TY - JOUR
AU - Helms, Kristen, L.
AB - Abstract Purpose. Devices used for home evaluation of fertility, pregnancy, menopause, colon cancer, breast cancer, and urinary-tract and vaginal yeast infections are discussed. Summary. Ovulation-prediction devices monitor natural changes in a woman’s body during the menstrual cycle, including changes in basal body temperature, urinary luteinizing hormone, and urinary estrone-3-glucuronide concentrations. Also available are devices that identify changes in the content of sodium chloride and other electrolytes in saliva and cervical–vaginal mucus. Home pregnancy tests are designed to detect human chorionic gonadotropin in the urine. Both urine and saliva tests are available for home evaluation of menopause; the most common devices use urine to measure follicle-stimulating hormone. The saliva tests measure estradiol, progesterone, and testosterone. Devices for home screening for colon cancer use either the guaiac test or the fecal immunochemical test. For aid in breast self-examination, patients may use a simulated-breast product designed to train them to detect lumps or a thin, silicone-containing pad intended to increase the sensitivity of the fingers to abnormalities. Urine-dipstick tests can be used to screen for urinary-tract infection, and a swab or panty liner can be used to detect vaginal pH changes indicative of vaginal yeast infection. Home-based tests may be convenient and economical but also have limitations; pharmacists can help educate patients and clinicians. Conclusion. Many devices are available to help evaluate women’s health concerns at home. Breast neoplasms, Colonic neoplasms, Home tests, Menopause, Ovulation, Pregnancy, Urinary tract infections, Vaginal diseases, Women Today’s patients are better educated and more health conscious than those of previous generations.1,2 In their quest for health, patients frequent health fairs and community screening events, use the Internet to research various diseases and conditions, and purchase a variety of self-testing devices.1 Frequently, patients seek methods for disease prevention and have a high interest in minimizing risk factors for chronic disorders, such as diabetes mellitus, heart disease, and cancer. Early detection of diseases and conditions has become a primary focus of patients and health care providers. The home-testing market is booming.3 This billion-dollar industry is expected to continue to grow at a rate of 6.7% per year through 2008. Soaring health care costs, decentralization of health care, technological advances, and patient demand for education and empowerment have contributed to the fast growth in this market. Patients frequently seek advice from pharmacists to help them decide whether home testing is appropriate and, if so, what tests to use. This article discusses devices that are used in the home setting to evaluate women’s health concerns, specifically fertility, pregnancy, menopause, colon cancer, breast cancer, and urinary-tract and vaginal yeast infections. The article explores the role these devices play in patient-centered care, the advantages and disadvantages of the devices, and how pharmacists can assist patients in proper device selection and use. The manufacturers of devices mentioned in this article are listed in the appendix. Ovulation prediction Tools to help predict ovulation are a valuable resource for couples who wish to conceive a child. The normal conception rate for fertile couples who are attempting to achieve pregnancy is 15–25% per cycle.4,5 Therefore, most couples will achieve pregnancy within one year.4 However, 1 in 10 couples of reproductive age encounter some level of infertility, and these couples often seek methods to help predict the window of maximum fertility.5 A number of home testing devices can help patients more accurately predict ovulation (Table 1).6,–10 If a couple does not conceive after one year of unprotected intercourse around the time of maximum fertility, the pair should be advised to seek medical care for infertility evaluation. However, if the woman is 35 years or older, has a complicated gynecological history (e.g., uterine disease, tubal disease, endometriosis, oligomenorrhea, amenorrhea), or has a partner with known subfertility, the couple should seek medical advice sooner.5 In the meantime, home fertility monitoring can help guide the couple as they attempt to conceive. Table 1. Products for Home Testing of Ovulation Product Type Predicts Ovulation (Days) Confirms Ovulation Accuracy (%) Initial Cost ($) Monthly Cost ($) Strengths and Limitations aExamples: OvuTemp Basal (Advanced Micronic Devices Limited), generic glass, generic digital. bwww.drugstore.com; regular glass or digital. cLH = luteinizing hormone. Examples: First Response Easy Read Ovulation Test (Church & Dwight Co.), Answer Quick and Simple One Step Ovulation Test (Carter-Wallace), OvuPlan Easy (Key Pharmaceuticals), OvuQuick (Quidel), BeSure Tests (Genix Technology), Clearblue Easy Digital Ovulation Test (Inverness Medical), Generic 1 Step Ovulation Prediction Test Kits (Inverness Medical). dwww.babyhopes.com; 25 test strips, range for generic and brand-name strips. eE3G = estrone-3-glucuronide. Examples: Clearblue Easy Fertility Monitor (Inverness Medical). fwww.drugstore.com; 30 test strips per package. gExamples: Fertility Tracker Fertile Focus (Fairhaven Health), OvuLite (Abbott Smith Labs), The Donna (Donna Distributing), Maybe Mom (MaybeMOM), OvuLens (Make-It Manufacturing). hwww.babyhopes.com. iExample: Ovacue Fertility Monitor (Zetek). jwhttps://www.zetek.net/order.php; price for Ovacue or Ovacue with vaginal sensor. Basal body temperature thermometersa No Yes 746 10–15b None Strengths: Affordable; easy to use; some digital devices have memory; computer software for data tracking available. Limitations: Does not predict fertility in given cycle; changes in lifestyle and routine can alter results. Home urinary LH kitsc Yes (0–2) No 927 None 20–75d Strengths: Prospectively identifies up to two fertile days in each cycle; fast results in less than 5 min; easy to use; easy-to-read tests available. Limitations: Requires frequent urine samples; test results might be hard to interpret (color change); provides short window of advance notice for intercourse. Home urinary LH–E3G monitore Yes (1–5) No 918 200f 30–50f Strengths: Prospectively identifies up to six fertile days in each cycle; indicates peak fertility; easy to read and interpret results; monitors two hormones (estrogen and LH); stores data in memory. Limitations: Expensive; test sticks sold separately (in boxes of 30). Home saliva microscopyg Yes No 36.89–9810 30–50h None Strengths: Affordable; reusable slides; portable, lipstick-sized microscopes available. Limitations: Results not reliable; results may be hard to read and interpret; chance of error (saliva volume, bubbles, etc.); factors such as food, drink, and toothpaste can cause error. Home saliva monitori Yes (5–7) Yes (with vaginal sensor) 617–986 298–398j None Strengths: Prospectively identifies up to seven fertile days in each cycle; results reported with digital reading; vaginal sensor available to confirm ovulation; memory chip stores 4 mo of data; data downloadable to computer; no testing strips or other supplies required. Limitations: Expensive; conflicting data concerning accuracy. Product Type Predicts Ovulation (Days) Confirms Ovulation Accuracy (%) Initial Cost ($) Monthly Cost ($) Strengths and Limitations aExamples: OvuTemp Basal (Advanced Micronic Devices Limited), generic glass, generic digital. bwww.drugstore.com; regular glass or digital. cLH = luteinizing hormone. Examples: First Response Easy Read Ovulation Test (Church & Dwight Co.), Answer Quick and Simple One Step Ovulation Test (Carter-Wallace), OvuPlan Easy (Key Pharmaceuticals), OvuQuick (Quidel), BeSure Tests (Genix Technology), Clearblue Easy Digital Ovulation Test (Inverness Medical), Generic 1 Step Ovulation Prediction Test Kits (Inverness Medical). dwww.babyhopes.com; 25 test strips, range for generic and brand-name strips. eE3G = estrone-3-glucuronide. Examples: Clearblue Easy Fertility Monitor (Inverness Medical). fwww.drugstore.com; 30 test strips per package. gExamples: Fertility Tracker Fertile Focus (Fairhaven Health), OvuLite (Abbott Smith Labs), The Donna (Donna Distributing), Maybe Mom (MaybeMOM), OvuLens (Make-It Manufacturing). hwww.babyhopes.com. iExample: Ovacue Fertility Monitor (Zetek). jwhttps://www.zetek.net/order.php; price for Ovacue or Ovacue with vaginal sensor. Basal body temperature thermometersa No Yes 746 10–15b None Strengths: Affordable; easy to use; some digital devices have memory; computer software for data tracking available. Limitations: Does not predict fertility in given cycle; changes in lifestyle and routine can alter results. Home urinary LH kitsc Yes (0–2) No 927 None 20–75d Strengths: Prospectively identifies up to two fertile days in each cycle; fast results in less than 5 min; easy to use; easy-to-read tests available. Limitations: Requires frequent urine samples; test results might be hard to interpret (color change); provides short window of advance notice for intercourse. Home urinary LH–E3G monitore Yes (1–5) No 918 200f 30–50f Strengths: Prospectively identifies up to six fertile days in each cycle; indicates peak fertility; easy to read and interpret results; monitors two hormones (estrogen and LH); stores data in memory. Limitations: Expensive; test sticks sold separately (in boxes of 30). Home saliva microscopyg Yes No 36.89–9810 30–50h None Strengths: Affordable; reusable slides; portable, lipstick-sized microscopes available. Limitations: Results not reliable; results may be hard to read and interpret; chance of error (saliva volume, bubbles, etc.); factors such as food, drink, and toothpaste can cause error. Home saliva monitori Yes (5–7) Yes (with vaginal sensor) 617–986 298–398j None Strengths: Prospectively identifies up to seven fertile days in each cycle; results reported with digital reading; vaginal sensor available to confirm ovulation; memory chip stores 4 mo of data; data downloadable to computer; no testing strips or other supplies required. Limitations: Expensive; conflicting data concerning accuracy. Open in new tab Table 1. Products for Home Testing of Ovulation Product Type Predicts Ovulation (Days) Confirms Ovulation Accuracy (%) Initial Cost ($) Monthly Cost ($) Strengths and Limitations aExamples: OvuTemp Basal (Advanced Micronic Devices Limited), generic glass, generic digital. bwww.drugstore.com; regular glass or digital. cLH = luteinizing hormone. Examples: First Response Easy Read Ovulation Test (Church & Dwight Co.), Answer Quick and Simple One Step Ovulation Test (Carter-Wallace), OvuPlan Easy (Key Pharmaceuticals), OvuQuick (Quidel), BeSure Tests (Genix Technology), Clearblue Easy Digital Ovulation Test (Inverness Medical), Generic 1 Step Ovulation Prediction Test Kits (Inverness Medical). dwww.babyhopes.com; 25 test strips, range for generic and brand-name strips. eE3G = estrone-3-glucuronide. Examples: Clearblue Easy Fertility Monitor (Inverness Medical). fwww.drugstore.com; 30 test strips per package. gExamples: Fertility Tracker Fertile Focus (Fairhaven Health), OvuLite (Abbott Smith Labs), The Donna (Donna Distributing), Maybe Mom (MaybeMOM), OvuLens (Make-It Manufacturing). hwww.babyhopes.com. iExample: Ovacue Fertility Monitor (Zetek). jwhttps://www.zetek.net/order.php; price for Ovacue or Ovacue with vaginal sensor. Basal body temperature thermometersa No Yes 746 10–15b None Strengths: Affordable; easy to use; some digital devices have memory; computer software for data tracking available. Limitations: Does not predict fertility in given cycle; changes in lifestyle and routine can alter results. Home urinary LH kitsc Yes (0–2) No 927 None 20–75d Strengths: Prospectively identifies up to two fertile days in each cycle; fast results in less than 5 min; easy to use; easy-to-read tests available. Limitations: Requires frequent urine samples; test results might be hard to interpret (color change); provides short window of advance notice for intercourse. Home urinary LH–E3G monitore Yes (1–5) No 918 200f 30–50f Strengths: Prospectively identifies up to six fertile days in each cycle; indicates peak fertility; easy to read and interpret results; monitors two hormones (estrogen and LH); stores data in memory. Limitations: Expensive; test sticks sold separately (in boxes of 30). Home saliva microscopyg Yes No 36.89–9810 30–50h None Strengths: Affordable; reusable slides; portable, lipstick-sized microscopes available. Limitations: Results not reliable; results may be hard to read and interpret; chance