Hormones & Steroids

Endocrine Disorders Reagents for Assay Development ISO Certified

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Company Overview

Extensive Capabilities & Services

Molecular Reagents qPCR | RT-qPCR | LAMP

Immuno Reagents Antigens | Antibodies | Blockers

ENZYMES • H ot-Start Taq technologies - chemical, antibody, aptamer • L yo & Air-Dryable enzymes (glycerol free) Taq, Bst, RTase • T hermostable MMLV RT MASTER MIXES • L yo & Air-Dryable formats • Inhibitor-tolerant mixes for stool, sputum, saliva, blood, plant, water. • F or multiplexing, GC-rich templates

VIRUS MANUFACTURING • L ive or inactivated • P roprietary Ag purification

RECOMBINANT PROTEINS •  E. coli, P. pastoris, S. cerevisiae , Sf9, Mammalian (CHO, HEK293) • 1 0L- 130L fermentation ANTIBODIES – MAbs/PAbs • 5 00+ MAbs produced in grams • M ulti-Kilograms of MIgG / year • H undreds of liters of GxhIgG • A scites production (55,000 Mice)

NUCLEOTIDES • d NTPs, Na or Li salts • U ltra high purity, >99%

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Endocrine Disorders - Reagents for Assay Development

Commercial scale manufacturing of antigens and antibodies with protein purification expertise.

Meridian has been providing innovative life science solutions and building trusted partnerships for over 43 years. Meridian’s focus is to offer complete solutions for the development of molecular and immunological assays.

• 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 13485:2016

Global presence

WATERLOO, Belgium

LONDON, United Kingdom

QUEBEC, Canada

LUCKENWALDE, Germany

BILLERICA, MA

MANASQUAN, NJ

BEIJING, China

PARIS, France

CINCINNATI, OH (Headquarters)

CHANGZHOU, China

MILAN, Italy

MEMPHIS, TN

BOCA RATON, FL

MODIIN, Israel

SYDNEY, Australia

Diagnostic Manufacturing | Life Science Manufacturing | Sales & Warehouse

MERIDIAN BIOSCIENCE, INC. Parent Company | Founded in 1977 | Nasdaq: VIVO | 750+ Employees Headquartered in Cincinnati, OH | Presence in 70+ Countries.

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Company Overview

Antigens & Antibodies

INFECTIOUS DISEASE EXPERTISE

Gastro •  H. Pylori

Tropical • Zika • D engue 1, 2, 3, 4 • Chikungunya

ToRCH & Childhood • Toxo • Rubella • CMV

Viral Hepatitis • HAV • HBV • HCV • HDV • HEV

•  C. Difficile • Norovirus • Adenovirus • Rotavirus

• Malaria • Chagas

• HSV-1,2 • Rubeola • EBV • Mumps • Coxsackie • Rotavirus • RSV • Parvo B19 • VZV

• Cryptosporidium • Campylobacter •  E. Coli

• Leishmaniasis • Leptospirosis • Newcastle Disease

• Salmonella •  G. Lambia • Astrovirus

• Yellow Fever • Nipah Virus • JEV

STD • HSV-1, 2 • HIV-1, 2 • HPV • Syphilis • Chlamydia • Neisseria

Respiratory • SARS-CoV-2

•  M. Pneumoniae •  C. Pneumoniae • Influenza A, B • Parainfluenza •  L. Pneumophilia • RSV •  M. Tuberculosis • Streptococcus • Staphylococcus • Adenovirus

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Endocrine Disorders - Reagents for Assay Development

Cardiac • T roponin I, T • Myoglobin • BNP • NT-proBNP

Cancer • CA125 • CA15-3 • CA19-9 • CA72-4 • CA50 • CA242 • Cyfra 21-1 • CEA

Veterinary • ASFV • Avian Influenza • Borrelia •  Brucella abortus • Canine Distemper • Feline Immunodeficiency

