Evaluation of a New Rapid Diagnostic Kit (FemExam) for Bacterial Vaginosis in Patients With Vaginal Discharge Syndrome in The Gambia

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 $0.74 and US $1.54, respectively, for Gram stain diagnosis, to US $8.32 and US $18.49 for the FemExam two-card method. CONCLUSIONS: In a setting where BV was frequently associated with vaginal discharge, the FemExam test compared favorably with conventional clinical diagnosis, and it has the advantage of being rapid, less subjective, and easily performed. Cutting its cost would provide wider accessibility in developing countries.