of error (saliva volume, bubbles, etc.); factors such as food, drink, and toothpaste can cause error. Home saliva monitori Yes (5–7) Yes (with vaginal sensor) 617–986 298–398j None Strengths: Prospectively identifies up to seven fertile days in each cycle; results reported with digital reading; vaginal sensor available to confirm ovulation; memory chip stores 4 mo of data; data downloadable to computer; no testing strips or other supplies required. Limitations: Expensive; conflicting data concerning accuracy. Product Type Predicts Ovulation (Days) Confirms Ovulation Accuracy (%) Initial Cost ($) Monthly Cost ($) Strengths and Limitations aExamples: OvuTemp Basal (Advanced Micronic Devices Limited), generic glass, generic digital. bwww.drugstore.com; regular glass or digital. cLH = luteinizing hormone. Examples: First Response Easy Read Ovulation Test (Church & Dwight Co.), Answer Quick and Simple One Step Ovulation Test (Carter-Wallace), OvuPlan Easy (Key Pharmaceuticals), OvuQuick (Quidel), BeSure Tests (Genix Technology), Clearblue Easy Digital Ovulation Test (Inverness Medical), Generic 1 Step Ovulation Prediction Test Kits (Inverness Medical). dwww.babyhopes.com; 25 test strips, range for generic and brand-name strips. eE3G = estrone-3-glucuronide. Examples: Clearblue Easy Fertility Monitor (Inverness Medical). fwww.drugstore.com; 30 test strips per package. gExamples: Fertility Tracker Fertile Focus (Fairhaven Health), OvuLite (Abbott Smith Labs), The Donna (Donna Distributing), Maybe Mom (MaybeMOM), OvuLens (Make-It Manufacturing). hwww.babyhopes.com. iExample: Ovacue Fertility Monitor (Zetek). jwhttps://www.zetek.net/order.php; price for Ovacue or Ovacue with vaginal sensor. Basal body temperature thermometersa No Yes 746 10–15b None Strengths: Affordable; easy to use; some digital devices have memory; computer software for data tracking available. Limitations: Does not predict fertility in given cycle; changes in lifestyle and routine can alter results. Home urinary LH kitsc Yes (0–2) No 927 None 20–75d Strengths: Prospectively identifies up to two fertile days in each cycle; fast results in less than 5 min; easy to use; easy-to-read tests available. Limitations: Requires frequent urine samples; test results might be hard to interpret (color change); provides short window of advance notice for intercourse. Home urinary LH–E3G monitore Yes (1–5) No 918 200f 30–50f Strengths: Prospectively identifies up to six fertile days in each cycle; indicates peak fertility; easy to read and interpret results; monitors two hormones (estrogen and LH); stores data in memory. Limitations: Expensive; test sticks sold separately (in boxes of 30). Home saliva microscopyg Yes No 36.89–9810 30–50h None Strengths: Affordable; reusable slides; portable, lipstick-sized microscopes available. Limitations: Results not reliable; results may be hard to read and interpret; chance of error (saliva volume, bubbles, etc.); factors such as food, drink, and toothpaste can cause error. Home saliva monitori Yes (5–7) Yes (with vaginal sensor) 617–986 298–398j None Strengths: Prospectively identifies up to seven fertile days in each cycle; results reported with digital reading; vaginal sensor available to confirm ovulation; memory chip stores 4 mo of data; data downloadable to computer; no testing strips or other supplies required. Limitations: Expensive; conflicting data concerning accuracy. Open in new tab How the devices work Ovulation-prediction devices monitor natural changes that occur in a woman’s body during the menstrual cycle. During the follicular phase of the menstrual cycle, there is a gradual rise in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estrogen.5,11,12 Once estrogen levels reach a critical concentration and duration, the pituitary gland releases an LH surge, which results in the final maturation of the follicle, follicle release, and corpus luteum formation.12 After ovulation, estrogen and progesterone levels continue to rise in order to promote a thick, fertile endometrium for optimal implantation.11,12 Around the time of ovulation, a woman experiences variations in her basal body temperature (BBT) and changes in the consistency of her oral and vaginal secretions.4 She might also notice increased libido and abdominal or lower-back discomfort. FSH and LH increase in the bloodstream and the urine.4,5,11,13 After ovulation, the ovum is viable for only about 12–24 hours, while sperm survive for up to 72 hours in the female reproductive tract. Therefore, the window for maximum fertility extends from two days before to 24 hours after ovulation.4 Wilcox et al.14 found the highest conception rate when couples had intercourse within six days of ovulation, with the highest probability (estimated conception rate ± S.E.) occurring two days before (0.27 ± 0.7), one day before (0.31 ± 0.6), and on the day of ovulation (0.33 ± 0.9). Therefore, to identify the time of maximum fertility, it is important to accurately predict the time of ovulation.4,5,13,14 Reproductive endocrinologists predict ovulation by drawing daily blood samples in midcycle to monitor changes in plasma FSH, LH, and estradiol and by conducting daily vaginal ultrasound monitoring to visualize follicular growth and collapse.15 Evaluating serum progesterone concentrations during the luteal phase may also confirm ovulation.4,12 These techniques, although very accurate, involve invasive testing and daily physician office visits. They are often used for the management of infertility, especially when couples pursue artificial reproductive technologies.4,5,15 Several more affordable, noninvasive testing options are sold in pharmacies that can help patients monitor fertility at home. BBT monitoring One simple and useful method for predicting fertility is BBT monitoring.4,5,16 The female body temperature measured orally typically ranges from 96 to 98 °F before ovulation.17 Just before ovulation there is a slight dip in temperature, followed by an increase of 0.5 to 1.6 °F in the basal reading because of increased progesterone levels in the body. Therefore, after ovulation the female body temperature taken orally is typically 97 to 99 °F.16,–18 The temperature remains high throughout the remainder of the cycle. By carefully monitoring, documenting, and charting temperature readings, a woman can track small changes that might signal that ovulation has occurred.16,–18 To facilitate monitoring, special BBT thermometers are available. These thermometers measure temperatures from 96 to 101 °F in 0.1 °F increments. BBT thermometers on the market range from simple, mercury-free glass thermometers to digital models with memory. The digital models often report temperature to within 0.01 °F. Charts are often included in the packaging so that women can graph the results; alternatively, blank charts can be downloaded from the Internet.17 Computer software programs are also available for tracking.19,20 BBT monitoring should begin on the first day of a woman’s menstrual cycle. Women must take their temperature after at least three to four hours of sleep.5,17 They should take their temperature as soon as they wake up, while they are still lying in bed. It is important that they do not eat, drink, or exercise before the reading. Temperatures should be measured for five minutes, and then the scale should be carefully read and the results recorded.5 Digital models usually take less time to detect a stable reading and beep when ready to be read. Temperatures can be measured orally or vaginally, but the method of measurement should be consistent throughout the month. At the time of ovulation, BBT will rise 0.4–0.8 °F; this temperature change may be gradual or rapid.5,17,18 BBT monitoring is most useful to analyze menstrual cycle trends from month to month so that a woman can become more aware of her ovulation patterns, enabling the couple to time intercourse during the projected window of fertility in future months. Patients should be aware that BBT indicates that ovulation has already occurred.16 Once the trend in BBT is noted, the 24-hour window for fertilization has already passed for the current month. To predict the time of ovulation, other devices are necessary.4,16 Because BBT monitoring is most effective when the temperature is measured at approximately the same time each day after a good night’s sleep, it might not be a good alternative for a woman who has an unpredictable schedule, disrupted sleep, or inconsistent sleep patterns. BBT readings can be affected by factors such as illness, infection, anxiety, stress, fatigue, jet lag, nightmares, insomnia, smoking, exercise, and electric blanket use.5,16 Urinary LH testing Several ovulation-prediction devices monitor changes in urinary LH concentrations. The surge in LH that triggers ovulation is detectable in the urine within 8–12 hours; ovulation should follow within 12–24 hours.13 Home devices for testing urinary LH contain monoclonal antibodies or a mixture of monoclonal and polyclonal antibodies that bind LH in the urine. During the test, if LH is present in the urine sample it is “sandwiched” between two antibodies.21 An enzyme-linked immunosorbent assay then detects the LH–antibody complex, causing a color change that the patient can view and interpret.21,22 The intensity of the color change increases with higher concentrations of LH.21 The color for a positive result varies among products but is usually blue, blue-green, or pink.16,21 All products contain a control window that must activate after the urine sample is applied to show that the testing device is working correctly and the test result is valid. This control window may display a change in color or a line or symbol. Most products also have a window that displays the test results in the same manner as the control data.13,21 A positive result may be difficult for the patient to interpret. For instance, with some test devices, the patient must watch for a peak change in color, indicating the highest concentration of LH.21 To simplify interpretation, newer products display an unambiguous symbol (such as a “smiley face”) when the LH complex is detected.23 Some clinicians define the LH surge as beginning when detectable LH reaches a concentration of 35–60 mIU/mL.21,24 However, others define the surge as starting when the serum LH level reaches 1.5 times the mean preovulatory level observed during the follicular phase.21,25 Most home urinary LH kits can detect LH concentrations at or above 20–40 mIU/mL, and when the devices are used as directed the results generally agree with those of more invasive laboratory tests used to predict ovulation.15,21,26 Studies have been conducted to evaluate the value of urinary LH kits for predicting ovulation in both fertile and infertile women.21,26 In infertile women, ovulation was accurately predicted within 48 hours after the peak measured urinary LH level in 90–100% of cases; among fertile women, the predictive value ranged from 92% to 97%. However, some test devices are more sensitive than others.17 In one study, the ClearPlan Easy Ovulation Test Pack (Inverness Medical) was found to have the best sensitivity for detecting urinary LH—concentrations as low as 22 mIU/mL were detected. Other devices were comparable with good sensitivity, except Answer Quick (Carter–Wallace) and Simple One Step Ovulation Test (Carter–Wallace), which showed poor LH sensitivity.22,27 Patients may dislike collecting and handling urine samples, so some manufacturers have developed onestep testing strips that can be held in the urine stream. Patients should be instructed to perform all urine tests first thing in the morning with the first urination of the day, when LH is most concentrated in the urine. It is very important that the patient read and follow the product-specific instructions for testing.5 If the test cannot be performed at the time of the day’s first urination, then the urine sample can be refrigerated and tested later in the day; the sample should be returned to room temperature before testing.22 The optimal time to begin daily urine testing varies from patient to patient, depending on the length of her menstrual cycle. For instance, if a woman has a 21-day cycle she should begin testing on day 6, but if she has a 30-day cycle she should delay testing until day 13.13 A table indicating when to initiate testing is included in the kit.13 Once started, testing should be continued for five to seven days. If a woman has an irregular menstrual cycle, she should continue testing for at least nine consecutive days until she detects an LH surge or begins her menstrual period.13 Failure to detect a surge between cycles might indicate that the surge was