Beta-hCG, Quantitative (Tumor Marker), CSF

Casandra

Casandra Test Code AR24313Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 0020730CPT Code 84702

Beta-hCG, Quantitative (Tumor Marker), CSF

Clinical Use

Use

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 from clinical evaluation and other diagnostic procedures. It has applications in detecting increased hCG concentrations in melanoma, carcinomas of the breast, gastrointestinal tract, lung, and ovaries, as well as in benign conditions such as cirrhosis, duodenal ulcer, and inflammatory bowel disease. It should be noted that this test cannot be interpreted as absolute evidence of the presence or absence of malignant disease and is not interpretable as a tumor marker in pregnant females.

Special Instructions

Results obtained with different test methods or kits cannot be used interchangeably. Although this assay is FDA cleared for 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 Laboratories, and it's intended for clinical purposes in a CLIA certified laboratory.

Limitations

The test has not been cleared or approved by the US Food and Drug Administration for use as a tumor marker or with CSF specimens. It was developed and its performance determined by ARUP Laboratories. The use in clinical diagnostics is based on an LDT (Laboratory Developed Test) compliance category, which may have variances in regulatory acceptance.

Test Details

New York Approved