A Hepatic Iron Index (HII) is not calculated for patients less than 14 years. An HII less than 1.0 is consistent with normal iron accumulation. An HII 1.0 through 1.9 is consistent with mild iron accumulation such as in heterozygous hemochromatosis or alcoholic liver disease. An HII greater than 1.9 is consistent with iron overload such as in homozygous hemochromatosis, porphyria cutanea tarda, and cirrhotic liver disease. The HII will decrease with chelation, chronic blood loss, or phlebotomy.
Statement B: Compliance Statement B
: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations.
This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.