Detection of sexually transmitted disease –causing pathogens from direct clinical specimens with the multiplex PCR-based STD Direct Flow Chip Kit

AbstractPathogens causing sexually transmitted diseases (STDs) include viruses, bacteria, and parasites. The ability to rapidly and efficiently detect these pathogens in a single reaction still remains a health challenge. The aim of this study was to evaluate the clinical reliability and accuracy of the STD Direct Flow Chip Kit (Vitro, IVD-EC approved), which can simultaneously detect up to 9 different species of STD pathogens at once. This kit enables direct analysis —direct-PCR—of clinical specimens (urine, semen, endocervical, urethral, nasopharyngeal, and perianal swabs) without DNA purification for the following pathogens:Chlamydia trachomatis (serovars A-K and L1-L3),Haemophilus ducreyi, Herpes Simplex Virus (Types I and II),Mycoplasma genitalium,Mycoplasma hominis,Neisseria gonorrhoeae,Treponema pallidum,Trichomonas vaginalis, andUreaplasma. The Anyplex â„¢ II STI-7 Detection Kit (Seegene, IVD-EC) was used as the reference’s method. Existing discordances were resolved using either a third molecular assay or DNA sequencing. Clinical performance was evaluated at two different stages: (i) from purified DNA of three hundred and fifty-eight clinical s pecimens with a diagnostic sensitivity (SE) and specificity (SP) of 99.4% and 100%, respectively, and an agreement of 99% (kappa index,κ = 0.97) with the reference’s method and; (ii) by direct-PCR from six hundred and thirty-three specimens rendering SE, SP, and agreement values of 98.4%, 99.9%, and 98.0% (κ =â...
Source: European Journal of Clinical Microbiology and Infectious Diseases - Category: Microbiology Source Type: research