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Fertility and Pregnance

REPRODUCTION AND PREGNANCY

K202        K203        K205        K206        K207        K208  

K209        K215        K217        K235        K238        K268   

K202 Luteinizing hormone (LH) EIA                                                             New 1 step version

Luteinizing hormone (LH) is produced in both men and women by the anterior pituitary gland in response
to luteinizing hormone-releasing hormone (LH-RH or Gn-RH), which is released by the hypothalamus.
LH, also called interstitial cell-stimulating hormone (ICSH) in men, is a glycoprotein with a molecular
weight of approximately 30,000 daltons. It is composed of two noncovalently associated amino acid
chains: alpha and beta.
The basal secretion of LH in men is episodic and has the primary function of stimulating the interstitial
cells (Leydig cells) to produce testosterone. The variation in LH concentrations in women is subject to
the complex ovulatory cycle of healthy menstruating women, and depends on sequence of hormonal
events along the gonado-hypothalamus-pituitary axis. During the cycle, LH level is low except for the
middle of the cycle when its concentration may increase up to 5-10 fold. LH peak is preceeded by a
peak of Estradiol which occurs approximately 12 hours earlier. Ovulation occurs 12-120 hrs after LH
peak. When the ovum is released, the corpus luteum is formed which secretes progesterone and estradiol,
these latter exerting negative feedback effects on LH and FSH levels through hypothalamo-pituitary axis.
LH concentration in blood is subject to circadian rhythms; therefore blood sample for LH assay should
always be taken at the same time of the day. Circadian variations of LH level are more pronounced in
women depending on the stage of menstrual cycle: they become less frequent at the end of luteinic
phase and less pronounced – at the end of follicular stage.
Increased LH levels are found in primary dysfunction of gonadal glands, in amenorrhea caused by
ovarian insufficiency, in Stein-Leventhal syndrome, after menopause. Increased concentrations of LH
are also present during renal failure, cirrhosis, hyperthyroidism, and severe starvation.
Decreased LH concentrations are seen in dysfunction of hypophysis or hypothalamus, in galactorrheaamenorrhea
syndrome, in isolated decrease of gonadotropins, in isolated LH decrease; in neurotic
anorexia, in patients with retardation of growth and sexual development, after intake of digoxin,
phenotiazine, progesterone, estrogens.
In the differential diagnosis of hypothalamic, pituitary, or gonadal dysfunction, assays of LH concentration are
routinely performed in conjugation with FSH assays since their roles are closely interrelated. Furthermore, the
hormone levels are used to determine menopause, pinpoint ovulation, and monitor endocrine therapy.

Sample type: serum, plasma                         Incubation: 60’/15’, 370С                           Control sample: 1
Sample volume: 50 μl                                   Calibrators: 5 (0-100 IU/l)                         Shelf life: 12 months
Sensitivity: 0.3 IU/l

K203 Follicle Stimulating Hormone (FSH) EIA                                               New 1 step version

Follicle stimulating hormone (FSH) is a glycoprotein with molecular weight 28 kDa secreted by basophil
cells in hypophysis. Gonadotropin releasing hormone (GnRH) produced by the hypothalamus controls
the release of FSH from anterior pituitary. FSH and Luteinizing hormone (LH) are intimately involved in
the control of the growth and reproductive activities of the gonadal tissues, which synthesize and secrete
male and female sex hormones. The levels of circulating FSH and LH are controlled by these sex hormones
through a negative feedback. Like LH, TSH and HCG, FSH consists of two subunits – alpha and beta, its
biological and immunological properties being dependent on the hormone-specific beta subunit.
In females, FSH stimulates the growth and maturation of ovarian follicles. At the beginning of normal
menstrual cycle FSH level is higher than at the final stage of follicular phase. Peak FSH levels are seen
in the middle of the cycle concomitantly with LH peak levels. Increased estradiol and progesterone
production during luteinic phase leads to decreased FSH blood concentrations by negative feedback
mechanism. The same mechanism leads to elevation of FSH levels at the end of the cycle due to decreased
estrogen and progesterone concentrations, and the new cycle is initiated.
In men, FSH regulates growth of seminiferous tubules and maintenance of spermatogenesis. However,
androgens, unlike estrogen, do not lower FSH level, therefore demonstrating a feedback relationship only
with serum LH. High levels of FSH in women are seen in menopause, preliminary ovarian failure, agenesia of
ovaries; in men elevated FSH levels may be found in primary testicular failure, dysgenesia of seminiferous
tubules, delayed sexual maturation, and Klinefelter syndrome. Elevated concentrations are also found in
cases of starvation, renal failure, hyperthyroidism, cirrhosis and after intake of clomifen, l-DOPA.
Decreased FSH levels are found in hypopituitarism and after intake of oral contraceptives, phenotiazine,
estrogens.

