Ordering Recommendation

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube. Also acceptable: Lavender (K2EDTA or K3EDTA), pink (K2EDTA), or green (lithium heparin).

Specimen Preparation

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)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

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.

Remarks
Stability

After separation from cells: Ambient: 5 days; Refrigerated: 2 weeks; Frozen: 1 year

Methodology

Quantitative Electrochemiluminescent Immunoassay

Performed

Sun-Sat

Reported

Within 24 hours

Reference Interval

Male: 0-3 IU/L
Female: 0-5 IU/L

Interpretive Data

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.

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.

Compliance Category

Modified FDA

Note

Hotline History

N/A

CPT Codes

84702

Components

Component Test Code* Component Chart Name LOINC
0070029 Beta-hCG Quant Tumor Marker 21198-7
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Beta-HCG levels
  • Beta-HCG serum concentration
  • Beta-HCG, serum
  • human chorioinic gonadotropin, serum
Beta-hCG, Quantitative (Tumor Marker)