Vagisil Screening Kit

US Pharm. 2008;33(9):Epub.

The Vagisil Screening Kit is an in-home test that allows a woman to screen for the presence of vaginal infection by measuring her vaginal pH (FIGURE 1). Adult women commonly develop vaginal infections, but the symptoms they experience lead many of them to believe that they have a yeast infection and self-treat it with OTC products.¹ Sometimes, what appears to be a yeast infection may actually be a bacterial infection, which requires treatment by a health care practitioner (HCP).¹ Typical symptoms of vaginal infection include burning, itching, unusual odor, and discharge.¹

Estrogen stimulates the production of glycogen in the vaginal epithelial cells.² Lactobacillus, a genus of bacterium commonly found in the vagina, produces hydrogen peroxide and lactic acid as a by-product of glycogen metabolism.² These substances maintain a pH of 3.5 to 4.5.³ When vaginal pH remains in this range, suppression of abnormal vaginal bacteria occurs; however, this does not apply to yeast, which exists in the presence of normal vaginal pH.⁴ A vaginal pH of greater than 5 has been correlated with abnormal vaginal conditions such as trichomoniasis and bacterial vaginosis.² Vaginal pH level, together with a culture or microscopy, may assist in the diagnosis of abnormal vaginal conditions.

Indication and Usage
Developed by Combe Incorporated, the Vagisil Screening Kit is designed for use by women who experience symptoms of vaginosis.⁵ Usage instructions are given in TABLE 1. The Vagisil Screening Kit should be used only by women with normal menstrual periods. The kit does not test for diseases like Group B streptococcus or for sexually transmitted diseases such as HIV, chlamydia, herpes, gonorrhea, or syphilis. The kit should not be used for 72 hours after application of vaginal preparations (e.g., contraceptive creams and internal yeast infection products). The kit also should not be used within 48 hours of sexual intercourse or douching or within five days of menses. Perimenopause, menopause, or the presence of cervical mucus, blood, or semen may result in abnormal vaginal-pH results.⁵

Efficacy
Roy et al conducted a study of the role of OTC vaginal pH self-test products in improving the use of antifungal medications.⁶ The study's objectives were to: 1) assess patients' ability to understand how to use a vaginal pH self-test product to diagnose vaginitis; 2) determine whether there is similarity between vaginal pH readings by patients and by HCPs; and 3) decide whether a vaginal pH self-test product can help reduce the inappropriate use of OTC antifungal medications. The patients were of varied backgrounds, educational levels (range, 0 years of formal education to graduate school), and ages (range, 17 to 73 years). Of the 151 women studied, 33 (22%) were asymptomatic and 118 (78%) were symptomatic. Of the 118 symptomatic patients, 96 were premenopausal, were not pregnant, and had a uterus in situ. Since a final diagnosis was not supplied by the HCP for eight patients, 88 symptomatic patients were used for analysis. A vaginal pH level exceeding 4.5 was considered to be a positive finding for conditions that result in vaginitis. Patients with a pH under 4.5 were deemed "normal"; those with no pH reading were designated "no conclusion" or "no response."

According to HCP diagnosis, 32% of patients (n = 28) had a yeast infection, 23% (n = 21) had a bacterial infection or trichomoniasis, and 45% (n = 39) were normal.⁶ In comparison, patient self-diagnosis was as follows: 43% (22/51) believed that they had a yeast infection, 26% (13/51) thought that they had a bacterial or trichomonal infection, and 31% (16/51) thought that they had no infection. Consequently, if participants had self-treated with an OTC antifungal, 57% would have been wrong. See TABLE 2.

The patient questionnaire, administered after the patient read the package insert and performed the self-test, assessed how well the patient understood the modified instructions in the package insert.⁶ When asked if the test was easy to use, 146 patients said yes, two said no, and three did not respond; thus, 97% of patients found the test easy to use. When asked if the instructions were easy to follow, 145 patients said yes, three said no, and three did not respond; thus, 96% found the instructions easy to follow.

Conclusion
The Vagisil Screening Kit is a convenient and useful tool for women who experience symptoms indicative of a vaginal infection. This product is only for assessment of a condition; it does not identify specific types or causes of infection.⁷ For more information about the Vagisil Screening Kit, contact Combe Incorporated at (800) 431-2610.

REFERENCES
1. Coyle EA, Prince RA. Urinary tract infections and prostatitis. In: DiPiro JT, Talbert RL, Yee GC, et al. Pharmacotherapy: A Pathophysiologic Approach. 7th ed. New York, NY: McGraw-Hill; 2008:1899-1913.
2. Vagisil^® Vaginal Health Initiative Advisory Board. Clinical management of vulvovaginitis: pH-based approach to patient assessment. White Plains, NY: Combe Inc; 2007.
3. Nester EW, Anderson DG, Roberts CE Jr, et al. Microbiology: A Human Perspective. 4th ed. New York, NY: McGraw-Hill; 2004:304-306,639-640.
4. Borchardt KA, Noble MA, eds. Sexually Transmitted Diseases: Epidemiology, Pathology, Diagnosis, and Treatment. Boca Raton, FL: CRC Press; 1997:4-39.
5. Vagisil Screening Kit package insert. White Plains, NY: Combe Inc; 2007.
6. 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;11:209-216.
7. Vagisil Women's Health Center. Introducing the Vagisil™ Screening Kit for vaginal infections. http://newsroom.vagisil.com/product_news_1.shtml. Accessed August 20, 2008.

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