Sample type: serum, plasma                         Incubation: 60’/15’, 370С                           Control sample: 1
Sample volume: 50 μl                                   Calibrators: 5 (0-100 IU/l)                         Shelf life: 12 months
Sensitivity: 0.3 IU/l

K206 Prolactin EIA                                                                                    New 1 step version

Prolactin is a 198 aminoacids polypeptide with molecular weight ca. 22.5 kDa which is secreted
by eosinophil cells of hypophysis.
Hyperplasia and adenomas of hypophysis are the main causes of infertility. Functional changes
in regulation of reproductory function are also caused by alterations in secretion of hormones
of hypophysis. One of markers of such alterations is changes in Prolactin secretion. That is why
WHO recommended to use determination of Prolactin level as a screening test in primary laboratory
investigation of couples claiming for infertility.
In women Prolactin level remains low before menarche and elevates during puberty. During this period,
Prolactin stimulates development of mammary glands. Prolactin level changes during menstrual cycle
with elevations up to 900 mIU/l seen during periovulatory period and the second stage of luteinic
phase. That is why it is recommended to evaluate Prolactin level during the first stage of the cycle.
Besides, physiological hyperprolactinemia is seen in stress conditions and after physical exercises.
Prolactin secretion is subject to circadian rhythms with maximal levels found during the night (3-7 fold
higher than during the day). That is why time of sampling is extremely important.
Elevated Prolactin levels are seen in Prolactin-producing tumors of hypophysis, idiopathic
hyperprolactinemias (symptoms: in women – alteration of menstrual cycle, in men – impotence),
hypofunction of the thyroid gland, renal insufficiency, after intake of phenothiazine derivatives,
haloperidol, estrogens, oral contraceptives, histamine preparations, opiates, in hypoglycemia caused
by insuline intake.
Low Prolactin levels are found after surgical resection of hypophysis, after X-ray therapy, after
bromocriptin therapy, after intake of T4.

Sample type: serum, plasma                         Incubation: 60’/15’, 370С                            Control sample: 1
Sample volume: 50 μl                                   Calibrators: 5 (0-2000 mIU/l)                      Shelf life: 12 months
Sensitivity: 10 mIU/l

K207 Progesterone EIA

Progesterone is a gestagen with a MW of 314.5 Dalton. Progesterone is secreted by corpus luteum,
adrenals and testis; it plays a role of a precursor for corticosteroids and androgens. Being an estrogen
antagonist, Progesteron induces characteristic changes in endometrium necessary for implantation
of an impregnated ovum.
During normal menstrual cycle, Progesterone level remains low until LH peak level begins to drop: only
slight but statistically significant elevation of Progesterone level occurs concomitantly with LH peak
followed by a decrease of Progesterone concentration. During second stage of the cycle, Progesterone
and Estradiol levels increase again to complete luteinization. By the end of the cycle, Progesterone level
drops again up to levels seen during follicular phase. This quick drop causes menstrual bleeding.
During pregnancy, Progesterone concentration continuously increases, and it induces proliferation
and development of mammary glands and inhibits ovulation. During the first trimester, Progesterone
is secreted by corpus luteum while from month 3-4 – by mitochondria of the trophoblast. Progesterone
level in maternal blood increases rapidly – by week 7-8 it increases 2-fold and continues to increase
by week 37-38. Decreased Progesterone levels indicate pathology of pregnancy while elevated levels
suggest renal insufficiency.
Elevated Progesterone levels are found in pregnancy, tumors of adrenals or testicles, chorionepithelioma,
in lipid tumors of ovaries as well as after intake of preparations of Progesterone or its analogs.
Decreased Progesterone levels are seen in galactorrhea-amenorrhea syndrome, in pregnant women
at risk of premature delivery, and in persons taking some drugs such as oral contraceptives, ampicilline,
ethynilestradiol.

