P07.10 Evaluation of the new bd max gc real time pcr assay, analytically and as a supplementary test to the bd probetec gc qx amplified dna assay, for molecular detection ofneisseria gonorrhoeae

Abstract

Introduction The BD ProbeTec GC Qx Amplified DNA assay (Becton, Dickinson and Company) is used on the BD Viper System to detect Neisseria gonorrhoeae . However, suboptimal specificity and cross-reaction with commensal Neisseria species have been described. Recently, the BD Max GC real time (rt) PCR assay was developed for the BD Max System (BD) as a supplementary test. Methods We evaluated the performance of the new BD Max GC rt PCR assay by examining clinical specimens positive in the BD ProbeTec GC Qx Amplified DNA assay during July–October 2014 among 23815 screening or clinical patients (14846 females and 8969 males) as well as samples spiked with isolates of gonococci (n = 189), non-gonococcal Neisseria species (n = 261) and other closely related bacteria (n = 10). Results Of 23815 patients tested with the BD ProbeTec GC Qx Amplified DNA assay, 85 (0.6%) females and 259 (2.9%) males were positive. Of these 344 positive specimens, 322 were tested with BD Max GC rt PCR assay. Sixty-nine (21%) of these samples were negative in BD Max GC rt PCR assay, a gonococcal dual target PCR and in the APTIMA Combo 2 (Hologic). These 69 specimens were obtained from pharynx (50% of all screening positive pharyngeal specimens), urine (33%), vagina (11.4%), rectum (4.3%), and cervix (1.4%). In the analytical evaluation of the BD Max GC rt PCR assay, all gonococcal isolates were positive and all but one ( N. cinerea ) of the non-gonococcal isolates (99.4%) were negative. The N. cinerea isolate also cross-reacted in the BD ProbeTec GC Qx Amplified DNA assay. Conclusion The BD ProbeTec GC Qx Amplified DNA assay had a suboptimal specificity for both urogenital and extragenital clinical specimens. The new BD Max GC rt PCR assay showed a high clinical and analytical sensitivity and specificity, and might also be used for initial detection of N. gonorrhoeae . Disclosure of interest statement We are grateful to BD Diagnostics for providing the BD Max GC real time PCR tests. The present work was funded by grants from the Orebro County Council Research Committee and the Foundation for Medical Research at Orebro University Hospital, Sweden.