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| MenocheckPro Menopause Testing Device | ||||||
MenoCheck Pro is a rapid, non-invasive, in-office diagnostic that detects elevated FSH associated with the onset of menopause.
Follicle stimulating hormone (FSH), or follitropin is a gonadotropin in the family of pituitary hormones secreted by pituitary in normal men and women. The function of FSH is to regulate the early development of the ovarian follicle in the female and initial steps of spermatid maturation in the male. FSH is structurally related to certain other pituitary and placental hormones including human chorionic gonadotropin (hCG), human thyroid stimulating hormone (hTSH), and human luteinizing hormone (hLH). In women, FSH stimulates the growth and maturation of ovarian follicles during the menstrual cycle. During the menstrual cycle the FSH level varies in response to the changes of estradiol and progesterone. Shortly before ovulation, a significant rise in FSH and LH can be observed. After ovulation, the follicle is ruptured, an egg is released and the developed corpus luteum then secretes estradiol and progesterone, which decrease the levels of FSH and LH back to the lower levels. Prior to the onset of menopause, ovarian function and estradiol secretion diminish and circulating FSH levels rise significantly as a result of removal of the negative feedback control on the hypothalamus. FSH is present in blood and excreted in the urine. The concentration of FSH in urine correlates with FSH levels present in serum(ref.1- 4). In women with normal menstrual cycles, the levels of FSH fluctuate during the cycle with peak levels on an average of approximately 25 mlU/mL occurring at the menstrual mid-cycle(5). As a woman approaches to and goes through menopause, the levels of FSH surges to an average of approximately 110 mlIU/mL and can reach as high as 500 mlU/mL(ref.4).
PRINCIPLE MenocheckPro is a qualitative, two site sandwich immunoassay for the determination of follicle stimulating hormone in urine. The membrane is pre-coated with anti-FSH capture antibody on the test line region and goat anti-donkey antibody on the control line region. During testing, the urine specimen reacts with a colored conjugate (anti-FSH monoclonal antibody-colloidal gold conjugate) that is pre-dried on the test strip. Also pre-dried on the test strip is a pre-determined quantity of gold-labeled donkey IgG. The donkey IgG and FSH bind to the gold labeled antibody then move across the membrane chromatographically by capillary action. When FSH is present in the sample, a color line consisting of specific antibody – FSH – antibody – gold conjugate will form at the test line region of the membrane. A colored line will always appear at the control region, which serves as a reference line with the color intensity of approximately 25 mlU/mL FSH. When the intensity of the test line is equal to or stronger than that of the control line, the result is positive. If the test line intensity is less than that of the control line, the result is negative. To serve as a procedural control, a pink-colored line at the control region should always appear
Enhancing the Understanding of Menopause Women increasingly need and want to understand the health risks and options for therapy regarding the onset of menopause. The controversy over the clinically appropriate use of estrogen replacement therapy (ERT) and hormone replacement therapy (HRT) may cause women to delay seeking counsel regarding not only the vasomotor symptoms, but more critically, the increase in long-term health risks associated with the onset of menopause.
The use of MenocheckPro will not change the textbook definition of menopause as one year of amenorrhea. Physicians and patients can use the test to help guide discussions on whether a woman’s symptoms may reflect the onset of menopause — or another condition — and then how best to address diagnosis and treatment specific to that individual. Facilitating a Dialog — The Role of MenocheckPro Appropriate use of MenocheckPro helps the physician, other health care professionals, and women begin to understand if symptoms such as irregular periods, hot flashes, vaginal dryness, or sleep problems are related to the onset of menopause. The knowledge gained in this understanding serves to guide further discussions around therapeutic and lifestyle options with each patient. MenocheckPro provides one resource in enhancing the quality of care from a professional and for a woman. Offering professionals and patients a rapid, one-step, in-office diagnostic to assist in enhancing understanding whether specific symptoms may be related to the onset of menopause is increasingly important to establish the level of dialog necessary for appropriate patient care among women of menopausal age. A survey commissioned by Synova Healthcare in 2003 of approximately 1,500 American women ages 35 to 60 highlights the current limitations in evaluating and treating symptoms and clinical risks associated with the onset of menopause.
