Description

INTENDED USE
The Calbiotech, Inc. (CBI) Ultra Sensitive LH lumELISA (Chemiluminescence Enzyme Linked Immunosorbent Assay) is used for the ultra sensitive quantitative measurement of LH in human serum or plasma.

SUMMARY AND EXPLANATION
Luteinizing hormone (LH) is produced in both men and women from the anterior pituitary gland in response to luteinizing hormone-releasing hormone (LH-RH or Gn-RH), that is released by the hypothalamus. LH, also called interstitial cell-stimulating hormone (ICSH) in men, is glycoprotein with a molecular weight of approximately 30,000 Dalton. It is composed of two noncovalently associated dissimilar amino acid chains, alpha and beta. The alpha chain is similar to that found in human thyroid-stimulating hormone (TSH), follicle-stimulating hormone (FSH), and human chorionic gonadotropin (hCG). LH stimulates ovulation and ovarian steroid production in the female. In the male, LH controls Leydig cell secretion of testosterone. LH is elevated in Luteal phase of menstrual cycle, primary hypogonadism, Gonadotropin-secreting pituitary tumors and menopause. LH is deceased in hypothalamic Gn-RH deficiency, pituitary LH deficiency and ectopic steroid production.
In children, abnormalities in concentration of LH can be aid in the diagnosis of pituitary disorders, and may be indicative of problems in the reproductive system of both genders, infertility problems, early and delay puberty.

PRINCIPLE OF THE TEST
The Ultra Sensitive LH lumELISA kit is based on the streptavidin and biotin principle. In this procedure, the immobilization takes place during the assay at the surface of a microplate well through the interaction of streptavidin coated on the well and exogenously added biotinylated monoclonal anti-LH antibody. Upon mixing the monoclonal biotinylated antibody, the enzyme-labeled antibody and a serum containing the native antigen, reaction results between the native antigen and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction streptavidin and biotinylated antibody. After one hour incubation, unbound protein and conjugates are washed off by wash buffer. Upon the addition of the substrate, the enzyme activity in the enzyme-bound fraction is directly proportional to the concentration of LH in the samples. A standard curve is prepared relating light units to the concentration of the LH.