Objective To validate the use of Seegene Allplex™ Vaginitis assay in the diagnosis of candidiasis, bacterial vaginosis (BV) and trichomoniasis. Design Cross‐sectional, prospective study conducted in a single centre. Setting Outpatient clinic of a gynaecology department. Population Consecutive symptomatic and asymptomatic women (18–60 years of age). Methods Comparison of the assay test with the reference standards for the diagnosis of vaginitis (cultures for yeasts, Nugent for BV and nucleic acid amplification test for trichomoniasis). Main outcome measures Performance of the investigational assay, in comparison with the reference standards for the diagnosis of the presence of Candida spp., Trichomonas vaginalis and BV. Secondary objectives are the evaluation of the performance of the test in postmenopausal women and in symptomatic women. Results A diagnosis of vaginitis was established in 14.0%. The global prevalences of BV, Candida spp. and T. vaginalis were 22.3%, 13.2% and 2.4%, respectively. The sensitivity and specificity of the assay test for those three causes of vaginitis were as follows: BV 91.7% and 86.6%; any Candida spp. 91.1% and 95.6%; Candida albicans 88.1% and 98.2%, non‐albicans Candida 100% and 97.5%, and T. vaginalis 94.4 and 99.9%. The performance of the test was identical in the subgroup of women that reported vulvovaginal symptoms. The presence of multiple infections did not interfere with the performance of the test. Conclusions The Seegene Allplex™ Vaginitis assay has an excellent performance in the diagnosis of the BV and presence of Candida; the results were good for trichomoniasis, but the study was underpowered for this outcome. Tweetable abstract Seegene Allplex™ Vaginitis is an excellent option for screening and diagnosis of vaginitis.

ObjectiveThe aim of the study was to evaluate risk factors for positive margins on surgical specimens of patients submitted to transformation zone excision (TZE).Materials and MethodsWe conducted a retrospective study evaluating women submitted to TZE in our center, between 2012 and 2020. Our study population included only women with the diagnosis of high-grade intraepithelial lesion (HSIL) in the pathologic examination of the TZE surgical specimen. Positive margins were defined as the presence of HSIL in the endocervical and/or ectocervical margin of the specimen. Factors evaluated included demographic characteristics, pretreatment Pap smear and human papillomavirus test, colposcopic findings, TZE indication, and pathologic features of the surgical specimen. We performed univariate analysis and logistic regression modeling including variables associated with the outcome of positive margins in the univariate analysis.ResultsOur sample included 264 women, with a 15.2% positive margins rate (40 patients). In the univariate analysis, patients with immunocompromised status, HSIL Pap smear, and higher number of quadrants involved in colposcopic examination were more likely to have positive margins. After multivariate analysis, only immunocompromised status was found to be an independent risk factor (odds ratio = 4.94; 95% CI = 1.43–17.15; p < .05).ConclusionsImmunocompromised status was the sole significant predictor for positive margins in TZE surgical specimens. To our knowledge, this is the first report of immunodepression as a risk factor for positive margins in cervical excisional procedures.

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