DESCRIPTION (provided by applicant): This multidisciplinary collaborative research project between investigators of the University of Laval and Infectio Diagnostic (I.D.I.) Inc. in Quebec City and the University of California at Irvine, aims at developing novel, flexible, and rapid diagnostic devices based on nucleic acid testing. The pinnacle in molecular diagnostics is to have a disposable point-of-care handheld device combining nucleic acid extraction, concentration, purification, amplification, and detection to specifically and sensitively detect the target sequences. Such devices would allow the integration of diagnosis and therapy as well as development of personalized medicine. Technologies based on nucleic acid detection that are currently available or under development are slow, complicated, insufficiently sensitive, and expensive. The objective of this application is to merge our expertise in microfluidics and polymeric transducers to design and construct diagnostic devices of the future which do not require prior nucleic acid amplification. A rapid molecular assay for the specific and sensitive detection of Group B Streptococci (GBS) colonization in pregnant women at delivery will be developed. GBS are an important cause of neonatal morbidity and mortality. A portable micro total analysis system (mu/TAS) using a microfluidic platform on a compact disc support will be developed. It will be compact, battery operated and its simple utilization and low cost will make it suitable for testing at a field site, in a clinic, or in hospitals. This novel diagnostic platform will be optimized for GBS detection from vaginal/anal specimens. It will be validated by a pre-clinical study with samples obtained from consenting pregnant women at delivery that will be performed in collaboration with several hospitals. This new technological platform should provide unprecedented point-of-care diagnostic tools for GBS, permitting a better control of antibiotic use, and reducing dissemination of resistant microbes. Moreover, this technology could also be applicable to the detection of other infectious disease agents including biological warfare agents.