Devices for Home Evaluation of Women's Health Concerns

Kelly L. Scolaro; Kimberly Braxton Lloyd; Kristen L. Helms

Disclosures

Am J Health Syst Pharm. 2008;65(4):299-314. 

In This Article

Menopause Testing

The several-year transition from a premenopausal state to clinical menopause is known as perimenopause and can be defined by several readily observable phenomena, including menstrual-cycle irregularity, prolonged amenorrhea, and advancing age (>40 years).[47,48] In addition, laboratory testing, specifically of levels of FSH, may help confirm a diagnosis of perimenopause.[47,48,49,50] Early identification of a perimenopausal state has become particularly relevant in the aftermath of the Women's Health Initiative and HERS II studies.[51,52,53] Decisions on whether and when to initiate treatment for menopausal symptoms or osteoporosis can be daunting for patients; having early knowledge of menopausal status may help support these decisions.

Urine tests and saliva tests are available for home evaluation of menopause. Home menopause monitors, the most common devices, use urine to measure FSH levels. There is a detectable rise in FSH prior to menopause, and all FDA-approved devices can detect urinary FSH concentrations of greater than 25 mIU/mL.[54,55,56] The average perimenopausal woman will have a urinary FSH concentration above 110 mIU/mL.[56] Each testing device contains a sample well or an absorbent tip for urine application; the sample travels through the device by capillary action to the reaction site, where FSH forms immune complexes with antibodies to FSH. If sufficient FSH is present in the urine (≥25 mIU/mL), the immune complexes result in a color change, indicating the perimenopausal state. Because rises in FSH may also occur at times other than menopause (e.g., prior to menstruation), each product provides two testing devices to be used one week apart. Two separate positive results confirm perimenopause.[54,55,56]

The saliva tests measure estradiol, progesterone, and testosterone.[57] Lipophilic hormones circulating in the bloodstream have been shown to readily cross into saliva by passive diffusion.[58] Levels of estradiol, progesterone, and testosterone in saliva have been shown to be correlated (r = 0.78, 0.47–0.58, and 0.97, respectively) with free concentrations of these hormones in the bloodstream.[58] During the perimenopausal state, dramatic fluctuations in estradiol, progesterone, and testosterone may occur.[57] Although saliva tests cannot diagnose perimenopause, especially in the absence of perimenopausal symptoms, they are commonly used for determining bioidentical hormonal replacement therapy. The reliability of saliva testing is still in question, despite the correlation of bloodstream with saliva hormone levels.[59,60,61]

Products on the market for saliva testing of hormone levels include Female Check (Body Balance of Genova Diagnostics), Saliva Test Kits (ZRT Laboratory), and Menopause Hormone Profile (North Bay Diagnostics).[57,62,63,64] Each test requires a test-tube-sized sample of saliva and costs between $80 and $140 for the estradiol, progesterone, and testosterone levels. All tests require samples to be mailed to the laboratory and take 7–10 days for results. All results require interpretation by a health care professional.[57,62,63,64] With the questionable reliability of these products, no product can be recommended over another.

Although many home menopause monitors have been FDA approved for marketing, only three urine tests are marketed and consistently available in the United States ( Table 3 ). Prices are comparable, with similar levels of reported accuracy. Menocheck (Synova) has a slightly lower efficacy, according to FDA; however, this appears to be due to difficulty in interpreting the results rather than to the device itself. Both the Estroven (Amerifit Nutrition) and RU25 Plus (Hormone Check) devices have relatively clear indicators of a positive result (the presence or absence of a second line). Menocheck relies on the patient to determine whether the test line is darker or lighter than the control line. The window that displays results is small, making the changes difficult to see. Because of this, the Estroven and RU25 Plus devices may be preferred.

The makers of all three urine tests recommend that the patient use a urine sample obtained immediately after waking in the morning, when FSH levels tend to be more concentrated. The Estroven monitor requires four drops of urine to activate the reaction. A collection cup and dropper are provided by the manufacturer; however, using these can be cumbersome for patients with poor eyesight or poor manual dexterity. Alternatively, urine may be applied to the test sticks used with the Menocheck and RU25 Plus monitors by placing the sticks directly in the stream or by first collecting the urine and then dipping the stick into it.

The waiting time for results and the availability of specific instructions may play a part in product selection. With Menocheck and RU25 Plus, results should be read after 5 minutes; results are invalid after 10 minutes. With the Estroven device, results may appear after 5 minutes but can take up to 15 minutes to be final. The manufacturers of Estroven and RU25 Plus supply patient instructions, including detailed diagrams, that are easy to follow.

One positive result with a single urine-testing device is not enough to confirm the onset of perimenopause. Patients should understand the possibility of rises in FSH secondary to impending menstruation and the need to perform the test twice, with approximately seven days between tests. Also, all testing devices have one control line against which to compare the test line. If the control line does not appear, then the test results are invalid, and the device should be discarded. Of particular concern for patients is the occurrence of one positive result and one negative result without a confirmed reason (e.g., menstruation). If this occurs, the results are inconclusive, and third and fourth tests may be administered approximately one week apart. If the test results are again contradictory, the patient should consult a physician.

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