Beta-hCG, Quantitative (Tumor Marker), CSF

Interpretive Data: Human chorionic gonadotropin (hCG) is a valuable aid in the management of patients with trophoblastic tumors, nonseminomatous testicular tumors, and seminomas when used in conjunction with information available from the clinical evaluation and other diagnostic procedures. Increased hCG concentrations have also been observed in melanoma, carcinomas of the breast, gastrointestinal tract, lung, and ovaries, and in benign conditions including cirrhosis, duodenal ulcer, and inflammatory bowel disease. 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.

The combination of the specific monoclonal antibodies used in the Roche Beta HCG electrochemiluminescent immunoassay recognize the holo-hormone, "nicked" forms of hCG, the beta-core fragment, and the free beta-subunit. Results obtained with different test methods or kits cannot be used interchangeably. Although this assay is FDA cleared for use in the detection of pregnancy, it is not labeled for use as a tumor marker or with CSF specimens. The performance characteristics of this assay were determined by ARUP.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.