Women's Health

Diabetes & Blood Sugar, Women's Health

The American College of Obstetricians and Gynecologists (ACOG) recommends that all pregnant women be screened for gestational diabetes mellitus (GDM)—whether by patient history, clinical risk factors, or with a 50-gram, one-hour loading test at 24 to 28 weeks of gestation to determine blood glucose levels—and suggests relying on the result of the 100-gram, three-hour oral glucose tolerance test for diagnosis (often referred to as a "two-step" method).2The American Diabetes Association (ADA)3released standards that vary from the ACOG recommendations. The ADA recommends a simplified "one-step" approach to the screen and diagnosis of gestational diabetes mellitus with a 75-gram, two-hour glucose tolerance test. The LabCorp test according to the ADA recommendations isGestational Glucose Tolerance Screening and Diagnostics Test (Two-hour, ADA Recommendations) [101000]. A glucose tolerance screen glucose threshold >139 mg/dL after a 50-gram load identifies approximately 80% of women with gestational diabetes mellitus, while the sensitivity is further increased to approximately 90% by a threshold >129 mg/dL. Perform a diagnostic 100-gram oral glucose tolerance test(102004)on a separate day on women who exceed the chosen threshold on 50-gram screening.

Hormone Testing, Women's Health

Levels rise during pregnancy and are elevated during lactation, in postpartum subjects, and following bilateral oophorectomy. Destructive pituitary diseases cause low levels. Hypothalamic lesions may be associated with increased values. Many pituitary tumors which previously were called chromophobe adenomas are now recognizable as prolactinomas.Patients with hyperprolactinemia may have the multiple endocrine neoplasia syndrome, MEN-1.6Provocative tests used in work-up of hyperprolactinemia include metyrapone stimulation of ACTH-2 and TRH provocative test.7Antipsychotic drugs may elevate serum prolactin. Antipsychotics block dopamine, thereby elevating serum prolactin levels. Hyperprolactinemia is present in many patients receiving neuroleptics with an occasional patient developing amenorrhea, galactorrhea, and/or decreased libido. Amoxapine, a dibenzoxazepine type of tricyclic with antidepressant and antipsychotic characteristics, has been found to cause galactorrhea and oligomenorrhea with hyperprolactinemia. Amoxapine may have a dopamine blocking action.8The prolactin level may rise significantly but only briefly. Point prolactin level determinations during therapy may be within normal range while total integrated 24-hour secretion is significantly increased. It has been recommended that patients who develop amenorrhea and/or galactorrhea during neuroleptic therapy should be observed regularly for possible emergence of a pituitary tumor.Persistent elevations of plasma prolactin levels may be observed with, and after withdrawal from, chronic cocaine abuse, and may reflect a cocaine-induced derangement in the neural dopaminergic regulatory systems.9

Women's Health

Similarly to LH, FSH, and TSH, human chorionic gonadotropin (hCG) is a member of the glycoprotein family and consists of two subunits (α- and β-chains) that are associated to the intact hormone.1-7The α-chains in all four of these glycoprotein hormones are virtually identical, whereas the β-chains have greatly differing structures and are responsible for the respective specific hormonal functions.hCG is produced in the placenta during pregnancy. In nonpregnant women, it can also be produced by tumors of the trophoblast, germ cell tumors with trophoblastic components, and some nontrophoblastic tumors.Human chorionic gonadotropin consists of a number of isohormones with differing molecular size. The biological action of hCG serves to maintain the corpus luteum during pregnancy. It also influences steroid production. The serum of pregnant women contains mainly intact hCG.Measurement of the hCG concentration permits the diagnosis of pregnancy just one week after conception. The determination of hCG in the first trimester of pregnancy is of particular importance. Elevated values here serve as an indication of chorionic carcinoma, hydatiform mole, or multiple pregnancy. Depressed values indicate threatening or missed abortion, ectopic pregnancy, gestosis or intrauterine death.Elevated hCG concentrations not associated with pregnancy are found in patients with other diseases, such as tumors of the germ cells, ovaries, bladder, pancreas, stomach, lungs, and liver.6,7

