CE Marked STI Panel Detects and Differentiates in One Single Reaction
ELITechGroup Molecular Diagnostics now have CE-IVD marking for their STI ELITe MGB® Panel: a real-time PCR multiplex assay for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium, three major bacteria involved in sexually transmitted infections.
In combination with the ELITe InGenius system, the STI ELITe MGB Panel is the first CE-IVD triplex assay available with a sample-to-result solution to simultaneously detect and differentiate in one single reaction C. trachomatis, N. gonorrhoeae and M. 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 C. trachomatis, N. gonorrhoeae and M. genitalium.
Recently identified, M. genitalium is highly prevalent in the general population, and shares similar symptoms with C. trachomatis and N. gonorrhoeae, but their specific antibiotic treatments are not fully efficient enough to cure M. genitalium and can generate antibiotic resistance strains. Co-detection of M. genitalium, along with C. trachomatis and N. 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.
Date Published: 13th June 2017
Source article link: ELITechGroup