Rapid Point of Care Testing for Sexually Transmitted Infections Using a Portable Isothermal Loop Mediated Nucleic Acid Amplification Platform

Abstract

Purpose To analyze sensitivity and specificity of the rapid point-of-care (POC) eazyplex STD complete testing platform for 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 eayzplex STD complete and the university microbiology laboratory. Results Compared to the reference diagnostic method, the overall sensitivity/specificity of STD complete 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 excellent sensitivity depending on sampling site and pathogen as well as excellent specificity overall eazyplex STD complete is a useful rapid diagnostic method for POC STI-testing especially for N. gonorrhoeae and C. trachomatis, allowing for almost immediate treatment initiation.