Endocrinology Assessments
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2013 Edition Endocrinology Assessments PRODUCT LINE GUIDE THE GENOVA DIAGNOSTICS Advantage Our comprehensive line of assessments for personalized treatment & prevention of chronic disease: • Provides Fully Licensed and Certified Laboratory Services • Saves Practitioner Time with Easy-to-Read Test Results • Features Rapid Turnaround • Includes Support for Practitioner and Patient • Offers Patient and Practitioner Billing Options Visit us anytime on the web at www.GDX.net or call 800-522-4762 Monday through Friday, 8:30 am to 6:30 pm (Eastern Time) to order tests or more information about our services. ACCREDITATION Genova Diagnostics is fully licensed federally under Clinical Laboratory Improvement Amendments (CLIA) and certified by Medicare (all states), and by New York State. TABLE OF CONTENTS Endocrinology Product Line Guide for Genova Diagnostics 2-5 Steroidogenic Pathways Chart __________________________________18 Essence Hormone Tests ____________ First Morning Void vs. 24-Hour Collection __________________________19 Specimen Selection Salivary Assessments A Guide to Choosing Sample Types ________________________________2 Menopause Plus ______________________________________________20 Complete Testing Line Rhythm ____________________________________________________22 Individual Components Breakdown Chart __________________________4 Male Hormones Plus __________________________________________24 One Day Hormone Check ______________________________________26 Therapeutic Ranges for Menopause Profile ________________________28 Profiles __________________________6-38 Serum Assessments Urinary Assessments Hormonal Health ______________________________________________30 Complete Hormones ____________________________________________6 Hormonal Health Support Guide __________________________________32 Complete Male Hormones ______________________________________8 Essential Estrogens __________________________________________10 Complete Hormones Treatment & Testing Guide ____________________12 Miscellaneous Comprehensive Urinary Hormones ________________________________16 Steroidogenic Pathways References ______________________________35 Recognized as a pioneer and leader in laboratory functional testing, Genova Diagnostics proudly offers Urinary Hormone testing as part of its extensive endocrine line. Hormone testing is a critical diagnostic tool for safe and effective prevention and treatment of hormone-related symptoms and conditions. With this diagnostic focus in mind, Genova Diagnostics has developed an unequaled endocrine line, establishing itself as the only laboratory to offer comprehensive hormone testing in all three matrices: blood, saliva, and now, urine. Employing state-of-the-art laboratory equipment and world-class medical education, Genova Diagnostics strives to lead the field of endocrine diagnostics. Genova Diagnostics offers expertise in blood, saliva and urine hormone testing, and related genomic evaluations, to provide the most accurate and comprehensive diagnostics for the prevention and treatment of hormone-related symptoms and conditions. 1 2 Specimen Selection Hormone Testing A Guide to Choosing Sample Types URINE SALIVA BLOOD Are reported hormones Urine reflects unbound Saliva reflects unbound Serum generally reflects total bound or unbound? (bioavailable) fraction of (bioavailable) fraction of hormones (bound and unbound), hormones. hormones. although “free testosterone”, free T3 and T4 are available. Sex hormone-binding globulin (SHBG) infers the amount of unbound testosterone, calculated as ‘Free Androgen Index’. Can estrogen Yes. Only urine provides all No, estrogen metabolites are not Yes, although serum testing is metabolites be estrogen metabolites (2-OHE1, measureable in the saliva. limited to estrogen metabolites measured? 16 α-OHE1, 4-OHE1, 2-MeOE1, 2-OHE1 and 16 α-OHE1. 4-Me-OE1, ratios) What is the advantage • Provides most comprehensive • Best way to evaluate diurnal • Reference ranges are well- of each specimen type? array of hormones and their patterns of cortisol and established and in agreement metabolites. melatonin. between labs. • Provides best reflection of • Provides evaluation of menstrual • Well-represented in the litera - tissue hormone utilization and cycle in premenopausal women, ture. metabolism. unless current or recent use • Provides average of hormone (within past year) of fluctuations over several hours. progesterone cream, which • Easy home collection raises salivary levels above (24 hr or FMV). normal reference range. • Easy home collection. • Reflects circulating levels of hormones. What are some aspects • Urine assessment should • Transdermal hormone creams • Single ‘snapshot in time’ does of each specimen type not be