The Beckman Coulter Access DxI AFP method is used. Results obtained with different assay methods or kits cannot be used interchangeably. AFP is a valuable aid in the management of nonseminomatous testicular cancer patients when used in conjunction with information available from the clinical evaluation and other diagnostic procedures. Increased AFP concentrations have also been observed in ataxia telangiectasia, hereditary tyrosinemia, primary hepatocellular carcinoma, teratocarcinoma, gastrointestinal tract cancers with and without liver metastases, and in benign hepatic conditions such as acute viral hepatitis, chronic active hepatitis, and cirrhosis. The result cannot be interpreted as absolute evidence of the presence or absence of malignant disease. The result is not interpretable as a tumor marker in pregnant females.
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.