Randomized Study of Usual Care vs Xpert® Xpress MVP at the Point of Care for Accurate Diagnosis and Appropriate Treatment of Vaginal Infections

BACKGROUND: Accuracy of vaginitis diagnoses in usual care varies. This study (clinicaltrials.gov NCT06438575) evaluated the clinical utility of Xpert ® Xpress MVP, a CLIA-waived nucleic acid amplification test (NAAT), for diagnosis of vaginal infections at the point-of-care (POC). METHODS: Women (n=276) seeking care for vaginal symptoms (discharge, odor, itch, irritation, discomfort) provided self-collected vaginal samples and were randomized to usual care or POC NAAT. True positives were defined as samples positive for bacterial vaginosis (BV), Candida, or Trichomonas vaginalis (TV) by two concordant FDA-cleared NAATs. The primary endpoint was the proportion of women prescribed appropriate CDC recommended or FDA approved treatment for the identified conditions within 24 hours of the visit. Groups were compared using Fisher's exact test. RESULTS: Median participant age was 33 years (range 17-76), with self-reported race of 50% black, 41% white and 9% other. Twenty (7%) participants were pregnant. The prevalence of BV, Candida and TV was 44.7%, 32.0% and 5.1%, respectively, and 36.9% of women had no pathogens detected. For women having BV, TV or Candida, 40/77 (51.9%) of the usual care arm received appropriate treatment vs 69/77 (89.6%) of women in the POC NAAT arm (P<0.001).Among women without pathogens, 21/42 (50.0%) were inappropriately treated with antifungals or antibiotics in the usual care arm vs 13/48 (27.1%) in the POC NAAT arm (P=0.031). CONCLUSION: POC NAATs have clinical utility for diagnosis of women with vaginal symptoms, increasing the likelihood of appropriate treatment and reducing over-treatment of women without pathogens compared to usual care.