Hormones & Steroids

Endocrine Disorders Reagents for Assay Development ISO Certified

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Endocrine Disorders

The endocrine system is a network of glands that produce and release hormones which regulate mood, growth and development, tissue function, metabolism, as well as sexual function and reproductive processes.

The eight major glands that make up the human endocrine system are the hypothalamus, pancreas, pituitary, thyroid, parathyroids, adrenals, pineal body, and the reproductive glands, (which include the ovaries and testes). The pancreas, which is mainly associated with the digestive system, is also part of this hormone- secreting system. Overall, although the endocrine glands are the body’s main hormone producers, some non-endocrine organs — such as the brain, heart, lungs, kidneys, liver, thymus, skin, and placenta — also produce and release hormones. Endocrine disorders are diseases that specifically relate to the endocrine glands and they are generally grouped into two categories: • Disease that results from producing too much or too little hormone, leading to a hormone imbalance • Disease that results from the development of a lesion (such as a nodule or tumor) in the endocrine system which may or may not affect hormone levels Common endocrine disorders include diabetes, acromegaly (overproduction of growth hormone), Addison’s disease (decreased production of hormones by the adrenal glands), Cushing’s syndrome (high cortisol levels for extended periods of time), hyperthyroidism (overactive thyroid), hypothyroidism (underactive thyroid), and prolactinoma (overproduction

of prolactin by the pituitary gland). These disorders often have widespread symptoms, affect multiple parts of the body, and can range from mild to very severe. Treatments depend on the specific disorder but often requires the use of synthetic hormones. Diagnosis for endocrine disorders is usually made using blood, urine or saliva tests that measure hormone levels. There is no single ideal method for assessment as each have their advantages and disadvantages. Serum-based assays provide a direct measurement of circulating hormones but are generally unable to distinguish the protein-bound, inactive form of the hormone from its free and biologically active form. Serum testing is ideal for peptide hormones such as FSH, LH, prolactin, fasting insulin, and thyroid hormones, including reverse T3, as well as thyroid antibodies. Serum tests can also be used to measure sex hormone binding globulin (SHBG) and, less commonly, cortisol binding globulin (CBG). In contrast, urine assays measure unbound hormone, reflecting the bioavailable levels. A 24-hour urine collection is the preferred method for assessing physiological hormone levels because it provides a comprehensive picture as opposed to a single time point analysis. Saliva testing has also gained in popularity and has the advantage of being noninvasive as well as being accessible to practitioners such as chiropractors, and acupuncturists who may be practicing in regions where they are not licensed to order blood tests or draw blood. Saliva collection also allows for multiple collections over a period of a day or month, which can help elucidate abnormal hormonal patterns, such as a shortened luteal phase. New diagnostic testing looks at the genetic basis for the endocrine disease. A variety of endocrine disorders are caused by gene variations which are now well understood in terms of their molecular basis and mode of inheritance. The recent advances in molecular testing and genomics have uncovered that genes play a far more important role in the pathogenesis of endocrine disease than previously appreciated. Overall, through the earlier detection of genetic carriers and/or through diagnosing the exact subtype of the disease, earlier and more targeted intervention and treatments are possible.

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Endocrine Disorders - Reagents for Assay Development

ENDOCRINE GLANDS & THEIR HORMONES

THYROID & PARATHYROID GLAND • Parathyroid hormone (PTH) • Thyroglobulin (Tg) • Thyroid peroxidase (TPO) • Thyroid-stimulating hormone (TSH) • Thyroxine-binding globulin (TBG) • Thyroxine (T4) • Triiodothyronine (T3)

PITUITARY GLAND & HYPOTHALAMUS

• Adrenocorticotropic hormone (ACTH) • Human growth hormone (hGH) • Luteinizing hormone (LH) • Prolactin • Thyroid-stimulating hormone (TSH)

