Androflor®

F.A.Q.

• Is there any special preparation needed for the assay? What should I know to collect biomaterial for Androflor®?

  Standard pre-analytical recommendations are also relevant for Androflor®. Like any other infection diagnostics method (microscopy, microbiology, etc.), real-time PCR requires observation of rules for patient preparation and biomaterial collection and storage. Those rules include abstaining from sexual intercourses or using barrier contraception methods for at least 3 days (to minimize the risk of biomaterial contamination with partner’s microflora), excluding antibiotics or antiseptics (including antibacterial soap), abstaining from urination for 3 hours before scrape collection, recommendations to urinate and perform genital toilet before collection of prostate fluid or ejaculate, etc.

  The most convenient biomaterial for the patient is ejaculate, which can be collected at home by masturbation. It is forbidden to collect ejaculate obtained by coitus interruptus (biomaterial will contain a major part of transient microflora) or ejaculate from a condom (lubricant components inhibit PCR). Collected biomaterial must be stored in a fridge for up to 24 hours or frozen. Strict biological sample storage conditions (urgent delivery to the laboratory, storage at a specific temperature) are not required, as the testing is performed using a non-cultivation-based method.

  
• How long does the assay take?

  Hands-on time from biomaterial acceptance in the laboratory is 4–6 hours. Please note that some time may be required for sample transportation, assay quality check, and in rare cases – for repeated testing. The factor of laboratory workflow organization is also important. Therefore, the average turnaround time for the test is 1-2 days.

• Why are there so many targets in the test? Why not reduce it to traditional STI screening?

  It is now obvious that the previously widespread approach of searching for specific pathogenic microbes in the reproductive tract is only informative for diagnosing STIs. In most cases, the source of unpleasant symptoms and patient complaints regarding urogenital infections is not the presence of pathogens (Chlamydia trachomatis, Mycoplasma genitalium, Neisseria gonorrhoeae, or Trichomonas vaginalis), but rather a dysbiotic process – a disruption in the qualitative and quantitative balance of normal and opportunistic flora. To address this issue, real-time PCR can be used, as it simultaneously allows for the detection of major STIs in the biological sample and characterizes the contribution of various microbial groups to the total bacterial mass. The innovation that has made such diagnostics financially accessible for routine practice lies in the group identification of microorganisms and the application of multiplex analysis.
• Is assigning several methods simultaneously recommended for diagnostics ofdiagnosing infections?

  In case of infection testing, it is allowed to assign Androflor® simultaneously with microbiological assay and obtain the result for all the necessary groups of bacteria, including non-culturable anaerobic bacteria, in 1–2 days. It is also possible to carry out PCR tests for viruses (HSV, CMV, EBV, HPV) with the same biomaterial, at the discretion of physician.
• Why do culture and Androflor® results not match?

  Periodic discrepancies between culture results and Androflor® are due to fundamental differences between the two technologies. Culture involves cultivation followed by identification and assessment of antibiotic resistance for all microorganisms that have "grown". The results of culture directly depend on the ability of microorganisms to be cultured under the conditions provided by a specific bacteriological laboratory.

  Androflor® detects the quantitative ratios of microorganisms directly based on DNA fragments that entered the tube during sample collection, regardless of the functional properties of the microorganisms.

  Nevertheless, we can observe a correlation between culture and real-time PCR results, particularly when detecting microorganisms from the Enterobacteriaceae family.

• Is examining both sexual partners recommended in case of chronic infectious inflammatory disease?

  In these cases, it is recommended to examine both partners, using Femoflor® for women and Androflor® for men. Both tests were developed using the same real-time PCR technology. Our studies have shown that microbiota of sexual partners can differ significantly. Therefore, it is crucial to screen the couple rather than prescribe empirical and often ineffective treatment for the woman based solely on her partner's test results, or vice versa (with the exception of STIs). Examining both sexual partners will help establish the etiology of the condition and select individualized therapy.
• Is Androflor® consistent with current global trends?

  Yes, in recent years, a global trend has emerged towards using high-tech methods to identify the microbiota of various human biotopes. International literature increasingly reports on the potential benefits of molecular genetic tests for diagnosing infectious-inflammatory processes of the genitourinary system. The primary method used is high-throughput DNA and RNA sequencing (Next Generation Sequencing, NGS), which is more suitable for research than routine practice due to the complexity and high cost of the technology.

  Leading experts recognize the limitations of bacteriological research methods and associate prospects for improving diagnosis, and consequently treatment, with the application of nucleic acid analysis methods. These methods enable the selection of antimicrobial drugs targeting specific bacterial groups that caused the inflammatory response. This task becomes particularly relevant given the problem of antibiotic-resistant bacterial strains, which have emerged in response to the unsystematic use of broad-spectrum antibiotics. However, in international urological practice, molecular biological methods currently remain largely within the realm of scientific research.

  When developing its Androflor® assay, which took over 7 years, DNA-Technology also used sequencing methods to create a prototype test with a large number of detectable parameters (over 50). After scientific research on various sample groups, the diagnostic profile was adjusted, and an algorithm for interpreting results was developed. The Androflor® assay currently has no international equivalents, which has generated significant clinical interest worldwide.

Quality guarantee

Developed by Russian physicians and scientists, Androflor® has been in use since 2016, with quality and security proved by clinical trials. Production facilities of DNA-Technology are equipped with modern instruments and tools. The production meets the requirements of GMP and ISO international quality standards, with each stage being controlled at the level of pharmaceutical production.

Androflor® is actively used in Russia and abroad for solving issues associated with the etiological diagnosis of reproductively significant infections. In recent years, the adoption of high-end microbiota assessment methods has become a global trend.

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