B-226 Performance Evaluation of the Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis using BD MAX™ System

Background Sexually transmitted infections represent a significant global health challenge, with millions of new cases being reported each year. Among the most common pathogens causing STIs are: Chlamydia trachomatis with 130.9 million, Neisseria gonorrhoeae with 78.3 million, and Trichomonas vaginalis with 142.6 million new cases annually. While many individuals with these infections remain asymptomatic, untreated STIs can result in severe and long-term consequences. The development and validation of an efficient diagnostic method is vital for improving public health outcomes. Methods The BD CTGCTV Panel for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT- PCR) test intended for the simultaneous, qualitative detection and differentiation of DNA from Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in vaginal swabs or urine. The BD CTGCTV2 assay is comprised of two targets for Chlamydia trachomatis (detected on the same optical channel), two targets for Neisseria gonorrhoeae (detected on two different optical channels) and one target for Trichomonas vaginalis (detected on one optical channel). Only one Chlamydia trachomatis target is required to be positive in order to report a positive result. Both Neisseria gonorrhoeae targets are required to be positive in order to report a positive result. The assay was evaluated for: precision, reproducibility, and accuracy; the percentage agreement for the evaluation steps was calculated. We collected 406 samples to test with the assay; the results were segregated based on the gender and age. Statistical analyses were done using Analyse-it. Results The percentage agreement for precision, reproducibility, and accuracy were 100%. The patients’ correlation was 100% when compared to the existing molecular testing in the reference laboratory. Female patients accounted for 34.9% of the samples tested (142 female and 265 male); positivity rate was higher in women for all target tested with the highest positivity for Trichomonas vaginalis, women at age 30-40 had the highest positivity among other ages. Conclusion The CTGCTC panel for BD MAX™ System gave the benefit of a fully automated, high precision, accuracy and acceptable sensitivity assay. It offers other advantages like easier collection (urine), faster turnaround time (less than 3 hours for all targets) which allow for quicker diagnosis and earlier treatment to prevent the serious consequences like adverse reproductive health outcomes, including pregnancy complications, pelvic inflammatory disease and an increased risk of HIV acquisition. In addition to reducing the risk of complication the early identification will help preventing/reducing the spreading of the infection. As with every molecular assay avoiding contamination is very important to eliminated false positive results.