OVARIES & TESTES

ADRENAL GLANDS

• Anti-Müllerian

hormone (AMH) • Dehydroepiandrosterone (DHEA) • Estradiol (E2) • Estriol (E3) • Follicle-stimulating hormone (FSH) • Human chorionic gonadotropin (hCG) • Luteinizing hormone (LH) • Pregnancy-associated plasma protein-A (PAPP-A) • Progesterone (P4) • Prolactin (PRL) • Testosterone

• Adrenocorticotropic hormone (ACTH) • Aldosterone • Cortisol

PANCREAS

• Glucagon • Insulin (C-peptide)

Catalog Guide

Company overview................................3 Adrenocorticotropic hormone (ACTH)..5 Aldosterone............................................6 Anti-Müllerian hormone (AMH).............7 Calcitonin................................................9 Cortisol. ................................................10 Dehydroepiandrosterone (DHEA).......11 Estradiol (E2)........................................12 Estriol (E3)............................................13 Follicle-stimulating hormone (FSH).....14

Glucagon..............................................15 Human chorionic gonadotropin (hCG)...16 Human growth hormone (hGH). ...........18 Insulin (C-peptide)................................19 Luteinizing hormone (LH)....................20 Parathyroid hormone (PTH).................21 Pregnancy-associated plasma protein-A (PAPP-A)...............................22 Progesterone (P4)................................23

Prolactin (PRL)......................................24 Testosterone........................................25 Thyroglobulin (Tg).................................27 Thyroid peroxidase (TPO)....................28 Thyroid-stimulating hormone (TSH)....29 Thyroxine-binding globulin (TBG). .......30 Triiodothyronine (T3) & Thyroxine (T4)...31 Next Generation Sequencing (NGS)...32 Full product list.....................................34

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Company Overview

Meridian Life Science, Inc. is a leading large scale manufacturer of: • Antibodies • Viral antigens • Recombinant proteins • PCR enzymes • Nucleotides • Critical assay reagents Meridian has been providing innovative life science solutions and building trusted partnerships for over 40 years. Meridian’s focus is to offer products and services that help to advance the development of diagnostic assays and vaccine development. • Commercial scale manufacturing of antigens and antibodies with protein purification expertise • Full line of immunoassay reagents, including antigens, antibodies and blockers

• Large scale production of reagents for molecular assays • Technical support with assay development experience • Dedicated R&D and manufacturing teams • Robust and mature Quality System ISO certified

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Endocrine Disorders - Reagents for Assay Development

Extensive Capabilities and Services Immunodiagnostics • A ntigens & Antibodies • Recombinant Proteins • Blocking Reagents Molecular Diagnostics • Nucleotides • Enzymes • qPCR/PCR Reagents • NGS Reagents Contract Services • A ntigens & Antibodies • C ell & Viral Banking • P CR/qPCR Assay Development

Global Presence MERIDIAN BIOSCIENCE, INC. Parent Company | Founded in 1977 | Nasdaq: VIVO Headquartered in Cincinnati, OH | 650+ Employees | Presence in 70+ Countries.

North America

EMEA

Asia Pacific

SYDNEY, AUSTRALIA Warehouse & Sales BEIJING, CHINA Wholly Owned Subsidiary

MEMPHIS, TN Viral Antigens Recombinant Proteins In Vitro Antibodies PCR Reagents BILLERICA, MA

LONDON, UK PCR Manufacturing & Sales PCR /qPCR Molecular Reagents LUCKENWALDE, GERMANY Large Scale Nucleotides PCR Enzymes Manufacturing PARIS, FRANCE EU Diagnostics Sales & Admin WATERLOO, BELGIUM EU Diagnostics Sales & Admin MILAN, ITALY EU Diagnostics Sales & Admin MODI’IN, ISRAEL BreathID ® Breath Test Systems

Magellan, Leadcare BOCA RATON, FL In Vivo Antibodies QUEBEC, CANADA GenePOC, Molecular Diagnostics