Drug of Abuse • Amphetamine • Barbital • Benzodiazepine • Buprenorphine

• CRP • PCT • CK-MB • D-Dimer

• Cocaine • Cotinine • EDDP

Microbial Detection • Legionella • Salmonella • Cryptosporidium •  G. Lambia •  C. Jejuni •  E. Coli • Newcastle Disease • Canine Parvovirus • Rabies Virus • S erum Amyloid A (SAA) • Trichomonas foetus • Nipah • Transmissible Gastroenteritis • Feline Leukemia • Foot-and-Mouth • Canine Heartworm • Infectious Bursal Disease • Marek Disease

• Fentanyl • Ketamine • K2 • MDMA (Ecstasy) • Methadone • Methamphetamine • Morphine • Norketamine • Opium • Oxycodone • PCP

• Cystatin-C • Galectin-3 • Vitamin D • A po A, B, E • NSE • FABP • SAH • MPO • Fibrinogen • EGF

• Thyroglobulin • erbB-2/HER2 • AFP • EGFR

• HE4 • NSE • PMA • PAP • PSA

• PSMA • S-100 • PIVKA II • B2M

• Lp-PLA2 • PAPP-A

• Phenobarbital • Propoxyphene • THC

Hormones • L H, FSH, hCG, • hGH, AMH

Immunoglobulins/ Blockers • TRU Block ™ & IgM Diluent • A nimal IgGs – Bovine, Chicken, Goat, Mouse, Rabbit, Sheep • H uman IgA, IgG, IgM, IgE • Kappa Light chain • Lambda Light chain • Goat Anti-Human IgG, IgM, IgA • G oat Anti-Mouse IgG

Autoimmune • Jo-1 • PCNA

Allergens • C at & Dog Allergen • Horse Allergen • Dust Mite • Alternaria alternate • Timothy Grass •  Platanus acerifolia • Mugwort • Cortisol • Estradiol • Insulin, C-peptide • Prolactin • Progesterone • PTH • PAPP-A • T SH, T3, T4, ACTH • Thyroglobulin

• pANCA • cANCA • Sm Ag • dsDNA • La(SSA) • Ro(SSA) • Histone • GMB • C1q • Scl-70 • SS-A • BS-Gly-1

•  B. Anthracis • Clostridium • Listeria

• Streptococcus • Staphylococcus

• Cathepsin G • Calprotectin

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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................................ ii Adrenocorticotropic hormone (ACTH)..3 Aldosterone............................................4 Anti-Müllerian hormone (AMH).............5 Calcitonin................................................7 Cortisol. ..................................................8 Dehydroepiandrosterone (DHEA).........9 Estradiol (E2)........................................10 Estriol (E3)............................................11 Follicle-stimulating hormone (FSH).....12

Glucagon..............................................13 Human chorionic gonadotropin (hCG)...14 Human growth hormone (hGH). ...........16 Insulin (C-peptide)................................17 Luteinizing hormone (LH)....................18 Parathyroid hormone (PTH).................19 Pregnancy-associated plasma protein-A (PAPP-A)...............................20 Progesterone (P4)................................21

Prolactin (PRL)......................................22 Testosterone........................................23 Thyroglobulin (Tg).................................25 Thyroid peroxidase (TPO)....................26 Thyroid-stimulating hormone (TSH)....27 Thyroxine-binding globulin (TBG). .......28 Triiodothyronine (T3) & Thyroxine (T4)...29 Full product list.....................................30

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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

E54057M

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)

Suitable for use in ELISA & IHC

MAb to ACTH N-Terminal • Capture antibody • Reacts with ACTH a.a. 1–39 and a.a. 1-24 • Minimal cross reaction (< 0.02%) with CLIP, ß-LPH, ß-endorphin and Insulin MAb to ACTH N-Terminal • Detection antibody • Reacts with ACTH a.a. 1–39 and a.a. 1-24 • Minimal cross reaction (< 0.02%) with CLIP, ß-LPH, ß-endorphin and Insulin

E01372M

Suitable for ELISA, WB and IHC

E01373M

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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%)

Suitable for use in ELISA

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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)

AMH levels can predict Ovarian Reserve

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Endocrine Disorders - Reagents for Assay Development

