Evaluation of thE triPlEx rEal-timE PCr assay for DEtECtion of ChlamyDia traChomatis anD nEissEria GonorrhoEaE in urinE anD vaGinal

organisms. Analytical sensitivity was determined using titered, purified CT elementary bodies and cultured NG cells. Results The Xpert CT/NG assay detects all CT serovars, new variant CT, and 48 geographically diverse NG strains. The CT primers and probes do not cross-react with DNA or RNA from non-trachomal species. All non-gonococcal Neisseria species yielded negative results, including N. mucosa and N. cinerea, because both NG targets must be PCR positive for a “NG DETECTED” result. The LoDs for the Xpert CT/NG Assay for CT serovar D in male urine and vaginal swab matrix respectively were 75 and 84 Eb/mL; for CT serovar H, LoDs were 134 and 161 Eb/mL. In both matrices, the LoD for two NG strains was approximately 2 cfu/mL. Conclusion The Xpert CT/NG assay is highly specific and sensitive. The ease of use and fast time to result could lead to reduced time to treatment of CT and NG infections.