missed or that the patient had an anovulatory cycle.13,22 An irregular menstrual cycle that necessitates an expanded testing window increases the cost of monitoring significantly. Several health conditions related to infertility, and the drugs used to treat them, can interfere with the accuracy of urinary LH test results. This is an important counseling point.13,22 Health conditions include endometriosis, polycystic ovarian syndrome, premature ovarian failure, perimenopause, menopause, and hyperthyroidism13,22; others include renal failure, gonadotropin-producing neoplasia, and pregnancy. Medications include menotropins, danazol, clomiphene, human chorionic gonadotropin (HCG), hormone supplementation, and steroids.13 Urinary LH and estrone-3-glucuronide monitoring The Clear-blue Easy Fertility Monitor (CBEFM) (formerly known as the ClearPlan Easy Fertility Monitor, Inverness Medical) tests for two hormones in the urine, LH and estrone-3-glucuronide (E3G), which is the dominant metabolite of estradiol.28 Studies have found that urinary E3G concentrations are a good marker of the fertility window, while LH levels are the best predictors of imminent ovulation. Therefore, evaluating these two hormones together may provide more data on fertility status than either alone.8,22 The CBEFM requires the patient to monitor her urine daily for 20 consecutive days in one month in order to collect baseline data on hormone levels before fertility testing begins. After this, the patient tests her urine once daily for 10–20 days per month. The monitor stores data and compares readings from day to day. The results are displayed on an easy-to-read screen that indicates low, high, or peak fertility on a bar graph. An egg symbol appears in the testing window on days of maximum fertility.22,28 Behre and colleagues8 found very good results with the CBEFM. The device never indicated peak fertility before ovulation occurred, and 63.5% of patients had up to seven days of warning before ovulation occurred; 91.1% of patients ovulated during the two-day window of maximum fertility indicated by the device; and 97.0% ovulated either during the two-day window or during the one day of high fertility that was indicated after the peak. The CBEFM is an expensive initial investment compared with urinary LH test strips. In addition to the monitor, test strips must be purchased separately. However, the device is easy to use, results are very clear, and the patient receives more information concerning the fertility window than with other urine-testing methods.28 Saliva microscopy During a woman’s menstrual cycle, as estrogen levels increase in the body there is a corresponding increase in the amount of sodium chloride in mucus secretions (saliva and cervical–vaginal mucus), which results in crystallization or “ferning” of mucus when it is dried.10,29 Therefore, one method that has been used to monitor fertility is visual inspection of saliva throughout the month. When a saliva sample is placed on a glass microscope slide and dried, a characteristic pattern of crystals may be seen. During the fertile period, the pattern changes from small dots to small ferns to large ferns, indicating low, intermediate, and high fertility, respectively. Several compact, portable, and inexpensive microscopes are available for home monitoring of saliva.29 Several come in containers shaped and sized like lipstick cases.10 According to the manufacturers’ websites, when used as directed these devices can provide 24–72 hours of advance notification of ovulation.29 However, for best results the patient should collect a “passive saliva” sample first thing in the morning, before she eats, drinks, or brushes her teeth. The sample should be evenly distributed across the slide. Air bubbles or excess saliva can alter the results. After the sample has air dried, it is visually inspected under the microscope, and the pattern is compared with reference patterns.29 Pregnancy, perimenopause, menopause, hormone imbalance, hormone replacement therapy, and hormonal contraception can interfere with the results. Studies that have assessed home saliva microscopy for fertility monitoring have yielded conflicting results. One small study (n = 12) found a high correlation between saliva microscopy results and those of home urinary LH monitoring (r = 0.98, p < 0.001).10 However, the subjects found it very difficult to define the beginning and end of the fertility window. The subjects were not blinded to their urinary LH results, so this could have influenced saliva-ferning interpretation. Also, the subjects were fertility-planning teachers, which may have decreased the generalizability of the findings. One subject observed ferning throughout the menstrual cycle. One male investigator who tested the microscope observed ferning of his own saliva; similarly, Braat and colleagues30 found positive results for both men and postmenopausal women. Guida et al.9 observed that saliva microscopy detected ovulation 36.8% of the time but that 58.7% of the results were uninterpretable. Saliva testing was found to be an option for detecting ovulation, but only after many samples were excluded because of unclear results. Freundl et al.31 reported a high rate of false-negatives (a low indicated level of fertility on days of high fertility). When considering the total number of fertile days within a cycle, the false-negative rates for three microscopes studied were 73.4%, 58.0%, and 51.6%. Although home saliva microscopes are inexpensive and portable, the results can be difficult to read and interpret, and it is difficult to define the window of fertility. In general, this technique requires more steps, skill, and interpretation than other fertility-monitoring methods, and the results are not very reliable. Oral saliva fertility monitoring Saliva and cervical–vaginal mucus can be tested for electrolytic changes during the menstrual cycle by using a monitor that measures changes in electrical resistance. Zetek, Inc., manufactures an electronic saliva monitor for use at home and offers two models, the Cue II and the OvaCue. An optional vaginal sensor can be used in conjunction with these monitors to test vaginal mucus to confirm ovulation. Using the oral and vaginal data together provides information about the beginning and end of the fertility window. The OvaCue model is newer and has been upgraded for data storage; an optional software package is available for downloading data from the device for expanded analysis, charting, and tracking.6 Oral saliva fertility monitoring (OSFM) is straightforward. The patient applies a spoon-sized sensor to her tongue for five seconds first thing in the morning. The monitor displays the patient’s current cycle day, her current level of fertility, the window of possible fertility for this cycle, the time of maximum fertility, and whether ovulation has occurred. Fertility status is depicted by one to seven bars, indicating low to high fertility. The optional vaginal probe is required for ovulation confirmation. According to the manufacturer, when used exactly as recommended on consecutive days, OSFM can predict ovulation five to seven days in advance.6,32 The OSFM device uses a patented technology called the Electrolyte Method. The monitor tests for changes in levels of electrolytes, such as sodium and potassium, in secretions. Salivary electrolytes reach a peak approximately seven days before ovulation. By measuring these electrolytes daily, OSFM can predict the LH surge and subsequent ovulation. The LH surge is also associated with changes in electrolyte concentrations in vaginal secretions. After the LH surge, the cervical mucus becomes less viscous to give sperm maximum motility; therefore, electrolyte levels in the mucus temporarily drop. After ovulation, the cervical mucus returns to normal and there is a rise in vaginal electrolytes. The vaginal probe tests for this temporary dip and subsequent rise, confirming that ovulation has occurred and defining the end of the fertility window.6,26 In studies, subjects were instructed to limit dietary sodium and the use of sodium-containing antacids during the testing window.32 Also, study participants were instructed to avoid sexual intercourse and douching before analysis.26 Studies have reported conflicting results concerning the accuracy of OSFM for ovulation prediction. A 1988 study found no significant salivary resistance peak during menstrual cycles and concluded that the OSFM device tested was not useful for fertility monitoring.32,33 In another study, an OSFM device with both oral and vaginal probes was tested in a sample of spontaneously ovulating infertile women. The correlation coefficient for the association between the peak in salivary electrical resistance and the serum LH peak was 0.61 (p < 0.01).7 However, the LH peak occurred four to nine days after the salivary peak. Urinary LH testing performed twice daily was the best predictor of ovulation (r = 0.93, p = 0.0001). In 1997, Moreno et al.34 reported that, on average, OSFM (the Cue) predicted ovulation eight days in advance. The method was found to be a reliable predictor of ovulation as part of natural family planning. OSFM is more expensive than other options and requires a substantial initial investment by the patient. The vaginal probe and software are sold separately, so the customer can customize components. However, no test strips or other supplies have to be purchased, and the instrument can be used repeatedly. This technology does not require urine or saliva collection, and the results are clear and easy to interpret.6 However, the conflicting results in the literature raise doubts about accuracy and reliability for ovulation prediction. Device selection and patient counseling The choice of a device for ovulation prediction depends on the couple’s timetable for conception, desire for accuracy, comfort with technology, and willingness to pay. Pharmacists should review the patient’s medical and medication histories to screen for any health conditions or medications that might interfere with the accuracy of results for the device being considered. Patients must be educated on how to use the device and should understand the basic principles of the menstrual cycle, including viability of the ovum and sperm in the reproductive tract. The patient should know how to time intercourse to maximize the likelihood of successful fertilization. Patients should always check expiration dates, and supplies should be stored according to the manufacturer’s specifications. Patients should understand that BBT and saliva testing must be completed first thing in the morning—immediately after waking and before eating, drinking, exercising, or brushing the teeth. Urine tests must use the first urine of the day, which is the most concentrated urine and should provide the most accurate results. The test should be completed with the first voiding. If this opportunity is missed, the patient should avoid drinking too much fluid for four to six hours before a sample is collected.22 If a urine test cannot be completed immediately, the patient should refrigerate the sample and bring it to room temperature before testing. If the patient is using a vaginal sensor in conjunction with OSFM, the probe should be used in the evening before intercourse or douching.26 Patients should understand that there are multiple causes of infertility. If a couple uses a product exactly as directed and does not conceive, a gynecologist or infertility specialist should be consulted for further assessment. Pregnancy testing The search for an effective and reliable pregnancy test began as early as the 1920s.35 The first home pregnancy test, E.P.T. (Warner–Lambert), was approved by the Food and Drug Administration (FDA) in 1976 and marketed to the public in 1977.35 Since then, millions of women have used these devices for early detection of pregnancy. Early detection allows the patient to make lifestyle changes and to seek prenatal care. How the devices work Home pregnancy tests (HPTs) are designed to detect HCG in the urine. Trophoblasts of the fertilized ovum begin to produce HCG after implantation until the placenta develops and begins producing HCG on its own. HCG is usually detectable 10–12 days after fertilization, but in some women detection may take up to three weeks. HCG peaks 60–70 days after fertilization and then plateaus as pregnancy progresses. HPTs produced after 1990 involve immunometric assays that use monoclonal or polyclonal antibodies to bind to HCG and produce a reaction resulting in a color change, the appearance of lines, or, with the new digital models, the appearance of the word “pregnant.”36,37 