Microfluidic system for point of care diagnosis of GBS

描述(由申请人提供)： 这是拉瓦尔大学研究人员和传染病诊断(I.D.I.)研究人员之间的一个多学科合作研究项目。公司与加州大学欧文分校合作，致力于开发基于核酸检测的新型、灵活和快速的诊断设备。分子诊断学的巅峰是拥有一种一次性手持式设备，它结合了核酸提取、浓缩、纯化、扩增和检测，以特异和灵敏地检测目标序列。这样的设备将允许诊断和治疗的整合以及个性化医学的开发。目前可用的或正在开发的基于核酸检测的技术缓慢、复杂、不够灵敏和昂贵。这项应用的目标是融合我们在微流体和聚合物换能器方面的专业知识，设计和制造未来不需要事先进行核酸扩增的诊断设备。建立一种快速、灵敏、特异的检测孕妇分娩时B组链球菌(GBS)定植的分子检测方法。GBS是新生儿发病率和死亡率的重要原因。将开发一种便携式微量全分析系统(MU/TAS)，该系统使用光盘支架上的微流控平台。它将是紧凑型的，电池供电，其简单的使用和低成本将使其适合在野外现场、诊所或医院进行测试。这一新的诊断平台将优化为从阴道/肛门样本中检测GBS。它将通过一项临床前研究进行验证，该研究从分娩时同意的孕妇那里获得样本，将与几家医院合作进行。这一新的技术平台应该为GBS提供前所未有的医疗保健诊断工具，允许更好地控制抗生素的使用，并减少耐药微生物的传播。此外，该技术还可应用于包括生物战剂在内的其他传染病病原体的检测。

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.