Fertility hormone array

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Intended Use

Evidence Fertility Hormone Array is to be used for the in vitro simultaneous quantitative detection of multiple related fertility immunoassays in parallel from a single patient sample, run on the automated biochip array analyser, Evidence.

Clinical Significance

Fertility hormones can not only test for pregnancy in women but are also be very important in the diagnosis of other conditions such as the onset of menopause and gonadal dysfunction. In men, fertility hormones can be accurate indicators of conditions such as liver cirrhosis and testicular cancer.

Principle

The Evidence analyser is a fully automated Biochip Array System. It performs simultaneous quantitative detection of multiple analytes from a single patient sample. The core technology is the Randox Biochip, a solid state device containing an array of discrete test regions containing immobilised antibodies and antigen complexes specific to different fertility markers.

A combination of competitive and sandwich chemiluminescent immunoassays is employed for the Fertility Array. Increased levels of fertility markers Prolactin, Follicle-Stimulating Hormone and Luteinising Hormone in a specimen will lead to increased binding of antibody labeled with horse radish peroxidase (HRP) and thus an increase in chemiluminescence being emitted. Increased levels of fertility markers Testosterone, Progesterone and Estradiol lead to decreased binding of antibody labelled with HRP and thus a decrease in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected using digital imaging technology and compared to that from a stored calibration curve. The concentration of analyte present in the sample is calculated from the calibration curve.

Several different immunoassay based multi-analyte panels have been developed for use on Evidence. In the Evidence Fertility Hormone Array, it will successfully quantitatively test for Follicle-Stimulating Hormone, Prolactin, Luteinising Hormone, Progesterone, Estradiol and Testosterone simultaneously.

 

Follicle-Stimulating Hormone (FSH) Assay

Intended Use

The Evidence Follicle-Stimulating Hormone assay has been designed for the quantitative measurement of FSH in human serum using the Evidence analyser.

Clinical Significance

Human follicle stimulating hormones, like human luteinising hormone (hLH, lutropin), are glycoproteins that are synthesised and secreted by the anterior pituitary. Their effect is targeted at the gonads. Their levels are controlled by gonadotrophin releasing hormone. Human FSH has a dimeric structure consisting of a non-specific alpha chain (this chain is interchangeable in FSH and LH) and a beta chain that determines hormone specificity. The two chains are non-covalently linked to one another.

In women, FSH helps control the menstrual cycle and the production of eggs in the ovaries. The amount of FSH varies throughout a women's menstrual cycle, and is highest just before she ovulates. In men, FSH helps control the production of sperm, with the level normally remaining constant.

The measurement of FSH is widely used in the diagnosis of disorders of reproduction and development. The primary use of FSH measurement is to assess gonadal function. Through a classical Endocrine feedback pathway, an elevated level of FSH indicates reduced gonadal function or gonadal failure, whereas a normal serum concentration of FSH suggests normal gonadal function. A low serum FSH may indicate a problem at the level of hypothalamus or pituitary. The majority of FSH tests will be for investigations of menopause status, diagnosis of infertility/ amenorrhea, and infertility in men.

Principle

The Evidence FSH assay is a sandwich chemiluminescent immunoassay for the detection of FSH in serum.

 

Luteinising Hormone (LH) Assay

Intended Use

The Evidence Luteinising Hormone assay has been designed for the quantitative measurement of LH in human serum using the Evidence analyser.

Clinical Significance

Human LH is secreted by the anterior pituitary and functions, in the female, in conjunction with human follicle-stimulating hormone (hFSH, follitropin) in controlling the menstrual cycle and steroidgenesis. Serial daily serum LH measurements can be used to estimate ovulation time by adding 12-18 hours to the time of LH peak, and this can be useful for the timing of artificial insemination, intrauterine insemination or non-surgical embryo transfer. In addition, the measurement of LH can aid in diagnosis and management of amenorrhea, pituitary or ectopic tumours and polycystic ovaries.

In males, LH promotes the production of testosterone from the interstitial (Leydig) cells, and, along with FSH is required to maintain spermatogenesis. The secretion of LH is controlled by a negative feedback of testicular hormones to the hypothalmus.

Raised levels of LH are found in the following instances: -

Clinical Polycystic Ovarian Disease, Menopause, Premature Ovarian Failure, Primary Testicular Failure, Klinefelter's Syndrome, Hypogonadism, Hyperthyroidism, Renal Failure, Cirrhosis, and Severe Starvation.

Reduced levels of LH are found in the following instances: -

Hypopituitarism, from pituitary dysfunction and Hypothalmus Dysfunction in women with clinical features of Anorexia Nervosa.

Principle

The Evidence LH assay is a sandwich chemiluminescent immunoassay for the detection of LH in serum.

