SCC antigen levels alone should not be interpreted as evidence to the presence or absence of malignant disease. In patients with known or expected cancer, other tests and procedures must be considered for diagnosis and patient management. Results obtained with different assay methods or kits cannot be used interchangeably.
Compliance Statement A
: Analyte specific reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. 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. This test should not be regarded as investigational or for research use.