Validity of Patient-Collected Wet Mounts

Study Summary

Purpose/Objectives: To compare wet mount findings for clue cells, yeast, trichomonads and white blood cells per high-power field in self-collected vaginal specimens, compared to clinician-collected specimens, among symptomatic women visiting the San Antonio Metropolitan Health sexually transmitted disease clinic. Research Design/Plan: Prospective, non-randomized, non-blinded trial Methods: Obtain informed consent and specimens from 40 symptomatic adult females (eg abnormal discharge, odor and/or itching). Calculate concordance between clinician- and patient-collected samples using a Wilcoxon Matched-Pair test. Calculate sensitivity, specificity, positive predictive value and negative predictive value of the patient-collected wet mount, using the clinician-collected specimens as the "gold standard." Clinical Relevance: A "wet mount," or microscopic examination, is commonly used to diagnose trichomoniasis and yeast in females, and constitutes one diagnostic element for bacterial vaginosis. While patient-collected vaginal swabs are acceptable for nucleic acid probe tests for chlamydia and gonorrhea and nucleic acid probe tests for trichomoniasis little information about patient-collected wet mounts exists in the literature. Self-collection by women before being seen by a clinician can increase the speed and efficiency of the visit. The method is highly acceptable to women. In the investigators' clinic, women routinely collect their own gonorrhea and chlamydia swabs, so adding an additional swab would not be burdensome.

Primary Outcome

Assess for concordance of clue cells, yeast, trichomonads and white blood cells per high-power field between patient collected vaginal swab and physician collected vaginal swab.

Interventions

• OTHER vaginal swab