URINE-BASED POINT-OF-CARE CHLAMYDIA/GONORRHOEA TEST

描述(由申请人提供)：在第一阶段Xtra/BioPool(以前 分子创新公司)论证了以尿液为基础的 可能在临床上进行的诊断测试，以检测 生殖器衣原体和淋病。该战略涉及发布 沙眼衣原体(CT)和淋球菌(GC)核糖体RNA，捕获 涂到Xtra/Biopool的XtraBind固相微珠基质上，然后直接 基于核酸序列的同源异硫氰酸酶扩增 (NASBA)。在NASBA之后，加入半抗原引物，使扩增出的 产品直接显示为一条蓝线，紧跟在灯芯之后 通过侧向流动的膜。集成了固相捕获、直接 等温放大和可视侧向流动检测使设备 具有与核酸测试兼容的简单协议的平台 仅使用仪器的热块即可降低成本的看护点。 完成化学、设备设计、原型和制造，然后 临床验证研究将在第二阶段进行。在 阶段11，提取、扩增和检测化学在 将完成样机并利用尿液对其性能进行表征 标本。 建议的商业应用： 不可用

DESCRIPTION (provided by applicant): During phase I Xtrana/BioPool (formerly Molecular Innovations, Inc.) demonstrated the feasibility of a urine-based diagnostic test that potentially could be performed in the clinic to detect both genital chlamydia and gonorrhea. The strategy involves the release of Chlamydia trachomatis (CT) and Neisseria gonorrhoea (GC) ribosomal RNA, capture onto Xtrana/Biopool's XtraBind solid phase bead matrix, followed by direct isothennal amplification using Nucleic Acid Sequence Based Amplification (NASBA). After NASBA, haptenized primers are added so that the amplified product is directly visualized as a blue line immediately following wicking through a lateral flow membrane. The integration of solid phase capture, direct isothermal amplification, and visual lateral flow detection enables device platforms with simple protocols compatible with nucleic acid testing at the point-of-care at reduced cost using only a heat block for instrumentation. Finalized chemistry, device design, prototyping, and manufacturing, followed by clinical validation studies will be performed in phase II. At the conclusion of phase 11, extraction, amplification, and detection chemistry run within the prototype will be completed and its performance characterized utilizing urine specimens. PROPOSED COMMERCIAL APPLICATION: Not Available