Evaluation of a new rapid diagnostic kit (FemExam) for bacterial vaginosis in patients with vaginal discharge syndrome in The Gambia.

摘要

BACKGROUND: Diagnosis of bacterial vaginosis (BV) in resource-poor primary health care settings is often overlooked; there is a need for a cheap, rapid, objective point-of-care diagnostic test. GOAL: The goal was to determine the prevalence of BV and to evaluate the performance of a new commercial diagnostic test kit in a developing country environment. STUDY DESIGN: Vaginal and cervical swabs were collected from 230 consecutive women attending a genitourinary medicine clinic with reported symptoms of vaginal discharge and/or itching. Etiological testing was carried out. BV was diagnosed on the basis of the Nugent score, the Amsel clinical criteria, and results of FemExam card tests. Card 1 is for pH and amines, and card 2 measures proline iminopeptidase (PIP) activity. RESULTS: BV prevalence was 47.9% according to the Nugent score. When compared with the Nugent score, the Amsel clinical criteria had a sensitivity of 77.9% and specificity of 58.4%, FemExam card 1 had a sensitivity of 71.4% and specificity of 72.8%, FemExam card 2 had a sensitivity of 70% and specificity of 81.0%, and FemExam cards 1 and 2 combined had a sensitivity of 91.0% and specificity of 61.5%. Cost per patient and cost per true case detected ranged from US