Evaluation of Alinity m Sexually Transmitted Infection Assay for Simultaneous Detection of Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis , and Mycoplasma genitalium in Male Urine Specimens.

BACKGROUND

This study evaluated the performance of the Alinity m sexually transmitted infection (STI) assay that can simultaneously detect Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in comparison with other commonly used Food and Drug Administration-cleared assays and laboratory-developed tests in male urine specimens.

METHODS

Urine specimens were collected from symptomatic and asymptomatic men across the United States. The Alinity m STI results were compared with the Composite Comparator Algorithm results established for each analyte.

RESULTS

The prevalence of single infections ranged from 1.8% for NG and TV to 6.1% for CT, with 2.6% of individuals coinfected with at least 2 STI pathogens. The overall positive agreement was ≥97.5% for all 4 analytes, with MG showing the lowest agreement. The κ score ranged from 0.82 to 0.98 across all analytes.

CONCLUSIONS

The Alinity m STI assay showed excellent concordance with the comparator assays demonstrated by the strong κ scores in male urine specimens.