Alpha-Fetoprotein (AFP) and AFP-L3

1. Heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays. Samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference and can potentially cause an anomalous result. The Wako uTAS System has been formulated to minimize the risk of hte interference; however, potential interactions between rare sera and ingredients can occur.
2. For diagnostic purposes, the results obtained from this assay should always be used and interpreted in conjunction with clinical examination, patient medical history, and other findings.
3. Pregnancy can cause high values of AFP-L3% and AFP is not interpretable in pregnant females.
4. AFP producing tumors other than HCC can show high values of AFP-L3% adn AFP.
5. Samples from patients having acute hepatitis and fulminant hepatitis can show high values of AFP-L3% and AFP.
6. It is recommended that this assay be used in conjunction with imaging studies for clinical diagnosis.
7. Liver diseases caused by other etiologies such as alcoholic liver disease, hemachromatosis, Wilson's disease, autoimmune hepatitis and steatohepatisis have not been studied with this assay.
8. The assay is linear for AFP concentration of 0.3 to 1000 ng/mL.
9. Values obtained with different assay methods or kits cannot be used interchangeably.