Reagents for Immunoassay Development

9602

MAb to AMH • Capture Antibody

• Recognizes the N-terminal domain of AMH • Does not cross react with human LH, FSH or human activin A and activin B MAb to AMH • Detection Antibody • Recognizes the C-terminal domain of AMH • Does not cross react with LH, FSH or human activin A and activin B AMH Recombinant • Expressed in insect cells • ≥ 90% (SDS-PAGE), 55kDa MW • Control antigen for MAb pair 9602 and 9603

9603

9604

Suitable for use in ELISA & CLIA

E01349M

MAb to AMH • Capture Antibody MAb to AMH

E01350M

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

R01713

E01347M

MAb to AMH • Capture Antibody MAb to AMH

E01348M

• Detection Antibody AMH Recombinant • Contains a His-tag • Partial AMH sequence (MW ~32kDa) • Expressed in E. coli • Control antigen for MAb pair E01347M and E01348M

Suitable for use in ELISA, CLIA & LF

R01712

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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%)

Suitable for use in Competitive ELISA

E86322M

E86322M

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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

Estradiol (E2)

Estradiol, also known as E2 or 17 β -estradiol, is an estrogen steroid hormone and the major female sex hormone. It is involved in the regulation of female reproductive cycles and it is responsible for the development of female secondary sexual characteristics. Estradiol is predominately produced within the follicles of the ovaries and upon menopause in women, production of estrogens by the ovaries stops and estradiol levels decrease to very low levels. Low levels of estradiol can lead to loss of bone mass and fertility challenges in both sexes, premature menopause, depression and premature skin aging. Abnormally high levels of estradiol can result in early puberty in both sexes, development of breast tissue in males (gynecomastia), and may drive ovarian, breast and endometrial cancer. Testing for Estradiol is useful to diagnose cases of infertility, abnormal menses, and to monitor follicular development during assisted reproduction protocols. Typically, a quantitative serum test is sufficient to make a differential diagnosis and subsequent treatment plan.

Reagents for Immunoassay Development

MAb to Estradiol • Cross-reactivity: Estriol (2.3%), Estrone (0.17%), Testosterone (0.01%), Androstanedione (<0.005%), Cortisone (<0.005%), Cortisol (<0.005%), Progesterone (<0.005%), Corticosterone (<0.005%) MAb to 17-beta-Estradiol • Reacts with 17-beta-Estradiol-BSA conjugate and free Estradiol • No cross-reactivity with BSA

MAS04-267

Suitable for use in Competitive ELISA

E86022M

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Estriol (E3)

Estriol (E3) is one of three major estrogens, the others being estradiol (E2) and estrone. Its levels are only detectable during pregnancy where it is synthesized in very high quantities by the placenta (levels increase 100-fold during pregnancy). Its role is to ensure a quiescent uterus during prelabor and as such it can be used as a marker of fetal health and well-being. During pregnancy, 90 to 95% of estriol in the maternal circulation is conjugated in the form of estriol glucuronide and estriol sulfate, and levels of unconjugated estriol are slightly less than those of unconjugated estradiol and similar to those of unconjugated estrone. If levels of unconjugated estriol (free estriol) are abnormally low in a pregnant woman, this may indicate chromosomal or a congenital anomaly like Down syndrome or Edward’s syndrome. Estriol is included as part of the triple test and quadruple test for antenatal screening for fetal anomalies. However, because many pathological conditions in a pregnant woman can cause deviations in estriol levels, screening tests are often seen as less definitive of fetal-placental health than a nonstress test. Conditions which can create false positives and false negatives in estriol testing for fetal distress include pre-eclampsia, anemia, and impaired kidney function. Estriol tests are usually a solid-phase competitive immunoassay that quantitatively measures unconjugated estriol in serum.

