hCG + β in Human Serum with Roche e801

Detection of hCG + β in Human Serum with Roche e801

Test Name: Immunoassay for the in vitro quantitative determination of the sum of human chorionic gonadotropin (hCG) plus the hCG β subunit in human serum and plasma.
Method Name: The combination of the specific monoclonal antibodies used in the Elecsys HCG+β assay recognize the holo hormone, “nicked” forms of hCG, the β core fragment and the free β subunit. The ruthenium labeled and biotinylated antibodies used are directed against different epitopes of the hCG molecule.
Results: Technical Range: 0.200-10000 mIU/mL
Reportable Range: 0.200-9304 mIU/mL
Reference Ranges: Children
Birth-3 months: < or =50 IU/L* >3 months-<18 years: <1.4 IU/L Females
Birth-3 months: < or =50 IU/L* >3 months-<18 years: <1.0 IU/L Adults
Males: <1.4 IU/L Females:
Premenopausal, nonpregnant: <1.0 IU/L Postmenopausal: <7.0 IU/L
Clinical Significance: Similarly to LH (Luteinizing hormone), FSH (Follicle stimulating hormone) and TSH (Thyroid stimulating hormone), human chorionic gonadotropin (hCG) is a member of the glycoprotein family and consists of 2 subunits (α  and β chains) which are associated to form the intact hormone. The α chains in all four of these glycoprotein hormones are virtually identical, whereas the β chains have greatly differing structures and are responsible for the respective specific hormonal functions.

hCG is produced in the placenta during pregnancy. In non pregnant women, it can also be produced by tumors of the trophoblast, germ cell tumors with trophoblastic components and some non trophoblastic tumors.

Human chorionic gonadotropin consists of a number of isohormones with differing molecular size. The biological action of hCG serves to maintain the corpus luteum during pregnancy. It also influences steroid production. The serum of pregnant women contains mainly intact hCG.

Elevated values here serve as an indication of chorionic carcinoma, hydatidiform mole or multiple pregnancy. Depressed values indicate threatening or missed abortion, ectopic pregnancy, gestosis or intra uterine death.

Elevated hCG concentrations not associated with pregnancy are found in patients with diseases such as tumors of the germ cells, ovaries, bladder, pancreas, stomach, lungs, and liver.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Plasma: Li-heparin and K2-EDTA plasma Do not use fluoride plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, therefore not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases.  When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.
Storage and Stability:    12 months at -20°C
14 days at 2-8°C
5 days at 20-25 °C

Rejection Criteria: Rejection criteria include but are not limited to:
1. Specimens containing fibrin or clots.
2. Excessive platelet clumping
3. Leaking specimens
4. Substandard mixing or collection
5. Expired or improperly stored collection tubes.
6. Improperly filled tubes based on collection tube manufacturer’s guidelines.
7. Contaminated specimens (IV fluid, foreign particles, etc.)
8. Specimens not analyzed within the appropriate time frame.
9. Samples not shipped at appropriate temperature.
10. Samples without 2 proper identifiers or samples having identifiers that do not match the electronic or paper lab requisition.
Authorization: Diagnostic testing can only be performed with approval from an authorized provider/agency.
Turn Around Time: 1 day.