DEVELOPMENT AND EVALUATION OF A DIAGNOSTIC MICROCHIP PANEL FOR THE DETECTION OF AGENTS OF UROGENITAL INFECTIONS

O.S. Ryzhkova (1), E.V. Shipitsyna (1), A.I. Aniskina (2), M.N. Slyadnev (2), A.M. Savicheva (1)
1 -D.O. Ott Reasearch Institute of Obstetrics and Gynecology, Mendeleyevskaya linia, 3, St. Petersburg, Russian Federation, 199034;
2 -Limited Liability Company «Lumex marketing», Obukhovskoy Oborony pr., 70, bld. 2, St. Petersburg, Russian Federation, 192029

Introduction. Development of rapid and accurate tests is of priority in microbiological diagnostics, including diagnostics of urogenital infections. The aim of the study. The study aimed to develop and evaluate a diagnostic microchip panel based on real-time PCR for simultaneous detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium. Methods. For assessment of analytical and diagnostic parameters of the panel, laboratory and clinical strains of microorganisms, as well as clinical samples obtained from patients of gynecological, urological and dermatovenereological settings were used. As reference standards, validated real-time PCR tests manufactured in Russia were used. Results. On the basis of the universal platform for rapid microchip real-time PCR amplification AriaDNA, a diagnostic microchip panel for the detection of C. trachomatis, N. gonorrhoeae, T. vaginalis and M. genitalium was developed. Diagnostic sensitivity of the panel was 97, 100, 92 and 97% for the detection of C. trachomatis, N. gonorrhoeae, T. vaginalis and M. genitalium, respectively. Diagnostic specificity was 100%. Conclusion. The characteristics of the panel were shown to be comparable with those of validated Russian traditional real-time PCR based tests, which allows us to recommend it for routine diagnostics.
Keywords: 
urogenital infections, diagnostics, PCR, microchip panel