Reagents for Immunoassay Development

Suitable for use in Competitive ELISA, CLIA & RIA

E01360M

MAb to Estriol (E3) • Produced in Cell Culture

A82605P

Estriol (E3) Antigen, HRP conjugated • Estriol linked at the 6 position • Buffer: Tris containing protein stabilizers

Suitable for use in ELISA

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Endocrine Disorders - Reagents for Assay Development

Follicle-stimulating hormone (FSH) Follicle-stimulating hormone (FSH) is a gonadotropin secreted by the anterior pituitary glands and regulates the activity of the gonads (e.g. ovaries and testes). Specifically, it operates in conjunction with luteinizing hormone (LH) to stimulate the development of graafian follicle in females, and promote the development of the tubules in the testes and the differentiation of sperm. The production and secretion of FSH and LH are 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. In women, follicle stimulating hormone levels start to rise naturally around the menopausal period, reflecting a reduction in function of the ovaries and a decline of oestrogen and progesterone production. However, at any other time, an increase in FSH levels are a sign of malfunction in the ovary or testis. A wide variety of disorders are associated with high FSH including premature ovarian failure, gonadal dysgenesis, systemic lupus erythematosus, testicular failure and klinefelter syndrome. Low levels of FSH are also problematic and can lead to incomplete development at puberty for both men and women. FSH is typically measured through a quantitative serum test. Only third generation FSH testing is sensitive enough (0.03 mIU/mL) to assess gonadal dysfunction in children 18 years and under.

Reagents for Immunoassay Development

MAF02-264

MAb to FSH • Reacts with intact FSH molecule • Does not cross-react with other alpha hormones • Capture Antibody

MAF02-243

MAb to FSH • > 90% pure (SDS-PAGE) • Detection Antibody

Suitable for use in ELISA

H6F02-323

FSH > 98% • Activity: 6,217 IU/mg • Contaminants: hTSH (0.13%), hLH (<1%), hGH (0.0001%), PRL (0.0062%) • Lyophilized

E87701M

MAb to Human FSH (Intact) • Recognizes the c1 epitope of intact FSH

Suitable for use in ELISA & RIA

• Not cross-reactive with FSH Beta • Capture or Detection Antibody

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Glucagon

Glucagon is a peptide hormone produced by the alpha cells of the pancreas. Its primary function is to elevate the concentration of glucose in the blood by promoting gluconeogenesis and glycogenolysis. It also decreases fatty acid synthesis in adipose tissue and the liver, as well as promotes lipolysis in these tissues, causing them to release fatty acids into circulation where they can be catabolized to generate energy. Its effect is opposite to that of insulin, which lowers the extracellular glucose. Glucagon belongs to the secretin family of hormones and together with insulin, it forms part of the feedback system that keeps blood glucose levels stable. Glucagon increases energy expenditure and is elevated under conditions of stress. A glucagon diagnostic assay is primarily useful for detecting a glucagon-secreting tumor of the pancreas (glucagonomas). Glucagonoma tumor cells produce large amounts of glucagon, and these high levels create severe, painful, and life-threatening symptoms. About 5-10% of neuroendocrine tumors that develop in the pancreas are glucagonomas and 75% of the time these glucagonomas are malignant. Glucagon diagnostic tests are typically quantitative two-site sandwich immunoassays and the performance between manufacturers can vary significantly due to antibody cross reactivity. It is important to select highly specific antibodies to glucagon in order reduce the potential for cross-reactive binding to other circulating pro-glucagon derived peptides, such as glicentin. In addition, cross-reactivity can occur with different isoforms of glucagon, not all of which are biologically active. Some diagnostic assays remove the biologically inactive isoforms before measurement, while others do not.

Reagents for Immunoassay Development

PAb to Human Glucagon • Specific for the N-terminal of human Glucagon • Produced in Goat • >95% pure (Protein G purified) MAb to Glucagon-Like Peptide 1 • Specific for the C-terminal of GLP-1 • Does not cross-react against GLP2, GRPP, PYY, VIP, PHI, GIP, Glucagon or Oxyntomodulin • Produced in Cell Culture and Lyophilized

D24460R

Suitable for use in Dot Blot & IHC

D01234G

Suitable for use in ELISA

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Endocrine Disorders - Reagents for Assay Development

Human chorionic gonadotropin (hCG)