used with diuretics or tend to result in salivary levels not account for hormone to be aware of? abnormal renal function. above the normal reference fluctuations. • In urine, steroid hormones are range, which do not reflect what • Timing with luteal peak of partly represented as their is occurring physiologically. menstrual cycle may be hard to downstream metabolites, due to • Bleeding from the gums can gauge when cycling is irregular. extensive metabolism (e.g., the falsely elevate androgens such • Stress of blood draw may need for DHEA and testosterone as testosterone and DHEA. influence hormone levels. are inferred by ‘Total • Should not be used in • Transdermal hormone creams 17-ketosteroids’; progesterone conjunction with sublingual tend to be under-represented in is not measurable and is hormone treatments. serum samples. represented by downstream metabolites.) URINE SALIVA BLOOD Can I use this for a • Yes, urine provides a good base - • Yes, saliva provides a good base - • Yes, blood provides a good base - baseline assessment of line assessment of hormone line assessment of hormones, line assessment of hormone hormones (i.e., before levels. unless patient has used a trans - levels. starting HRT)? Note: Avoid under- or over- dermal cream hormone within the hydration during urine collection. past year (elevated levels in the Aim for fluid consumption of ~2 saliva may persist after stopping qts/day for an average adult, the HRT for at least 3-12 months). spread out evenly over the day. • For past use of transdermal gel Note: (For FMV collections): If you HRT, wait at least 1 month before need to urinate during the night using saliva for baseline assess - within 6 hrs of your rising time, ment. collect this urine and refrigerate; • For past use of sublingual drops or add to sample in the morning. troches, wait ~1 week. What about Urine can be used to monitor any Transdermal creams produce Blood provides reliable monitoring monitoring HRT? form of bioidentical form of HRT. abnormally high salivary levels. of most forms of bio-identical We recommend 24 hr collections to IF the decision is made to still hormones, with possible exception average HRT peaks and troughs. monitor with saliva, note that: of transdermal cream hormones, Due to metabolism, HRT dosing • Current reference ranges are not which are somewhat under- should be based upon parent based on transdermal HRT; represented in serum. hormones, and their metabolites: • Testing may be employed for • For Testosterone & DHEA, refer to initial monitoring of transderma l Total 17-ketosteroids; cream HRT, or when dose is • For Progesterone, refer to increased; Pregnanediol; • Salivary testing is not reliable • Normal or high levels of Total when dose is decreased, due to 17- hydroxycorticosteroids persisting elevations in the saliva do not rule out adrenal for an indefinite period of time. insufficiency. Will all types of HRT be • All bioidentical forms of HRT are • All bioidentical forms of HRT are • All bioidentical forms of HRT are reflected on the report? reflected on report. reflected on report. reflected on report. • Conjugated equine estrogens • Conjugated equine estrogens • Conjugated equine estrogens (e.g., Premarin™) are only (e.g., Premarin™) are only (e.g., Premarin™) are only partially represented as estrone; partially represented as estrone; partially represented as estrone other estrogens are NOT repre - other estrogens are NOT repre - and estrone- sulfate; other estro - sented. sented. gens are NOT represented. Medroxyprogesterone acetate Medroxyprogesterone acetate Medroxyprogesterone acetate (e.g., Provera™) is synthetic and (e.g., Provera™) is synthetic and (e.g., Provera™) is synthetic and NOT represented. NOT represented. NOT represented. When should specimen 24 hour urine collections should be Collect saliva 8-12 hours after last Collect blood 8-10 hours after last be collected relative to used with HRT, in order to average dose of HRT (all forms except dose of HRT (all forms except HRT dosing? hormone peaks and troughs with patch). patch). once or twice a day dosing. Once/week patch collect ~3 Once/week patch collect ~3 Once/week patch collect ~3 days after applying. days after applying. days after applying. Twice/week patch collect ~19 Twice/week patch collect ~19 Twice/week patch collect 1 day hours after applying. hours after applying. after applying. Can the test be run on No. The hormones in the pill will not No. The hormones in the pill will not No. The hormones in the pill will not a patient using oral be represented and the patient’s be represented and the patient’s be represented and the patient’s contraceptives? own hormone production will be own hormone production will be own hormone production will be suppressed for those supplemented suppressed for those supplemented