Optimization of screening for vaginal infections associated with human papillomaviruses

Kira E.F., Semenova K.E., Bobrova M.V., Belyakova A.A., Gasilova N.A.

1 Institute for Postgraduate Training of Physicians, N.I. Pirogov National Medical and Surgical Center, Ministry of Health of Russia, Moscow, Russia; 2 City Polyclinic Seventeen, Saint Petersburg, Russia; 3 INVITRO LLC, Moscow, Russia
Objective. To investigate the possibilities of early screening for sexually transmitted infections (STIs), including human papillomavirus (HPV) infection, to validate and comparative analyze the currently available test kits for self-sampling of vaginal biomaterial.
Subjects and methods. A multicenter simple study comparing two test systems for self-sampling of vaginal biomaterial, which are intended for early diagnosis of HPV infection, was conducted. At the screening stage, 110 women aged 21 to 45 years (mean age 29±0.6 years) were examined; four vaginal fluid samples were taken from each of them and found to contain bacteria and viruses. The systems were validated by STIs caused by Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genital, Trichomonas vaginalis, or human papillomavirus. Twenty-two HPV genotypes and viral load were determined using real-time multiplex polymerase chain reaction assay with detection of results. The clinical examination of the patients embraced traditional assessment of complaints, collection of clinical and anamnestic data, physical examination, clinical examination, and determination of the gynecological status; vaginal fluid (VF) pH-metry was also carried out.
Results. The indicator of the quality of material sampling using the studied procedures is comparable in the levels of ≥ 4 lg (p > 0.005). The detection rate for the infections is comparable both when a physician takes a smear from the vagina and cervical canal and when two test systems compared are used (p > 0.005). The use of these methods could detect HPV of different types in 23 out of the 110 examined women, which amounted to 20.9%. Eleven of the 22 HPV types tested were identified. There was a complete coincidence of the studied and compared methods in 108 patients.
Conclusion. The comparative analysis of the two methods for self-sampling of vaginal biomaterial showed that they were identical to medical manipulations, as well as the high reliability of the results of the study. Unlike the foreign analogue, the Russian test system had advantages. This system can be recommended to implement HPV-associated disease screening programs in clinical practice.

Keywords

human papilloma virus (HPV)
diagnosis of sexually transmitted infections
self-sampling of VF

References

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Received 08.06.2018

Accepted 22.06.2018

About the Authors

Kira, Eugene F., honored scientist of the Russian Federation, honored Doctor of the Russian Federation, academician of RAS, MD, Professor, head of the Department of Women’s Diseases and Reproductive health of the 1Institute for Improvement of Physicians, N.I. Pirogov National Medical and Surgical Center, Ministry of Health of Russia. 105203, Russia, Moscow, Nizgnya Pervomayskaya str. 70. Tel.: + 74994645654. E-mail: profkira33@gmail.com
Semenova, Ksenia Y., Doctor obstetrician-gynecologist City Polyclinic № 17.
195176, Russia, St. Petersburg, Metallistov str. 56. Tel.: +78122229076 E-mail: semenovak1981@mail.ru
Bobrova, Maria V., the head of the organizational-methodical Department of interaction with specialists of the healthcare sector of Invitro LLC.
125047, Russia, Moscow, 4th Tverskaya-Yamskaya str. 16, bld. 3. Tel.: +74953630363. E-mail: mbobrova@invitro.ru
Belyakova, Anna A., candidate of medical sciences, Doctor of Clinical and Laboratory Diagnostics, Invitro LLC.
125047, Russia, Moscow, 4th Tverskaya-Yamskaya str. 16, bld. 3. Tel.: +74953630363. E-mail: abelyakova@invitro.ru
Natalia, Gasilova A., Head of the Laboratory of Molecular Diagnostics “Invitro-Moscow”, Invitro LLC.
125047, Russia, Moscow, 4th Tverskaya-Yamskaya str. 16, bld. 3. Tel.: +74953630363. E-mail: NGasilova@invitro.ru

For citations: Kira E.F., Semenova K.E., Bobrova M.V., Belyakova A.A., Gasilova N.A. Optimization of screening for vaginal infections associated with human papillomaviruses. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2018; (8): 167-73. (in Russian)
https://dx.doi.org/10.18565/aig.2018.8.167-173

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