Sample type: serum, plasma                         Incubation: 60’/15’, 370С                            Control sample: 1
Sample volume: 25 μl                                   Calibrators: 6 (0-100 nmol/l)                       Shelf life: 12 months
Sensitivity: 0.5 nmol/l

K208 Estradiol EIA

Estradiol (E2) is a steroid hormone with molecular weight 272.4 Da. In humans, E2 shows the highest
physiological activity among the estrogens. In males, minor quantities of E2 are produced by adrenals
and testicles. In females, E2 is produced by ovarian follicles. The physiological activity of E2 involves
multiple functions in female reproductive system. Regulation of E2 production and secretion is complex
and depends on pituitary and ovarian hormones.
Serum E2 level is low in follicular phase of the menstrual cycle; 3-5 days before serum LH peak, serum E2
level begins to rise and reaches its maximum ca. 12 hours before LH peak. After LH peak, E2 level drops
dramatically to the minimal level and starts to rise again. The maximal E2 level in serum is observed in luteal
phase, at day 9 after ovulation; then the decline of serum E2 reflects the degradation of corpus luteum.
During pregnancy, the determination of serum E2 reflects the status of foetoplacental system. In first
trimester, serum E2 level is in the range corresponding to the ovulation levels. Sharp increase of serum
E2 in pregnant women is observed between 9th and 10th week; then the increase continues less
sharply by the end of pregnancy.
Increased levels of serum estradiol are characteristic for metrorrhagias in post-menopausal age;
adrenal hyperplasia; estrogen-secreting tumors; liver cirrhosis; feminization in children and males;
intake of gonadotropins and estrogens.
Decreased levels of serum estradiol are observed in Turner syndrome, primary or secondary hypogonadism;
germaphroditism; post-climacteric syndrom; fetal disfunctions; intake of oral contraceptives.


Sample type: serum, plasma                         Incubation: 120’/15’, 370С                          Control sample: 1
Sample volume: 25 μl                                   Calibrators: 6 (0-20 nmol/l)                        Shelf life: 12 months
Sensitivity: 0.05 nmol/l

K209 Testosterone EIA

Testosterone is a steroid with a MW of 288.4 Dalton. The main sites of testosterone
secretion are Leidig cells in interstitial tissue of testicles in men. In women
testosterone is secreted in the adrenals and is controlled by luteinizing hormone.
Testosterone stimulates development of male genital organs and formation of
secondary sexual features.
In males, Testosterone secretion undergoes circadian rhythms with maximal concentrations seen in the
morning (6 am) and minimal – in the evening (8 pm). In females, Testosterone secretion is regulated
by menstrual cycle with maximal levels found in luteinic phase and during ovulation.
Leidig cell tumors producing high levels of serum testosterone in young boys lead to development
of “little Hercules” syndrome. Elevated testosterone level in women causes the clinical signs of
masculinization.
In men, decreased Testosterone levels may lead to female habitus or underdevelopment of male
genital organs in boys. To differentiate between primary and secondary hypogonadism, Testostrerone
should be assayed in conjunction with LH and FSH.

Sample type: serum, plasma                         Incubation: 120’/15’, 370С                          Control sample: 2
Sample volume: 25 μl                                   Calibrators: 6 (0-40 nmol/l)                        Shelf life: 12 months
Sensitivity: 0.3 nmol/l

K209S Salivary Testosterone EIA                                                                               New kit!

In serum, Testosterone is found both in free and bound form, the latter being a complex with transport
proteins (SHBG, albumin). But only free form exerts biological activity, although its proportion is lt 1%
of total Testosterone. Currently, there are no reliable immunochemical method for quantitative
determination of free Testosterone in serum. At the same time, complicated reference laboratory
methods (e.g., dialysis) are not suitable for everyday use. That is why the only method of direct
determination of free Testosterone is its determination in saliva. Follow-up of salivary Testosterone
level is a very informative and non-traumatic method widely used in endocrinology, physiology,
sport medicine, veterinary, etc. for estimation of masculine status. Elevated salivary Testosterone
in females is characteristic for hirsutism, polycystosis of ovaries and serves as a laboratory marker
of masculinization. Stably low levels of salivary Testosterone in males suggest primary or secondary
hypogonadism.

