Hepatitis B Core IgM

The Atellica IM aHBcM assay is limited to the detection of IgM antibodies to hepatitis B core antigen in human serum and plasma. A reactive anti-HBc IgM result does not exclude co-infection by another hepatitis virus. The performance of the assay has not been established for populations of
immunocompromised or immunosuppressed patients. Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. Additional information may be required for diagnosis. Specimens that contain biotin at a concentration of 150 ng/mL demonstrate < 10% negative bias in aHBcM Index values. Biotin concentrations greater than this lead to higher negative bias and can lead to falsely depressed results. The recommended adult daily dietary intake for biotin is 30 µg/day. Over the counter dietary supplements promoted for use in hair, skin and nail health may contain 5–100 mg of biotin, with recommendations to take multiple pills per day. Some pharmacokinetic studies in a small number of apparently healthy adults have shown that ingesting 5 mg, 10 mg, and 20 mg of biotin serum concentrations of biotin can reach up to 73 ng/mL, 141 ng/mL, and 355 ng/mL, respectively.17 However, some patients may be taking supplements with biotin at levels greater than 20 mg per day. Subjects who take up to 300 mg of biotin per day may have plasma biotin levels as high as 1160 ng/mL.18 Clearance of
biotin could be different in patients that are not apparently healthy, for example patients with impaired renal function may have higher concentrations of biotin in serum.