The indications and intended use for the pHEM-ALERT device are:
- Vaginal pH testing
- Convenient, unique, patented applicator “key” with pH paper attached to tip
- CPT codes: 83986 & 83986QW
- Box of 12
The pHEM-ALERT test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms:
- Unpleasant odor
- Unusual discharge
- This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.
Recent findings by Gutman et al1 demonstrate that two positive criteria, vaginal pH and amines, yield high sensitivity and specificity in diagnosing bacterial vaginosis.
Results: The prevalence of bacterial vaginosis in our study population was 38.7%. Vaginal pH was the most sensitive of all the criteria, at 89%, and a positive amine odor was the individual criteria with the highest specificity at 93%. Similar specificity was seen with combinations of two criteria and Amsel’s criteria. Receiver operating characteristic curve analysis yielded a preferred pH and percentage of clue cells of 5.0 and 20% respectively. However, a pH of 4.5 or greater improves sensitivity with minimal loss of specificity.
Conclusion: The clinical criteria for diagnosing bacterial vaginosis can be simplified to 2 clinical criteria without loss of sensitivity and specificity.
A complete bibliography of recent papers on the role of vaginal pH in diagnosis of BV, menopausal status and self-monitoring of vaginal health is available from GYNEX.
1Obstet Gynecol 2005; 105: 55 1–6. © 2005 by the American College of Obstetricians and Gynecologists.