Women's Health

Offered as part of multiple lab tests

Women's Health, Hormone Testing

Estradiol is responsible for the regulation of the estrous and menstrual female reproductive cycles and for the development and maintenance of female secondary sex characteristics.3,4Estradiol plays a key role in germ cell maturation and numerous other, non−gender-specific processes, including growth, bone metabolism, nervous system maturation, and endothelial responsiveness. Estrogens are crucial for the normal development and maintenance of the breasts and the uterus.5However, excessive estrogen levels can promote cell proliferation and may increase the risk of developing breast and uterine cancer as well as uterine endometriosis.5The three major naturally occurring estrogens in women are estrone (E1), estradiol (E2), and estriol (E3). E2 is the predominant estrogen during reproductive years, both in terms of absolute serum levels as well as in terms of estrogenic activity.3During menopause, a dramatic drop in E2 production leaves estrone as the predominant circulating estrogen. Estriol is the main pregnancy estrogen, but it does not play a significant role in nonpregnant women or men.3The concentration of E2 in men is much lower than in women of reproductive age. All estrogens are synthesized from androgen precursors by the enzyme aromatase.3,5Aromatase converts the androgenic substrates androstenedione, testosterone, and 16-hydroxytestosterone to the corresponding estrogens: estrone, estradiol, and estriol.5E2 is produced primarily in ovaries and testes by aromatization of testosterone.3A lesser amount of E2 is produced in the adrenal glands and some peripheral sites, most notably adipose tissue. Most of the circulating estrone is derived from peripheral aromatization of androstenedione (mainly in the adrenal gland). E2 and E1 can be converted to each other, and both are inactivated via hydroxylation and conjugation. E2 demonstrates two to five times the biological potency of E1.3The importance of E2 testing and the need for reliable and accurate estradiol measurements throughout the analytic range are emphasized in several recent publications.6-8LabCorp offers a sensitive estradiol by LC/MS(140244). Measurement of serum E2 serves an integral role in the assessment of reproductive function in females and in the assessment of infertility, oligomenorrhea, and menopausal status. E2 is commonly measured for monitoring ovulation induction, as well as during preparation for in vitro fertilization. Because of the relatively high serum concentrations of E2 in these patients, readily available automated immunoassay methods with modest sensitivity meet the clinical requirements.Adult female.In premenopausal women, E2 levels, along with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels, delineate the stage of the menstrual cycle.3E2 levels are lowest during the early follicular phase and rise gradually. Two to three days before ovulation, estradiol levels start to increase much more rapidly to a peak just before ovulation. This dramatic increase in circulating E2 levels induces a surge in LH and FSH. E2 levels decline modestly during the ovulatory phase and then increase again gradually until the midpoint of the luteal phase and ultimately decline back to early follicular levels.Assessment of E2 levels is useful for the evaluation of hypogonadism and oligomenorrhea in women. Decreased ovarian estrogen production is classified as hypergonadotropic or hypogonadotropic, depending on whether the disease is of gonadal or pituitary/hypothalamic origin.9-11Measurement of gonadotropins (LH and FSH) is fundamental in differentiating these two low estradiol states. The main causes of primary gonadal failure (hypergonadotropic) are genetic (Turner syndrome, familial premature ovarian failure), autoimmune (autoimmune ovarian failure, autoimmune polyglandular endocrine failure syndrome type II), and toxic (related to chemotherapy or radiation therapy for malignant disease).Low E2 with low or inappropriately "normal" LH and/or FSH in young adult females is consistent with hypogonadotrophic hypogonadism.11-13This can be caused by hypothalamic or pituitary failure due to conditions including multiple pituitary hormone deficiency and Kallmann syndrome. Diagnostic workup includes the measurement of E2, along with pituitary gonadotropins and prolactin and, possibly, imaging. This endocrine presentation can be caused by starvation, overexercise, severe physical or emotional stress, and drug/alcohol abuse. While early studies suggested that E2 levels could be used to predict ovarian reserve in women of reproductive age undergoing assisted reproduction procedures, more recent studies have found the marker less useful.14Estradiol measurement is useful in assessing the status of ovulation induction in women with hypogonadotropic hypogonadism,15and for the prediction and prevention of ovarian hyperstimulation syndrome in patients undergoing assisted reproduction.16Normal or high E2 with irregular or absent menstrual periods is suggestive of possible polycystic ovarian syndrome, androgen producing tumors, or estrogen producing tumors. In these cases, measurement of total and bioavailable androstenedione, dehydroepiandrosterone (sulfate), and sex hormone-binding globulin can aid in differential diagnosis.The main site of estrogen biosynthesis in the nonpregnant premenopausal woman is the ovarian granulosa cells; however, the adipose tissue becomes a major source of circulating estradiol in postmenopausal women.3After menopause, androstenedione, secreted by the adrenal gland, is converted into estrone in the adipose tissue.3The conversion of plasma androstenedione to estrone increases with excess body weight in both pre- and postmenopausal women.3Estrone is then eventually converted to estradiol by 17-β-hydroxysteroid dehydrogenase enzymes present in peripheral tissues.3Measurement of E2 level, together with FSH and/or anti-Müllerian hormone (AMH) can be useful in predicting the timing of the transition into menopause.17,18A large population study (Randolph) found that the mean E2 level started to decline approximately two years prior to the final menstrual period (FMP) and exhibited a maximal rate of change at the FMP. The mean E2 level stabilized a menopausal level approximately two years after FMP.17A sensitive estradiol assay is required to measure E2 levels accurately in postmenopausal women. The current recommendations for postmenopausal female hormone replacement are to administer therapy in the smallest beneficial doses for as briefly as possible. Estrogen replacement in reproductive-age women should aim to mimic natural estrogen levels as closely as possible, while levels in menopausal women should be held near the lower limit of the premenopausal female reference range. Postmenopausal women with lower E2 levels are at increased risk of osteoporotic fractures, while higher estradiol levels are associated with increased risk of malignancy and cardiovascular disease.19,20Accurate measurement of E2 in women receiving hormone replacement may play a role in optimizing therapy.Gonadotropin receptor hormone (GNRH) analogues are used therapeutically to reduce the ovarian production of estradiol in sex hormone-dependent disorders, including endometriosis and uterine fibroids.21Aromatase inhibitors are also used therapeutically to reduce circulating estrogens (E2 and E1) levels in hyperestrogenic conditions (ie, endometriosis in women and gynecomastia in men) and in estrogen-sensitive malignancies.22-26The complete or near complete suppression of estradiol production induced by these treatments produces low serum levels that can only be accurately measured by sensitive methods.27SeeEstradiol, Sensitive (LC/MS) [140244].Adult male.The use of a sensitive, LC/MS assay for serum E2 measurement in males is preferred over direct immunoassays because of its greater sensitivity and lesser interference by other steroids.28See LabCorp testEstradiol, Sensitive (LC/MS) [140244]. In males, estradiol is present at low concentrations in blood, but it is extraordinarily high in semen.3Estradiol plays an important role in epididymal function and sperm maturation and is essential for normal spermatogenesis and sperm motility.3Gynecomastia refers to a syndrome of abnormal feminization with swelling of the breast tissue in boys or men, caused by an imbalance of the hormones estrogen and testosterone.29Gynecomastia is common during puberty in boys and can be seen in older males due to increased estrogen levels related to obesity (increased aromatase activity), decreased hepatic clearance, estrogen ingestion, and estrogen-producing tumors. Asymptomatic gynecomastia is common in older men, but individuals who present with gynecomastia of recent onset (associated with pain and tenderness) may require clinical workup.29Gynecomastia and other signs of male feminization may be caused by an absolute increase in E2 and/or E1. The testes may directly secrete too much estradiol due to a Leydig-cell or Sertoli-cell tumor. They may also secrete estradiol indirectly through the stimulatory effect of a human chorionic gonadotropin-secreting tumor of gonadal or extragonadal germ-cell origin.29Alternatively, men with normal estrogen levels can develop gynecomastia, if testosterone levels are low due to primary/secondary testicular failure, resulting in an abnormally elevated estrogen:androgen ratio. Feminization may also occur in men treated with antiandrogen therapy or drugs with antiandrogenic effects (eg, spironolactone, digitalis). Conversely, individuals with elevated androgen levels will often exhibit gynecomastia caused by aromatase-catalyzed estrogen production.Estrogens (and androgens) play an important role in the normal physiology of the skeleton in both sexes.3Males with diminished estrogen levels (due to congenital aromatase deficiency) or insensitivity to estrogens (due to estrogen receptor deficiency) have a characteristic phenotype with regard to bone development.3,25These males exhibit significant increased overall height due to lack of estrogen-induced epiphyseal closure.25The importance of estradiol in bone health is further supported by the fact that estradiol levels correlate better with bone mineral density than do testosterone levels in aging men.25The Endocrine Society has recently reported that low estradiol levels are associated with increased fracture risk and accelerated bone loss in older men.30Children and adolescents.A sensitive method is required to measure accurately the E2 concentrations found in boys and prepubertal girls. See LabCorp testEstradiol, Sensitive (LC/MS) [140244]. Levels in boys and heavier girls are generally lower than in girls of normal weight.31,32Adrenal steroids tend to increase prior to gonadal steroids at the beginning of the pubertal transition.31In girls, E2 concentrations increase just before breast development.31In precocious puberty (PP), estradiol and the gonadotropins, LH and FSH, tend to be above the prepubertal range.33E2 measurement in children suspected of having PP is performed to support the diagnosis and to determine the origin of the condition or disease. The source of increased estradiol can be exogenous estrogens or an ovarian cyst that has produced transient estrogens. Elevation of E1 or E2 alone suggests pseudoprecocious puberty, possibly due to a steroid-producing tumor.It is not normal for an adolescent to be amenorrheic for greater than three months, even in the early gynecologic years,34and menstrual cycle duration persistently outside 21 to 45 days in adolescents is unusual.35Since estrogen deficiency is a risk factor for later development of osteoporosis and cardiovascular disease, a workup including sensitive E2 measurement is recommended for adolescent girls and women with potentially disordered hypothalamic-pituitary-gonadal function.11,34Persistently low estrogens and elevated gonadotropins in children with delayed puberty suggest primary ovarian failure, while low gonadotropins suggest hypogonadotrophic hypogonadism. In this latter case, Kallmann syndrome (or related disorders) or hypothalamic/pituitary tumors should be excluded in well-nourished children.36Both E2 and E1 levels are very low or undetectable in children with aromatase deficiency.35Affected girls have hypergonadotropic hypogonadism, fail to develop secondary sexual characteristics, and exhibit progressive virilization.35The affected boys exhibit normal male sexual differentiation and pubertal maturation. However, boys with aromatase deficiency are typically extremely tall with eunuchoid proportions and continued linear growth into adulthood, severely delayed epiphyseal closure, and osteoporosis due to estrogen deficiency. Highly sensitive E2 measurement can be of value in the assessment of therapeutic efficacy of estrogen replacement in hypogonadal girls.32