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Adrenocorticotropic hormone (ACTH) ACTH is a hormone secreted by the pituitary gland and is often produced in response to biological stress. Its principal effect is increased production and release of cortisol by the cortex of the adrenal gland. ACTH also plays a role in circadian rhythm in many organisms. Deficiency of ACTH leads to a reduction in the secretion of adrenal hormones (e.g. adrenaline, aldosterone and cortisol), resulting in secondary adrenal insufficiency (hypoadrenalism), the manifestations of which are clinically indistinguishable from those of glucocorticoid deficiency. Symptoms include weight loss, lack of appetite, muscle weakness, nausea and vomiting, and low blood pressure (hypotension). ACTH deficiency can either be congenital or acquired, and several genetic mutations have been linked to this disease. In contrast, chronically elevated ACTH levels occur in primary adrenal insufficiency in which damage to the adrenal glands prevents them from producing the hormones in adequate amounts. An example is Addison’s disease which can be caused by autoimmune disorders or infections, such as TB or HIV, and tumors. Another disorder, Cushing’s disease, can be caused by medication or by a pituitary tumor and leads to an

excess of cortisol (hypercortisolism). Quantitative plasma ACTH assays are useful in the differential diagnosis of pituitary Cushing’s disease, Addison’s disease, autonomous ACTH producing pituitary tumors (e.g. Nelson’s syndrome), hypopituitarism with ACTH deficiency and ectopic ACTH syndrome. Hypopituitarism with ACTH deficiency, which is secondary adrenocortical insufficiency, is characterized by low plasma ACTH and cortisol concentrations,

and a subnormal, but usually distinct adrenal response to stimulation with synthetic ACTH (Cortrosyn).

Reagents for Immunoassay Development

E54056M

MAb to ACTH C-Terminal • Reacts with human and rat C-terminal ACTH MAb to ACTH N-Terminal • Specific for Synacthen (1-24 ACTH) • Reacts with ACTH (a.a. 1–17) and has no cross-reactivity with CLIP (ACTH 17-39)

E54057M

Suitable for use in ELISA & IHC

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Endocrine Disorders - Reagents for Assay Development

Aldosterone Aldosterone is a steroid hormone produced by the adrenal cortex that plays an important role in cardiac health and can be a cause of endocrine hypertension. It is essential for sodium conservation in the kidney, salivary glands, sweat glands and colon, and is involved in the homeostatic regulation of blood pressure, plasma sodium (Na + ), and potassium (K + ) levels. Aldosterone is closely linked to two other hormones, renin and angiotensin, and together these are the renin-angiotensin-aldosterone system. This system is activated when the body experiences a decrease in blood flow to the kidneys, such as after a drop in blood pressure, or a significant drop in blood volume after a hemorrhage or serious injury. Primary aldosteronism (Conn syndrome) is caused by the overproduction of aldosterone by the adrenal glands, usually from a benign tumor or a genetic disorder (familial hyperaldosteronism). The high aldosterone level increases reabsorption of sodium and loss of potassium by the kidneys, often resulting in an electrolyte imbalance. Secondary aldosteronism, which is more common than primary aldosteronism, is caused by anything that leads to excess aldosterone, other than a disorder of the adrenal glands. It could be caused by any condition that decreases blood flow to the kidneys, decreases blood pressure, or lowers sodium levels. Secondary aldosteronism may be seen with congestive heart failure, cirrhosis of the liver, kidney disease and toxemia of pregnancy (pre-eclampsia). Low aldosterone (hypoaldosteronism) usually occurs as part of adrenal insufficiency. It causes dehydration, low blood pressure, a low blood sodium level, and a high potassium level. When infants lack an enzyme needed to make cortisol, a condition called congenital adrenal hyperplasia, they may not be able to produce enough aldosterone. Aldosterone and renin tests are generally ordered together to evaluate whether the adrenal glands are producing appropriate amounts of aldosterone and to distinguish between the potential causes of excess or deficiency. Typically they are quantitative plasma or serum assays that are based on competitive EIA principles. Reagents for Immunoassay Development

E30451M

MAb to Aldosterone • Cross-reactivity: Androstenedione (<0.01%), Corticosterone (<0.01%), & Desoxycorticosterone (<0.01%) PAb to Aldosterone • Cross-reactivity: Androstenedione (<1%), Corticosterone (<1%), DHEA (<1%) & Desoxycorticosterone (<1%) • Produced in Rabbit

