Test Code HCGB 
Methodology Electrochemiluminescence (ECLIA)

NOTE: This procedure has been approved by the FDA only for the diagnosis and monitoring of pregnancy. 

Description Human Chorionic Gonadotropin (hCG), Quantitative, (Pregnancy), is useful for the early detection of pregnancy and monitoring in vitro fertilization patients. Elevated values serve as an indication of chorionic carcinoma, hydatiform mole or multiple pregnancy. Depressed values indicate threatening or missed abortion, ectopic pregnancy, gestosis or intrauterine death.
Mildly elevated values (5 mIU/ml - 25 mIU/ml) have been observed in postmenopausal women. LH and/or FSH levels can be used for postmenopausal diagnosis.

No sample should be collected on patients receiving therapy with high biotin doses(i.e. biotin therapy for Multiple Sclerosis or oncology patients; skin, hair and nail supplements, or multivitamins containing > 5 mg/day) until at least 12 hours after the last biotin administration. If unsure, or if the clinical picture does not fit the results please contact the laboratory . We have methods to check for biotin interference as well as for any other interferences and for the accuracy of the results.

Biotin interference would falsely decrease the result of this assay.

NOTE: This test, when ordered on Medicare patients, is subject to the National Coverage Determination (NCD) policy "Human Chorionic Gonadotropin". Please verify that the diagnosis code (ICD-9) you have chosen demonstrates medical necessity for the test as documented in the physician's patient record. The CMS web site or the NorDx Limited Coverage Documentation Guide are available to assist you with this verification. A properly executed Advance Beneficiary Notice (ABN) must be submitted with the specimen if medical necessity is not demonstrated by the ICD-9 code chosen. 

Specimen Draw blood in serum gel tube. Spin down and send 1.0 mL (minimum volume: 0.5 mL) of serum refrigerated. 
Reference Values Values less than 5.3 mIU/mL are consistent with nonpregnant females.

Weeks Gestation________HCG mIU/mL
3______________________5.8 - 71.2
4______________________9.5 - 750
5 _____________________ 217 - 7138
6______________________158 - 31,795
7 _____________________ 3,697 - 163,563
8______________________32,065 - 149,571
9______________________63,803 - 151,410
10_____________________46,509 - 186,977
12_____________________27,832 - 210,612
14_____________________13,950 - 62,530
15_____________________12,039 - 70,971
16_____________________9,040 - 56,451
17_____________________8,175 - 55,868
18_____________________8,099 - 58,176

This procedure has been approved by the FDA only for the diagnosis and monitoring of pregnancy. 

Analytic Time 1 Day - Available STAT 
Day(s) Test Set Up Monday through Sunday 
CPT Code(s) 84702