Women's Health

Similarly to LH, FSH, and TSH, human chorionic gonadotropin (hCG) is a member of the glycoprotein family and consists of two subunits (α and β chains) that are associated to the intact hormone.1-7The α-chains in all four of these glycoprotein hormones are virtually identical, whereas the β-chains have greatly differing structures and are responsible for the respective specific hormonal functions.hCG is produced in the placenta during pregnancy. In nonpregnant women, it can also be produced by tumors of the trophoblast, germ cell tumors with trophoblastic components, and some nontrophoblastic tumors.Human chorionic gonadotropin consists of a number of isohormones with differing molecular size. The biological action of hCG serves to maintain the corpus luteum during pregnancy. It also influences steroid production. The serum of pregnant women contains mainly intact hCG.Measurement of the hCG concentration permits the diagnosis of pregnancy just one week after conception. The determination of hCG in the first trimester of pregnancy is of particular importance. Elevated values here serve as an indication of chorionic carcinoma, hydatiform mole, or multiple pregnancy. Depressed values indicate threatening or missed abortion, ectopic pregnancy, gestosis, or intrauterine death.Elevated hCG concentrations not associated with pregnancy are found in patients with other diseases, such as tumors of the germ cells, ovaries, bladder, pancreas, stomach, lungs, and liver.6,7

Women's Health, Hormone Testing

Progesterone is a steroid hormone with a molecular weight of 314.5 daltons.2Progesterone is mainly formed in the cells of the corpus luteum and during pregnancy in the placenta. Progesterone is increased in congenital adrenal hyperplasia due to 21-hydroxylase, 17-hydroxylase, and 11-β-hydroxylase deficiency. Progesterone is decreased in primary or secondary hypogonadism and short luteal phase syndrome.The progesterone concentration correlates with the development and regression of the corpus luteum. Whereas progesterone is barely detectable in the follicular phase of the female cycle, a rise in the progesterone level is observed one day prior to ovulation. Increased progesterone synthesis occurs during the luteal phase. In the second half of the cycle pregnanediol is excreted in urine as the main degradation product of progesterone.Progesterone brings about the conversion of the uterine mucosa into a tissue rich in glands (secretion phase), in order to prepare for the intrauterine implantation of the fertilized ovum. During pregnancy, progesterone inhibits the contraction of the myometrium. In the mammary gland, progesterone (together with estrogens) promotes the proliferation and secretion disposition of the alveoli.2,3The determination of progesterone is utilized in fertility diagnosis for the detection of ovulation and assessment of the luteal phase.3,4

