Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study

J Clin Microbiol. 2020 Jan 28;58(2):e01643-19. doi: 10.1128/JCM.01643-19. Print 2020 Jan 28.


Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for VVC, and a composite of NAAT and culture for T. vaginalis The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the Candida species group, 4% for VVC due to Candida glabrata, and 10% for T. vaginalis Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata; and 96.5% and 95.1% for T. vaginalis Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians' diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians' diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis.

Keywords: Amsel criteria; Aptima; Nugent score; bacterial vaginosis; candidiasis; clinician’s diagnosis; diagnostic accuracy; molecular test; sensitivity; specificity; trichomoniasis.

Publication types

  • Clinical Study
  • Comparative Study
  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Bacteria / genetics
  • Candida / genetics
  • Candidiasis, Vulvovaginal / diagnosis*
  • Candidiasis, Vulvovaginal / microbiology
  • Cross-Sectional Studies
  • Female
  • Humans
  • Middle Aged
  • Nucleic Acid Amplification Techniques / methods
  • Nucleic Acid Amplification Techniques / standards*
  • Prospective Studies
  • Reagent Kits, Diagnostic / standards*
  • Sensitivity and Specificity
  • Trichomonas Vaginitis / diagnosis*
  • Trichomonas vaginalis / genetics
  • United States
  • United States Food and Drug Administration
  • Vagina / microbiology
  • Vaginosis, Bacterial / diagnosis*
  • Vaginosis, Bacterial / microbiology
  • Young Adult


  • Reagent Kits, Diagnostic