Human chorionic gonadotropin (hCG) is a heterodimeric glycoprotein with an alpha subunit identical to that of LH, FSH and TSH, and a unique beta-subunit. It is a hormone produced by cells of the fetal placenta and it maintains the function of the corpus luteum during the first 3 to 4 months of pregnancy. hCG is secreted as soon as the trophoblast implants in the uterine wall and it is at its highest concentration between the 7th and 10th weeks of pregnancy. The urine of women in the first month of pregnancy contains enough hCG to be detected by ELISA. Total hCG is commonly used to confirm and monitor pregnancy, but it also has clinical utility in detecting miscarriages, preeclampsia, neoplasms, trophoblastic diseases, and risk calculations for Trisomy-21 and Trisomy-18. Some cancerous tumors also produce beta-hCG and accordingly, free beta-hCG has some use as a tumor marker in gestational trophoblastic disease, certain testicular tumors, where the ratios of the free β subunit to intact hCG can be quite high. Free β -hCG may also have clinical utility in first-and second-trimester prenatal screening for Down syndrome and other chromosomal anomalies. Qualitative blood tests based on lateral flow technology can detect hCG levels as low as 10 mIU/mL-100ml U/mL, depending on the brand. Each of these assays are based on the two-site sandwich enzyme immunoassay principles and are prone to possible false-positive results from heterophilic antibodies.

Reagents for Immunoassay Development

MAF05-043

MAb to hCG beta • Recognizes the beta subunit of intact hCG • Does not cross-react with hCG alpha subunit MAb to hCG beta • Cross-reactivity: LH (0.5%) • Detection Antibody MAb to hCG beta • Specifically recognizes the beta subunit of hCG • Does not cross-react with hLH, hTSH or hFSH

Suitable for use in ELISA

MAF05-627

E86820M

• Capture Antibody MAb to hCG beta

Suitable for use in ELISA & LF

E86308M

• Specifically recognizes the beta subunit of hCG • Does not cross-react with hLH, hTSH and hFSH • Detection Antibody

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Human chorionic gonadotropin (hCG) continued

Reagents for Immunoassay Development continued

D01241G

MAb to hCG beta • Not cross-reactive with LH, FSH or TSH MAb to hCG beta • Recognizes the beta subunit of intact hCG • Cross-reactivity: Free beta subunit (49.0%), Free alpha subunit (0%), LH (38.4%), FSH (3.7%), TSH (3.7%) hCG Native Antigen • USP grade, Activity: 14,800 IU/mg (Bio-assay) • Buffer: Sodium Chloride hCG Native Antigen • Sourced from human urine • > 98% pure (SDS-PAGE) • Lyophilized from 50 mM Ammonium Bicarbonate PAb to Intact hCG • Reacts with alpha subunit and beta subunit of the hCG molecule • Produced in Goat • >98% pure (SDS-PAGE) • Pairs with E01323M in a free beta-hCG sandwich immunoassay MAb to hCG beta • Recognizes the free beta hCG subunit • Does not cross-react with the alpha subunit • Cross-reactivity: intact hCG (0.5%) • Pairs with Catalog #D01241G in a free beta-hCG sandwich immunoassay

E01323M

Suitable for use in ELISA

MAF05-023

MKF05-148

A01376H

A01322H

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Endocrine Disorders - Reagents for Assay Development

Human growth hormone (hGH)