Suitable for use in ELISA

E01293R

Suitable for use in ELISA & IHC

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Anti-Müllerian Hormone (AMH) Anti-Müllerian Hormone (AMH) is a glycoprotein hormone structurally related to inhibin and activin and is part of the transforming growth factor beta superfamily. It is expressed by granulosa cells of the ovary during a female’s reproductive years and plays a key role in growth differentiation and folliculogenesis. Specifically, AMH expression inhibits primordial follicle recruitment and decreases the sensitivity of follicles for the FSH-dependent selection. Besides its functional role in the ovary, AMH serum levels also serve as a biomarker for ovarian reserve. AMH is a dimeric glycoprotein molecule that consists of two identical subunits linked by sulfide bridges. Each subunit contains a pro-region (pro-AMH or N-terminal) and a C-terminal domain (also called the “mature” region) which is cleaved at monobasic sites between the two domains. After cleavage, the pro-region (110-kDa) and C-terminal (25 kDa) homodimers remain associated in a noncovalent complex that bind to AMH Receptor II to activate signaling. AMH is considered an extremely sensitive marker of ovarian function and ovarian aging. It is useful to assess conditions such as polycystic ovary syndrome and premature ovarian failure. AMH is also a predictor for ovarian response in in vitro fertilization (IVF). Overall, a higher level of AMH in normal, healthy women aged 30-44 has a positive correlation with natural fertility for spontaneous conception. Diagnostic tests that measure AMH levels in serum or plasma are usually quantitative sandwich-ELISA that use antibodies directed against epitopes in the stable pro-region and mature region.

Anti-Müllerian Hormone (AMH) Protein Structure

Pro-AMH (N-Terminal)

Mature (C-Terminal)

Cleavage (a.a. 451)

Figure based from C. Heule, W. Salzburger, and A. Böhn, Genetics. 196: 579–591 (2014)

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Endocrine Disorders - Reagents for Assay Development

AMH levels can predict Ovarian Reserve

Reagents for Immunoassay Development

E01349M

MAb to AMH • Capture Antibody MAb to AMH • Detection Antibody

E01350M

Suitable for use in ELISA & CLIA

AMH Recombinant • Represents the full AMH sequence (MW 60 kDa) • Recombinant, (E. coli) • >90% pure (SDS-PAGE) • Control Antigen for MAb pair E01349M and E01350M

R01713

E01347M

MAb to AMH • Capture Antibody MAb to AMH • Detection Antibody

E01348M

Suitable for use in ELISA, CLIA & LF

R01712

AMH Recombinant • Contains a His-tag • Partial AMH sequence (MW ~32kDa) • Recombinant, (E. coli) • Control Antigen for MAb pair E01347M and E01348M

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Calcitonin

Calcitonin is a polypeptide hormone that is produced by the C-cells of the thyroid gland and it acts to reduce blood calcium and phosphate levels, opposing the effects of Parathyroid Hormone (PTH). Calcium is an essential structural component of the skeleton and plays a key role in muscle contraction, blood coagulation, enzyme activity, neural excitability, secondary messengers, hormone release, and membrane permeability. Three major hormones (PTH, vitamin D, and calcitonin) interact to maintain a constant concentration of calcium in the body.

Calcitonin is measured using quantitative sandwich immunoassays that employ MAbs for the recognition of intact and mature calcitonin. High levels of calcitonin identify patients with nodular thyroid diseases and diagnose medullary thyroid cancers which originate from the C-cells of the thyroid gland. Medullary tumors are the third most common of all thyroid cancers.

