Clinical Evaluation of a New Molecular Test for the Detection of Organisms Causing Vaginitis and Vaginosis

J Clin Microbiol. 2023 Mar 23;61(3):e0174822. doi: 10.1128/jcm.01748-22. Epub 2023 Feb 28.

Abstract

In this prospective, observational, method comparison clinical study, the Xpert Xpress MVP test (MVP) was evaluated using both clinician-collected (CVS) and self-collected vaginal swabs (SVS) collected in a clinical setting. The study was conducted at 12 sites, including point-of-care (POC) settings, from geographically diverse locations in the United States. Participants were biologically female patients ≥ 14 years old with signs and/or symptoms of vaginitis/vaginosis. MVP test results for BV were compared to the BD MAX Vaginal Panel (BDVP). Results for Candida group and Candida glabrata and Candida krusei targets (species not differentiated) were assessed relative to yeast culture followed by mass spectrometry for species identification. Trichomonas vaginalis (TV) results were compared relative to a composite method that included results from the BDVP and InPouch TV culture. The investigational test demonstrated high positive percent agreement ranging from 93.6 to 99.0%, and negative percent agreement ranging from 92.1% to 99.8% for both CVS and SVS specimens, indicating it may be a valuable tool for the diagnosis of vaginitis/vaginosis in laboratory and POC settings.

Keywords: Candida vaginitis; Trichomonas vaginalis; bacterial vaginosis; molecular diagnostics; point of care test; vaginitis diagnosis panel.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Candidiasis, Vulvovaginal* / diagnosis
  • Female
  • Humans
  • Prospective Studies
  • Trichomonas Vaginitis* / diagnosis
  • Trichomonas vaginalis* / genetics
  • Vagina
  • Vaginosis, Bacterial* / diagnosis