin B7) is a common ingredient in multivitamins and dietary supplements to enhance hair, nail, and skin growth. Biotin can interfere with the assay performance and cause possible false-negative hepatitis B e antigen (HBeAg) and false-positive HBe antibody (anti-HBe) results. Patients should be instructed to stop taking such multivitamins and dietary supplements for at least 24 hours prior to blood collection.
Disappearance of HBeAg or appearance of anti-HBe in serum does not completely rule-out chronic hepatitis B carrier state or infectivity.
Performance characteristics of these 2 assays have not been established in patients under the age of 2 or in populations of immunocompromised or immunosuppressed patients. These 2 assays are not licensed by FDA for testing cord blood samples or screening donors of blood, plasma, human cell, or tissue products.
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 >61 mg/dL)
-Specimen containing particulate matter