Sample type: saliva                                     Incubation: 120’/15’, 370С                          Control sample: 1
Sample volume: 100 μl                                 Calibrators: 7 (0-10 ng/ml)                         Shelf life: 12 months
Sensitivity: 0.015 ng/ml

K215 DHEA-S EIA

Dehydroepiandrosterone (DHEA) is an androgen with a MW of 288.4 Dalton secreted in adrenals.
The main derivate of DHEA present in human tissue is DHEA sulfate (DHEAS). Since birth, DHEAS
serum concentration is increasing continuously showing a pronounced peak after puberty and maximal
levels at the age of 20. After that, serum DHEAS level continuously decreases. As DHEAS is the main
component of 17-ketosteroids in serum, this test may substitute for column tests for determination of
17-ketosteroids in urine.
Elevated DHEAS concentrations are found in adrenogenital syndrome, hirsutism, acne, benign
hyperplasia of adrenals and adrenal tumors, Stein-Leventhal syndrome, polycystic ovary syndrome.
Decreased levels of DHEAS are found in hyperlipidemia, psychotic states, psoriasis, adrenal
insufficiency.

Sample type: serum, plasma                         Incubation: 60’/15’, 370С                           Control sample: 1
Sample volume: 25 μl                                   Calibrators: 6 (0-26 mcmol/l)                      Shelf life: 12 months
Sensitivity: 0.05 mcmol/l

K217 17-ОН-Progesterone EIA

17-ОН-progesterone (17-ОН-P) is a steroid with molecular weight 330 D, an intermediate precursor in
biosynthesis of glucocortiosteroids, estrogens and androgens.
17-OH-P is secreted by adrenals, ovaries and testicles by the enzyme 21-hydroxylase. 17-ОН-Р is
secreted by ovaries during follicular phase; its serum level remains stable by the end of luteal phase.
In case of non-fertile cycle, the serum level of 17-OH-P decreases; in case of fertilization, this hormone
is secreted by corpus luteum.
The determination of 17-OH-P is important for diagnosis of inborn adrenal hyperplasia which causes
elevated secretion of androgens and the development of adrenogenital syndrome (AGS). In AGS, the
deficient 21-hydroxylase activity causes blocked steroid synthetic pathway and correspondent dramatic
increase in serum 17-OH-P level. If the deficiency of 21-hydroxylase is acquired in mature age, or in
case of delayed inborn defect, the serum 17-OH-P may remain normal.

Sample type: serum, plasma                         Incubation: 90’/15’, 370С                           Control sample: 1
Sample volume: 50 μl                                   Calibrators: 6 (0-100 nmol/l)                      Shelf life: 12 months
Sensitivity: 0.20 nmol/l
 

K205 Human Chorionic Gonadotropin (HCG) EIA

Human chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by trophoblastic cells
of placenta. A molecule of HCG consists of two noncovalently bound subunits: alpha- and beta-.
Beta-subunit is specific for HCG hormone.
Determination of HCG is widely used for early diagnosis of pregnancy. Multiple pregnancy results
in correspondent elevation of serum HCG; while ectopic pregnancy and placental insufficiency cause
decreased serum HCG levels. Determination of HCG in serum during second trimester is used for
pregnancy monitoring, especially in screening for Down syndrome, along with other laboratory tests
(AFP and Estriol).
Serum HCG is also a laboratory marker of trophoblastic tumors - chorionepitheliomas, some seminomas
and theratomas. Serial determination of serum HCG may be used for therapy monitoring in these
cancers.The present test system uses beta chain specific monoclonal antibody XK27 as the capture,
and alpha-chain specific monoclonal antibody XK77 as the tracer; therefore only the whole intact HCG
molecule is detected.

Sample type: serum, plasma                         Incubation: 30’/30’/15’, 370С                      Control sample: 1
Sample volume: 50 μl                                   Calibrators: 6 (0-200 IU/l)                          Shelf life: 12 months
Sensitivity: 2.5 IU/l
 

K235 Free beta-HCG EIA                                                                                          New kit!

