C-170. Performance of the BD ProbeTec™ CTQx and GCQx Amplified DNA Assays with Urine and Vaginal Swabs in the Presence of Potential Interfering Substances

J. Kendall;
Becton Dickinson, Sparks, MD.

Background: We have developed two novel assays for detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) for use with the BD Viper™ System in extracted mode. The purpose of this study was to investigate the performance of the assays with urine and vaginal swabs in the presence of endogenous and exogenous substances likely to be present in these specimen matrices. Methods: Pools of urine or expressed vaginal swabs were spiked with CT and GC at a low level near the analytical limits of detection of the assays, or left unspiked. Potential exogenous or endogenous interfering substances were added to each pool. Compounds tested included blood, leukocytes, mucus, semen, albumin, hormones, antibiotics and analgesics. Parallel controls lacking the interferents were also prepared. DNA was extracted on the BD Viper™ System and tested using the BD ProbeTec™ CT/GC Qx Amplified DNA Assays. A non-amplified Extraction Control was included in each assay to monitor for reagent failure. Results were evaluated against pre-determined thresholds to determine the proportion positive/negative/non-reportable. Results: There was ≥95% agreement with expected results for both CT/GC positive and negative specimens. No failures of the Extraction Control were reported. Conclusion: The performance of the BD ProbeTec™ CT/GC Qx Amplified DNA Assays and Extraction Control with urine and vaginal swabs was robust to the levels of endogenous and exogenous substances tested in this study. Product not for sale, for investigational use only in the US.