Femoflor ® 16

Vaginal microbiome composition is a complex dynamic system, which at any given time is affected by many endogenous and exogenous factors, including age, sexual behavior and obstetric history, hormonal status and hormonal disorders, use of hormone replacement therapy and combined oral contraceptives, antibiotic therapy and presence of extragenital pathology. The status of vaginal microbiome composition has a serious impact on maintenance of the reproductive function and as a consequence, on quality of women’s life.

Femoflor ® 16 REAL-TIME PCR Detection Kit is a qualitative in vitro nucleic acid test:

• Femoflor ® 16 REAL-TIME PCR Detection Kit is intended for the study of microbiome composition of female urogenital tract.

• Femoflor ® 16 REAL-TIME PCR Detection Kit is designed to detect the DNA of opportunistic pathogens (see table 2 for the reference), DNA of Lactobacillus sp., and human genomic DNA (sample intake control, SIC).

• Femoflor ® 16 REAL-TIME PCR Detection Kit is intended for research and diagnostic applications.

The scope of the method:

• Comparison of the amount of lactobacillus with the total amount of bacteria allows evaluating the evidence of disorders in microbiota;

• 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;

• Quantitative analysis of genomic DNA of human epithelial cells in bioassay ensures quality control at the pre-analytical stage and prevents from obtaining false-negative results of the analysis;

• Detection of etiologically significant opportunistic microorganisms and determination of the degree of dysbiosis manifestation allows a clinician to determine the scope of therapeutic maneuver and prescribe causal treatment;

• An individual approach to therapy permits to reduce a number of side effects caused by excess medication;

• For the first time it has become possible to monitor drug-induced effects on the urogenital tract microbiota, evaluate treatment efficacy and microbiota recovery.

Sample: epithelial scrapes from cervical canal, posterolateral vaginal wall and urethra can be used for analysis depending on professional prescription

DNA extraction: PREP-NA PLUS, PREP-GS PLUS extraction kits

Certification: CE/IVD