Validation of a set of reagents for PCR diagnostics of diphtheria.

We have developed a set of RT-PCR reagents that can detect the rpoB gene (identification of C. diphtheriae), the tox gene of C. diphtheriae, and the tox gene of C. ulcerans. The high analytical characteristics of the reagent kit have been proven in the study of strains and model samples of clinical material. With the help of this kit for diagnostic purposes, it is advisable to investigate samples from the oropharynx, nose, eyes, vagina and wounds in patients with suspected diphtheria. In the epidemiological surveillance system, the developed test can be optimally used for preventive examinations or, according to epidemiological indications, as a rapid screening test followed by the isolation of a culture from PCR-positive (containing C. diphtheriae DNA and the toxin gene; or  C. ulcerans toxin gene) samples, as well as for the purpose of additional identification of C. diphtheriae during cultural studies.