Quantitative Electrochemiluminescent Immunoassay
Within 24 hours
CSF. Also acceptable: CSF collected in plain red or green (sodium or lithium heparin).
Transfer 0.5 mL CSF to an ARUP Standard Transport Tube. (Min: 0.3 mL)
Any other body fluids.
Ambient: 5 days; Refrigerated: 2 weeks; Frozen: 1 year
18 years and older: 0-3 IU/L
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.
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.
|Component Test Code*||Component Chart Name||LOINC|
|0020730||Beta-hCG, CSF Quant (Tumor Marker)||14041-8|
- Beta-HCG CSF concentration
- Beta-HCG CSF levels
- Beta-HCG, CSF
- human chorioinic gonadotropin, CSF