Journal of obstetrics and women's diseasesJournal of obstetrics and women's diseases1684-04611683-9366Eco-Vector582510.17816/JOWD65476-82Research ArticleComparison of diagnostics of bacterial vaginosis according to clinical signs with results of laboratory investigationsShipitsinaElena V.PhD, Senior Researcher, Laboratory of Microbiologyiagmail@ott.ruKhusnutdinovaTatyana A.Researcher, Laboratory of Microbiologyiagmail@ott.ruRyzhkovaOlga S.Researcher, Laboratory of Microbiologyiagmail@ott.ruKrysanovaAnna A.Researcher, Laboratory of Microbiologyiagmail@ott.ruBudilovskayaOlga V.Researcher, Laboratory of Microbiologyiagmail@ott.ruRybinaElena V.Bacteriologist, Laboratory of Microbiologyiagmail@ott.ruVorobyovaNadezhda E.PhD, MD, Researcher, Department of Endocrinology of Reproductioniagmail@ott.ruSavichevaAlevtina M.MD, Professor, Head of Laboratory of Microbiologysavitcheva@mail.ruGushchinAlexander E.PhD, Head of the Laboratory for Molecular Diagnostic and Epidemiology of Reproductive Tract Infectionsaguschn@pcr.ruD. O. Ott Research Institute of Obstetrics and Gynecology, RAMSCentral Research Institute for Epidemiology15092016654768215092016Copyright © 2016, Shipitsina E.V., Khusnutdinova T.A., Ryzhkova O.S., Krysanova A.A., Budilovskaya O.V., Rybina E.V., Vorobyova N.E., Savicheva A.M., Gushchin A.E.2016<p><strong>Introduction.</strong> Bacterial vaginosis (BV) is associated with a number of reproductive health disorders, therefore timely and accurate diagnosis of this condition is exceedingly important. </p><p><strong>Objective.</strong>Comparison of effectiveness of clinical and laboratory diagnostics of BV in women with vaginal discharge. </p><p><strong>Material and methods.</strong> In total, 318 patients addressing gynecological clinics with complaints about vaginal discharge participated in the study. Clinical diagnostics of BV was performed in the clinics participating in patient enrollment in accordance with their clinical practice. For laboratory diagnostics, microscopy of Gram stained smears according to the Nugent method and quantitative real-time PCR were used. Sensitivity and specificity of clinical diagnostics of BV and the molecular method were evaluated using the Nugent method as reference standard. </p><p><strong>Results.</strong> With the Nugent method, BV was diagnosed in 27% of women, with real-time PCR — in 37% of women. Using clinical signs of BV, the condition was diagnosed in 91% women. Sensitivity and specificity of the real-time PCR were 97% and 87%, respectively. Sensitivity of clinical diagnostics was 100%, but specificity was only 17%. </p><p><strong>Conclusions.</strong> Diagnostics of BV based only on the presence of vaginal discharge leads to false positive results and requires laboratory confirmation. The molecular method has a high sensitivity and satisfactory specificity for BV diagnosis and can be used as an alternative to the Nugent method.</p>bacterial vaginosisvaginal dischargediagnosticsthe Nugent methodбактериальный вагинозвыделения из влагалищадиагностикаметод Нуджента[1. Kenyon C, Colebunders R, Crucitti T. The global epidemiology of bacterial vaginosis: a systematic review. Am J Obstet Gynecol. 2013;209(6):505-523. doi: 10.1016/j.ajog.2013.05.006.][2. Allsworth JE, Peipert JF. Severity of bacterial vaginosis and the risk of sexually transmitted infection. Am J Obstet Gynecol. 2011;205(2):113.e1-6. doi: 10.1016/j.ajog.2011.02.060.][3. Taylor BD, Darville T, Haggerty CL. Does bacterial vaginosis cause pelvic inflammatory disease. Sex Transm Dis. 2013;40(2):117-122. doi: 10.1097/OLQ.0b013e31827c5a5b.][4. Donati L, Di Vico A, Nucci M, et al. Vaginal microbial flora and outcome of pregnancy. Arch Gynecol ¬Obstet. 