P2.047 Evaluation of a Multiplex Real-Time PCR Assay For Rapid Detection ofC.trachomatisandN. Gonorrhoeaefrom Genital Clinical Specimens

Abstract

Background Sexually transmitted diseases (STDs) are among the most common causes of illness in the world, being associated to acute disease, infertility, long term disability and death. In particular the prevalence of C.trachomatis and N. gonorrhoeae infections appear to remain steady or increasing, although both diagnostic and therapeuthical tools are available, at least in developed countries. Standard diagnostic protocols can be complex, time-consuming, and sensitivity of culture methods affected by specimen characteristics. In addition, certified methods are today required, especially in the management of cases of sexual abuse. Methods Multiplex real-time PCR method (Xpert CT/NG, Cepheid) has been tested versus N. gonorrhoeae standard culture and C. trachomatis molecular assay (Artus C. trachomatis TM PCR Kit, Qiagen). 45 clinical samples (female and male urogenital swabs, ocular infections, first void of urine, seminal fluid, and external quality control samples - UK NEQAS) were selected and stored at - 20°C. Xpert CT/NG allowed to perform in one-step extraction, amplification and detection of C.trachomatis and N. gonorrhoeae DNA directly from all the variety of selected clinical specimens, within 60 min. Results 100% results agreement was found between Xpert CT/NG and standard protocols, including expected results by UK-NEQAS quality assessment specimens. However, batch PCR is a multi-step time-consuming process, the turn-around-time (TAT) required from 8 to 48 hrs versus the single technical and computer-assisted interpretation step by Xpert CT/NG, resulting in a Conclusions Xpert CT/NG test is a easy, rapid, accurate and certified method in routine diagnostics of N. gonorrhoeae and C. trachomatis infections.