HCG - Tumor Marker or Pregnancy, Serum, Quantitative
Label Mnemonic: HCG
Epic Lab Code: LAB142
Downtime Form: A-1a General Laboratory Requisition
Chemistry
6240 RCP
356-3527
Specimen(s):
Plasma
Collection Medium:
Plasma Separator Tube 4.5 mL
Alternate Collection Media:
Call laboratory for additional acceptable specimen collection containers.
Minimum:
3 mL whole blood from light green top tube or TWO Microtainer® devices
Testing Schedule:
24 hrs/day, 7 days a week, including holidays.
Turn Around Time:
1 hour (upon receipt in laboratory)
Reference Range:
Non-Pregnant Females: < 3.0 mIU/mL Males: < 2.0 mIU/mL Healthy non-pregnant peri-menopausal and post-menopausal females may have HCG values up to 8 mIU/mL Weeks of | | HCG mIU/mL gestation | N | Median | 5th-95th percentile 3 | 25 | 17.5 | 6 - 71 4 | 43 | 141 | 10 - 750 5 | 23 | 1,398 | 217 - 7,138 6 | 19 | 3,339 | 158 - 31,795 7 | 13 | 39,759 | 3,697 - 163,563 8 | 23 | 90,084 | 32,065 - 149,571 9 | 23 | 106,257 | 63,803 - 151,410 10 | 20 | 85,172 | 46,509 - 186,977 12 | 17 | 66,676 | 27,832 - 210,612 14 | 67 | 34,440 | 13,950 - 62,530 15 | 666 | 28,962 | 12,039 - 70,971 16 | 766 | 23,930 | 9,040 - 56,451 17 | 190 | 20,860 | 8,175 - 55,868 18 | 64 | 19,817 | 8,009 - 58,176
Comments:
This assay recognizes the intact HCG "holo-hormone" produced in pregnancy as well as other forms of HCG (e.g., "nicked" HCG) that may be found in other conditions such as tumors of germ cells, ovaries, bladder, pancreas, stomach, lungs, and liver.

Heterophile antibodies present in the serum of some patients may cause a false positive result in this assay. Before making the diagnosis of malignancy based on an elevated serum HCG, confirm with a urine HCG.
Test Limitations:
Hemolysis: No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL).

Lipemia: No significant interference up to an L index of 1400 (approximate triglycerides concentration: 2800 mg/dL). Note there is poor correlation between turbidity and triglyceride concentration.

Icterus: No significant interference up to an I index of 24 (approximate conjugated and unconjugated bilirubin concentration: 24 mg/dL).

In patients receiving therapy with high biotin doses (i.e. is greater than 5 mg/day) no sample should be taken until at least 8 hours after the last biotin administration.* No interference was observed from rheumatoid factor up to 3400 U/mL and samples from dialysis patients. In vitro tests were performed on 15 commonly used pharmaceuticals. No interference with the assay was found. There is no high-dose hook effect for hCG concentrations up to 750,000 mIU/mL. As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. In rare cases, interference due to extremely high titers of antibodies to streptavidin or ruthenium can occur. HCG+beta contains additives which minimize these effects. For diagnostic purposes, the HCG+beta findings should always be assessed in conjunction with the patient's medical history, clinical examination and other findings. *Sturgeon CM, McAllister EJ. Analysis of hCG: clinical applications and assay requirements. Ann Clin Biochem 1998;35:460-491.
Methodology:
Electrochemiluminescence Immunoassay
CPT Code:
84702