Package size

100 Tests, 50 Tests, 25 Tests, 10 Tests, 5 Tests, 100 Tests (N-QC), 50 Tests (N-QC), 25 Tests (N-QC), 10 Tests (N-QC), 5 Tests (N-QC).

Intended use

This device is intended to be used for the in vitro quantitative determination of Follicle Stimulating Hormone (FSH) in human whole blood, serum or plasma. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.

Summary

In women's menstrual cycle, due to the regulation of the hypothalamic-pituitary-ovarian axis (HPOA), the follicles develop normally and ovulate. Gonadotrophin-releasing hormone (GmRH) secreted by the hypothalamus acts on the gonadotropin cells of the pituitary to secrete follicle-stimulating hormone (FSH) and luteinizing hormone (luteinizing hormone, LH) in a pulsatile, and also acts on the ovary to promote the normal development and ovulation of follicles by the way of accepting the positive and negative feedback regulation of the ovary at the same time.

Both FSH and LH are glycoprotein hormones, which are formed by covalent bonding of two subunit peptide chains, α and β. They have the common α subunit structure, but the β subunit structure is different. The β subunit determines the specific antigenicity and specific function of the hormone, but it must be combined with the α subunit to form a complete molecule to have biological activity.

FSH and LH could work together to promote the growth and development of follicles and ovulation. Although FSH independently promotes follicle growth in the absence of LH, it may result in insufficient estradiol (E2) secretion and lack of capacity of luteinization and rupture. Initially, there is no LH receptor on granulosa cells. With the growth and development of follicles, FSH induces granulosa cells to generate LH receptors. Due to the upper limit of LH level varies among developmental stages and individual follicular development. When LH exceeds the upper limit, it inhibits the proliferation of granulosa cells, leading to follicular regression atresia or premature follicle luteinization, which suggests that LH has a negative selection effect on non-dominant follicles. During ovulation, the estrogen produced by the follicles has a positive feedback on the pituitary and hypothalamus to form the LH peak before ovulation, which can prompt the oocyte to resume the first meiosis and terminate in the middle of the second meiosis. The eggs are finally matured and released. During the luteal phase, the main role of LH is to maintain luteal function and promote the secretion of estrogen and progesterone.

The current clinical methods for detecting FSH include chemiluminescence, immunochromatography and so on.

PRODUCT PARAMETER

TEST PARAMETER
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA®FSH
Format	Cassette	Reaction Time	10min
Linearity	1～200mIU/L	Reference Interval	45 ～109 mIU/mL
Sample	WB / S / P	Certificate	CE

ORDERING
Cat. No.	LMTHFS25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LATHFS25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T