Femoflor complex (biocenosis of the urogenital tract of women)

The vaginal microbiome represents the dynamic microflora of the vagina, whose balance plays an essential role in female reproductive health. The composition of the microbiota changes throughout life under the influence of the menstrual cycle, pregnancy, hormonal variations, stress, lifestyle, diet, and the administration of certain medications, including antibiotics.

These changes occur at all stages of life — from childhood and puberty to pregnancy and menopause. Physiologically, the microbiome is dominated by lactobacilli, while the proportion of conditionally pathogenic microorganisms remains low.

A decrease in normal flora below approximately 80% leads to dysbiosis, which can cause various clinical imbalances: bacterial vaginosis, aerobic vaginitis, vulvovaginal candidiasis, or other forms of vaginal microbiocenosis disruption.

Vaginal dysbiosis is associated with an increased risk of sexually transmitted infections, progression of cervical intraepithelial neoplasia, and obstetric complications.

Timely diagnosis and correction of the vaginal microbiome allow restoration of balance, reduction of inflammatory disease risk, improvement of reproductive health, and prevention of pregnancy complications.

FEMOFLOR® complex is a comprehensive molecular investigation performed using real-time polymerase chain reaction (PCR), designed for qualitative and quantitative evaluation of the female urogenital tract microbiota. The test enables proportional analysis of normobiota (especially lactobacilli and bifidobacteria), identification of opportunistic flora, and detection of clinically relevant pathogens — including sexually transmitted agents, herpes viruses, and oncogenic and non-oncogenic HPV types. Real-Time PCR technology allows precise determination of microbial load (GE/ml) and assessment of the ecological balance of the microbiocenosis.

Investigation Components

Purpose of the Investigation

FEMOFLOR® Complex provides a comprehensive assessment of the urogenital microbiota and helps identify microbial imbalances and clinically relevant infections. The investigation allows:

• Assessment of vaginal microbiota balance and differentiation between eubiosis and dysbiosis.
• Quantification of lactobacilli and identification of predominant patterns.
• Rapid diagnosis of bacterial vaginosis, candidiasis, and mixed vaginitis.
• Early detection of urogenital infections, including latent and recurrent forms.
• Identification of major pathogens (Chlamydia, Gonorrhoeae, Mycoplasma, Trichomonas).
• Detection of ureaplasmas, mycoplasmas, aerobic and anaerobic bacteria.
• Detection of HSV-1, HSV-2, CMV viruses, and oncogenic HPV typing.
• Establishment of indications for antibacterial, antiviral, or antifungal therapy.
• Monitoring treatment efficacy and clinical follow-up.
• Assessment of microbial status before pregnancy, IVF/ART, or gynecological procedures.

Indications

Clinical

• Symptoms of vaginal inflammation: itching, unpleasant odor, abnormal discharge
• Suspicion of bacterial vaginosis, recurrent candidiasis, or mixed vaginitis
• Recurrent or persistent urogenital infections
• Pelvic pain of unclear origin
• Infertility of unexplained etiology
• Monitoring response to antimicrobial and antifungal treatment

Reproductive

• Preconception planning and evaluation
• Preparation for IVF/ART
• Pregnancy screening to reduce maternal-fetal complications
• History of spontaneous abortions or premature rupture of membranes

Preventive

• Annual preventive screening
• Unprotected or high-risk sexual contact
• Recurrent dysbiosis after antibiotic therapy

Contraindications

There are no absolute contraindications. The test can be performed in most patients with the following relative limitations:

• Unexplained vaginal bleeding
• Antibiotic use in the last 14 days
• Avoid sexual intercourse 2 days before sample collection
• Stop using intra-vaginal medications (creams, tablets, ovules, suppositories 72 hours before testing; antibacterial preparations 14 days before testing)
• Urogenital swab should not be performed during menstruation or uterine bleeding (recommended between day 5 and day 20 of the menstrual cycle)
• Avoid intimate hygiene at least 6–8 hours before sample collection
• Do not urinate within 2 hours before sample collection
• Intimate hygiene should be performed only with water, without soap or antiseptics, the evening before the test

Procedure

Sample collection is performed using a vaginal/cervical swab — material is collected from the cervical canal using a sterile cytology brush. The procedure lasts a few minutes, may cause mild discomfort, and does not require a recovery period. The sample is placed in a specialized DNA stabilizer transport medium.

In the laboratory, DNA is extracted, real-time PCR amplification is performed, and analytic software calculates the quantity of each microorganism (GE/ml) and ecological ratios. The final report includes quantitative microbial levels, normobiota profile, ecological index, pathogen detection, and clinical interpretation.

Sources:

DNKOM – Official FEMOFLOR® page: https://dnkom.ru/actions/femoflor/

DNKOM – FEMOFLOR® II technical description (Real-Time PCR method)

Clinical and Laboratory Standards Institute (CLSI)

Centers for Disease Control and Prevention (CDC) – STI Treatment Guidelines

European STI Guidelines Editorial Board

ACOG Practice Bulletin – Vaginitis, Cervicitis, Bacterial Vaginosis