Specimen

Plasma

Collection Medium:

Alternate
Collection Media:

Call laboratory for additional acceptable specimen collection 
containers.

Minimum:

5 ml whole blood from light green top tube

Testing Schedule:

24 hrs/day, 7 days a week, including holidays.

Analytic Time:

2 hours (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

Data are given only for the week of gestation for which the case 
numbers (n) were greater than 10.

Weeks of   |        |      HCG mIU/mL
gestation  |   N    |  Median  |  5th-95th percentile
    3      |  25    |   17.5   |    5.8   -    71.2
    4      |  43    |    141   |    9.5   -     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:

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:

The assay is unaffected by icterus (bilirubin is less than 24 mg/dl), 
hemolysis (Hb is less than 1.0 g/dl), lipemia (Intralipid is less than 
1400 mg/dl) and biotin is less than 80 ng/ml (criterion: recovery 
within plus or minus 10% of initial value).

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:

Electrochemiluminescent Immunoassay

CPT Code:

84702