The composition of the vaginal microbiome represents a complex, dynamic system that is continuously influenced by multiple endogenous and exogenous factors (age, pregnancy, hormonal status, pharmacological therapies). The balance of the vaginal microbiota plays a key role in women’s reproductive health and overall quality of life.

FEMOFLOR® 16 REAL-TIME PCR Detection Kit is a highly specialized molecular diagnostic test designed for comprehensive and quantitative analysis of the microbial composition of the female urogenital tract, including assessment of both normal and opportunistic microflora.

FEMOFLOR® 16 REAL-TIME PCR Detection Kit enables simultaneous detection and quantitative analysis of:

• Representatives of the normal microflora (Lactobacillus spp.)
• Facultative anaerobic microorganisms (Enterobacteriaceae; Staphylococcus spp.; Streptococcus spp.)
• Obligate anaerobic microorganisms (Gardnerella vaginalis/ Prevotella bivia/ Porphyromonas spp.; Eubacterium spp.; Sneathia spp./ Leptotrichia spp./ Fusobacterium spp.; Megasphaera spp./ Veillonella spp./ Dialister spp.; Lachnobacterium spp./ Clostridium spp.; Mobiluncus spp./ Corynebacterium spp.; Peptostreptococcus spp.; Atopobium vaginae)
• Mycoplasmas and ureaplasmas (Mycoplasma genitalium; Mycoplasma hominis; Ureaplasma urealyticum/ Ureaplasma parvum)
• Fungi of the genus Candida

CHARACTERISTICS AND ADVANTAGES OF THE METHOD:

• Assessment of the microbiome status by determining the ratio between the quantity of lactobacillus and the total bacterial load in the sample.
• Comparison of the amount of opportunistic biota with the amount of lactobacillus allows determining etiologic significance of various microorganisms in developing dysbiosis as well as the degree of its manifestation.
• Pre-analytical quality control via the SIC (Sample Intake Control) parameter, which verifies the amount of collected material, ensuring high analytical quality, reliable interpretation, and confidence in the diagnostic result.
• Possibility for targeted and specific therapy based on the identified pathogens, as well as monitoring of treatment effectiveness over time.

VALIDATED SAMPLE TYPES FOR ANALYSIS:

• Еpithelial scrapes from cervical canal, posterolateral vaginal wall, urethra and others.

KIT CONTENT:

• Preloaded ready to use PCR mix - 24 x 8-PCR strips
• Taq-polymerase - 4 x 500 μL
• Mineral oil - 4 x 1.0 mL
• Positive control - 160 μL

Storage: from 2°С to 8°С

Expiration date: 12 months

CE-IVD certified