Method for the detection and/or assay of hormones, and antibodie

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...

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435 792, 435 793, 435 795, 435962, 435963, 435967, 435975, 436518, 5303871, G01N 33543

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056747004

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BRIEF SUMMARY
FIELD OF THE INVENTION

The present invention relates to a method for the detection and/or assay of hormones, including the placental hormones, as well as to antibodies which can be used in the said detection method.


BACKGROUND OF THE INVENTION

The term hormones designates the substances elaborated by the various human and animal endocrine glands, and in particular the hypophysial hormones (FSH, LH, TSH, GH, ACTH, prolactin, oxytocin, MSH, ADH), the related chorionic gonadotropins (eCG), chorionic somatomammotropin (CS), placental GH!, the thyroid hormones, the adrenal hormones, the gonadal hormones and the pancreatic hormones.
Depending on their chemical structure, these hormones belong to different categories: the hormones derived from amino acids (thyroid hormones, medullo-adrenal hormones), the peptide and protein hormones (pancreatic hormones, GH, ACTH, prolactin, MSH, ADH, oxytocin), the steroid hormones (gonadal hormones, adrenocortical hormones) and the glycoprotein hormones (LH, FSH, TSH, hCG, eCG).
The glycoprotein hormones are characterised by one structural organisation: they are formed by the combination of two sub-units .alpha. and .beta.. The .alpha. sub-unit is identical for all the glycoprotein hormones of one and the same animal species. Conversely, the .beta. sub-unit is different from one hormone to another and confers the specificity of action. Similarly, the peptide hormones exhibit a structural relationship, as well as the polypeptide hormones (example: GH and prolactin).
These hormones are not generally secreted at constant rates, but instead exhibit variations of circulating concentration of low amplitude (micropulsatility) or, in certain cases, of great amplitude (example: peak secretion of FSH and then LH in the preovulatory phase). It is therefore necessary to have available assay methods which permit accurate and specific measurement of the circulating level of these various hormones, in the blood or in any other possible biological fluid.
These assay methods should in addition be very sensitive inasmuch as the basal concentrations of these various hormones are relatively low (for example, 0.1 ng/ml to a few ng/ml for the hypophysial hormones), except for all pathological cases.
By way of example, the detection and/or assay of the gonadotropic hormones LH and FSH is particularly important in the study of the physiology of male and female reproduction in animals and man. In mammals, for example, the functioning of the ovary comprises, during the phase of genital activity (continuous or seasonal depending on the species), a succession of ovarian cycles during which the female gametes mature at regular intervals.
The ovarian cycle comprises two phases: the follicular phase (growth of the follicle and maturation of the oocyte) leading to ovulation, the phase propitious to fertilisation, and the luteal phase (formation of the corpus luteum). FSH is responsible for the growth and the maturation of the preovulatory follicle; LH is involved more particularly in the terminal follicular growth of the latter and in the triggering of ovulation. Indeed, ovulation occurs at a very precise and regular time, for each species, after the LH peak (17 to 24 hours depending on the species). It therefore appears useful and important to be able to have at ones disposal, both in the laboratory for very precise assays as well as in the field or at home for detecting the preovulatory LH peak (in order to predict the optimum time for artificial insemination, for example), instruments for specific detection of LH, in different animals and in humans.
Similarly, the possibility of detecting very low circulating levels of chorionic gonadotropin (CG) is particularly important for the development of kits for the earliest possible diagnosis of pregnancy, especially in women.
As regards humans, a number of tests which can be carried out at home on the basis of the urine have been developed and marketed for LH and hCG.
As far as LH is concerned, a number of kits are now available which permit a precise determi

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