Clinical evaluation of two commercial PCR kits for the detection of nonviral sexually transmitted infections.

Abstract

Introduction. Sexually transmitted infections (STIs) are a worldwide health issue with a high number of asymptomatic cases and the possibility of multiple infections.Gap statement. New multiplex real-time PCR kits targeting pathogens involved in nonviral STIs are regularly launched, but only some of them have been evaluated in comparative studies.Aim. This study evaluated the clinical performance of two multiplex real-time PCR commercial kits for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis: the Bosphore STD Urethritis Mini Bundle Kit (BK; Anatolia Geneworks) and the Viasure Sexually Transmitted Disease Real-Time PCR Detection Kit (VK; CerTest BIOTEC).Methodology. A total of 240 clinical specimens were evaluated. The results were compared with those of the Cobas CT/NG and TV/MG kits (Roche Diagnostics), used as reference methods.Results. Positive agreement ranged between 83.3% and 87.8% for the detection of C. trachomatis, N. gonorrhoeae and T. vaginalis using validated specimen types. For M. genitalium detection, positive agreement was 83.0% for the BK and 68.1% for the VK, which missed 31.9% of M. genitalium-positive specimens. Negative agreement ranged between 98.4% and 100% across the targeted micro-organisms. Both kits were easy to use and compatible with several DNA extraction and PCR thermal cyclers. The VK also detected the genital commensal bacteria Ureaplasma spp. and Mycoplasma hominis, which should not be targeted in STI detection kits.Conclusion. Both kits are convenient methods and showed good performance for the detection of nonviral STIs, but users should be aware of a lower sensitivity of the VK for the detection of M. genitalium.