Women's Health

This immunoassay is intended for the in vitro quantitative determination of OC 125 reactive determinants in human serum and plasma.1The Elecsys CA 125 II assay is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for second-look procedures.1The Elecsys CA 125 II assay is further indicated for serial measurement of CA 125 to aid in the management of cancer patients.1CA 125 belongs to the family of hybridoma-defined tumor markers. The values measured are defined by the use of the monoclonal antibody (MAb) OC 125. The antigenic determinant CA 125 is located on a high-molecular weight glycoprotein (200-1000 kd) isolated from cell culture or serum. The antigenic determination CA 125 has a protein structure with associated carbohydrate side-chains.2,3These determinants are associated with a high-molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer (excluding those with cancer of low malignant potential).CA 125 is found in a high percentage of nonmucinous ovarian tumors of epithelial origin4and can be detected in serum.5,6It does not occur on the surface epithelium of normal ovaries (adult and fetal). Ovarian carcinoma accounts for about 20% of gynecologic tumors; the incidence is 15/100,000.7CA 125 has been found in the amniotic fluid and in the coelomic epithelium; both of these tissues are of fetal origin. In tissues of adult origin, the presence of CA 125 has been demonstrated in the epithelium of the oviduct, in the endometrium, and in the endocervix.8Elevated values are sometimes found in various benign gynecologic diseases, such as ovarian cysts, ovarian metaplasia, endometriosis, uterus myomatous, or cervicitis. Slight elevations of this marker may also occur in early pregnancy and in various benign diseases (eg, acute and chronic pancreatitis, benign gastrointestinal diseases, renal insufficiency, autoimmune diseases, and others). Markedly elevated levels have been found in benign liver diseases, such as cirrhosis and hepatitis. Extreme elevations can occur in any kind of ascites due to malignant and benign diseases. Although the highest CA 125 values occur in patients suffering from ovarian carcinoma, clearly elevated values are also observed in malignancies of the endometrium, breast, gastrointestinal tract, and various other malignancies.Although CA 125 is a relatively unspecific marker,9-13it is today the most important tumor marker for monitoring therapy and progress of patients with serous ovarian carcinoma. At primary diagnosis, the sensitivity of CA 125 depends on the FIGO stage (FIGO = Federation of Gynecology and Obstetrics); higher tumor stages are associated with higher CA 125 levels.14The diagnostic sensitivity and specificity of the Elecsys CA 125 II test was calculated by comparing ovarian carcinoma patients at primary diagnosis (FIGO stage I to IV) with patients suffering from benign gynecologic diseases.1At a cutoff value of 65 U/mL, the sensitivity is 79% (at a low specificity of 82%). The cutoff level has to be raised if higher specificity is desired. The optimal clinical value is reached at 150 U/mL (sensitivity 69%, specificity 93%).1

Women's Health

Androstenedione (also known as 4-androstenedione and δ4-androstenedione) is a 19-carbon steroid hormone produced in the adrenal glands and the gonads that is the common precursor in the biochemical pathway that produces the androgen testosterone and the estrogens estrone and estradiol.1-7Androstenedione has approximately one tenth of the androgenic potency of testosterone.1Androstenedione is synthesized by means of two biochemical pathways. The predominant pathway involves conversion of 17-hydroxypregnenolone to dehydroepiandrosterone (DHEA) catalyzed by the enzyme 17,20-lyase, with subsequent conversion of DHEA to androstenedione catalyzed by the enzyme 3-β-hydroxysteroid dehydrogenase. A secondary pathway for androstenedione production involves conversion of 17-hydroxyprogesterone to androstenedione directly by 17,20-lyase. 17,20-lyase is required for both pathways of androstenedione synthesis.The production of adrenal androstenedione is controlled by ACTH, whereas production of gonadal androstenedione is governed by the gonadotropins, luteinizing hormone (LH), and follicle stimulating hormone (FSH). Androstenedione produced in the adrenal gland of both men and women is further converted to testosterone by the enzyme 17-β-hydroxysteroid dehydrogenase.1In women, androstenedione produced by theca cells of the ovary is converted to estrogen by the enzyme aromatase in the granulosa cells of the ovary.5Androstenedione secreted into the plasma by either the adrenal or ovary can be converted to testosterone and estrogens by the same enzymes in peripheral tissues. Androstenedione, largely of ovarian origin, is the only circulating androgen that is higher in premenopausal women than in men.1After menopause, androstenedione production is about halved, primarily due to the reduction of the steroid secreted by the ovary. Nevertheless, androstenedione is the principal steroid produced by the postmenopausal ovary.Congenital adrenal hyperplasia (CAH) is a family of disorders caused by defects in one of the enzymes of the adrenal steroidogenic pathway.1,3,6The most common form of CAH results from mutations in the gene that codes for the 21-hydroxylase enzyme.1,3,6Patients with CAH develop varying degrees of glucocorticoid and mineralocorticoid deficiency due to the inability to produce cortisol and aldosterone, respectively.1,3,6Diminished cortisol levels cause an increase in pituitary adrenocorticotrophic hormone (ACTH) secretion due to a lack of negative feedback. The resultant high levels of ACTH lead to adrenal hyperplasia and dramatically increased production of adrenal steroids proximal to the enzyme block.1,3,6These steroids (progesterone and 17-hydroxyprogesterone) are shunted into the adrenal androgen pathway that leads to increased concentrations of dehydroepiandrosterone and androstenedione.1,3,6These weakly androgenic steroids are then peripherally converted to testosterone that produces the androgenic symptoms frequently associated with CAH.1,3,6The diagnosis and therapeutic monitoring of CAH is based on clinical parameters and the measurement of the concentrations of adrenal steroid products and their metabolites.1,3,6Recent clinical guidelines have recommended the use of 17-hydroxyprogesterone (17OHP) as the primary marker for diagnosis and monitoring of CAH.6Other steroid products--including androstenedione and testosterone--can provide additional clinical information in some circumstances.3,6,8-11There is generally a good correlation between 17OHP, androstenedione, and testosterone concentrations in a single blood sample, suggesting these hormone concentrations are all under similar influences.9Random serum steroid levels in CAH patients tend to fluctuate with time of day and timing relative to glucocorticoid administration.3For this reason, samples for a given patient should be collected at a consistent time before the administration of the morning glucocorticoid dose.3Polycystic ovary syndrome (PCOS) is a syndrome of ovarian dysfunction characterized by hyperandrogenism, menstrual irregularities, and polycystic ovaries.9,12PCOS is associated with an increased risk of diabetes and cardiovascular disease.1The measurement of circulating androstenedione levels has been applied to the diagnosis of PCOS in several studies.6,12-14

Cancer Screening, Women's Health

CA 27.29 is a highly polymorphic glycoprotein belonging to the mucin family and is the product of the muc-1 gene. It is most useful using serial measurements to monitor both the course of disease and response to therapy because the direct correlation of changing levels of CA 27.29 with clinical status. In patients with known metastases, a reduction in levels of this marker indicates a good response to treatment while increasing levels indicate resistance to therapy and progressive disease and justify further clinical evaluation and regular monitoring. It has also recently been shown that an elevation of CA 27.29 levels above the upper limit of normal in patients with no clinical evidence of disease is an early indicator of recurrence. An elevated serum CA 27.29 level in patients in remission of stage II or III breast cancer provided a positive predictive value of 83.3% for recurrent disease, with an average lead time of 5.3 months before recurrence was clinically established.

