DEVELOPMENT OF A PCR REAL-TIME FOR DIAGNOSTIC OF DIPHTHERIA INFECTION

The results of testing the of reagent kit «C. diphtheriae Tox+» (DNA-Technologiya TS, Russia) for diagnostics of diphtheria are presented. 15 typical strains were used, including toxigenic C. diphtheriae № 665, 300 strains and clinical samples (nasal, oropharyngeal and skin swabs) sent to Reference Center for monitoring measles, rubella, mumps, whooping cough and diphtheria G. N. Gabrichevsky Research Institute of Epidemiology and Microbiology. Cultivation was carried out according to MUK 4.2.3065-13. For DNA extraction – Ribo-prep (CRIE, Russia), Proba-NK, Proba-GS (DNA-Technologiya, Russia), Proba-MH-Rapid, Proba-Optima (DNA-Technologiya TS, Russia) were used. The comparative reagent kit was AmpliSens Corynebacterium diphtheriae/tox-genes-FL (CRIE, Russia). The analytical sensitivity of the reagent kit after amplification was 5 copies of DNA (103 GE/ml). Diagnostic sensitivity was 100% (92,9-100), diagnostic specificity was 100% (97,6-100). In comparative studies with the reagent kit AmpliSens Corynebacterium diphtheriae/tox-genes-FL, the results were 100% consistent with a 95% confidence interval of 88,43-100%. The absence of cross-reactivity was show in biomaterial samples containing other microorganisms isolated from the naso-, oropharynx and skin. © 2023, Klinichescheskaya Laboratornaya Diagnostika. All rights reserved.