Quantitative Electrochemiluminescent Immunoassay
Within 24 hours
Serum separator tube. Also acceptable: Lavender (EDTA), pink (K2EDTA), or green (sodium or lithium heparin).
Allow specimen to clot completely at room temperature. Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.4 mL)
CSF (refer to Beta-hCG, Quantitative (Tumor Marker) CSF, ARUP test code 0020730). Specimens left to clot at 2-8°C or specimens subjected to repeated freeze/thaw cycles.
After separation from cells: Ambient: 5 days; Refrigerated: 2 weeks; Frozen: 1 year
Male: 0-3 IU/L
Female: 0-5 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 serum 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. This result cannot be interpreted as absolute evidence of the presence or absence of malignant disease. This 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.
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|
|0070029||Beta-hCG Quant Tumor Marker||21198-7|
- Beta-HCG levels
- Beta-HCG serum concentration
- Beta-HCG, serum
- human chorioinic gonadotropin, serum