Women's Health

Offered as part of multiple lab tests

Diabetes & Blood Sugar, Women's Health

A value of 140 mg/dL or greater indicates the need for a full diagnostic, gestational glucose tolerance performed in the fasting state to determine if the patient has gestational diabetes.

Women's Health

hCG may reach detectable limits within 7-10 days of conception. hCG is produced by the placenta and reaches a peak between the 7th and 10th week of gestation. hCG is a glycoprotein hormone produced by the syncytiotrophoblast of the placenta and secreted during normal pregnancy and with pathologic conditions such as hydatidiform mole, choriocarcinoma and testicular neoplasm.  Order hCG, Total, Qualitative, Urine, if hCG serum result is inconsistent with clinical presentation.

Women's Health

This test should be used only to determine pregnancy.

Women's Health, Hormone Testing

FSH and LH are secreted by the anterior pituitary in response to gonadotropin-releasing hormone (GNRH) secreted by the hypothalamus. In both males and females, FSH and LH secretion is regulated by a balance of positive and negative feedback mechanisms involving the hypothalamic-pituitary axis, the reproductive organs, and the pituitary and sex steroid hormones. FSH and LH play a critical role in maintaining the normal function of the male and female reproductive systems. Abnormal FSH levels with corresponding increased or decreased levels of LH, estrogens, progesterone, and testosterone are associated with a number of pathological conditions. Increased FSH levels are associated with menopause and primary ovarian hypofunction in females and primary hypogonadism in males. Decreased levels of FSH are associated with primary ovarian hyper-function in females and primary hypergonadism in males. Normal or decreased levels of FSH are associated with polycystic ovary disease in females. In males, LH is also called interstitial cell-stimulating hormone (ICSH). Abnormal LH levels with corresponding increased or decreased levels of FSH, estrogens, progesterone, and testosterone are associated with a number of pathological conditions. Increased LH levels are associated with menopause, primary ovarian hypofunction, and polycystic ovary disease in females and primary hypo-gonadism in males. Decreased LH levels are associated with primary ovarian hyperfunction in females and primary hyper-gonadism in males.

Pregnancy & Fertility, Women's Health

This test is specific for hCG beta subunit and offers sensitivity necessary to detect pregnancy as early as ten days post conception.

Women's Health

The concentration of free testosterone is very low, typically <2% of the total testosterone concentration. In most men and women, >50% of total circulating testosterone is bound to sex hormone-binding globulin (SHBG) and most of the rest is bound to albumin.2Routinely available assay methods used to measure total testosterone are not sensitive enough to accurately quantitate the free testosterone fraction directly. Free testosterone is estimated in this profile by an indirect method, equilibrium ultrafiltration. Tritiated testosterone is added to the sample and allowed to come to equilibrium with testosterone in the serum at physiological temperature.3,4The amount of the added radiolabeled testosterone must be low enough to ensure that the addition will not significantly increase the total testosterone concentration. Once equilibrium is achieved, the free testosterone is separated from the bound by filtration through a membrane by centrifugal ultrafiltration.5The radioactivity of the protein-free ultrafiltrate is measured and used to calculate the percent free testosterone. The concentration of free testosterone is then calculated by multiplying the percent free testosterone by the total testosterone concentration.

Women's Health, Hormone Testing

This test is useful in the differential diagnosis of pituitary and gonadal insufficiency and in children with precocious puberty.

Hormone Testing, Women's Health

Gonadotropin releasing hormone (Gn RH or LH RH) is a ten amino acid peptide produced mainly in the hypothalamus. It stimulates pituitary for the production of LH and FSH. The stimulation is predominantly on LH secretion and hence it is called LH RH. LH and FSH stimulate the production of gonadal hormones (e.g testosterone in males and estrogens in females). These steroid hormones have a feedback control on Gn RH secretion. Increased secretion occurs during puberty leading to the raise in concentration of LH and FSH for the stimulation of gonads. LH RH levels are high when there is secondary hypogonadism with decreased level of LH and FSH. LH RH levels are low in tertiary (hypothalamic) hypogonadism and also individuals with high stress levels with elevated dopamine and prolactin. LH RH and its agonists are routinely used in IVF settings to induce ovulation.

Cancer Screening, Women's Health

Offered as part of multiple lab tests

Women's Health, Hormone Testing

Estriol, E3, is synthesized in the placenta from 16-α-hydroxydehydroepiandrosterone of fetal origin. Thus, normal production can serve as a measure of the integrity of the fetoplacental unit. Sequential monitoring of estriol in high-risk pregnancy has made possible early intervention and fetal salvage. Chronically low estriol values are found in intrauterine growth retardation but also are sometimes seen in normal pregnancy. A decreasing trend is indicative of fetal distress. The sensitivity and specificity of this test for detecting fetal distress are very poor;thus its use for this purpose has been largely abandoned.Combined evaluation of unconjugated serum estriol, maternal serum hCG, maternal serum AFP, and maternal age has value in predicting risk for fetal chromosomal abnormalities during pregnancy. The use of maternal serum AFP, hCG, and estriol predicts 65% of Down syndrome, as opposed to 28% if only serum AFP is used.3-5

Women's Health, Hormone Testing

Levels increase sharply during the luteal phase of the menstrual cycle. The level increases from 9 to 32 weeks of pregnancy.

Hormone Testing, Women's Health

Offered as part of multiple lab tests

Hormone Testing, Women's Health

Offered as part of multiple lab tests

Hormone Testing, Women's Health

During pregnancy and postpartum lactation, serum prolactin can increase 10- to 20-fold. Exercise, stress, and sleep also cause transient increases in prolactin levels. Consistently elevated serum prolactin levels (>30 ng/mL), in the absence of pregnancy and postpartum lactation, are indicative of hyperprolactinemia. Hypersecretion of prolactin can be caused by pituitary adenomas, hypothalamic disease, breast or chest wall stimulation, renal failure or hypothyroidism. A number of drugs, including many antidepressants, are also common causes of abnormally elevated prolactin levels. Hyperprolactinemia often results in galactorrhea, amenorrhea, and infertility in females, and in impotence and hypogonadism in males. Renal failure, hypothyroidism, and prolactin-secreting pituitary adenomas are also common causes of abnormally elevated prolactin levels.

Women's Health

Offered as part of multiple lab tests

Women's Health

This test is used to detect significant RBC antibodies.

