STI multiplex assay panel
ELITechGroup Molecular Diagnostics announces the CE-IVD marking of the STI ELITe MGB Panel: a multiplex assay for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG), three major bacteria involved in sexually transmitted infections. STIs are a global burden with more than 1 million infections acquired every day worldwide. Accurate and specific detection is important to reduce transmission and complications. In combination with the ELITe InGenius system, the STI ELITe MGB Panel makes it possible to simultaneously detect and differentiate in one single reaction Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium. Patient samples can be directly loaded into the system, which automatically performs all the steps of molecular diagnostics from extraction to result interpretation with minimal hands-on time. The clinical study has demonstrated excellent performance: respectively 96.4%, 100% and 100% diagnostic sensitivity and 100%, 98.4% and 98.4% specificity with C. trachomatis, N. gonorrhoeae and M. genitalium. STI ELITe MGB Panel is the 22nd CE-IVD assay of ELITe InGenius’ menu and the first one intended to diagnose sexually transmitted infections. Recently identified, M. genitalium is highly prevalent in the general population, and share similar symptoms with C. trachomatis and N. gonorrhoeae, but their specific antibiotic treatments are not fully efficient to cure M. genitalium and generate antibiotics resistance strains. Co-detection of Mycoplasma genitalium, along with Chlamydia trachomatis, Neisseria gonorrhoeae improves the efficiency of STI diagnosis and patient management. ELITe InGenius offers a unique menu with quantitative and qualitative assays for transplant pathogen monitoring, healthcare associated infections, respiratory infections, meningitis, sexually transmitted infections, and the testing of coagulation factors.