Device-selection guidelines In April 2007 there were 162 pregnancy test products registered with FDA, of which 33 were intended for home use (Table 2).38,–41 Patients often seek guidance about the “best test,” and pharmacists can assist patients by knowing the limitations of HPTs. Most HPTs claim to be 94–99% accurate, but these claims are based on testing under ideal conditions by the manufacturers. Studies have shown that, when patients use HPTs in the home environment, accuracy and effectiveness may decrease. A meta-analysis of five studies involving a total of 16 HPTs found that summary sensitivity scores decreased from 0.91 (95% confidence interval [CI], 0.84–0.96) to 0.75 (95% CI, 0.64–0.85) and that effectiveness scores (comparison of the relative and absolute ability of an HPT to distinguish between women who are pregnant and those who are not) decreased from 2.75 (95% CI, 2.3–3.2) to 0.82 (95% CI, 0.4–1.2) when HPTs were used by woman volunteers at home versus in the laboratory setting.42 The wide variation in HCG concentrations (e.g., from 12 to 2438 IU/L during the fourth week of pregnancy) is another limiting factor of HPTs.39 The two major factors that reduced sensitivity and effectiveness scores in the volunteer groups were user error and testing too early (before HCG was detectable).39 Table 2. Examples of Devices for Home Testing for Pregnancy39,–41,a Test Results at Various HCG Concentrations (Intact HCG Result/H-HCG Result) Device Manufacturer’s Recommended Time to Result (min) Manufacturer’s HCG Detection Limit (IU/L) 6.3 IU/L 12.5–13 IU/L 25 IU/L 50 IU/L 100 IU/L Consumer ReportsRating41,b Price ($) aHCG = human chorionic gonadotropin, H-HCG = hyperglycosylated HCG, − = negative result, ± = faintly positive result, + = clearly positive result, NA = not available. bExcellent = detection at ~6.25 IU/L, fair = detection at ~100 IU/L, very good and good levels not reported. cPrice obtained from www.drugstore.com on April 24, 2007; does not include shipping or taxes. dThis brand gave false-positive results when HCG/H-HCG concentrations were zero.40 ePrice obtained from www.cvs.com on April 24, 2007; does not include shipping or taxes. fPrice obtained from www.walgreens.com on April 24, 2007; does not include shipping or taxes. Accu-Clear (Inverness) 3 100 −/− −/− +/− +/− +/NA Fair 9.99c American Fare (KMart) 3 100 −/− +/+ +/+ +/+ NA NA NA Answer (Armkel) 2 100 −/− +/− +/± +/+ +/NA Very good 14.99c Clearblue Easy, 1 min (Inverness) 1 50 +/− +/− +/+ +/+ +/NA Good 16.99c Clear Choice (Pharmatech)d 5 NA NA ±/NA +/NA +/NA +/NA Excellent 10.99c Confirm (Durex)d 5 25 −/− −/+ −/+ +/+ ±/NA Fair 13.19c CVS brand 3 NA NA −/NA −/NA −/NA +/NA Fair 8.99e E.P.T. (Warner–Lambert) 3 40 −/− −/+ +/+ +/+ +/NA Good 12.99c Equate (Wal-Mart) 1 25 −/− −/− +/− +/+ ±/NA Fair NA Fact Plus Select (Abbott) 3 100 −/− −/− +/+ +/+ NA NA 15.99c First Response Early Result (Armkel) 3 50 +/− +/− +/+ +/+ +/NA Excellent 11.99c One Step     Rite Aid 3 50 −/− −/− +/− +/− +/NA Fair 7.99c     Sav-On, Osco 3 NA NA −/NA −/NA −/NA ±/NA Fair NA     Target 3 50 ±/− +/− +/− +/− +/NA Fair NA     Walgreens 3 50 −/− −/− +/− +/− +/NA Fair 12.99f Test Results at Various HCG Concentrations (Intact HCG Result/H-HCG Result) Device Manufacturer’s Recommended Time to Result (min) Manufacturer’s HCG Detection Limit (IU/L) 6.3 IU/L 12.5–13 IU/L 25 IU/L 50 IU/L 100 IU/L Consumer ReportsRating41,b Price ($) aHCG = human chorionic gonadotropin, H-HCG = hyperglycosylated HCG, − = negative result, ± = faintly positive result, + = clearly positive result, NA = not available. bExcellent = detection at ~6.25 IU/L, fair = detection at ~100 IU/L, very good and good levels not reported. cPrice obtained from www.drugstore.com on April 24, 2007; does not include shipping or taxes. dThis brand gave false-positive results when HCG/H-HCG concentrations were zero.40 ePrice obtained from www.cvs.com on April 24, 2007; does not include shipping or taxes. fPrice obtained from www.walgreens.com on April 24, 2007; does not include shipping or taxes. Accu-Clear (Inverness) 3 100 −/− −/− +/− +/− +/NA Fair 9.99c American Fare (KMart) 3 100 −/− +/+ +/+ +/+ NA NA NA Answer (Armkel) 2 100 −/− +/− +/± +/+ +/NA Very good 14.99c Clearblue Easy, 1 min (Inverness) 1 50 +/− +/− +/+ +/+ +/NA Good 16.99c Clear Choice (Pharmatech)d 5 NA NA ±/NA +/NA +/NA +/NA Excellent 10.99c Confirm (Durex)d 5 25 −/− −/+ −/+ +/+ ±/NA Fair 13.19c CVS brand 3 NA NA −/NA −/NA −/NA +/NA Fair 8.99e E.P.T. (Warner–Lambert) 3 40 −/− −/+ +/+ +/+ +/NA Good 12.99c Equate (Wal-Mart) 1 25 −/− −/− +/− +/+ ±/NA Fair NA Fact Plus Select (Abbott) 3 100 −/− −/− +/+ +/+ NA NA 15.99c First Response Early Result (Armkel) 3 50 +/− +/− +/+ +/+ +/NA Excellent 11.99c One Step     Rite Aid 3 50 −/− −/− +/− +/− +/NA Fair 7.99c     Sav-On, Osco 3 NA NA −/NA −/NA −/NA ±/NA Fair NA     Target 3 50 ±/− +/− +/− +/− +/NA Fair NA     Walgreens 3 50 −/− −/− +/− +/− +/NA Fair 12.99f Open in new tab Table 2. Examples of Devices for Home Testing for Pregnancy39,–41,a Test Results at Various HCG Concentrations (Intact HCG Result/H-HCG Result) Device Manufacturer’s Recommended Time to Result (min) Manufacturer’s HCG Detection Limit (IU/L) 6.3 IU/L 12.5–13 IU/L 25 IU/L 50 IU/L 100 IU/L Consumer ReportsRating41,b Price ($) aHCG = human chorionic gonadotropin, H-HCG = hyperglycosylated HCG, − = negative result, ± = faintly positive result, + = clearly positive result, NA = not available. bExcellent = detection at ~6.25 IU/L, fair = detection at ~100 IU/L, very good and good levels not reported. cPrice obtained from www.drugstore.com on April 24, 2007; does not include shipping or taxes. dThis brand gave false-positive results when HCG/H-HCG concentrations were zero.40 ePrice obtained from www.cvs.com on April 24, 2007; does not include shipping or taxes. fPrice obtained from www.walgreens.com on April 24, 2007; does not include shipping or taxes. Accu-Clear (Inverness) 3 100 −/− −/− +/− +/− +/NA Fair 9.99c American Fare (KMart) 3 100 −/− +/+ +/+ +/+ NA NA NA Answer (Armkel) 2 100 −/− +/− +/± +/+ +/NA Very good 14.99c Clearblue Easy, 1 min (Inverness) 1 50 +/− +/− +/+ +/+ +/NA Good 16.99c Clear Choice (Pharmatech)d 5 NA NA ±/NA +/NA +/NA +/NA Excellent 10.99c Confirm (Durex)d 5 25 −/− −/+ −/+ +/+ ±/NA Fair 13.19c CVS brand 3 NA NA −/NA −/NA −/NA +/NA Fair 8.99e E.P.T. (Warner–Lambert) 3 40 −/− −/+ +/+ +/+ +/NA Good 12.99c Equate (Wal-Mart) 1 25 −/− −/− +/− +/+ ±/NA Fair NA Fact Plus Select (Abbott) 3 100 −/− −/− +/+ +/+ NA NA 15.99c First Response Early Result (Armkel) 3 50 +/− +/− +/+ +/+ +/NA Excellent 11.99c One Step     Rite Aid 3 50 −/− −/− +/− +/− +/NA Fair 7.99c     Sav-On, Osco 3 NA NA −/NA −/NA −/NA ±/NA Fair NA     Target 3 50 ±/− +/− +/− +/− +/NA Fair NA     Walgreens 3 50 −/− −/− +/− +/− +/NA Fair 12.99f Test Results at Various HCG Concentrations (Intact HCG Result/H-HCG Result) Device Manufacturer’s Recommended Time to Result (min) Manufacturer’s HCG Detection Limit (IU/L) 6.3 IU/L 12.5–13 IU/L 25 IU/L 50 IU/L 100 IU/L Consumer ReportsRating41,b Price ($) aHCG = human chorionic gonadotropin, H-HCG = hyperglycosylated HCG, − = negative result, ± = faintly positive result, + = clearly positive result, NA = not available. bExcellent = detection at ~6.25 IU/L, fair = detection at ~100 IU/L, very good and good levels not reported. cPrice obtained from www.drugstore.com on April 24, 2007; does not include shipping or taxes. dThis brand gave false-positive results when HCG/H-HCG concentrations were zero.40 ePrice obtained from www.cvs.com on April 24, 2007; does not include shipping or taxes. fPrice obtained from www.walgreens.com on April 24, 2007; does not include shipping or taxes. Accu-Clear (Inverness) 3 100 −/− −/− +/− +/− +/NA Fair 9.99c American Fare (KMart) 3 100 −/− +/+ +/+ +/+ NA NA NA Answer (Armkel) 2 100 −/− +/− +/± +/+ +/NA Very good 14.99c Clearblue Easy, 1 min (Inverness) 1 50 +/− +/− +/+ +/+ +/NA Good 16.99c Clear Choice (Pharmatech)d 5 NA NA ±/NA +/NA +/NA +/NA Excellent 10.99c Confirm (Durex)d 5 25 −/− −/+ −/+ +/+ ±/NA Fair 13.19c CVS brand 3 NA NA −/NA −/NA −/NA +/NA Fair 8.99e E.P.T. (Warner–Lambert) 3 40 −/− −/+ +/+ +/+ +/NA Good 12.99c Equate (Wal-Mart) 1 25 −/− −/− +/− +/+ ±/NA Fair NA Fact Plus Select (Abbott) 3 100 −/− −/− +/+ +/+ NA NA 15.99c First Response Early Result (Armkel) 3 50 +/− +/− +/+ +/+ +/NA Excellent 11.99c One Step     Rite Aid 3 50 −/− −/− +/− +/− +/NA Fair 7.99c     Sav-On, Osco 3 NA NA −/NA −/NA −/NA ±/NA Fair NA     Target 3 50 ±/− +/− +/− +/− +/NA Fair NA     Walgreens 3 50 −/− −/− +/− +/− +/NA Fair 12.99f Open in new tab Several studies show that most HPTs work best when the HCG concentration reaches a minimum of 25 IU/L.39,40 However, this concentration is rarely achieved on the day or week of missed menstruation, which is when most patients desire to self-test.39,40,43 Complicating the situation are the multiple forms of HCG: hyperglycosylated HCG, intact HCG, free α-subunit, and free β-subunit.43 Hyperglycosylated HCG is the primary form detected in early pregnancy (80% of HCG one week after implantation), whereas the intact form is more prevalent in the second and third trimesters.43 Curiously, not all HPTs are designed to effectively detect hyperglycosylated HCG.22 A 2001 study in which 15 HPT products were tested with 592 urine samples found that only 7 devices effectively detected the hyperglycosylated form.39 To add even more to the confusion, the literature is inconsistent in documenting problems with HPTs. In 1996, Consumer Reports recommended Answer (Armkel) as the top HPT on the market.44 In 2003, based on new testing, Consumer Reports chose First Response Early Results (Armkel) and Clear Choice (Pharmatech) as the top HPTs.41 The First Response Early Results HPT also performed well in a study by Cole et al.40 However, the Clear Choice and Confirm (Durex) products had significant technical problems: Both gave positive results for urine containing zero HCG.40 A 2006 survey of 5000 community pharmacists showed E.P.T. and First Response Early Results to be the two most recommended tests.45 Overall, First Response Early Results may be the best test for detecting pregnancy before the fourth week of gestation, when HCG levels are low. After that point, most of the HPTs are equivalent. Patient counseling The following information should be obtained from the patient to help decide if an HPT is appropriate: number of days after unprotected sex, number of days since missed menstrual period; experience with HPTs, preferred urine-collection method, patient limitations (visual impairment, colorblindness, tremors, illiteracy, etc.), and presence of interactions involving any drug (e.g., HCG injection) or condition (e.g., HCG-secreting tumors, ovarian cysts, miscarriage or abortion in the preceding eight weeks).36,37 Patients should understand that HCG levels are extremely variable from the day of missed menstruation to the fourth week of gestation, that there is a chance for false-negatives, and that retesting is necessary if menstruation has not begun within one week of a negative finding. If the repeat test is negative and menstruation does not begin as expected, patients should see a physician for a serum HCG test and a physical examination. Patients should be aware that early pregnancy losses, which are estimated to occur in 30% of patients, may result in a positive early test result but negative follow-up test results.46 Patients may benefit from tips for increasing the sensitivity of the test, such as waiting 10 minutes before reading results, sampling the first urine of the day, and making sure that the test strips are stored properly and have not expired. 