Rapid point of care testing for four bacterial sexually transmitted infections using the portable isothermal loop-mediated nucleic acid amplification eazyplex platform

Abstract

Purpose: To analyze sensitivity and specificity of the rapid point-of-care (POC) eazyplex testing platform for bacterial sexually transmitted infections (STI) among men who have sex with men (MSM). Methods: 272 anal, urethral, and pharyngeal swabs collected from 153 MSM were tested by both the eazyplex platform and an in-house PCR or culture in the university microbiology reference laboratory. Results: Compared to the reference diagnostic method, the overall sensitivity/specificity of eazyplex was 88%/98% for N. gonorrhoeae, 82%/100% for C. trachomatis, 70%/ > 99% for U. urealyticum, and 85%/98% for M. hominis, respectively. Sensitivity for N. gonorrhoeae and U. urealyticum in urethral samples was 100%. Conclusion: With good to very good sensitivity depending on the sampling site and pathogen as well as very good specificity overall the eazyplex platform is a useful rapid diagnostic method for POC bacterial STI-testing especially for N. gonorrhoeae and C. trachomatis, allowing for almost immediate treatment initiation.