Abstract Background The Alinity m STI is a nucleic-acid amplification testing for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) in one assay. This study evaluated the performance of the Alinity m STI in comparison with other commonly used FDA-cleared assays and laboratory-developed tests (LDTs) across multiple female urogenital specimens. Methods Clinician-collect (CC) and self-collect (SC) vaginal swab, endocervical swab and urine specimens were collected from symptomatic and asymptomatic women across the US. The Alinity m STI results were compared to the Composite Comparator Algorithm (CCA) to establish specimen-specific agreement with six FDA cleared assays and two LDT. Results In this study population, the prevalence of single infections ranged from 0.8% (NG) to 7.6% (TV), with 3.4% of individuals coinfected with at least two pathogens. The overall positive agreements (OPA) for CC and SC vaginal swab and for endocervical swab were ≥ 97.5%, ≥98.0% and ≥ 97.3%, respectively, for all four analytes, with TV showing the lowest agreement for these sample types. The OPA for urine was ≥99.2% for all four targets. The kappa score ranged from 0.84 to 0.99 across all analytes and specimen types. Conclusions The Alinity m STI assay showed excellent concordance with the comparator assays, as demonstrated by strong kappa scores in female urogenital specimens.
Gentil et al. (Mon,) studied this question.