Human growth hormone (hGH), also known as somatotropin, is a peptide hormone that stimulates growth, cell reproduction, and cell regeneration and is essential for normal growth and development in children. In adults, growth hormone plays a role in regulating bone density, muscle mass, and glucose and lipid metabolism. It can also affect heart and kidney function. Growth hormone is produced by the pituitary gland and is normally released into the bloodstream in pulses throughout the day and night. As a result, obtaining a single measurement of GH in blood is difficult to interpret and not clinically useful. GH stimulation and suppression tests are therefore often used to diagnose GH abnormalities. Growth hormone deficiency (GHD) is a rare disorder characterized by the inadequate secretion of GH and it can result from congenital abnormalities or from damage to the pituitary gland caused by a head injury, brain tumor, or surgery or radiation treatment. Childhood-onset GHD results in growth retardation, short stature, and maturation delays. Adult-onset GHD is characterized by a number of variable symptoms including reduced energy levels, altered body composition, osteoporosis (reduced bone mineral density), reduced muscle strength, lipid abnormalities such as increased LDL cholesterol, insulin resistance, and impaired cardiac function. Excess GH is most often due to a GH-secreting pituitary tumor (usually benign) and can result in acromegaly (gigantism) in children. Among the most serious symptoms of acromegaly are type 2 diabetes, high blood pressure, increased risk of cardiovascular disease, and arthritis. To determine hGH levels, dynamic tests are required for proper diagnosis. These tests are meant to stimulate the pituitary (via insulin, arginine, clonidine and l-dopa) to secrete GH allowing for the testing of blood samples at timed intervals. hGH assays are based on the two-site sandwich enzyme immunoassay principles using monoclonal antibodies or a combination of monoclonal and polyclonal antibodies. One challenge faced with hGH assays is that the normal composition of hGH in blood is actually mixture of different isoforms, present at constant relative proportions. The primary isoform is a 22 kD molecule and a 20 kD molecule, as well as hetero- and homodimers and multimers. Assay results can vary considerably depending on reactivity with various isoforms.

Reagents for Immunoassay Development

MAF06-154

MAb to hGH • Cross-reactive with Human Placental Lactogen (<0.02%) and Human Prolactin (<0.02%) • Capture Antibody MAb to hGH • Cross-reactive with Human Placental Lactogen (<0.02%) and Human Prolactin (<0.02%) • Detection Antibody hGH Native Antigen • Cross-reactivity: FSH (<0.01%), LH (<0.01%), TSH (<0.01%) and Prolactin (<0.01%) • >80% pure (SDS-PAGE) • Lyophilized from 50 mM Ammonium Bicarbonate

MAF06-210

Suitable for use in ELISA

A75714H

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Insulin (C-peptide) C-peptide and the hormone insulin are created from a larger molecule called proinsulin and stored in the beta cells of the pancreas. Intact proinsulin undergoes enzymatic cleavage to become des-31,32-proinsulin and des-64,65-proinsulin and eventually, insulin and C-peptide (an inactive peptide chain). Although insulin and C-peptide are secreted in equimolar amounts from beta-cells, C-peptide has a longer half-life and is present in peripheral blood in higher molar concentrations than insulin, making it less prone to marked fluctuations. The measurement of plasma insulin, C-peptide and proinsulin concentrations has been identified as the most useful test in identifying the cause of hypoglycaemia. Type 1 and type 2 are the two most common types of diabetes and although both of the types are characterized by high blood glucose, the pathogenesis between the two differ. The insulin/C-peptide test is useful in order to differentiate insulin-dependent patients from non-insulin-dependent patients. Overall raised plasma insulin, C-peptide, and proinsulin concentrations in the presence of hypoglycemia can indicate endogenous hyperinsulinaemia which is often seen in people with early stage type 2 diabetes mellitus. In general, c-peptide is considered to be a reliable marker of residual beta-cell function and serum or urine C-peptide determinations, in conjunction with blood glucose and insulin levels, aid in the differential diagnosis of hypoglycemia. Early assays for insulin, proinsulin, and C-peptide were competitive RIAs, however most commercial assays are now competitive (Insulin and C-peptide) or two-site enzyme immunoassays (total of intact proinsulin).

Reagents for Immunoassay Development

MHP18-601

Mab to C-peptide • Reacts with C-peptide of human proinsulin • > 98% pure (sequential precipitation using caprylic acid and ammonium sulphate)

Suitable for use in Competitive ELISA

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Endocrine Disorders - Reagents for Assay Development

Luteinizing hormone (LH)

Luteinizing hormone (LH) is a gonadotropic hormone that is produced by the pituitary gland and operates in conjunction with FSH to drive puberty, menstruation and fertility. A surge in LH levels triggers ovulation and the development of the corpus lutem in females, and in males it causes the Leydig cells to release testosterone. LH is composed of two noncovalently associated dissimilar amino acid chains, alpha and beta. The alpha chain is similar to that found in human thyroid-stimulating hormone (TSH), follicle-stimulating hormone (FSH), and human chorionic gonadotropin (hCG). LH diagnostic assays are useful to evaluate fertility issues, the function of reproductive organs (ovaries or testicles), or to detect ovulation. In children it can also be useful to evaluate early or delayed sexual maturation. The most sensitive LH assays on the market are monoclonal antibody based competitive-ELISAs. However, lateral flow devices using antibody sandwich-based formats are widely used for at-home ovulation tracking.

