P2.017 Clinical Evaluation of the PelvoCheck® CT/NG For the Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae

Background In the present study the performance of the PelvoCheck ® CT/NG, a microarray-based nucleic acid amplification assay for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), was evaluated in single and pooled urine specimen of young women. Methods A total of 1649 female urine specimens were collected and examined for urogenital chlamydia infections. Because of a low prevalence (2.12%), 50 CT-negative urine specimens were enriched with CT reference material mimicking the natural chlamydial distribution in female urine. The results were compared to those of the Roche COBAS ® TaqMan ® CT assay as the first and the Abbott RealTime CT/NG assay as the second reference method. Similarly, NG pre-screened female urine specimens (60 NG-positive and 60 NG-negative specimens) were analysed with the PelvoCheck ® CT/NG test and compared to a validated in-house Q-PCR method and the Abbott RealTime CT/NG assay. Furthermore, the PelvoCheck ® CT/NG assay was tested for pooled urine specimens (52 CT-negative and 55 CT-positive specimens). Each pool consisted of either five individual CT-negative specimens or four CT-negative and one CT-positive individual specimens. Results For the detection of CT the overall positive agreement (sensitivity) and overall negative agreement (specificity) of the PelvoCheck ® CT/NG were 98.8% and 100%, for the detection of NG 98.3% and 98.2%, respectively. The comparison of data obtained with the PelvoCheck ® CT/NG for pooled urine specimens resulted in a positive agreement of 90.9% and a negative agreement of 100%. Four CT-positive pooled specimens with final CT-concentrations of 0.05 – 0.13 IFU/ml were not detected. Conclusion In summary, we show that the PelvoCheck ® CT/NG assay is a highly sensitive and highly specific method for the detection of CT and NG. To our knowledge, this is the first commercial CT/NG test system validated for the analysis of pooled urine specimens.