Women's Health, Hormone Testing

Measuring the circulating levels of estradiol is important for assessing the ovarian function and monitoring follicular development for assisted reproduction protocols. Estradiol plays an essential role throughout the human menstrual cycle. Elevated estradiol levels in females may also result from primary or secondary ovarian hyperfunction. Very high estradiol levels are found during the induction of ovulation for assisted reproduction therapy or in pregnancy. Decreased estradiol levels in females may result from either lack of ovarian synthesis (primary ovarian hypofunction and menopause) or a lesion in the hypothalamus-pituitary axis (secondary ovarian hypofunction). Elevated estradiol levels in males may be due to increased aromatization of androgens, resulting in gynecomastia.

Diabetes & Blood Sugar, Women's Health

Plasma glucose levels may be abnormally high (hyperglycemia) or abnormally low (hypoglycemia). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolic disorders.

Women's Health, Hormone Testing

This test is useful in the differential diagnosis of pituitary and gonadal insufficiency and in children with precocious puberty.

Cancer Screening, Women's Health

The CA 125 level can provide prognostic information in the follow-up management of patients with ovarian carcinoma. The assay should be used as an adjunctive test in the management of ovarian cancer patients. CA 125 is not recommended as a cancer screening procedure to detect cancer in the general population.

Cancer Screening, Women's Health

CA 15-3 may be useful for monitoring patients with metastatic breast cancer and certain ovarian cancers. The CA 15-3 values from sequential samples have a high correlation with the clinical course in most patients with metastatic breast cancer.

Women's Health, Hormone Testing

Estrone (E1) is a steroid, a weak estrogen, and a minor female sex hormone.3,4Estrone is one of three major endogenous estrogens, the others being estradiol and estriol.3,4Like the other estrogens, estrone is synthesized from cholesterol and secreted mainly from the gonads, though they can also be formed from adrenal androgens in adipose tissue. Estrone is primarily derived from metabolism of androstenedione in peripheral tissues, especially adipose tissues. Individuals with obesity have increased conversion of androstenedione to estrone, leading to higher concentrations. Estrone can be converted into estradiol and serves mainly as a precursor or metabolic intermediate of estradiol. In addition, an increase in the ratio of estrone to estradiol may be useful in assessing menopause in women.

Women's Health

Offered as part of multiple lab tests

Women's Health, Hormone Testing

Offered as part of multiple lab tests

Women's Health

Leptin is a 16-kilodalton protein that was first identified when it was cloned in 1994.3,4Humans and mice with defects in the gene that codes for leptin, referred to as the obese orOBgene, tend to become morbidly obese.4Obese mice with the ob/ob defect lose weight when treated with exogenous leptin.4Leptin is primarily produced by the adipose tissue in proportion to the size of fat stores.4-7Besides adipose tissue, leptin is also produced by other tissues, such as the stomach, placenta, and mammary gland.5Leptin secreted by adipose tissue regulates energy homeostasis, neuroendocrine function, metabolism, immune function and other systems through its effects on the central nervous system and peripheral tissues.8-10Increased leptin levels stimulate the central nervous system to reduce appetite and increase energy expenditure.4,5,7Leptin is thought to play an important role in the body's response to food deprivation or starvation.7,8,11,12Rare homozygous mutations in the leptin (LEP) gene can cause complete leptin deficiency that results in hyperphagia and severe early-onset obesity.13-15Patients heterozygous for these mutations show partial leptin deficiency and increased body weight.16,17Leptin administration has been shown to restore metabolic and neuroendocrine abnormalities in individuals with leptin-deficient states, including patients with congenital leptin deficiency generalized lipodystrophy, hypothalamic amenorrhea and lipoatrophy.13-15Hyperleptinemia and resistance to reducing body mass are two characteristics of typical obesity.18,19Strong positive associations exist between plasma leptin levels and body fat percentage.6In obesity the efficacy of the anorexic effect of leptin is decreased with leptin resistance developing due to a defect in intracellular signaling associated with the leptin receptor or decreases in leptin transport across the blood–brain barrier.20A decrease in tissue sensitivity to leptin leads is characterized by reduced satiety, overconsumption of nutrients, and increased total body mass and the development of metabolic disorders, such as insulin resistance and dyslipidemia.6,20,21A role for leptin has been implicated in the control of angiogenesis, hematopoiesis, immunity and bone formation, and a number of other functions.4Leptin is thought to play a role in normal sexual development and in reproduction.11,22Humans and mice with genetic absence of leptin fail to complete puberty and increased leptin levels in mice lead to early puberty.11Studies also suggest that leptin levels affect fertility in females and may be involved in the development of normal pregnancy.11,22During pregnancy, the placenta produces leptin, and maternal circulating levels during the second and third trimesters are approximately twice the level of the non-pregnant state.11,22

Women's Health

Offered as part of multiple lab tests

Women's Health, Hormone Testing

Estrone is primarily derived from metabolism of androstenedione in peripheral tissues, especially adipose tissues. Individuals with obesity have increased conversion of androstenedione to Estrone leading to higher concentrations. In addition, an increase in the ratio of Estrone to Estradiol may be useful in assessing menopause in women.

Women's Health

Offered as part of multiple lab tests

Bone Health, Women's Health

NTx is useful to assess bone resorption in patients with metabolic bone disease. The test is also useful in monitoring therapy to slow or halt osteoporotic bone loss. A decline of 30% or more of NTx over a six-month period suggests effective therapy.

Cancer Screening, Women's Health

CA 27.29 may be useful for monitoring patients for metastatic breast cancer.

Women's Health

Offered as part of multiple lab tests

Women's Health, Hormone Testing

Diagnostic applications of estradiol assays include assessment of ovarian function in a wide variety of situations (menstrual disorders, precocious or delayed puberty, assisted reproduction protocols). For men, estradiol measurement may be useful in the evaluation of gynecomastia.

Women's Health

Offered as part of multiple lab tests

Women's Health, Pregnancy & Fertility

Offered as part of multiple lab tests

Women's Health

NTx is useful to assess bone resorption in patients with metabolic bone disease and monitor therapy to slow or halt osteoporotic bone loss. A decline of 30% or more of NTx over a six-month period suggests effective therapy.

