Content Update for Chapter 8, "Vaginal and Vulvovaginal Disorders"

OTC Vaginal pH Tests Launched

Vaginal Infection Screening Tests

Two products that help to screen vaginal bacterial infections from yeast (fungal) infections, on the basis of vaginal pH and signs and symptoms, are now on the market. Fem-V Vaginal Infection Test measures vaginal pH and watery discharge with the use of a panty liner, whereas Vagisil Screening Kit for Vaginal Infections uses a vaginal swab.

Usage Considerations

The vaginal pH tests use the symptoms of vaginal discharge, odor, and itching along with the pH to determine whether a bacterial infection might be present. Normal vaginal pH is 4.5. Fungal vaginal infections usually do not affect the vaginal pH, whereas a pH of 5 or greater may indicate a bacterial or trichomonal vaginal infection. The kits, however, do not identify specific causes of an infection. Bacterial vaginosis (BV) and trichomonal vaginal infections must be treated with prescription medications to prevent pelvic inflammatory disease¹ and possible complications in pregnant patients such as premature rupture of membranes, preterm labor or birth, and spontaneous abortion.² These tests might avoid delay in treating BV by helping patients to rule out a vaginal yeast infection.

Accuracy Rate

The Vagisil screening kit measures vaginal pH, which is one of the four Amsel criteria for diagnosing bacterial vaginosis: (1) vaginal pH greater than 4.5, (2) thin homogeneous vaginal discharge, (3) a positive "whiff" test for amine odor after addition of base, and (4) clue cells on wet mount. The manufacturer of Fem-V contends that because its product measures two parameters—pH and wateriness of vaginal discharge—Fem-V is more accurate than a screening test that measures only pH.⁷ However, the patient package insert does not mention the parameter wateriness.

A 2005 article in Obstetrics and Gynecology³ concluded that, in medical laboratory tests, two criteria—vaginal pH and positive amine odor—could be used to diagnose BV without loss of sensitivity and specificity. A 1999 clinical test⁴ concluded that the pH of vaginal fluid in combination with clinical signs and symptoms “had a considerably high sensitivity to screen for BV.” The Food and Drug Administration has also determined that home vaginal pH tests show “good agreement with a doctor's diagnosis.”⁵

A 2005 study⁶ undertaken to determine whether subjects could read and understand the package insert of a vaginal pH self-test showed that 200 of the 206 subjects (97.1%) correctly interpreted the insert information. The subjects understood the role of vaginal pH as an aid in the diagnosis of vaginal symptoms while also improving their decision of whether to use a nonprescription antifungal medication or to see a health care provider.

Exclusions for Self-Testing

For both products certain situations are exclusions to self-testing. Patients should wait 72 hours after application of vaginal preparations (contraceptive creams and antifungal products) and 48 hours after sexual intercourse or douching before using the vaginal pH test. It should not be used during or for 5 days after their menstrual period or in the presence of any vaginal bleeding. Patients experiencing abdominal pain, fever, chills, and/or abnormal vaginal bleeding should not use the kit and should see a primary care provider immediately. In addition, the Fem-V test should not be used when a patient is sweating (e.g., during exercise).

Fem-V Vaginal Infection Test

Mechanism of Action Fem-V uses a polymer indicator strip embedded in a panty liner to detect vaginal pH and the wateriness of vaginal discharge, according to the manufacturer.

Usage Guidelines⁷

• Secure panty liner to underwear.
• When vaginal discharge occurs, remove the indicator strip from the panty liner by pulling the tab.
• Place the indicator strip in the plastic drying tray provided with the kit.
• Wait 10 minutes to read the results.
• If a blue or green color stain appears on the indicator strip, consult a primary care provider. This color indicates an abnormal vaginal pH, which may be associated with bacterial vaginosis or trichomoniasis and which may require treatment with prescription medications.
• If the indicator strip remains yellow or fades back to yellow, vaginal pH (acidity) more likely indicates a yeast (fungal) infection. You may choose to use a nonprescription antifungal treatment if you have had a previous yeast infection. (See Pharmacologic Therapy, pages 138-143, for information on nonprescription antifungal agents.)
• If using an antifungal, seek medical attention if (1) symptoms do not improve within 3 days of use or if symptoms persist beyond 7 days, (2) if vaginal symptoms worsen or change (e.g., discharge becomes bad smelling, frothy, or discolored), or (3) other symptoms (e.g., abdominal tenderness) occur.