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,–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,–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. How the devices work 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,–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,–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,–61 Device selection 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,–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,–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. Patient counseling for FSH monitors 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. Table 3. Examples of Devices for Home Monitoring for Menopause Device Reported Accuracy (%) Time to Results (min) Cost ($)a How Results Expressed Comments aPrices obtained from www.drugstore.com, www.walgreens.com, and www.home-menopause-test.com on May 10, 2007, and do not include shipping or taxes. Estroven Menopause Monitor (Amerifit Nutrition) 99 15 20 Line(s) Positive result = one line, negative result = two lines. Each box contains two urine collection dishes, two droppers, two testing cassettes. Must catch urine sample in midstream, but it may be refrigerated for up to 24 hr. Test requires four drops of urine. Menocheck (Synova) 95 5 18–19 Color change Positive result = test line darker than control line, negative result = test line lighter than control line. Each box contains two test strips. Must hold specified end of strip under urine stream for 5 sec. RU 25 Plus Menopause Monitor (Hormone Check) 99 5 20 Line(s) Positive result = one line, negative result = two lines. Each box contains two test strips. Must hold specified end of strip under urine stream for 5 sec. Device Reported Accuracy (%) Time to Results (min) Cost ($)a How Results Expressed Comments aPrices obtained from www.drugstore.com, www.walgreens.com, and www.home-menopause-test.com on May 10, 2007, and do not include shipping or taxes. Estroven Menopause Monitor (Amerifit Nutrition) 99 15 20 Line(s) Positive result = one line, negative result = two lines. Each box contains two urine collection dishes, two droppers, two testing cassettes. Must catch urine sample in midstream, but it may be refrigerated for up to 24 hr. Test requires four drops of urine. Menocheck (Synova) 95 5 18–19 Color change Positive result = test line darker than control line, negative result = test line lighter than control line. Each box contains two test strips. Must hold specified end of strip under urine stream for 5 sec. RU 25 Plus Menopause Monitor (Hormone Check) 99 5 20 Line(s) Positive result = one line, negative result = two lines. Each box contains two test strips. Must hold specified end of strip under urine stream for 5 sec. Open in new tab Table 3. Examples of Devices for Home Monitoring for Menopause Device Reported Accuracy (%) Time to Results (min) Cost ($)a How Results Expressed Comments aPrices obtained from www.drugstore.com, www.walgreens.com, and www.home-menopause-test.com on May 10, 2007, and do not include shipping or taxes. Estroven Menopause Monitor (Amerifit Nutrition) 99 15 20 Line(s) Positive result = one line, negative result = two lines. Each box contains two urine collection dishes, two droppers, two testing cassettes. Must catch urine sample in midstream, but it may be refrigerated for up to 24 hr. Test requires four drops of urine. Menocheck (Synova) 95 5 18–19 Color change Positive result = test line darker than control line, negative result = test line lighter than control line. Each box contains two test strips. Must hold specified end of strip under urine stream for 5 sec. RU 25 Plus Menopause Monitor (Hormone Check) 99 5 20 Line(s) Positive result = one line, negative result = two lines. Each box contains two test strips. Must hold specified end of strip under urine stream for 5 sec. Device Reported Accuracy (%) Time to Results (min) Cost ($)a How Results Expressed Comments aPrices obtained from www.drugstore.com, www.walgreens.com, and www.home-menopause-test.com on May 10, 2007, and do not include shipping or taxes. Estroven Menopause Monitor (Amerifit Nutrition) 99 15 20 Line(s) Positive result = one line, negative result = two lines. Each box contains two urine collection dishes, two droppers, two testing cassettes. Must catch urine sample in midstream, but it may be refrigerated for up to 24 hr. Test requires four drops of urine. Menocheck (Synova) 95 5 18–19 Color change Positive result = test line darker than control line, negative result = test line lighter than control line. Each box contains two test strips. Must hold specified end of strip under urine stream for 5 sec. RU 25 Plus Menopause Monitor (Hormone Check) 99 5 20 Line(s) Positive result = one line, negative result = two lines. Each box contains two test strips. Must hold specified end of strip under urine stream for 5 sec. Open in new tab Colon cancer screening Colon cancer is the third leading cause of cancer in men and women in the United States and the second leading cause of cancer-related death; however, the death rate for colon cancer has decreased by approximately 15% over the past 10 years because of more frequent and more effective screening.65 Screening recommendations include annual fecal occult blood testing (FOBT), flex sigmoidoscopy every 5 years, and full colonoscopy every 10 years after the age of 50.65,66 Since patients are often reluctant to submit to sigmoidoscopy and colonoscopy, FOBT has become the standard for screening in average-risk individuals.65,–67 Multiple clinical trials have shown that annual FOBT can decrease morbidity and mortality associated with colorectal cancer.65,67,–69 Simple home and outpatient screening tests have become a mainstay for the FOBT market. How the devices work Two types of FOBT products are currently available for the home and ambulatory care settings (Table 4).65,70,–75 The most commonly used device is the guaiac test, which works via the oxidation of guaiac in the test strip by hydrogen peroxide in the reagent. The iron in the heme portion of the hemoglobin molecule catalyzes the reaction, and the reaction will not proceed without hemoglobin.72,–74 This oxidative process causes a change in color at the reaction site. The second type of FOBT is fecal immunochemical testing (FIT), which relies on antibodies to hemoglobin forming immune complexes.70,71 Table 4. Examples of Devices for Home Screening for Colon Cancer70,–75,a Device Reported Accuracy (%) Sensitivity Time to Results (min) Cost ($)b Type of Test Comments aHb = hemoglobin, NR = not reported, CLIA = Clinical Laboratory Improvement Amendments. bPrices obtained from www.drugstore.com, http://physlabs.stores.yahoo.net/index.html, and www.meditests.com on May 10, 2007, and do not include shipping or taxes. EZ Detect Stool Blood Test (Biomerica) >99 2.0 mg of Hb per 100 mL of water 2 7.99 (1.60 per test) Flushable reagent (guaiac) Positive result = blue-green color. Kit contains five test tissues, one control solution, patient instructions, one results post card to send to physician. First Check Home Early Detection (First Check Diagnostics) NR NR 2 12.99 (2.60 per test) Flushable reagent (guaiac) Positive result = blue-green color. Kit contains five test pads, one positive control, patient instructions, one results post card to send to physician. Hemoccult (Beckman Coulter) 95–97 0.3 mg of Hb per 1 g of stool 1 98 (0.98 per test) Guaiac Positive result = blue color. Kit contains 100 test slides, 100 applicators, two test solutions. Intended for use by health care provider but may be done in home setting; CLIA requirements waived. Hemosure One Step (Hemosure) 94.15 0.05 μg of Hb per 100 mL of water <5 300 ($150 per test) Immunoassay Positive result = two lines, negative result = one line. Kit contains two collection papers, two sample-collection tubes, two test cartridges. Intended for use in health care setting; CLIA requirements waived. Device Reported Accuracy (%) Sensitivity Time to Results (min) Cost ($)b Type of Test Comments aHb = hemoglobin, NR = not reported, CLIA = Clinical Laboratory Improvement Amendments. bPrices obtained from www.drugstore.com, http://physlabs.stores.yahoo.net/index.html, and www.meditests.com on May 10, 2007, and do not include shipping or taxes. EZ Detect Stool Blood Test (Biomerica) >99 2.0 mg of Hb per 100 mL of water 2 7.99 (1.60 per test) Flushable reagent (guaiac) Positive result = blue-green color. Kit contains five test tissues, one control solution, patient instructions, one results post card to send to physician. First Check Home Early Detection (First Check Diagnostics) NR NR 2 12.99 (2.60 per test) Flushable reagent (guaiac) Positive result = blue-green color. Kit contains five test pads, one positive control, patient instructions, one results post card to send to physician. Hemoccult (Beckman Coulter) 95–97 0.3 mg of Hb per 1 g of stool 1 98 (0.98 per test) Guaiac Positive result = blue color. Kit contains 100 test slides, 100 applicators, two test solutions. Intended for use by health care provider but may be done in home setting; CLIA requirements waived. Hemosure One Step (Hemosure) 94.15 0.05 μg of Hb per 100 mL of water <5 300 ($150 per test) Immunoassay Positive result = two lines, negative result = one line. Kit contains two collection papers, two sample-collection tubes, two test cartridges. Intended for use in health care setting; CLIA requirements waived. Open in new tab Table 4. Examples of Devices for Home Screening for Colon Cancer70,–75,a Device Reported Accuracy (%) Sensitivity Time to Results (min) Cost ($)b Type of Test Comments aHb = hemoglobin, NR = not reported, CLIA = Clinical Laboratory Improvement Amendments. bPrices obtained from www.drugstore.com, http://physlabs.stores.yahoo.net/index.html, and www.meditests.com on May 10, 2007, and do not include shipping or taxes. EZ Detect Stool Blood Test (Biomerica) >99 2.0 mg of Hb per 100 mL of water 2 7.99 (1.60 per test) Flushable reagent (guaiac) Positive result = blue-green color. Kit contains five test tissues, one control solution, patient instructions, one results post card to send to physician. First Check Home Early Detection (First Check Diagnostics) NR NR 2 12.99 (2.60 per test) Flushable reagent (guaiac) Positive result = blue-green color. Kit contains five test pads, one positive control, patient instructions, one results post card to send to physician. Hemoccult (Beckman Coulter) 95–97 0.3 mg of Hb per 1 g of stool 1 98 (0.98 per test) Guaiac Positive result = blue color. Kit contains 100 test slides, 100 applicators, two test solutions. Intended for use by health care provider but may be done in home setting; CLIA requirements waived. Hemosure One Step (Hemosure) 94.15 0.05 μg of Hb per 100 mL of water <5 300 ($150 per test) Immunoassay Positive result = two lines, negative result = one line. Kit contains two collection papers, two sample-collection tubes, two test cartridges. Intended for use in health care setting; CLIA requirements waived. Device Reported Accuracy (%) Sensitivity Time to Results (min) Cost ($)b Type of Test Comments aHb = hemoglobin, NR = not reported, CLIA = Clinical Laboratory Improvement Amendments. bPrices obtained from www.drugstore.com, http://physlabs.stores.yahoo.net/index.html, and www.meditests.com on May 10, 2007, and do not include shipping or taxes. EZ Detect Stool Blood Test (Biomerica) >99 2.0 mg of Hb per 100 mL of water 2 7.99 (1.60 per test) Flushable reagent (guaiac) Positive result = blue-green color. Kit contains five test tissues, one control solution, patient instructions, one results post card to send to physician. First Check Home Early Detection (First Check Diagnostics) NR NR 2 12.99 (2.60 per test) Flushable reagent (guaiac) Positive result = blue-green color. Kit contains five test pads, one positive control, patient instructions, one results post card to send to physician. Hemoccult (Beckman Coulter) 95–97 0.3 mg of Hb per 1 g of stool 1 98 (0.98 per test) Guaiac Positive result = blue color. Kit contains 100 test slides, 100 applicators, two test solutions. Intended for use by health care provider but may be done in home setting; CLIA requirements waived. Hemosure One Step (Hemosure) 94.15 0.05 μg of Hb per 100 mL of water <5 300 ($150 per test) Immunoassay Positive result = two lines, negative result = one line. Kit contains two collection papers, two sample-collection tubes, two test cartridges. Intended for use in health care setting; CLIA requirements waived. Open in new tab Device selection Guaiac test products are significantly less expensive than FIT products, and the test may be conducted at home. FIT products are intended for analysis in a health care setting; however, the testing procedure has a Clinical Laboratory Improvement Amendments waiver and may be a useful option for many clinicians. Patients may obtain samples at home and return to the clinic or laboratory for analysis and interpretation of results. Guaiac test products have much lower average sensitivity (50%) than FIT devices (94%).70,–75 All guaiac test products require at least three tests of consecutive stools to determine a positive or negative result, with many clinicians suggesting at least four to six separate tests.72,–74 FIT devices require only two consecutive tests to reach a conclusive result and seldom yield contradictory results.70,71,75 Many older guaiac test products (including Hemoccult, Beckman Coulter) require patients to avoid red meat and foods that contain peroxidase for at least three days prior to testing (the Hemoccult test does not differentiate between human hemoglobin and animal hemoglobin).71 Raw foods high in peroxidase (e.g., horseradish, pineapple, red fruits) may serve to oxidize the guaiac despite