 

Prolactin Hormone (PRL) Assay

Intended Use

The Evidence Prolactin assay has been designed for the quantitative measurement of PRL in human serum using the Evidence analyser.

Clinical Significance

Human Prolactin consists of a single peptide chain of 198 amino acids. It has a molecular weight of approximately 23,000 Daltons. Prolactin is produced by the anterior pituitary gland, where its synthesis and release are subject to an inhibiting or stimulating influence of the hypothalamus. In women the main function of prolactin is the induction and maintenance of lactation.

In human serum, prolactin exists in several molecular forms, including monomeric, big, and "big, big" prolactin (macroprolactin) with molecular weights of 23, 50 and 150-170 Kilodaltons respectively. Monomeric prolactin is the predominant form in the general population, but the distributions of the other forms vary. The macromolecular form of prolactin may be biologically less active than the monomers. Prolactin levels exhibit a diurnal variation with maximum levels during sleep. Levels also vary during the menstrual cycle, due to stress, breast stimulation and pregnancy.

Hyperprolactinemia (excessive secretion of prolactin) is a common cause of gonadal dysfunction and infertility in men and women. In women, hyperprolactinaemia may cause amenorrhea, galactorrhea, menstrual disorders and infertility. Men with hyperprolactinaemia typically exhibit hypogonadism, loss of libido, impotence and decreased sperm volume. There are numerous causes for this disorder including prolactin-secreting tumours and certain drug therapies.

Principle

The Evidence PRL assay is a sandwich chemiluminescent immunoassay for the detection of PRL in serum.

 

Progesterone (PROG) Assay

Intended Use

The Evidence Progesterone assay has been designed for the quantitative measurement of PROG in human serum using the Evidence analyser.

Clinical Significance

Progesterone is secreted by the corpus luteum of the ovary in females during the normal menstrual cycle and to a lesser extent by the adrenal cortex.

Progesterone is primarily involved in the preparation of the uterus for implantation and maintenance of pregnancy.

Levels are most often measured in investigations of ovarian function in order to gauge the adequacy of luteinisation and to confirm that ovulation has taken place.

Measurement of progesterone in the first 10 weeks of gestation has been shown to be reliable and effective for the diagnosis and treatment of patients with threatened abortion and ectopic pregnancy ¹.

Principle

The Evidence PROG assay is a competitive chemiluminescent immunoassay for the detection of PROG in serum.

REFERENCES

1. Witt, B.R., et al Relaxin, CA-125, Progesterone, Estradiol, Schwangerschaft Protein and Human Chorionic Gonadotropin as Predictors of outcome in threatened and non-threatened pregnancies. Fertil. Steril. 1990; 53:1029-36.

 

Testosterone (TEST) Assay

Intended Use

The Evidence Testosterone assay has been designed for the quantitative measurement of TEST in human serum using the Evidence analyser.

Clinical Significance

Testosterone is the principle androgen. It is synthesised in the testes, the ovary and the adrenal cortex. It is responsible for the development and maintenance of male secondary sex characteristics.

98% of testosterone in circulation is protein bound. In males, Sex Hormone Binding Globulin (SHBG) and serum albumin bind the majority of testosterone ¹.

The level of testosterone in men decreases with age and is measured in investigations of hypogonadism, infertility, hypopituitarism, testicular failure and hyperprolactinemia. In women it is measured most often in hirsutism but polycistic ovary syndrome, adrenal hyperplasia, infertility, amenorrhoea, obesity and virilization can also cause changes in serum testosterone levels ².

Principle

The Evidence TEST assay is a competitive chemiluminescent immunoassay for the detection of TEST in serum.

REFERENCES

1. Dunn, J.F., Nisula, B.C., Rodbard, D. J of Clinical Endocrinology and Metabolism, 1981; 53:58-68.

2. Berkow, R (Editor) The Merck Manual of Diagnostics and Therapy. Published - Merck Sharp & Dohme Research laboratories. 1987, 15^th Edition pp.1055, 2071-2076, 1695.

 

Estradiol (EST) Assay

Intended Use

The Evidence Estradiol assay has been designed for the quantitative measurement of EST in human serum using the Evidence analyser.

Clinical Significance

Estradiol is mainly secreted by the ovaries in non-pregnant women. Small amounts are also secreted by the testes in men and the adrenal cortex in both men and women. During pregnancy, the placenta produces most of the circulating estradiol, which helps to maintain pregnancy. Estradiol plays important roles in female sexual development and regulation of the menstrual cycle. In menstruating women cyclic estradiol shows cyclic variation with the highest values observed the day before ovulation. This is believed to be essential for the mid cycle LH peak that results in ovulation.

Measurement of estradiol is important in the diagnosis of amenorrrhoea and for assisted reproduction technology.

Principle

The Evidence EST assay is a competitive chemiluminescent immunoassay for the detection of EST in serum.