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

BackgroundIn 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. Methods260 urine, urogenital, and extragenital clinical specimens were tested with the Alinity m STI assay and the results were compared to those from the Abbott RealTime CT/NG assay in our lab and TV and MG assays run at an external reference laboratory. ResultsAlinity m STI assay results for urine specimens had an overall percent agreement (OPA) with the RealTime 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. ConclusionsThe 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 MESSAGESO_ST_ABSWhat is already known on this topicC_ST_ABSO_LIMycoplasma 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. C_LI What this study addsO_LIThis study aimed at assessing Trichomonas and Mycoplasma prevalence and association with a positive Chlamydia and/or Gonorrhoeae result. C_LI How this study might affect research, practice, or policyO_LIIncluding 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. C_LI