Microfluidic system for point of care diagnosis of GBS

描述（由申请人提供）： 这个多学科的合作研究项目之间的研究人员拉瓦尔大学和诊断（I.D.I.）Inc.位于魁北克市和位于尔湾的加州大学的研究所，旨在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具有一次性护理点手持装置，其组合核酸提取、浓缩、纯化、扩增和检测以特异性和灵敏性地检测靶序列。这种设备将允许诊断和治疗的整合以及个性化医疗的发展。目前可用或正在开发的基于核酸检测的技术是缓慢、复杂、不够灵敏且昂贵的。本申请的目的是将我们在微流体和聚合物换能器方面的专业知识结合起来，以设计和构建不需要预先核酸扩增的未来诊断设备。将开发一种快速分子检测方法，用于特异性和敏感性检测孕妇分娩时B族链球菌（GBS）定植。GBS是新生儿发病和死亡的重要原因。将开发一种便携式微全分析系统（mu/TAS），该系统使用光盘支持上的微流体平台。它将是紧凑的，电池供电，其简单的使用和低成本将使其适合在现场，诊所或医院进行测试。该新型诊断平台将针对阴道/肛门标本中的GBS检测进行优化。它将通过一项临床前研究进行验证，该研究将与几家医院合作，从同意分娩的孕妇中获得样本。这种新的技术平台应该为GBS提供前所未有的即时诊断工具，从而更好地控制抗生素的使用，并减少耐药微生物的传播。此外，这项技术还可用于检测其他传染病制剂，包括生物战剂。

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.