Reagents for Immunoassay Development

E01357M

MAb to Calcitonin • Produced in Cell Culture • Capture Antibody MAb to Calcitonin • Produced in Cell Culture • Detection Antibody

Suitable for use in CLIA, ELISA & RIA

E01356M

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Endocrine Disorders - Reagents for Assay Development

Cortisol

Cortisol is the primary glucocorticoid secreted by the adrenal gland in response to ACTH stimulation, stress, or low blood-glucose concentration. It functions to increase blood sugar through gluconeogenesis, to suppress the immune system, and to aid in the metabolism of fat, protein, and carbohydrates. It also decreases bone formation. It is secreted in a diurnal pattern with levels rising in the early morning, peaking around 8 am, and flattening in the evening.

The production of too much cortisol can cause Cushing’s syndrome which, if left untreated, can lead to serious health problems such as heart attack, stroke, blood clots and Type 2 diabetes. The most common cause of Cushing’s syndrome is the long-term, high-dose use of the cortisol-like glucocorticoids which are used to treat other medical conditions like asthma, rheumatoid arthritis, and lupus. The second most common cause is pituitary tumors or a tumor on the adrenal gland itself. Too little cortisol can be caused by Addison’s disease (also called primary adrenal insufficiency), a condition in which your adrenal glands do not function well due to autoimmune disorders, tumors, or infections like tuberculosis or HIV. Cortisol disorders are generally diagnosed using competitive quantitative immunoassays from urine, saliva, or blood samples.

Reagents for Immunoassay Development

E01332M

MAb to Cortisol • Cross-reactivity: Prednisolone (5.6%),

11-Deoxycortisol (0.9%), Corticosterone (0.6%), 11-Deoxycorticosterone (<0.1%), Progesterone (<0.1%), 17-Hydroxyprogesterone (<0.1%), Testosterone, Estradiol & Estriol (<0.1%), Danazol (<0.01%) • Produced in Cell Culture MAb to Cortisol • Recognizes cortisol-BSA conjugate and free cortisol • No cross-reactivity with BSA • Cross-reactivity: Corticosterone (20%) MAb to Cortisol • Recognizes cortisol-BSA conjugate and free cortisol • No cross-reactivity with BSA • Cross-reactivity: Corticosterone (49%) Cortisol Antigen (Synthetic), HRP Conjugated • Cortisol linked with HRP at the 3 CMO-position • Buffer: Tris with protein stabilizers (pH 7.0)

Suitable for use in Competitive ELISA

E86322M

E86322M

A82601P

Suitable for use in ELISA

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Dehydroepiandrosterone (DHEA) Dehydroepiandrosterone (DHEA) is one of the most abundant circulating steroids and is produced in the adrenal glands, the gonads, and the brain, where it functions as a metabolic intermediate in the biosynthesis of the androgen and estrogen sex steroids. Its production is controlled by ACTH and the majority of DHEA is secreted as 3-sulfoconjugate dehydroepiandrosterone sulfate (DHEAS). In the circulation, DHEA and DHEAS are mainly bound to albumin, with a small amount bound to sex hormone-binding globulin (SHBG). Elevated DHEA/DHEAS levels caused by androgen-producing adrenal tumors can cause symptoms of hyperandrogenism in women. Men are usually asymptomatic, however peripheral conversion of androgens to estrogens can occasionally produce mild estrogen excess. In small children, excessive DHEA/DHEAS levels can be due to congenital adrenal hyperplasia (CAH) caused by 3 beta-hydroxysteroid dehydrogenase deficiency, 21-hydroxylase deficiency (the most common form of CAH) or 11 beta- hydroxylase deficiency. Serum DHEAS diagnostic assays are used to help evaluate adrenal gland function, to detect adrenal tumors or cancers, and to help determine the cause of masculine physical characteristics (virilization) in girls and women or early puberty in boys. The test may also be used with other hormone tests to rule out certain diseases of the testes or ovaries.

Reagents for Immunoassay Development

E01236M

MAb to DHEA • Reacts with DHEA and DHEAS • Cross-reactivity: Cholesterol (<1%), Progesterone (<1%), Hydrocortisone (<1%), Estradiol (<1%) and Vitamin D3 (<1%) • HPLC purified

Suitable for use in ELISA

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Endocrine Disorders - Reagents for Assay Development

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