Using MenocheckPro offers health care professionals an option to address the concerns of women in proactively assessing and responding to the onset of menopause. Clinically Appropriate Use Clinical judgment by a health care professional in evaluating symptoms specific to each woman determines the appropriate use of MenocheckPro. The diagnostic is indicated for use in evaluating hormone changes related to symptoms associated with the onset of menopause. Patient age, length of amenorrhea and other factors assessed by the health care provider define appropriate use for each woman. Follicle-Stimulating Hormone (FSH), the Female Menstrual Cycle, and Perimenopause Correct use of MenocheckPro as one of the prognosis factors for the evaluation of the onset of menopause builds upon several points regarding FSH, the female menstrual cycle and perimenopause.
MenocheckPro can detect FSH surges in urine above 25 mIU/mL, a median concentration achieved at the midpoint of the menstrual cycle. Using MenocheckPro in detecting FSH surges then provides physicians and patients a rapid, one-step diagnostic tool defining one factor in assessing the onset of menopause.
INTENDED USE MenocheckPro is a lateral flow, one-step immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in human urine for evaluation of hormone changes related to the symptoms associated with the onset of menopause. It is intended for professional or laboratory use only. MenocheckPro will detect a FSH surge above the average peak level of FSH during the menstrual cycle. In some women, the peak level observed during the menstrual cycle may be equivalent to surge levels. If this is suspected, the test should be repeated 5 to 7 days after the initial test. For patients with irregular cycles or other symptoms of menopause, a first positive result suggests that the patient may be perimenopausal. The patient should be retested at a later date. A positive result on a second test suggests that the patient is perimenopausal. However, contraception should not be discontinued on the basis of test Result interpretation alone. If the test' s Result interpretation are negative, the patient does not appear to be perimenopausal. If symptoms persist, test again. Menopause is a normal — and natural — part of every woman’s life. Menopause occurs when there is a decline in levels of estrogen and progesterone and an increase in follicle - stimulating hormone (FSH). Estrogen and progesterone are important for maintaining normal menstrual cycles and having a successful pregnancy. Your body’s transition to menopause is called perimenopause. It is a time when you may begin to experience physical and emotional changes. The typical age range for perimenopause is 42 to 58. Some women reach menopause before they are 40, and a few not until their 60s. The average age for menopause is 51. Menopause is marked by the absence of your menstrual period for 12 consecutive months. During menopause, your ovaries gradually become less and less active. They are running low on eggs for ovulation at this stage of your reproductive life, so they reduce the production of sex hormones needed for conception. Your ovaries are winding down, not shutting down. Postmenopause is the stage of life following menopause. You are no longer menstruating, and your hormone levels have stabilized at much lower levels than before menopause. It’s important during this stage of your life to talk to your health care provider about known risk factors such as heart disease, osteoporosis, and breast cancer. During all 3 phases of this life transition, women can experience a wide variety of symptoms. Many of these symptoms are caused by changes in hormone levels. A recent national survey1 on menopause reveals that two-thirds of American women do not visit their health care provider to discuss menopause symptoms. If they do, they wait a critical six months on average to seek counsel. According to Dr. Laura Corio, a renowned New York obstetrician/gynecologist at Mt. Sinai Medical Center, waiting this long may have negative effects on a woman’s health and well-being. “Early confirmation of menopause is important as it provides women with a sense of control and allows them to be proactive about countering the effects of menopause,” states Dr. Corio. “By diagnosing the onset of menopause early, treatment can be sought for the relief of stressful symptoms. An early and accurate diagnosis can improve long-term health and offer peace of mind that symptoms, such as mood changes and feelings of anxiety, are associated with menopause and not a potential illness.”
