All-in-one microfluidic nucleic acid diagnosis system for multiplex detection of sexually transmitted pathogens directly from genitourinary secretions.

Sexually transmitted infections are a serious public health concern worldwide, especially in young people. More than 30 pathogens can cause sexually transmitted diseases and co-infection often occurs. Therefore, the development of fast, low-cost and easy-to-use diagnostic screening methods is urgently needed for disease prevention and control. Herein, we established an all-in-one microfluidic nucleic acid diagnosis system, which could simultaneously detect Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma hominis and Ureaplasma urealyticum directly from genitourinary secretions with minimal manual manipulations. This system integrated nucleic acid extraction, amplification, and detection on a single microfluidic chip and could be automatically performed in an integrated detection device. This novel diagnosis tool showed good detection limits, stability (coefficient of variation <6%), specificity (no cross-reaction with 23 other pathogens for each target) and resistance to interference by other substances and the diagnostic efficacy was similar to that of PCR. The turnaround time was reduced to 50 min from sample to answer with automated testing steps. This novel diagnosis tool has the advantages of highly integrated, automated, sample-to-answer detection, and could thus replace the traditional method. This could significantly improve the prevention and control of sexually transmitted diseases.