Objectives
Nucleic acid amplification testing (NAAT) is commercially available for the diagnosis of vaginitis, but only validated in the setting of a STD clinic. The aim of this study was to compare NAAT to traditional testing for vulvovaginal candidiasis (VVC), bacterial vaginosis (BV), and Trichomonas vaginalis (TV) in a general gynecology population.
Methods
Women with (n=192) and without symptoms (n=88) of vaginitis were enrolled from outpatient gynecology offices and a vulvovaginal referral clinic from July 2014 to March 2015. Participants completed a structured questionnaire and clinicians collected vaginal swabs for wet mount, yeast culture, Gram stain (GS, Nugent score), T. vaginalis InPouch™ culture and NAAT (NuSwab®, LabCorp). NAAT was compared to GS for BV and culture for VVC and TV to assess agreement between the methods.
Methods
Women with (n=192) and without symptoms (n=88) of vaginitis were enrolled from outpatient gynecology offices and a vulvovaginal referral clinic from July 2014 to March 2015. Participants completed a structured questionnaire and clinicians collected vaginal swabs for wet mount, yeast culture, Gram stain (GS, Nugent score), T. vaginalis InPouch™ culture and NAAT (NuSwab®, LabCorp). NAAT was compared to GS for BV and culture for VVC and TV to assess agreement between the methods.
Results
The mean age of the women was 34 years; 56% were Caucasian and 52% had a college degree. Among symptomatic women 66/192 (34%) tested positive for yeast by culture or NAAT with 91% concordance between tests. Of the discordant results 13/17 (76%) were NAAT-positive and culture negative for yeast (see table). Overall, 75/192 (39%) of women had a positive result for BV by either GS or NAAT, with 88% concordance between tests. Of the discordant results for BV 10/24 (42%) were NAAT-positive and GS negative, 70% of which were positive by Amsel criteria. Rates of TV were lower with 14/192 (7%) testing positive by culture or NAAT, yielding 99.5% concordance. In asymptomatic women 8% tested positive for yeast by culture and 13% by NAAT, while 20% and 23% tested positive for BV using GS and NAAT, respectively. Of the asymptomatic women, 35% tested positive for yeast or BV using any testing method. Adjudication of discordant results will be assessed by medical record review.
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