DIAGNOSIS OF CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE INFECTIONS IN WOMEN WITH PELVIC INFLAMMATORY DISEASE SUSPICION: EVALUATION OF CLINICAL USE OF A RAPID MOLECULAR DETECTION ASSAY

Nadine Hefner, Ulrich Eigner – Labor Limbach, Heidelberg, GermanyBackground: The WHO estimates that more than 1 million sexually transmitted infections (STI) are acquired every day worldwide including curable bacterial STIs such as Chlamydia or Gonorrhoea. In this study, we evaluated the RIDA®GENE CT/NG/MG PCR assay (R-Biopharm AG) for the simultaneous, direct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium as an aid in the diagnosis of urinary tract infections or infections of the genital area.Methods: Prospectively and retrospectively collected samples were tested with the RIDA®GENE CT/NG/MG assay on the LightCycler® 480II (Roche). In total 508 samples were tested for C. trachomatis, 108 specimens for N. gonorrhea and 106 samples for M. genitalium. Results were compared to real-time PCR (Volkmann method, FluoroType ®CT, FluoroType ®NG) and PCR multiplex panel (Seegene Allplex™ STI-7 Essential Assay). All assays were performed according to manufacturer’s instructions. Results: In summary the specimen contained 44 bacterial STI pathogens (C. trachomatis (n=23), N. gonorrhea (n=14), M. genitalium (n=7)). Co-infections were found for CT/MG (n=2) and CT/NG (n=1). Positive and negative agreement to the PCR multiplex panel accounts for 92,59% and 99,59% respectively for CT, 92,59% and 98,96% for NG and 85,71% and 94,29% for MG. The positive and negative agreement for the RIDA®GENE CT/NG/MG assay in comparison to the reference in-house method was 89,66% and 99,38% respectively for CT, (FluoroType ®CT) , 100% and 100% for NG (FluoroType ®NG) and 100% and 98,99% for MG (Volkmann method). Conclusions: The RIDA®GENE CT/NG/MG multiplex-PCR assay showed sensitive and specific results for the detection of C. trachomatis, N. gonorrhea and M. genitalium in human urine samples, genital swabs and ejaculate.