an absence of dietary hemoglobin, again resulting in a false-positive result. Each of these restrictions is avoided with FIT products, since the antibody responsible for the reaction is specific to human hemoglobin. The newer flushable-reagent guaiac test products do not impose dietary restrictions,72,73 nor do they require much manipulation of the stool sample, which may promote patient compliance.76,77 Patient counseling Dietary restrictions must be strictly adhered to with the older guaiac test devices to avoid false-positive results. In addition to observing limitations in diet, the patient must avoid aspirin in dosages of greater than 325 mg/day, non-steroidal antiinflammatory drugs, corticosteroids, phenylbutazone, reserpine, anticoagulants, antimetabolites, and antineoplastic agents for at least seven days prior to using all guaiac test devices. (If a patient is taking any of these medications, the prescribing physician should be consulted prior to their discontinuation.) Supplementary vitamin C in dosages of greater than 250 mg/day may result in false negatives.72,–74 Both types of FOBT devices respond to blood in the feces, so a positive result is not specific for colon cancer. These tests are not useful in patients who have hemorrhoids or other known causes of rectal bleeding. Many colorectal cancers may bleed intermittently, so taking at least three samples after three separate bowel movements is important to optimize the likelihood of detecting a cancer. Because of the lack of quantitative results with FOBT, all guaiac test findings should be discussed with a health care provider. Since FIT is performed in a clinic setting, results will be reviewed by the provider before being given to the patient. Results are often inconclusive and ambiguous, necessitating further testing (often sigmoidoscopy or colonoscopy). Patients should be aware that these tests are not diagnostic and are simply screens to determine if further testing is required. Aids for breast self-examination The five-year survival rate in women diagnosed with breast cancer is 98% for patients with disease limited to the breast tissue. Progression of cancer to the surrounding tissues decreases the five-year survival rate to 81%, and metastatic disease results in a survival rate of only 26%.78 Annual mammograms are recommended for all women older than 40 years and have been shown to identify 80–90% of breast cancers.78,–80 Between mammograms, and for all women older than 20 years, the American Cancer Society recommends monthly breast self-examination to aid in early detection.78 Although clinical trials have shown no mortality benefit from self-exams, the practice may allow some patients to detect early stages of cancer.78 How the devices work Two types of devices are available to assist with breast self-exams. The first type is a simulated breast designed to train patients to detect lumps.81 MammaCare (Mammatech) provides personal kits that meet the specific concerns and needs of the patient. Breast models are available with two skin tones (dark and light), two types of breast firmness (soft and firm), and three depths of simulated nodules (low, medium, and high). Each model contains several lumps ranging in diameter from 3 mm to 1 cm. The kits include a 45-minute instructional tape. Prices range from $55 to $60. Also available are videotapes in multiple languages, instruction in Braille, record books, and professional kits for practitioner training and patient education.81 The second type of product is used during the breast exam to optimize nodule palpation. The Aware Self Examination Pad (Biomerica) is a thin polyurethane pad approximately 9.5 in in diameter and containing 25 mL of silicone.82 The manufacturer states that this pad should be placed over the breast prior to a self-exam to increase the sensitivity of the fingers to abnormalities and to decrease friction between the breast and the fingers. Each kit contains one poly-urethane pad, one instructional videotape, and one resource guide and costs $24.90 from the manufacturer; the usable life of a pad is not identified in the product information. This product is also available in 3-, 6-, and 12-pad kits. There are no data to suggest that these products increase the detection of breast cancer or decrease mortality.82 These devices may enhance patient comfort and skill in performing self-exams. In addition, for health care providers with limited time for counseling patients about self-exams, the MammaCare education tool may be helpful in reinforcing what is discussed with the patient in the clinic setting. Much of the information provided to patients is written, so the visual images may prove especially helpful in populations with low literacy rates. These products are primarily intended to increase awareness and to optimize technique in self-exams. Patient counseling Annual mammograms are recommended for all women greater than 40 years of age, and self-exams should be performed monthly. For self-exams, the patient should be advised as follows78,83: Perform your monthly breast exam while lying down. This allows the breast tissue to spread out over the chest wall for an easier and more thorough exam. With the pads of the three middle fingers of the hand opposite the breast you are examining, press against the breast tissue and make small circular motions. Either start from the center of the breast and work outward or make vertical “lines” from one side of the breast to the other. You should also examine the armpits. Use three levels of pressure in each location to detect lumps at various depths within the breast and armpit tissue. Repeat this process with your other hand on the opposite side. Stand in front of the mirror with your hands on your hips and look for any abnormalities or changes in your breasts from their previous appearance. Evaluation of common genitourinary infections One woman in four will have at least one urinary-tract infection (UTI) during her lifetime, and 75% will have at least one vaginal yeast infection.84,85 Recurrence of both types of infections is very common and results in millions of physician office visits annually. Symptoms of UTIs and yeast infections are often vague and are similar to those of other disorders and infections. Some patients with yeast infections may be asymptomatic. Clinicians frequently use rapid-testing methods to aid in diagnosis of these disorders. Since 1986, several types of FDA-approved urine-dipstick tests have been available for home use (Table 5). FDA approved the marketing of two vaginal pH tests, pHEM-Alert (Femtek) and Fem-V (originally approved as VI-SENSE, Synova), for home use in 2001 and 2006, respectively.38 How the devices work UTI test devices Older UTI tests, such as the First Response Uriscreen test (Carter–Wallace), detected the presence of catalase produced by bacteria and white blood cells. Newer urine dip-sticks are designed to detect leukocyte esterase (LE), nitrites, blood, and protein. The patient either dips the stick into a cup of collected urine or holds the strip in the urine stream for 1–10 seconds. The result should be read within one to two minutes. The reagent pad is acidic, and the presence of protein, which is more basic, will cause a pH change and therefore a color change. If nitrites are present they will react with arsanilic acid and produce a color change (e.g., pink). If LE is present it will cause a hydrolysis reaction with an amino acid ester, which produces a pyrrole, which then reacts with diazonium salts to produce a color change (e.g., purple).86 Vaginal pH kits These tests employ litmus paper to test the pH of the vagina. The normal vaginal environment is acidic (pH 4–4.5).87 Studies have shown that an elevated vaginal pH is an excellent way to differentiate between candidiasis and bacterial vaginitis (BV) or trichomoniasis vaginalis (TV).87,88 Pavletic et al.87 found that an abnormal pH (>4.5) was significantly (p < 0.001) associated with BV, TV, or a mixed infection in a study in 443 women. To use the pHEM-Alert kit, the patient inserts the swab into the lower vagina and, after two seconds, compares the color of the sample with a pH test chart.89 The Fem-V test uses a panty liner with a yellow litmus paper strip in the center of the liner.90 The patient wears the liner until discharge occurs or for 6–12 hours.90 The patient then removes the indicator strip and places it in the drying tray provided. The strip should be allowed to dry for 10 minutes. A blue or green stain remaining after 10 minutes indicates an abnormal pH and the need for the patient to contact a health care provider. Device-selection guidelines The literature suggests that patients with recurrent symptoms may be the best candidates for home testing.84,87 Pharmacists should discourage self-testing for first-time UTIs or yeast infections and refer the patient to her provider. If home testing is appropriate for the patient, the pharmacist can help her select a specific test device by discussing personal preferences, cost, and accuracy. Costs of UTI test kits vary (Table 5). pHEM-Alert retails for $36 for 12 tests.89 Fem-V retails for $7.99 for one kit (one liner and drying tray).90 The accuracy of UTI tests has been debated in the literature. Franco84 cited unacceptable false-negative rates of 40–80% when urine dipsticks were used alone. A 2004 meta-analysis examined 72 studies of nitrite- and LE-based UTI tests and provided guidance on how to improve their performance.91 For example, the authors found that, in general, nitrite-based tests had low sensitivity (45–60%) and high specificity (85–98%). However, when specific populations were examined, higher levels of accuracy were achieved in elderly, pregnant, and urology patients, although the differences were not significant. LE-based tests had a sensitivity of 48–86% and a specificity of 17–93% and were reported to be less accurate than nitrite tests. The accuracy of LE-based tests was highest when urine was collected from catheterized patients. When kits included both nitrite- and LE-based tests, overall sensitivity and specificity increased and the risk of false negatives was minimized. Pharmacists prefer the combination test.45 Table 5. Examples of Devices for Home Screening for Urinary-Tract Infection Device Detects Nitrites Detects LEa Detects Protein Price ($) aLE = leukocyte esterase. bFrom www.walgreens.com (2007 Dec 10). Does not include shipping or taxes. cFrom www.imed.com (2007 Dec 10). Does not include shipping or taxes. Azo test strips (Amerifit Nutrition) Yes Yes No 9.99 (3 tests)b UTI Home Screening Test Sticks (Consumers Choice Systems) Yes No Yes 10.99 (2 tests)b Multistix 2 (Bayer) Yes Yes No 57.89 (100 tests)c URISTIX 4 (Bayer) Yes Yes Yes 40.09 (100 tests)c Device Detects Nitrites Detects LEa Detects Protein Price ($) aLE = leukocyte esterase. bFrom www.walgreens.com (2007 Dec 10). Does not include shipping or taxes. cFrom www.imed.com (2007 Dec 10). Does not include shipping or taxes. Azo test strips (Amerifit Nutrition) Yes Yes No 9.99 (3 tests)b UTI Home Screening Test Sticks (Consumers Choice Systems) Yes No Yes 10.99 (2 tests)b Multistix 2 (Bayer) Yes Yes No 57.89 (100 tests)c URISTIX 4 (Bayer) Yes Yes Yes 40.09 (100 tests)c Open in new tab Table 5. Examples of Devices for Home Screening for Urinary-Tract Infection Device Detects Nitrites Detects LEa Detects Protein Price ($) aLE = leukocyte esterase. bFrom www.walgreens.com (2007 Dec 10). Does not include shipping or taxes. cFrom www.imed.com (2007 Dec 10). Does not include shipping or taxes. Azo test strips (Amerifit Nutrition) Yes Yes No 9.99 (3 tests)b UTI Home Screening Test Sticks (Consumers Choice Systems) Yes No Yes 10.99 (2 tests)b Multistix 2 (Bayer) Yes Yes No 57.89 (100 tests)c URISTIX 4 (Bayer) Yes Yes Yes 40.09 (100 tests)c Device Detects Nitrites Detects LEa Detects Protein Price ($) aLE = leukocyte esterase. bFrom www.walgreens.com (2007 Dec 10). Does not include shipping or taxes. cFrom www.imed.com (2007 Dec 10). Does not include shipping or taxes. Azo test strips (Amerifit Nutrition) Yes Yes No 9.99 (3 tests)b UTI Home Screening Test Sticks (Consumers Choice Systems) Yes No Yes 10.99 (2 tests)b Multistix 2 (Bayer) Yes Yes No 57.89 (100 tests)c URISTIX 4 (Bayer) Yes Yes Yes 40.09 (100 tests)c Open in new tab In view of these findings, patients may want to choose a nitrite- and LE-based UTI test kit. Self-testing for and self-treatment of UTIs have shown to be accurate and beneficial with proper training. In a 2001 study, 172 university students with a history of at least two UTIs were educated about UTI symptoms, taught to obtain a clean-catch urine specimen, and followed for one