DNA microarray for detection of eleven STIs

A new microarray based on state-of-the-art EUROArray technology provides parallel direct detection of eleven sexually transmitted infections (STIs) in one reaction, namely Chlamydia trachomatis, Neisseria gonorrhoea, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, Hemophilus ducreyi, Treponema pallidum, Trichomonas vaginalis and herpes simplex viruses 1 and 2. STIs are often asymptomatic, but if left untreated they can lead to serious sequelae, for example infertility, fetal damage during pregnancy, and severe postnatal infections in newborns. PCR-based detection allows identification of both manifest and silent infections, and is thus suitable for diagnosis of symptomatic patients as well as for general screening. It offers a huge time advantage over culture and is especially useful for detecting sexually transmitted pathogens that are difficult or impossible to culture, e.g. C. trachomatis, Mycoplasma, Ureaplasma, T. pallidum. Due to amplification of the pathogen DNA, infections with a reduced pathogen number can also be reliably detected. A broad screening of STI pathogens is particularly important in asymptomatic or clinically ambiguous cases and for detecting multiple infections, which are often missed during single parameter testing. The EUROArray procedure is extremely easy to perform and does not require any in-depth molecular biology knowledge. Specific sections of pathogen DNA from patient samples are amplified and fluorescently labelled in one multiplex polymerase chain reaction (PCR). The PCR products are then hybridized to BIOCHIP microarray slides containing immobilized complementary DNA probes and detected by their fluorescence signals. The evaluation, interpretation and archiving of results is fully automated by EUROArrayScan software, and is thus highly standardized and objective. Meticulously designed primers, ready-to-use PCR components and integrated controls all contribute to the reliability of the analysis. The entire EUROArray process from sample to report release is IVD-validated and CE-registered. A human papillomavirus (HPV) microarray based on the same technology, which detects all thirty relevant high- and low-risk HPV subtypes, can be performed in parallel if required.