Reagents for Immunoassay Development

MAF07-226

MAb to LH • Cross-reactivity: hCG (<0.01%), FSH (>0.1%) • Capture Antibody

MAF07-036

MAb to LH • > 90% pure (SDS-PAGE) • Detection Antibody

Suitable for use in ELISA

MAF07-412

MAb to LH • Cross-reactivity: hCG (<0.01%), FSH (>0.1%) • Capture Antibody MAb to LH • > 90% pure (SDS-PAGE) • Detection Antibody

MAF07-037

A01687H

LH > 98% pure • Sourced from human pituitary glands • Activity: 15,600 IU/mg

Suitable as a Control or Calibrator for EIA Assays

• Contaminants (<0.5% w/w): FSH (1 IU/mg), hGH (<0.001 mg/mg), PRL (<0.001 mg/mg), TSH (<0.01 IU/mg) • Lyophilized from 50 mM Ammonium Bicarbonate

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Parathyroid Hormone (PTH)

Parathyroid Hormone (PTH) is secreted by the parathyroid gland and plays an important role in bone remodeling. It also works together with Vitamin D to maintain healthy bones. PTH is secreted in response to low calcium levels as a 118 amino acid polypeptide that undergoes two successive cleavages to yield an 84 amino acid biologically active hormone. It has a very short half-life of less than five minutes and breaks down into various fragments of which the biological significance remains to be defined. A PTH blood test is useful in the differential diagnosis of overactive parathyroid glands (hyperparathyroidism). Primary hyperparathyroidism is most often caused by a benign tumor in one or more of the parathyroid glands and patients with this condition have high PTH and calcium levels. Secondary hyperparathyroidism is often seen in patients with chronic renal failure (CRF). The kidneys fail to excrete sufficient phosphate, and the parathyroid gland secretes PTH in an effort to lower calcium levels to balance the calcium-phosphate ratio. Tertiary hyperparathyroidism occurs when CRF causes a severe imbalance in the calcium- phosphate ratio, leading to very high PTH production that results in hypercalcemia. Current blood tests generally measure intact PTH by ELISA. Most assays use two antibodies in sequence, the first recognizing the N-terminal and the second the C- terminal.

Reagents for Immunoassay Development

E01306M

MAb to PTH (a.a. 1-34) • Reacts with a.a. 1-34 of human PTH

Suitable for use in ELISA & RIA

E24101M

MAb to PTH (a.a. 53-68) • Specific for human PTH peptide a.a. 53-68 • Does not cross-react with Synthetic human PTH peptide (a.a. 1-10, a.a. 1-34 and a.a. 1-38) • Lyophilized MAb to PTH (a.a. 53-84) • Does not cross react with synthetic human PTH peptide (a.a. 1-10, a.a. 1-34 and a.a. 1-38) • Produced in Cell Culture • Lyophilized from 0.1 M Phosphate Buffered Saline, pH 7.4

Suitable for use in ELISA, IHC & Immunoluminetric

E24150M

Suitable for use in ELISA & IHC

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Endocrine Disorders - Reagents for Assay Development