2010;281(4):589-600. doi: 10.1007/s00404-009-1318-3.][5. Haggerty CL, Totten PA, Tang G, et al. Identification of novel microbes associated with pelvic inflammatory disease and infertility. Sex Transm Infect. 2016. pii: sextrans-2015-052285. doi: 10.1136/sextrans-2015-052285.][6. Bradshaw CS, Morton AN, Hocking J, et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis.2006; 193:1478-1486. doi: 10.1086/503780.][7. Amsel R, Totten PA, Spiegel CA, et al. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Med. 1983;74:14-22.][8. Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol. 1991;29:297-301.][9. Шалепо К.В., Назарова В.В., Менухова Ю.Н., и др. Оценка современных методов лабораторной диагностики бактериального вагиноза // Журнал акушерства и женских болезней. — 2014. — Т. LXIII. — № 1. — С. 26–32. [Shalepo KV, Nazarova VV, Menuhova JN, et al. Assessment of current methods of laboratory diagnosis of bacterial vaginosis. Journal of Obstetrics and Women’s Diseases. 2014; 63(1):26-32.][(In Russ.).]][10. Rumyantseva TA, Bellen G, Romanuk TN, et al. Utility of microscopic techniques and quantitative real-time polymerase chain reaction for the diagnosis of vaginal microflora alterations. J Low Genit Tract Dis. 2015;19 (2):124-8. doi: 10.1097/LGT.0000000000000060.][11. Bautista CT, Wurapa E, Sateren WB, et al. Bacterial vaginosis: a synthesis of the literature on etiology, prevalence, risk factors, and relationship with chlamydia and gonorrhea infections. Mil Med Res.2016; 3:4. doi: 10.1186/s40779–016–0074–5.][12. Румянцева Т.А., Сурсяков В.А., Хайруллина Г.А., и др. Вагинальные выделения у пациенток гинекологического профиля: этиология и подходы к диагностике // Акушерство и гинекология. — 2015. — № 8. — С. 96–101.][[Rumyantseva TA, Sursyakov VA, Khairullina GA, et al. Vaginal discharge in gynecological patients: Etiology and approaches to diagnosis. Akusherstvo i Ginekologiya. 2015;8:96-101. (In Russ.).]][13. Modak T, Arora P, Agnes C, et al. Diagnosis of bacterial vaginosis in cases of abnormal vaginal discharge: comparison of clinical and microbiological criteria. J Infect Dev Ctries. 2011;5(5):353-360.][14. Mengistie Z, Woldeamanuel Y, Asrat D, Yigeremu M. Comparison of clinical and gram stain diagnosis methods of bacterial vaginosis among pregnant women in Ethiopia. J Clin Diagn Res. 2013;7(12):2701-2703. doi: 10.7860/JCDR/2013/5872.3736.][15. Sha BE, Chen HY, Wang QJ, et al. Utility of Amsel criteria, Nugent score, and quantitative PCR for Gardnerella vaginalis, Mycoplasma hominis, and Lactobacillus spp. for diagnosis of bacterial vaginosis in human immunodeficien¬cy virus-infected women. J Clin Microbiol. 2005;43(9):][4607-12. doi: 10.1128/JCM.43.9.4607-4612.2005.][16. Menard JP, Mazouni C, Fenollar F, et al. Diagnostic accuracy of quantitative real-time PCR assay versus clinical and Gram stain identification of bacterial vaginosis. Eur J Clin Microbiol Infect Dis. 2010;29(12): 1547-52. doi: 10.1007/s10096-010-1039-3.][17. Cartwright CP, Lembke BD, Ramachandran K, et al. Development and validation of a semi-quantitative, multi-target, PCR assay for the diagnosis of bacterial vaginosis. J Clin Microbiol. 2012;50:2321-2329. doi: 10.1128/JCM.00506-12.][18. Shipitsyna E, Roos A, Datcu R, et al. Composition of the vaginal microbiota in women of reproductive age - sensitive and specific molecular diagnosis of bacterial vaginosis is possible? PLoS One.2013;8(4):e60670. doi: 10.1371/journal.pone.0060670.][19. Fredricks DN, Fiedler TL, Thomas KK, et al. Targeted PCR for detection of vaginal bacteria associated with bacterial vaginosis. J Clin Microbiol. 2007;45:3270-3276. doi: 10.1128/JCM.01272-07.]