B-248 Rapid PCR Method for Sexually Transmitted Infection (STI) Multiplex Testing Based on Novel Microfluidic Chip

Abstract Background qPCR is being widely used for STI (Sexually Transmitted Infection) testing as the most sensitive and accurate diagnostic method. Genesystem developed a novel qPCR-based diagnostic platform, called Genoplex chip, which enables the simultaneous detection of multiple sexually transmitted pathogens with a single test. Genoplex chip realized high multiplex detection (up to 14 pathogens by a single pipetting), making it easy and fast to process more targets than conventional qPCR. In this study, Genoplex chip was used for diagnosing sexually transmitted infection(STI) to verify the usefulness in diagnostics. Methods Genoplex chip is a flat-shaped microfluidic chip where target-specific primers and probes are prelabeled free from contamination. This chip has 1 well for negative control and 9 connected wells for target detection. By a single pipetting into the inlet hole, samples are loaded and spread into every well of this microfluidic chip since all the wells are connected to each other. We completed performance validation of this new chip with STI diagnosis. Primers and probes for identifying STI pathogens are prelabeled on the inner surface of the Genoplex chip. We can detect and identify 12 major pathogens of STI, which are Chlamydia trachomatis (CT), Ureaplasma urealyticum (UU), Mycoplasma hominis (MH), Mycoplasma genitalium (MG), Neisseria gonorrhoeae (NG), Trichomanas vaginalis (TV), Ureaplasma parvum (UP), Gardnerella vaginalis (GV), Candida albicans (CA), Treponema pallidum (TP), Herpes simplex virus type 1 (HSV1) and Herpes simplex virus type 2 (HSV2) by using these probes. Amplification of the target genes was performed by Genechecker UF-300 PCR System. Results We estimated 50 copies of 12 STI pathogens by qPCR process in 40 min. We also confirmed that there was no contamination and no interference in 12 targets. Conclusion With Genoplex chip, various targets can be quantitatively detected in one sample and more accurate results can be provided in efficient way. This novel system gives an opportunity to overcome the limitations of current molecular diagnostics by innovative multiplex detection technology. Therefore, it is expected that the Genoplex chip system will attract attention in the molecular diagnostics market.