Pregnancy Associated Plasma Protein-A (PAPP-A) Pregnancy associated plasma protein-A (PAPP-A) is as a glycoprotein found in the serum of pregnant women. It is produced by the placenta and circulates in the form of a heterotetramer complexed with eosinophil major basic protein (proMBP). Its main role in pregnancy is to prevent the recognition of the fetus by the maternal immune system. In non-pregnant individuals, PAPP-A can also be produced by several cell types and detected at much lower levels (and in the form of a homodimer). Studies have shown that it can also be used as a potential biomarker for plaque instability in cardiac disease. In the first trimester of pregnancy, PAPP-A assays are used in conjunction with hCG or free beta hCG to screen for Down syndrome (Trisomy 21) and Edward’s syndrome (Trisomy 18). A low PAPP-A level can also be associated with pregnancy complications such as fetal growth restriction, fetal demise, preterm birth, and pre-eclampsia in the third trimester. As a cardiac marker, high PAPP-A serum levels indicate a risk for acute coronary syndromes (unstable angina and acute myocardial infarction), as PAPP-A is expressed by unstable and ruptured coronary artery plaques, but not stable plaques. Serum PAPP-A assays are based the two site sandwich immunoassay principles. For developing PAPP-A pregnancy diagnostics, antibodies that detect the heterotrimeric form (htPAPP-A/proMBP complex) must be used whereas antibodies that detect the homodimeric subunit dPAPP-A should be used for cardiac assays.

Reagents for Immunoassay Development

E86114M

MAb to PAPP-A (proMBP) • Detection Antibody

E86141M

MAb to PAPP-A • Recognizes human PAPP-A subunit of htPAPP-A • Can detect htPAPP-A and dPAPP-a in sandwich immunoassay when paired with Catalog #E86901M • Capture antibody MAb to PAPP-A • Recognizes human PAPP-A subunit of htPAPP-A • Detection antibody PAPP-A Native Antigen • Represents a heterotetrameric complex consisting of PAPP-A and pro-MBP subunits • Sourced from pooled human retroplacental blood • Lyophilized from 10 mM Tris-HCl, 0.15 M Sodium Chloride, pH 7.5

Suitable for use in ELISA

E86910M

A86864H

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Progesterone (P4)

Progesterone (P4) belongs to a group of steroid hormones called the progestogens and it is the major progestogen in the body. Its main role is to maintain pregnancy and to regulate the female’s menstrual cycle. Its levels increases sharply during the luteal phase of the menstrual cycle as it works to thicken the lining of the uterus to prepare it for a fertilized egg each month. In the event that an egg does implant, progesterone’s function is to maintain the uterine lining throughout the pregnancy and the levels increase from 9 to 32 weeks. If no fertilized egg implants, progesterone levels drop and menstruation begins. Progesterone is also necessary for breast development and breastfeeding and complements some effects of estrogen. In men it works with testosterone to help in sperm development. Progesterone diagnostic assays are useful to help determine the cause of infertility, track ovulation, help diagnose an ectopic or failing pregnancy, monitor the health of a pregnancy, monitor progesterone replacement therapy, and help diagnose the cause of abnormal uterine bleeding. A related progestogen steroid hormone is 17-Hydroxyprogesterone (17-OH P) which is synthesized from progesterone and 17-Hydroxypregnenolone. It functions as a precursor of cortisol in the adrenal glands or can be converted into androgenic and estrogenic hormones. Measurement of 17-OH P is used as an aid in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries. It is also part of newborn screening in many countries used to detect congenital adrenal hyperplasia (CAH). Progesterone assays are usually quantitative and based on the competitive immunoassay format.

Reagents for Immunoassay Development

E82321M

MAb to Progesterone Cross-reactivity: 1 μg cortisol = 5 ng 10 ng estradiol < 5 ng

500 ng estriol < 5 ng 20 ng testosterone < 5 ng

E86222M

MAb to Progesterone • Cross-reactive with 17-Hydroxyprogesterone (10%) and Deoxycorticosterone (1%) MAb to Progesterone • Cross-reactive with 17-Hydroxyprogesterone (1%) and Deoxycorticosterone (1%), 11-Hydroxyprogesterone (25%), Deoxycortisol (0.03%), 5-alpha-pregnane-3,20 dionene (10.5%), Cortisol (0.002%), Corticosterone (0.01%) Progesterone 3-HRP Conjugate • Progesterone antigen linked at the 3 position with HRP • MW ~ 45 kDa • Buffer: Tris, pH 7.6 containing protein stabilizers and 0.005% Thimerosal

E86702M

Suitable for use in competitive ELISA

A82606P

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Endocrine Disorders - Reagents for Assay Development

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