BD (Becton, Dickinson and Company) announced the outcome of a peer-reviewed study published in Obstetrics & Gynecology, showing that molecular diagnostics could improve the accuracy of vaginitis diagnosis and lead to more appropriate and timely treatment decisions, the company reports in a news release.
In the paper, which reports the findings from a BD clinical trial, the three causes of vaginitis (bacterial vaginosis [BV], vulvovaginal candidiasis [VVC] or Trichomonas vaginalis [TV]) were studied to compare clinician assessment with results from a molecular test. The study found that compared to the molecular test, clinician diagnosis missed 45.3% of positive cases (180 of 397) and incorrectly identified 12.3% of negative cases as positives (123 of 879).
The study was also selected for inclusion in the Obstetrics & Gynecology Journal Club, which selects two to three studies per issue to provide medical students an opportunity to review papers and help them build a foundation for evidence-based practice.
Between 6 million and 10 million healthcare visits by women in the U.S. are related to symptoms of vaginitis, BD said, citing previous research. Although vaginitis is a common condition, diagnosis of its usual causes (BV, VVC, or TV) in women of reproductive age is not standardized.
The study compared clinician diagnosis of vaginitis to results of a vaginal panel assay performed on the BD MAX System, an FDA-market authorized molecular test that uses nucleic acid amplification to detect the microbial causes of BV, VVC, and TV. The study involved 489 symptomatic participants. Participants received a clinical diagnosis and had a vaginal assay swab collected during their visit. Swabs were sent to a separate testing facility and later compared to clinician diagnosis.