Vagisil Screening Kit for Vaginal Infections

Mechanism of Action The pH of vaginal fluid is determined by comparing a pH paper moistened with vaginal fluid to a pH color guide that ranges from 4.5 to 7.5.⁸

Interferences Incorrect test results can occur if the pH paper comes in contact with blood, semen, or certain vaginal products. Reading the pH paper under fluorescent light might result in an inaccurate (higher) pH reading.

Usage Guidelines⁸ This kit contains two swabs packaged individually in a drying tray that also contains the pH color guide.

• Wash hands and dry them thoroughly.
• Remove one tray from the package, lift the seal, and remove the swab by grasping the large square handle.
• The smaller round end of the swab contains the pH test paper. Do not let the pH paper touch anything before use.
• Hold the handle of the swab between the thumb and forefinger, with the thumb placed on the word “Vagisil.”
• Use either of these positions to open the vagina: (1) Sit with knees spread apart or (2) stand with one foot on the toilet seat. Using your free hand, gently spread apart the folds of skin at the vaginal opening.
• Check to see on which side of the swab (small round end) the pH paper is located. Note: the pH paper should be on the “thumb” side of the swab.
• Gently insert the small end of the swab into your vagina up to the point where the square handle rests against the outside skin of the vagina.
• After it is inserted, gently tilt the swab so that the thumb side containing the pH paper touches the inside wall of the vagina. Press for 5 seconds.
• Remove the swab, being careful not to touch the pH paper to anything outside the vagina.
• Under a bright light (other than fluorescent) or daylight, compare the color of the pH paper with the colors on the pH guide. The guide colors range from bright yellow (4.5) to dark blue (7.5).
• Slide the pH swab along the pH guide until you find the color that matches the color on the pH swab. This number is your vaginal pH.
• If the pH is 5.0 or higher and symptoms of unpleasant or unusual odor, unusual discharge, and itching or burning are present, see a primary care provider for further testing, diagnosis, and treatment. You may have bacterial vaginosis or trichomoniasis.
• If the pH is 4.5 and itching, burning, unusual discharge, and yeasty odor are present, you may have a yeast infection. See your primary care provider if this is your first yeast infection. If not, you may self-treat with a nonprescription vaginal antifungal. (See Chapter 8, “Vaginal and Vulvovaginal Disorders.”)
• If using an antifungal, seek medical attention if (1) symptoms do not improve within 3 days of use or if symptoms persist beyond 7 days, (2) if vaginal symptoms worsen or change (e.g., discharge becomes bad smelling, frothy, or discolored), or (3) other symptoms (e.g., abdominal tenderness) occur.

References

1. womenshealth.gov. Bacterial vaginosis. Available at: http://www.4woman.gov/faq/stdbv.htm. Accessed June 10, 2007.
2. Guise JM, Mahon SM, Aickin M, et al. Screening for bacterial vaginosis in pregnancy. Am J Prevent Med. 2001;20:67-72.
3. Gutman RE, Peipert JF, Weitzen S, et al. Evaluation of clinical  methods for diagnosing bacterial vaginosis. Obstet Gynecol. 2005;105:551-6.
4. Thinkhamrop J, Lumbiganon P, Thongkrajai P, et al. Vaginal fluid pH as a screening test for vaginitis. Int J Gynaecol Obstet. 1999;66:143-8.
5. US Food and Drug Administration, Center for Devices and Radiological Health. Home-use tests – vaginal pH. Available at: http://www.fda.gov/cdrh/oivd/homeuse-vaginal.html. Accessed June 10, 2007.
6. Roy S, Caillouette JC, Faden JS, et al. The role of an over-the-counter vaginal pH self-test device package insert: can subjects learn what the device is for and how to use it? Am J Obstet Gynecol. 2005;192(6):1963-7; discussion 1967-9.
7. Synova Healthcare. How Fem-V works. Available at: http://www.fem-v.com/how_works.php. Accessed June 10, 2007.
8. Vagisil Screening Kit for Vaginal Infection product information. White Plains, NY: Combe Incorporated; 2006.
9. Geva A, Bornstein J, Dan M, et al. The VI-SENSE-vaginal discharge self-test to facilitate management of vaginal symptoms. Am J Obstet Gynecol. 2006;195:1351-6.