Human chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by trophoblastic cells
of placenta during pregnancy. HCG appears in blood and urine in about 7-13 day after fertilization,
reaching its maximum by the end of the first trimester. An intact molecule of HCG consists of two noncovalently
bound polypeptide chains: alpha- and beta-. Beta-chain is specific for HCG hormone while
alpha-chain is identical in TSH, LH, FSH and HCG..
Normally, blood levels of free alpha- and beta-chains come to not more than 0.5-1.0% of intact HCG
level and during pregnancy vary in parallel with intact HCG. Recently, it was shown that a pronounced
rise of free beta-chain is found in trisomy 21 (Down syndrome). Determination of free beta-chain
of HCG in conjunction with PABB-A (Xema Cat. K238) and USI of nuchal translucency allows to detect
trisomy 21 as early as in the first trimester of pregnancy.
In oncology, a marked rise of free beta-chain in blood is found in trophoblastic and germinal tumors
(choriocarcinoma, carcinoma of ovaries, etc.).

Sample type: serum, plasma                         Incubation: 30’/30’/15’, 370С                      Control sample: 1
Sample volume: 50 μl                                   Calibrators: 6 (0-200 ng/ml)                       Shelf life: 12 months
Sensitivity: 2.0 ng/ml

K238 PAPP-A EIA                                                                                                    New kit!

PAPP-A (pregnancy-associated plasma protein A) is a high molecular weight glycoprotein consisting
of two subunits. In normal pregnancy, PAPP-A level in maternal blood increases during the first two
trimesters. Functional significance of PAPP-A during pregnancy remains unclear.
Lowered levels of PAPP-A are observed in Down’s syndrome (trisomy 21) during weeks 8-12; after week
14, PAPP-A levels become similar to those in normal pregnancies. Low PAPP-A levels are also found in other
trisomies (18 and 13) and chromosomal abnormalities in the fetus and in complicated pregnancies.
Determination of PAPP-A level in the first trimester is used in the following combinations of tests:
- PAPP-A + free beta-HCG
- PAPP-A + free beta-HCG + USI of nuchal translucency
In men and non-pregnant women, PAPP-A level is extremely low – usually, it is below the sensitivity
level of most immunoassays. Recently, some evidence has appeared to confirm a link between raised
PAPP-A levels and increased risk of complications in patients with coronary disease.

Sample type: serum, plasma                         Incubation: 60’/15’, 370С                           Control sample: 1
Sample volume: 10 μl                                   Calibrators: 6 (0-10000 mU/l)                     Shelf life: 12 months
Sensitivity: 100 mU/l
 

K268 Sex Hormone-Binding Globulin (SHBG) EIA                                                          New kit!

Sex steroid binding globulin (SHBG) represents a glycoprotein with MW ca. 100 kDa secreted by
hepatocytes. SHBG effectively binds sex steroid hormones, especially testosterone, DHT and
estradiol. The up-regulation of SHBG synthesis is caused by thyroid hormones, estrogens, stress, high
carbohydrate intake. Other factors, ie glucocorticoids, testosterone, progesterone, prolactin, growth
hormone, adiposity and menopause, down-regulate the SHBG secretion. SHBG is a transport protein
for androgens and estrogens, delivering the biologically active hormones to the target organs and
tissues and preventing their degradation in circulation.
Known clinical situations with changed serum SHBG include:
- DECREASED LEVEL: hirsutism, mixedema, adiposity;
- INCREASED LEVEL: hypogonadism, gynaecomasty, Cushing syndrome, liver cirrhosis,
thyreotoxicosis.
In females with clinical signs of hyperandrogenaemia and normal or moderately elevated serum
testosterone serum SHBG is frequently considerably decreased. The clinical picture in such cases
is explained by higher proportion of free active testosterone and correspondent exposure of the
target tissues to higher androgenic effect.
Therefore SHBG measurement is recommended in cases when testosterone and estradiol data are
conflicting with the clinical data; as well as in other cases of sexual dysfunctions and multiple ovarian
cysts in females.
 

Sample type: serum, plasma                         Incubation: 120’/15’, 370С                          Control sample: 1
Sample volume: 25 μl                                   Calibrators: 5 (0-60 μg/ml)                         Shelf life: 12 months
Sensitivity: 0.7 μg/ml

Copyright © 2002 GENTAUR Molecular Products
Last modified: 05/29/09