Women's Health, Pregnancy & Fertility

AMH-MIS may be used in the investigation of ovarian reserve since AMH concentrations in adult women reflect the number of small antral and preantral follicles entering the growth phase of their life cycle. These follicles are proportional to the number of primordial follicles that still remain in the ovary, or the ovarian reserve.AMH decreases throughout a woman's reproductive life, which reflects the continuous decline of the oocyte/follicle pool with age and, accordingly, ovarian aging.

Bone Health, Women's Health

Approximately 90% of the organic matrix of mammalian bone consists of type I collagen that is cross-linked at the N-terminal and C-terminal ends.1This highly cross-linked structure provides for the basic fabric and tensile strength of bone tissue. The collagen infrastructure of bone undergoes a continuous process of remodeling that involves osteoclast-mediated bone resorption and osteoblast-mediated bone formation. Osteoporosis occurs when there is an imbalance between bone formation and bone resorption leading to net bone loss.2-5Certain aspects of this bone composition and structure that contribute to increased bone fragility may not be captured by bone mineral density measurements.5Bone resorption by osteoclasts results in the production of cross-linked N-telopeptides of type I collagen (NTx).1NTx is specific to bone and is found in urine as a stable end product of bone degradation. Levels of NTx correlate with the rate of bone resorption. Bone resorption rates exceeding bone formation results in a net loss of bone and ultimately osteopenia or osteoporosis.2-8Osteoporotic fractures are a major source of morbidity and mortality in older women.2The NTx test is intended for use in predicting skeletal response to hormonal antiresorptive therapy in postmenopausal women. The NTx test can also be used to monitor the efficacy of antiresorptive therapy7in postmenopausal women, women with osteoporosis, and individuals with Paget disease. The NTx test can also be used in monitoring the effect of estrogen-suppressing therapies on the rate of bone resorption. A recent study8supported the use of NTx to identify the probability of a decrease in bone mineral density after one year in postmenopausal women receiving a calcium supplement relative to those treated with hormonal antiresorptive therapy.Several studies have shown that certain biochemical markers of bone turnover, measured in serum or urine, can be used as independent predictors of fractures, especially spine and hip.2,6Bone mineral density (BMD) is often used to monitor the efficacy of osteoporosis treatment and to follow patient compliance. Unfortunately, changes in BMD in response to treatment are slow, and it takes at least one year of treatment before a significant change in BMD can be observed in many cases.2,7As a result, the absence of BMD increase does not necessarily indicate a lack of therapeutic response.2,7The use NTx can be helpful for assessing early changes in BMD (baseline vs post-treatment) revealing a biological effect of the medication and proving patient compliance and persistence.2,7

Women's Health, Hormone Testing

17-Hydroxyprogesterone is elevated in patients with Congenital Adrenal Hyperplasia (CAH). CAH is a group of autosomal recessive diseases characterized by a deficiency of cortisol and an excess of ACTH concentration. 17-Hydroxyprogesterone is also useful in monitoring cortisol replacement therapy and in evaluating infertility and adrenal and ovarian neoplasms.

Women's Health

Offered as part of multiple lab tests

Women's Health, Hormone Testing

Much of Estradiol is bound to proteins. The unbound portion and Estradiol bound to proteins with low affinity reflect the free concentration. The Free Estradiol may better correlate with medical conditions than the Total Estradiol concentrations.

Hormone Testing, Women's Health

Androstenedione may be useful in evaluating patients with androgen excess and managing patients with congenital adrenal hyperplasia (CAH).

Women's Health, Pregnancy & Fertility

Offered as part of multiple lab tests

Bone Health, Women's Health

Offered as part of multiple lab tests

Bone Health, Women's Health

Offered as part of multiple lab tests

Women's Health

The measurement of tumor markers in CSF is potentially important in neoplastic meningitis

Women's Health, Hormone Testing

Offered as part of multiple lab tests

Women's Health

CTx is useful to assess bone resorption in patients with metabolic bone disease. The test is also useful in monitoring therapy to slow or halt osteoporotic bone loss.

Bone Health, Women's Health

Osteocalcin, the most abundant non-collagen protein in bone matrix, is a bone-specific, calcium binding protein. Serum osteocalcin levels are related to the rate of bone turnover in various disorders of bone metabolism, e.g., osteoporosis, primary and secondary hyperparathyroidism, and Paget's disease.

Women's Health

Free and weakly bound (bioavailable) testosterone measurement involves the selective precipitation of SHBG with ammonium sulfate. Tritiated testosterone is added to serum which is then allowed to come to equilibrium at physiologic temperature. Testosterone bound to SHBG is then selectively precipitated with 50% ammonium sulfate, leaving free and albumin-bound testosterone in solution. The percentage of tritiated label not bound to SHBG is multiplied by the total testosterone to produce the bioavailable testosterone.Elevated levels of FWBT are observed in female hirsutism.2The measurement of free and weakly bound testosterone in women, when used in conjunction with the assay of the DHEA-S and SHBG, can be used to establish etiology of hirsutism. In males, decreased serum concentrations are associated with hypogonadism. FWBT levels tend to increase during pregnancy but have been found to remain below the upper limit of the reference interval.3Total testosterone levels in women decrease by approximately 30% after menopause.4Administration of exogenous estrogens has the physiologic effect of increasing SHBG concentrations and suppressing the production of androgens by the ovary.4This results in a net decrease in FWBT. Decreased FWBT levels have been associated with diminished libido4and loss of bone density.5FWBT levels in males fall with age6at a rate that exceeds that of total testosterone and parallels the drop in DHEA sulfate. This decrease is thought to be caused by diminished testicular production and not due to hypothalamic/pituitary insufficiency.7Decreased FWBT was not, however, found to correlate with diminished potency.8Since SHBG has been found to increase with age, the FWBT level may be a more reliable indicator of testosterone production than total testosterone.

Cancer Screening, Women's Health

Estrogen and progesterone receptor assays are routinely performed on breast carcinomas to assess responsiveness to endocrine therapy and prognosis. HER-2 is associated with cellular proliferation activity. Over-expression is observed in 20-25% of women with breast cancer. These patients are potential candidates for monoclonal therapy.

Cancer Screening, Women's Health

Estrogen and progesterone receptor assays are routinely performed on breast carcinomas to assess responsiveness to endocrine therapy and prognosis.

