Real-World Performance of the Alinity m STI Assay for the simultaneous detection of Chlamydia trachomatis, Neisseria gonorrhea, Mycoplasma genitalium, and Trichomonas vaginalis in Clinical Specimens at a Large Tertiary Hospital System in the United States

Abstract Background In the US, sexually transmitted infections (STI) are reported for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) but not Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG). TV and MG surveillance data in the US remains inadequate. We evaluated the performance of the fully automated, multi-plex PCR-based Alinity m STI assay, to simultaneously detect CT, NG, TV, and MG, at a large Veterans Affairs hospital system. Methods 260 urine, urogenital, and extragenital clinical specimens were tested with the Alinity m STI assay and the results were compared to those from the Abbott RealTi m e CT/NG assay in our lab and TV and MG assays run at an external reference laboratory. Results Alinity m STI assay results for urine specimens had an overall percent agreement (OPA) with the RealTi m e comparator assay of 187/187 (100.0%) for CT and 186/187 (99.5%) for NG. For 20 rectal specimens, the OPA for CT was 95% and for NG was 100%; for 13 oral specimens, OPA was 100% for CT and 92.3% for NG. Of the urine specimens sent for TV and MG testing, 100% agreement was observed between the Alinity m STI assay and TV (n=104) and MG (n=30) comparator assay results. Conclusions The Alinity m STI assay is an easy-to-use, sensitive and specific assay that allows high-throughput testing for common and undertested STI pathogens to facilitate surveillance efforts. KEY MESSAGES What is already known on this topic Mycoplasma genitalium and Trichomonas vaginalis are sexually transmitted infections, however, global prevalence data vary between geographical regions, as these sexually transmitted infections are not included in routine screening. What this study adds This study aimed at assessing Trichomonas and Mycoplasma prevalence and association with a positive Chlamydia and/or Gonorrhoeae result. How this study might affect research, practice, or policy Including Mycoplasma genitalium and Trichomonas vaginalis testing in a routine screening STI diagnostic algorithm, with cost-effective and accurate multiplex assays can improve diagnosis to initiation of appropriate treatment.