year.92 The study found that 94% (95% CI, 90–99%) of the self-identified symptomatic episodes turned out to be UTIs confirmed as such by the research laboratory. The accuracy of vaginal pH tests has been reported to be very high (sensitivities of 95–100%) when used by clinicians to rule out candidiasis.87 The sensitivity and specificity of Fem-V have been reported by the manufacturer to be 90.8% and 81.3%, respectively (n = 516).93 The pHEM-Alert test has also shown good accuracy. In a 2003 study, 96% of patients (144/151) were able to correctly use the test and interpret the results at home, leading to a 50% reduction in inappropriate use of nonprescription antifungal products (p = 0.018).94 In comparison, a 2002 study found that only 32 (33.7%) of 95 women could correctly self-detect candidiasis from symptoms alone.95 Patient counseling Patients should be reminded that UTI and vaginal pH test kits are meant for screening only; clinician input is needed for correct diagnosis and treatment. If the patient is a candidate for home testing, the pharmacist should educate her about device limitations. For example, UTI test kits may produce false-negative results because not all UTI-causing organisms produce nitrites and because LE is a polymorphic enzyme produced by white blood cells and may not be a definitive indicator of UTI.96 Vaginal pH tests are less likely to give false-negative results, but patients should still be aware of the possibility.87 UTI test kits work best with concentrated urine, so pharmacists should encourage patients to use the morning’s first urine or to hold their urine for four to six hours. Ingestion of dyes (dietary or pharmaceutical), antibiotic use, and large doses of vitamin C (>250 mg) may cause false-negative results.36 Also, menstrual blood interferes with UTI and vaginal pH tests, so patients should seek care from their provider if symptoms occur during menstruation. Proper self-testing for UTIs and yeast infections allows patients to provide objective information to clinicians. This information can help avoid incorrect empirical therapy when patients are triaged via telephone and may even help shorten clinic waiting time. Discussion The home-testing market is booming, and many high-quality devices are available for purchase by patients. Technology is making the testing process easier and more efficient than ever. New products for self-testing for a variety of disorders and diseases, such as sexually transmitted diseases, amniotic fluid leakage, and even strep throat are coming to market. However, this market is not without controversy. Areas of debate include testing for HIV infection and hepatitis C, genetic and paternity testing, and home drug tests conducted on children by their parents.97,–99 Many clinicians are also concerned about the availability of non-FDA-approved test devices via the Internet. Pharmacists can help to educate patients and clinicians about this emerging class of devices and can report adverse experiences to FDA. Conclusion Many devices are available to help women evaluate their special health concerns. Pharmacists can use their clinical judgment and knowledge to help patients decide if home testing is a safe and effective choice. Appendix— Manufacturers of home testing devices Manufacturer Location Abbott Smith Labs Weston, FL Advanced Micronic Devices Limited Bangalore, India Amerifit Nutrition, Inc. Bloomfield, CT Armkel, LLC Princeton, NJ Bayer Corp. Tarrytown, NY Beckman Coulter Fullerton, CA Biomerica, Inc. Newport Beach, CA Body Balance of Genova Diagnostics Asheville, NC Carter–Wallace, Inc. Panaji, India Church & Dwight Co., Inc. Ontario, Canada Common Sense, Ltd. Caesarea, Israel Consumers Choice Systems Owings Mills, MD Craig Medical Distribution, Inc. Vista, CA DNA Direct San Francisco, CA Donna Distributing, LLC Jericho, NY Durex Consumer Products Knutsford, Cheshire, United Kingdom Fairhaven Health, LLC Bellingham, WA Femtek, LLC Pasadena, CA First Check Diagnostics, LLC Lake Forrest, CA Genix Technology Vancouver, British Columbia, Canada Genosis PLC Kingston, United Kingdom Gynex Corp. Redmond, WA Hemosure El Monte, CA Hormone Check Lockport, IL Inverness Medical Innovations Waltham, MA Key Pharmaceuticals Concord West, New South Wales, Australia Make-It Manufacturing Paso Robles, CA Mammatech Corp. Gainesville, FL MaybeMOM, Inc. Lodi, NJ Molsgaard Medical AS Horsholm, Denmark North Bay Diagnostics, LLC Traverse City, MI Pacific Business Centre Vancouver, British Columbia, Canada Pharmatech, Inc. San Diego, CA Quidel San Diego, CA Savyon Diagnostics Ashdod, Israel Stratec Medizintechnik GmbH Pforzheim, Germany Synova Media, PA Warner–Lambert Consumer Healthcare Morris Plains, NJ Zetek Aurora, CO ZRT Laboratory Beaverton, OR Manufacturer Location Abbott Smith Labs Weston, FL Advanced Micronic Devices Limited Bangalore, India Amerifit Nutrition, Inc. Bloomfield, CT Armkel, LLC Princeton, NJ Bayer Corp. Tarrytown, NY Beckman Coulter Fullerton, CA Biomerica, Inc. Newport Beach, CA Body Balance of Genova Diagnostics Asheville, NC Carter–Wallace, Inc. Panaji, India Church & Dwight Co., Inc. Ontario, Canada Common Sense, Ltd. Caesarea, Israel Consumers Choice Systems Owings Mills, MD Craig Medical Distribution, Inc. Vista, CA DNA Direct San Francisco, CA Donna Distributing, LLC Jericho, NY Durex Consumer Products Knutsford, Cheshire, United Kingdom Fairhaven Health, LLC Bellingham, WA Femtek, LLC Pasadena, CA First Check Diagnostics, LLC Lake Forrest, CA Genix Technology Vancouver, British Columbia, Canada Genosis PLC Kingston, United Kingdom Gynex Corp. Redmond, WA Hemosure El Monte, CA Hormone Check Lockport, IL Inverness Medical Innovations Waltham, MA Key Pharmaceuticals Concord West, New South Wales, Australia Make-It Manufacturing Paso Robles, CA Mammatech Corp. Gainesville, FL MaybeMOM, Inc. Lodi, NJ Molsgaard Medical AS Horsholm, Denmark North Bay Diagnostics, LLC Traverse City, MI Pacific Business Centre Vancouver, British Columbia, Canada Pharmatech, Inc. San Diego, CA Quidel San Diego, CA Savyon Diagnostics Ashdod, Israel Stratec Medizintechnik GmbH Pforzheim, Germany Synova Media, PA Warner–Lambert Consumer Healthcare Morris Plains, NJ Zetek Aurora, CO ZRT Laboratory Beaverton, OR Open in new tab Appendix— Manufacturers of home testing devices Manufacturer Location Abbott Smith Labs Weston, FL Advanced Micronic Devices Limited Bangalore, India Amerifit Nutrition, Inc. Bloomfield, CT Armkel, LLC Princeton, NJ Bayer Corp. Tarrytown, NY Beckman Coulter Fullerton, CA Biomerica, Inc. Newport Beach, CA Body Balance of Genova Diagnostics Asheville, NC Carter–Wallace, Inc. Panaji, India Church & Dwight Co., Inc. Ontario, Canada Common Sense, Ltd. Caesarea, Israel Consumers Choice Systems Owings Mills, MD Craig Medical Distribution, Inc. Vista, CA DNA Direct San Francisco, CA Donna Distributing, LLC Jericho, NY Durex Consumer Products Knutsford, Cheshire, United Kingdom Fairhaven Health, LLC Bellingham, WA Femtek, LLC Pasadena, CA First Check Diagnostics, LLC Lake Forrest, CA Genix Technology Vancouver, British Columbia, Canada Genosis PLC Kingston, United Kingdom Gynex Corp. Redmond, WA Hemosure El Monte, CA Hormone Check Lockport, IL Inverness Medical Innovations Waltham, MA Key Pharmaceuticals Concord West, New South Wales, Australia Make-It Manufacturing Paso Robles, CA Mammatech Corp. Gainesville, FL MaybeMOM, Inc. Lodi, NJ Molsgaard Medical AS Horsholm, Denmark North Bay Diagnostics, LLC Traverse City, MI Pacific Business Centre Vancouver, British Columbia, Canada Pharmatech, Inc. San Diego, CA Quidel San Diego, CA Savyon Diagnostics Ashdod, Israel Stratec Medizintechnik GmbH Pforzheim, Germany Synova Media, PA Warner–Lambert Consumer Healthcare Morris Plains, NJ Zetek Aurora, CO ZRT Laboratory Beaverton, OR Manufacturer Location Abbott Smith Labs Weston, FL Advanced Micronic Devices Limited Bangalore, India Amerifit Nutrition, Inc. Bloomfield, CT Armkel, LLC Princeton, NJ Bayer Corp. Tarrytown, NY Beckman Coulter Fullerton, CA Biomerica, Inc. Newport Beach, CA Body Balance of Genova Diagnostics Asheville, NC Carter–Wallace, Inc. Panaji, India Church & Dwight Co., Inc. Ontario, Canada Common Sense, Ltd. Caesarea, Israel Consumers Choice Systems Owings Mills, MD Craig Medical Distribution, Inc. Vista, CA DNA Direct San Francisco, CA Donna Distributing, LLC Jericho, NY Durex Consumer Products Knutsford, Cheshire, United Kingdom Fairhaven Health, LLC Bellingham, WA Femtek, LLC Pasadena, CA First Check Diagnostics, LLC Lake Forrest, CA Genix Technology Vancouver, British Columbia, Canada Genosis PLC Kingston, United Kingdom Gynex Corp. Redmond, WA Hemosure El Monte, CA Hormone Check Lockport, IL Inverness Medical Innovations Waltham, MA Key Pharmaceuticals Concord West, New South Wales, Australia Make-It Manufacturing Paso Robles, CA Mammatech Corp. Gainesville, FL MaybeMOM, Inc. Lodi, NJ Molsgaard Medical AS Horsholm, Denmark North Bay Diagnostics, LLC Traverse City, MI Pacific Business Centre Vancouver, British Columbia, Canada Pharmatech, Inc. San Diego, CA Quidel San Diego, CA Savyon Diagnostics Ashdod, Israel Stratec Medizintechnik GmbH Pforzheim, Germany Synova Media, PA Warner–Lambert Consumer Healthcare Morris Plains, NJ Zetek Aurora, CO ZRT Laboratory Beaverton, OR Open in new tab References 1 Coile RC Jr. Futurescan 2003: a forecast of healthcare trends 2003–2007. Chicago: Health Administration Press; 2003 . 2 Agency for Healthcare Research and Quality. Women’s health care in the United States: selected findings from the 2004 national healthcare quality and disparities reports. Fact sheet. AHRQ publication no. 05-P021. 2005 May. www.ahrq.gov/qual/nhqrwomen/nhqrwomen.htm (accessed 2007 Apr 24). 3 Freedonia Group. Patient monitoring systems to 2008 . www.freedoniagroup.com/Patient-Monitoring-Systems.html (accessed 2006 Aug 10). 4 Shifren JL. Infertility. In: Carlson KJ, Eisenstat SA, Frigoletto FD et al., eds. Primary care of women. 2nd ed. St. Louis, MO: Mosby; 2002 :352–7. 5 Lieu CL, Yoshida T. Infertility. In: DiPiro JT, Talbert RL, Yee GC et al., eds. Pharmacotherapy: a pathophysiologic approach. 5th ed. New York: McGraw-Hill Medical; 1999 :1431–41. 6 Zetek Fertility and Conception. Ovacue Fertility Monitor product information. 2005 . www.zetek.net/ovacue_fertility_monitor.htm (accessed 2007 May 10). 7 Jacobs MH, Blasco L, Sondheimer SJ. Ovulation prediction by monitoring salivary and vaginal electrical resistance with the peak ovulation predictor. Obstet Gynecol . 1989 ; 73 : 817 –22. PubMed 8 Behre HM, Kuhlage J, Gabner C et al. Prediction of ovulation by urinary hormone measurements with the home use Clear-Plan Fertility Monitor: comparison with transvaginal ultrasound scans and serum hormone measurements. Hum Reprod . 2000 ; 15 : 2478 –82. Crossref Search ADS PubMed 9 Guida M, Tommaselli GA, Palomba S et al. Efficacy of methods for determining ovulation in a natural family planning program. Fertil Steril . 1999 ; 72 : 900 –4. Crossref Search ADS PubMed 10 Fehring RJ, Gaska N. Evaluation of the Lady Free Biotester in determining the fertile period. Contraception . 1998 ; 57 : 325 –8. Crossref Search ADS PubMed 11 Hall JE. Amenorrhea. In: Carlson KJ, Eisenstat SA, Frigoletto FD et al., eds. Primary care of women. 2nd ed. St. Louis, MO: Mosby; 2002 :328–35. 12 Ruggiero RJ. Women’s health: contraception. In: Koda-Kimble MA, Young LY, Kradjan WA et al., eds. Applied therapeutics: the clinical use of drugs. 7th ed. Baltimore: Lippincott Williams & Wilkins; 2001 :43–1–43–4. 13 Quattrocchi E, Hove I. Ovulation & pregnancy: home testing products. www.uspharmacist.com/oldformat.asp?url=newlook/files/feat/acf3003.htm (accessed 2007 May 8). 14 Wilcox AJ, Weinberg CR, Baird DD. Timing of sexual intercourse in relation to time of ovulation: effects on the probability of conception, survival of the baby, and sex of the baby. N Engl J Med . 1995 ; 333 : 1517 –21. Crossref Search ADS PubMed 15 Bryce RL, Shuter B, Sinosich MJ et al. The value of ultrasound, gonadotropin, and estradiol measurements for precise ovulation prediction. Fertil Steril . 1982 ; 37 : 42 –5. Crossref Search ADS PubMed 16 Kenigsberg D. New tests for the prediction of ovulation. Clin Obstet Gynecol . 1989 ; 32 : 533 –40. Crossref Search ADS PubMed 17 U.S. Department of Health and Human Services Office on Women’s Health. Basal body temperature (BBT) chart. 2005 Jul 8. www.womenshealth.gov/pregnancy/tools/bbt-chart-blank.pdf (accessed 2007 May 10). 18 Mayo Foundation for Medical Education and Research. How to get pregnant, basal body temperature (BBT). 2007 Jan 1. www.mayoclinic.com/health/how-to-get-pregnant/PR00103 (accessed 2007 May 10). 