Women's Health

This test (1) establishes the presence of a functioning corpus lutem or luteal cell function, (2) confirms basal body temperature measurements of the occurrence of ovulation (3) affords an indication of the day of ovulation, (4) assesses placental function during pregnancy.

Women's Health

This test quantifies an individual's IgE response to wormwood. Allergen-specific serum IgE testing is considered comparable to skin testing and may be preferred in some clinical situations. However, a positive test result only indicates that a patient is sensitized to the allergen of concern. Many IgE-sensitized individuals do not develop any symptoms when exposed to the allergen. A diagnosis of allergy should only be made by a trained medical provider after conducting a thorough clinical evaluation [1].More specific information about this allergen can be found on the following website:https://www.thermofisher.com/phadia/us/en/resources/allergen-encyclopedia.htmlReference1. Bernstein IL, et al.Ann Allergy Asthma Immunol. 2008;100(3 Suppl 3):S1-S148.

Women's Health

This panel measures the concentrations of estrone, estradiol, and estriol, the 3 main types of estrogens in serum. This panel may be useful in assessing estrogen status.Estrogens are endogenous steroids that regulate growth and maintenance of sex organs and secondary sex characteristics in women. Estrogens also have effects on many other organ systems such as maintenance of bone density, production of liver proteins, arterial vasodilation, reduction of intraocular pressure, and influence on mood [1]. Measurements of estrogens may help evaluating sexual maturity, menstrual abnormalities, fertility abnormalities, fetal-placental health in pregnancy, tumors that excrete estrogens, and feminization syndromes in men [2].Increased levels of estrogens may be observed in normal pregnancy, precocious puberty, hyperthyroidism, liver cirrhosis, and ovarian, testicular, and adrenal tumors. Decreased levels of estrogens may be observed in failing pregnancy, Turner syndrome, hypopituitarism, primary and secondary hypogonadism, menopause, Stein-Leventhal syndrome, and anorexia nervosa [3].Estriol becomes the predominant estrogen only in late pregnancy. Measurements of estriol are commonly used to help screen for certain fetal abnormalities such as Down syndrome. In non-pregnant women and men, measurements of estriol have limited clinical use [2].The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.References1. Gruber CJ, et al.N Engl J Med. 2002;346(5):340-352.2. Haymond S, et al. Reproductive related disorders. In: Burtis CA, et al. eds.Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed. Elsevier Inc; 2006:2097-2152.3. Pagana K, et al.Mosby's Diagnostic and Laboratory Test Reference. 15th ed. Elsevier Inc; 2020:346-400.

Sexual Health & STDs, Women's Health

Offered as part of multiple lab tests

Women's Health

Offered as part of multiple lab tests

Women's Health

Human epididymis protein 4 (HE4) was first identified in the epithelium of the distal epididymis and was originally predicted to be a protease inhibitor involved in sperm maturation.4,5HE4 is the gene product of theWFDC2gene that is located on chromosome 20q12-13.1. TheWFDC2gene is one of 14 homologous genes on this chromosome that encode proteins with WAP-type four disulphide coreWFDC2) domains.6,7HE4 belongs to the family of whey acidic four-disulfide core (WFDC2) proteins with suspected trypsin inhibitor properties.8However, no biological function has so far been identified for HE4.8The HE4 gene codes for a 13-kD protein, although in its mature glycosylated form the protein is approximately 20−25 kD, and consists of a single peptide and two WFDC domains.9HE4 has been reported to be expressed in a number of normal tissues, including epithelia of respiratory and reproductive tissues.9,10Elevated levels were found in several tumor cell lines, including ovarian, lung, colon, and breast cancer. A number of independent microarray studies have shown that theWFDC2gene is overexpressed in patients with ovarian carcinoma relative to normal controls.10-14In 2003, Hellstrom and coworkers showed that secreted HE4 was detected in high levels in the serum of ovarian cancer patients.15This group found that measurement of HE4 showed sensitivity and specificity comparable to that of CA125 for differentiating postmenopausal women with ovarian cancer from normal controls.15They suggested that the HE4 assay might be superior to CA125 in that it is less frequently positive in patients with nonmalignant disease.15Drapkin and coworkers used immunohistochemical techniques to show that cortical inclusion cysts lined by metaplastic Müllerian epithelium abundantly expresses HE4 relative to normal surface epithelium.16Using tissue microarrays, they showed that HE4 expression was restricted to certain histologic subtypes of epithelial ovarian carcinomas (EOC).16HE4 was expressed in 93% of serous and 100% of endometrioid EOC expressed HE4, whereas only 50% and 0% of clear cell carcinomas and mucinous tumors, respectively, were found positive.16This study also revealed that most nonovarian carcinomas do not express HE4, consistent with previous findings that HE4 protein expression is highly restricted in normal tissue of the reproductive tracts and respiratory epithelium.16Moore and coworkers showed that HE4 had a slightly better sensitivity for detecting EOC than CA125.17,18These researchers found that HE4 was particularly superior for detecting stage I disease, with no increase in sensitivity when combined with CA125 or any other marker.17,18Overall they found that combining CA125 and HE4 provided a more accurate predictor of malignancy than either alone.19Montagnana and coworkers found that receiver operating characteristics curve analysis on healthy controls and patients with ovarian cancers revealed that HE4 had a significantly higher area under the curve than CA125 (0.99 vs 0.91), with a sensitivity and specificity of 98% and 100%, respectively.20Mean HE4 levels were found to be significantly higher in patients with endometrial or ovarian cancer than in patients with ovarian endometriomas or other types of endometriosis.20,21These findings suggest that the HE4 test may be valuable in discriminating ovarian tumors from ovarian endometriotic cysts.20,21Shaw and coworkers showed that the ability of serum HE4 levels to discriminate ovarian cancer cases from healthy and benign controls is not influenced by risk status.22Several other studies have indicated that including HE4 in a multivariate analysis of ovarian cancer risk served to improve the accuracy of screening and/or disease monitoring.3,23-25

Women's Health

The percentage increase in HE4 values has been used as an aid in monitoring recurrence or progressive disease in patients with invasive epithelial ovarian cancer. Currently there is no clinically accepted cut-off for use in monitoring cancer progression in epithelial ovarian cancer subjects with this assay. Serial testing for patient HE4 assay values should be used in conjunction with methods used for monitoring ovarian cancer.

Pregnancy & Fertility, Women's Health

Offered as part of multiple lab tests