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
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.
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.
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.
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
7. Vagisil Women's
Health Center. Introducing the Vagisil™ Screening Kit for vaginal
infections. http://newsroom.vagisil.com/product_news_1.shtml. Accessed August
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