19 Charting your way to conception. www.fertilityfriend.com (accessed 2007 May 10). 20 Ovusoft, LLC. Taking charge of your fertility. www.ovusoft.com/products (accessed 2007 May 10). 21 Corsan GH, Ghazi D, Kemmann E. Home urinary luteinizing hormone immunoassays: clinical applications. Fertil Steril . 1990 ; 53 : 591 –601. Crossref Search ADS PubMed 22 Eichner SF, Timpe EM. Urinary based ovulation and pregnancy: point of care testing. Ann Pharmacother . 2004 ; 38 : 325 –31. Crossref Search ADS PubMed 23 Inverness Medical. Clearblue Easy, so advanced it is easy: digital ovulation test. 2006 . www.clearblueeasy.com/our_products_digital_ovulation_test_kit.cfm (accessed 2007 May 10). 24 Garcia JE, Jones GS, Wright GL. Prediction of the time of ovulation. Fertil Steril . 1981 ; 36 : 308 –15. Crossref Search ADS PubMed 25 World Health Organization Task Force Investigators. Temporal relationships between ovulation and defined changes in the concentration of plasma estradiol-17β, luteinizing hormone, follicle-stimulating hormone, and progesterone. Am J Obstet Gynecol . 1980 ; 138 : 383 –90. Crossref Search ADS PubMed 26 Miller PB, Soules MR. The usefulness of urinary LH kit for ovulation prediction during menstrual cycles of normal women. Obstet Gynecol . 1996 ; 87 : 13 –7. Crossref Search ADS PubMed 27 When the test really counts. Part two: the fertility window. Consum Rep. 2003 ; Feb: 48 –50. 28 Inverness Medical. Clearblue Easy Fertility Monitor: so clear it is easy. 2006 . www.clearblueeasy.com/about_us.cfm (accessed 2007 May 10). 29 Your preconception and pregnancy resource center: ovulation testing—saliva tests. www.ovulation-calculator.com/ovulation-tests/saliva-ovulation-predictor.htm (accessed 2007 May 10). 30 Braat DD, Smeenk JM, Manger AP et al. Saliva test as ovulation predictor. Lancet . 1998 ; 352 : 1283 –4. Crossref Search ADS PubMed 31 Freundl G, Godehardt E, Kern PA et al. Estimated maximum failure rates of cycle monitors using daily conception probabilities in the menstrual cycle. Hum Reprod . 2003 ; 18 : 2628 –33. Crossref Search ADS PubMed 32 Roumen FJ, Dieben TO. Ovulation prediction by monitoring salivary electrical resistance with the Cue fertility monitor. Obstet Gynecol . 1988 ; 71 : 49 –52. PubMed 33 Fernando RS, Betz G, Roumen FJ. Ovulation prediction by monitoring salivary electrical resistance with the Cue fertility monitor. Obstet Gynecol . 1988 ; 72 : 282 –3. PubMed 34 Moreno JE, Khan-Dawood FS, Goldzieher JW. Natural family planning: suitability of the Cue method for defining the time of ovulation. Contraception . 1997 ; 55 : 233 –7. Crossref Search ADS PubMed 35 Office of NIH History. A timeline of pregnancy testing. http://history.nih.gov/exhibits/thinblueline/timeline.html (accessed 2006 Aug 10). 36 Home diagnostics/devices. In: Covington TR, ed. Nonprescription drug therapy: guiding patient self-care. 3rd ed. St. Louis, MO: Wolters Kluwer Health; 2004 :1181–219. 37 Rosenthal WM, Briggs GC. Home testing and monitoring devices. In: Berardi RR, Kroon LA, McDermott JH et al., eds. Handbook of nonprescription drugs. 15th ed. Washington, DC: American Pharmacists Association; 2006 :1048–76. 38 Center for Devices and Radiological Health. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMN.cfm (accessed 2006 Jul 20). 39 Butler SA, Khanlian SA, Cole LA. Detection of early pregnancy forms of human chorionic gonadotropin by home pregnancy test devices. Clin Chem . 2001 ; 47 : 2131 –6. PubMed 40 Cole LA, Khanlian SA, Sutton JM et al. Accuracy of home pregnancy tests at the time of missed menses. Am J Obstet Gynecol . 2004 ; 190 : 100 –5. Crossref Search ADS PubMed 41 When the test really counts. Part one: earliest pregnancy detection. Consum Rep. 2003 ; Feb: 45 –7. 42 Bastian LA, Nanda K, Hasselblad V et al. Diagnostic efficiency of home pregnancy test kits: a meta-analysis. Arch Fam Med . 1998 ; 7 : 465 –9. Crossref Search ADS PubMed 43 Davies S, Byrn F, Cole LA. Human chorionic gonadotropin testing for early pregnancy viability and complications. Clin Lab Med . 2003 ; 23 : 257 –64. Crossref Search ADS PubMed 44 Bringing medicine home: self-test kits monitor your health. Consum Rep. 1996 ; Oct: 47 –55. 45 APhA annual over-the-counter product survey. Pharm Today . 2007 ; 13 (4, suppl 1): 1 ,4,10,14,20,23. 46 Wilcox AJ, Baird DD, Dunson D et al. Natural limits of pregnancy testing in relation to the expected menstrual period. JAMA . 2001 ; 286 : 1759 –61. Crossref Search ADS PubMed 47 Kahwati L, Haigler L, Rideout S. What is the best way to diagnose menopause? J Fam Pract . 2005 ; 54 : 1000 –2. PubMed 48 Bastian L, Smith C, Nanda K. Is this woman perimenopausal? JAMA . 2003 ; 289 : 895 –902. Crossref Search ADS PubMed 49 Burger H, Dudley E, Hopper J et al. Prospectively measured levels of serum follicle-stimulating hormone, estradiol, and the dimeric inhibins during the menopausal transition in a population-based cohort of women. J Clin Endocrinol Metab . 1999 ; 84 : 4025 –30. PubMed 50 Burger HG, Dudley EC, Hopper JL et al. The endocrinology of the menopausal transition: a cross-sectional study of a population-based sample. J Clin Endocrinol Metab . 1995 ; 80 : 3537 –45. PubMed 51 Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA . 2002 ; 288 : 321 –33. Crossref Search ADS PubMed 52 Grady D, Herrington D, Bittner V et al. HERS Research Group. Cardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/ progestin Replacement Study follow-up (HERS II). JAMA . 2002 ; 288 : 49 –57. Crossref Search ADS PubMed 53 Hulley S, Furberg C, Barrett-Connor E et al. HERS Research Group. Noncardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/ progestin Replacement Study follow-up (HERS II). JAMA . 2002 ; 288 : 58 –66. Crossref Search ADS PubMed 54 Amerifit Nutrition. Estroven Monitor. www.estrovenmonitor.com/FAQ.html (accessed 2006 Jul 28). 55 Synova Healthcare. Menocheck. www.menocheck.com/pages/aboutmenocheck.htm#2 (accessed 2006 Jul 28). 56 Hormone Check. RU25 Plus. www.home-menopause-test.com/faq.html (accessed 2006 Jul 28). 57 ZRT Laboratory. Advanced home testing + assessment. www.zrtlab.com (accessed 2007 May 10). 58 Kaufman E, Lamster I. The diagnostic applications of saliva—a review. Crit Rev Oral Biol Med . 2002 ; 13 : 197 –212. Crossref Search ADS PubMed 59 Dabbs JM, Campbell BC, Gladue BA et al. Reliability of salivary testosterone measurements: a multicenter evaluation. Clin Chem . 1995 ; 41 : 1581 –4. PubMed 60 Shirtcliff EA, Granger DA, Schwartz EB et al. Assessing estradiol in behavior studies using saliva and blood spots: simple radioimmunoassay protocols, reliability, and comparative validity. Horm Behav . 2000 ; 38 : 37 –147. 61 Hagen J, Gott N, Miller D. Reliability of saliva hormone tests. J Am Pharm Assoc . 2003 ; 43 : 724 –6. Crossref Search ADS 62 Hormone education and saliva testing kits. http://salivatesting.com/hormone_health_products/ (accessed 2007 May 10). 63 Home health testing. www.homehealthtesting.com/female-hormone-tests.htm (accessed 2007 May 10). 64 North Bay Diagnostics. www.northbaydiagnostics.com/Store/index.php (accessed 2007 May 10). 65 American Cancer Society. www.cancer.org (accessed 2006 Jun 18). 66 Bond J. Fecal occult blood test screening for colorectal cancer. Gastrointest Endosc Clin N Am . 2002 ; 12 : 11 –21. Crossref Search ADS PubMed 67 Hardcastle J, Chamberlain J. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet . 1996 ; 348 : 1471 –7. 68 Kronborg O, Fenger C. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet . 1996 ; 348 : 1467 –71. Crossref Search ADS PubMed 69 Mandel J, Bond J, Church T et al. Reducing mortality from colorectal cancer by screening for fecal occult blood. N Engl J Med . 1993 ; 328 : 1365 –71. Crossref Search ADS PubMed 70 Scholefield J. Immunochemical testing for colorectal cancer. Lancet Oncol . 2006 ; 7 : 101 –13. Crossref Search ADS PubMed 71 Fraser C, Matthew C, Mowat N et al. Immunochemical testing of individuals positive for guaiac faecal occult blood test in a screening programme for colorectal cancer: an observational study. Lancet Oncol . 2006 ; 7 : 127 –31. Crossref Search ADS PubMed 72 Bioamerica. EZ Detect. http://ezdetect.com/html/about.html (accessed 2006 Jun 17). 73 First Check. First Check Hemocheck. www.firstcheckfamily.com/?gclid=CJfrirWpzoYCFQxDVAod9yY6-A (accessed 2006 Jun 17). 74 Beckman Coulter. Hemoccult. www.hemoccultfobt.com/healthcare/health_gen_prod_instr.htm (accessed 2006 Jun 17). 75 Hemosure. Hemosure One Step. www.hemosure.com/product2.asp?CategoryID=Hemo100 (accessed 2006 Jun 17). 76 Greenwald B. A pilot study evaluating two alternate methods of stool collection for the fecal occult blood test. Medsurg Nurs . 2006 ; 15 : 89 –94. PubMed 77 Stokamer C, Tenner C, Chaudhuri J et al. Randomized controlled trial of the impact of intensive patient education on compliance with fecal occult blood testing. J Gen Intern Med . 2005 ; 82 : 216 –24. 78 American Cancer Society. Breast cancer. www.cancer.org (accessed 2006 Jun 22). 79 Humphrey L, Hefland M, Chan B. Breast cancer screening: a summary of the evidence for the US Preventative Services Task Force. Ann Intern Med . 2002 ; 137 : 347 –60. Crossref Search ADS PubMed 80 Tabar L, Vitak B, Chen H. Beyond randomized controlled trials: organized mammographic screening substantially reduces breast carcinoma mortality. Cancer . 2001 ; 91 : 1724 –31. Crossref Search ADS PubMed 81 Mammatech. Mammacare Personal Learning System. www.mammacare.com (accessed 2006 Jun 22). 82 Craig Medical Distribution. Aware Breast Self Examination and Resource Kit. www.craigmedical.com/products.htm (accessed 2006 Jun 20). 83 Lannin D, Ponn T. What should we teach women about breast self-examination today? J Womens Health . 2005 ; 14 : 529 –30. Crossref Search ADS 84 Franco AV. Recurrent urinary tract infections. Best Pract Res Clin Obstet Gynaecol . 2005 ; 19 : 861 –73. Crossref Search ADS PubMed 85 U.S. Department of Health and Human Services National Women’s Health Information Center. Vaginal yeast infections. www.4woman.gov/faq/yeastinfect.htm (accessed 2006 Aug 10). 86 Multistix and URISTIX package insert. Tarrytown, NY: Bayer; 1992 . 87 Pavletic AJ, Hawes SE, Geske JA et al. Experience with routine vaginal pH testing in a family practice setting. Infect Dis Obstet Gynecol . 2004 ; 12 : 63 –8. Crossref Search ADS PubMed 88 Riordan T, Macaulay ME, James JM et al. A prospective study of genital infections in a family-planning clinic. 1. Microbiological findings and their association with vaginal symptoms. Epidemiol Infect . 1990 ; 104 : 47 –53. Crossref Search ADS PubMed 89 Gynex. pHEM-Alert. www.gynex.com (accessed 2007 Apr 24). 90 Synova Healthcare. How Fem-V works. www.fem-v.com/how_works.php (accessed 2007 Apr 24). 91 Devillé WL, Yzermans JC, van Duijn NP et al. The urine dipstick test useful to rule out infections. A meta-analysis of the accuracy. BMC Urol . 2004 ; 4 : 1 –14. Crossref Search ADS PubMed 92 Gupta K, Hooton TM, Roberts PL et al. Patient-initiated treatment of uncomplicated recurrent urinary tract infections in young women. Ann Intern Med . 2001 ; 135 : 9 –16. Crossref Search ADS PubMed 93 Kessary H. Analysis of the VI-SENSE performance—manufacturer data. www.cs-commonsense.com (accessed 2006 Aug 10). 94 Roy S, Caillouette JC, Faden JS et al. Improving appropriate use of antifungal medications: the role of an over-the-counter vaginal pH self-test device. Infect Dis Obstet Gynecol . 2003 ; 11 : 209 –16. Crossref Search ADS PubMed 95 Ferris DG, Nyirjesy P, Sobel JD et al. Over-the-counter antifungal drug misuse associated with patient-diagnosed vulvovaginal candidiasis. Obstet Gynecol . 2002 ; 99 : 419 –25. PubMed 96 Sultana RV, Zalstein S, Cameron P et al. Dipstick urinalysis and the accuracy of the clinical diagnosis of urinary tract infection. J Emerg Med . 2001 ; 20 : 13 –9. Crossref Search ADS PubMed 97 Associated Press. Home genetic tests for disease. 2005 Mar 6. www.cbsnews.com/stories/2005/03/06/health (accessed 2006 Aug 10). 98 Lewis C. Home diagnostic tests: the ultimate house call? FDA Consum Mag. 2001 Nov–Dec. www.fda.gov/fdac/features/2001/601_home.html (accessed 2006 Jun 15). 99 Davidow J. Self-service: at-home diagnostic kits empower patients to take more responsibility for their health. 2006 May 30. www.signonsandiego.com/uniontrib/20060530/news_lz1c30self.html (accessed 2006 Jun 15). Copyright © 2008, American Society of Health-System Pharmacists, Inc. All rights reserved.
TI - Devices for home evaluation of women’s health concerns
JF - American Journal of Health-System Pharmacy
DO - 10.2146/ajhp060565
DA - 2008-02-15
UR - https://www.deepdyve.com/lp/oxford-university-press/devices-for-home-evaluation-of-women-s-health-concerns-6arkm9CfCE
SP - 299
VL - 65
IS - 4
DP - DeepDyve
ER -