Abstract
Background. Bacterial vaginosis is disturbance of the balance of the vaginal microflora, associated with a number of infectious diseases of the urogenital tract and adverse pregnancy outcomes. In this country, for the detection of vaginal dysbiotic conditions, the test Femoflor-16 (DNA-Technology, Moscow) is widely used, however interpretation algorithms of this test do not include the category of BV.
 Aim. The study aimed to elaborate diagnostic criteria for the detection of BV using Femoflor-16 test.
 Materials and methods. Women of reproductive age addressing a gynecologist with vaginal discharge were enrolled in the study. For clinical diagnosis of BV, the Amsel criteria were used, laboratory analysis for BV was performed via microscopic investigation of vaginal discharge using the Nugent score. Samples of vaginal discharge from all women were analyzed with the test Femoflor-16, intended for characterizing vaginal microbiocenosis using multiplex quantitative real-time PCR.
 Results. A total of 280 women were included in the study. BV was diagnosed in 86 women (31%) using the Amsel criteria, and in 81 women (29%) using the Nugent score. All groups of anaerobic bacteria included in Femoflor-16 test were shown to be associated with BV, with the exception of bacteria of the genus Mobiluncus, which are detected together with phylogenetically related but not BV-associated bacteria of the genus Corynebacterium. A low amount of lactobacilli (< 10% of total bacterial load) coupled with an elevated amount of Gardnerella vaginalis/Prevotella bivia/Porphyromonas (> 1%) and/or Eubacterium (> 2%) and/or Sneathia/Leptotrichia/Fusobacterium (> 0.1%) and/or Megasphaera/Veillonella/Dialister (> 0.1%) and/or Lachnobacterium/Clostridium (> 0.1%) and/or Peptostreptococcus (> 0.1%) and/or Atopobium vaginae (> 0.2%) detected BV with a sensitivity of 99% and specificity of 93%.
 Conclusions. Criteria for BV diagnosis using the test Femoflor-16 have been elaborated, which enable to detect BV or exclude it with a sensitivity of 99% and specificity of 93%. These criteria for BV and criteria of the test manufacturers for severe anaerobic dysbiosis determine to a large extent the same category of the vaginal microbiocenosis.
Highlights
Bacterial vaginosis is disturbance of the balance of the vaginal microflora, associated with a number of infectious diseases of the urogenital tract and adverse pregnancy outcomes
For the detection of vaginal dysbiotic conditions, the test Femoflor-16 (DNA-Technology, Moscow) is widely used, interpretation algorithms of this test do not include the category of BV
Women of reproductive age addressing a gynecologist with vaginal discharge were enrolled in the study
Summary
ФГБНУ «Научно-исследовательский институт акушерства, гинекологии и репродуктологии им. В нашей стране для выявления дисбиотических состояний влагалища широко используется тест Фемофлор-16 (ДНК-Технология, Москва), однако в алгоритмах интерпретации результатов этого теста не предусмотрена категория БВ. Для клинической диагностики БВ использовали критерии Амселя, лабораторный анализ на БВ производили путем микроскопического исследования отделяемого влагалища с применением метода Нуджента. Образцы отделяемого влагалища от всех женщин анализировали с применением теста Фемофлор-16, предназначенного для характеристики микробиоценоза влагалища методом мультиплексной количественной ПЦР в реальном времени. В нашей стране в последние годы для выявления дисбиотических состояний влагалища широко используется тест отечественного производства Фемофлор-16 (ДНК-Технология, Москва). С помощью теста определяют тотальную концентрацию бактериальной ДНК — общую бактериальную массу (ОБМ) и концентрацию (абсолютную и относительную) следующих видов/родов микроорганизмов: Lactobacillus, Enterobacteriaceae, Streptococcus, Staphylococcus, Gardnerella vagina lis/Prevotella bivia/Porphyromonas, Eubacterium, Sneathia/Leptotrichia/Fusobacterium, Megasphaera/ Veillonella/Dialister, Lachnobacterium/Clostridium, Corynebacterium/Mobiluncus, Peptostreptococcus, Atopobium vaginae. Целью исследования явилась разработка диагностических критериев определения БВ при анализе отделяемого влагалища тестом Фемофлор-16
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