There are a number of reasons why it is important to know that your symptoms are associated with hormonal changes. Menopause can be a confusing time for many women. When you know that fluctuating levels of estrogen and progesterone are likely causing your emotional and physical changes, you and your health care provider can work together to relieve these symptoms and take control of your health. Another reason early detection is important is that menopausal women are at a greater risk for diseases such as osteoporosis and cardiovascular disease. A simple self-diagnostic urine test device can now allow women to accurately check for the onset of menopause either in the privacy of their own home, or at their health care provider’s office. MENOCHECKPRO™ IS NOW AVAILABLE MenocheckPro, the first over-the-counter, one-step, at-home menopause indicator test, is now available at retail pharmacy outlets nationwide. The easy-to-use midstream wand device offers women the convenience of a one-step test, and an attractive, non-invasive alternative to clinical blood testing for initial screenings. Non-invasive and similar to an at-home pregnancy test in design, MenocheckPro works by measuring the level of follicle-stimulating hormone (FSH) in the urine. FSH is a hormone produced by the pituitary gland that signals the follicles (eggs in sacs in the ovaries) to produce estrogen. Typically, as women enter menopause, FSH levels gradually rise and stay permanently high once menopause has set in. MenocheckPro is FDA-approved and has been shown to be 99%* accurate, with Result interpretation appearing in five minutes. Each package includes two test devices and simple-to-follow instructions. FSH testing with MenocheckPro can empower women by informing them when they have entered this transition in their lives.
Overview MenocheckPro™ is the only CLIA-waived, in vitro diagnostic currently approved by the FDA for professional and laboratory use only for the qualitative detection of follicle-stimulating hormone (FSH) in human urine. This in-office test is intended for evaluating hormone changes related to the symptoms associated with the onset of menopause. Physicians and other health care professionals should use the specifically designated CPT code 83001-QW to seek reimbursement for administering the test in-office as part of a patient visit. Office Status - CLIA-Waived Approval Offices performing MenocheckPro need approval as a CLIA-waived site to conduct diagnostic testing. Only office locations approved* — at a minimum — to perform CLIA-waived tests can administer and seek reimbursement for using MenocheckPro. Contact your State Department of Health, Division of Laboratory Services, or other appropriate regulatory agency with any questions on CLIA-waived status for an office. Billing for MenocheckPro™ While MenocheckPro is valued by female patients because it is non-invasive and immediate, it provides your practice with a new revenue stream. The average reimbursement per test is $26. Physicians and other health care professionals should use the CPT Code 83001QW and description Gonadotropin; Follicle Stimulating Hormone (FSH) when seeking reimbursement for administering the in-office test as part of a patient visit. Individual plans, Medicaid programs, and other third-party payers set the specific provisions defining how to bill for in-office diagnostic testing using MenocheckPro and the level of reimbursement. Physicians should consult a provider services representative or other appropriate personnel within a plan, payer, or State Medicaid program to address specific questions on billing policy and payment for using MenocheckPro as an in-office diagnostic.
Reimbursement for MenocheckPro Many plans, payers, and State Medicaid programs reference the Medicare Laboratory Fee Schedule in setting reimbursement for diagnostic tests. The 2004 Clinical Diagnostic Laboratory Fee Schedule sets a National Limitation Amount for the assigned CPT code to MenocheckPro as follows:
Payment for in-office diagnostic testing using MenocheckPro will vary by plan, payer, and State Medicaid program. Please contact the assigned personnel within a plan, payer, or Medicaid program to determine the specific rate of reimbursement for MenocheckPro. Physicians and other health care professionals should use the assigned CPT code of 83001-QW in seeking reimbursement for MenocheckPro when used as an in-office diagnostic. The QW modifier is needed to denote MenocheckPro as a CLIA-waived test. Note the test as — Gonadotropin; FSH — consistent with the CPT code description. Synova Healthcare has in place a program to work with managed care plans, third-party payers, and State Medicaid programs supporting billing and reimbursement for the medically appropriate use of MenocheckPro as an in-office diagnostic. | ||||||
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A rapid, one-step, visual test for the qualitative detection of human follicle stimulating hormone (FSH) in urine. MenocheckPro is a rapid chromatographic immunoassay that can detect FSH surges in urine above 25 mlU/mL, a median concentration achieved at the midpoint of the menstrual cycle. The test is intended for use in detecting FSH surges as one of the prognosis factors for the evaluation of the onset of menopause. Menopause is clinically defined as 12 months after cessation of the menstrual flow. 
Review “Specimen Collection” instructions. If refrigerated, the test devices, patient samples, and controls should be brought to room temperature 20-30°C (68-86°F) prior to testing. Do not open pouches until ready to perform the assay. 