Evaluation of a rapid diagnostic test for bacterial vaginosis

Objective To evaluate a new rapid diagnostic test for bacterial vaginosis. Design Comparison of a new biochemical diamine test with low technology tests and microbiological culture. Setting General practice, family planning clinic. Participants Patients attending a general practice with vaginal symptoms, women consulting for family planning and cervical smears, and women invited for health checks. Main outcome measures Comparison of the new diamine test with microbiological culture for Gardnerella vaginalis, with clue cells, and with the amine test. Results Two hundred and twenty-nine vaginal swabs were assayed quantitatively by the new diamine test. When compared with microbiological culture of Gaudnerella vaginalis, the sensitivities and specificities were 86% and 81%, respectively. When compared with clue cell findings, the sensitivities and specificities were 97% and 83%, respectively. In the third comparison with the amine test the sensitivity was 94% and the specificity 84%. Since microbiological diagnosis of organisms related to bacterial vaginosis is difficult, the new test and existing sideroom tests may be more sensitive to the condition and the true frequency of false positives may be less than the specificity in this study suggests. Conclusions The new diamine test is accurate, sensitive and specific, and provides the basis for the rapid diagnosis of bacterial vaginosis. Such a test is needed if bacterial vaginosis is to be diagnosed and managed effectively in both general and specialist practice.