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

描述（由申请方提供）：在第I阶段Xtransa/BioPool（原 Molecular Innovations，Inc.）证明了尿液为基础的 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释放 沙眼衣原体（CT）和淋病奈瑟菌（GC）核糖体RNA，捕获 Xtrana/Biopool的XtraBind固相微珠基质上，然后直接 使用基于核酸序列的扩增的等温扩增 （NASBA）。在NASBA之后，添加半抗原化的引物，使得扩增的DNA片段被扩增。 产品在芯吸后立即直接显现为蓝线 通过横向流动膜。固相捕集一体化，直接 等温扩增和可视侧流检测使能装置 平台，具有简单的协议，可在 仅使用用于仪器的加热块以降低的成本进行即时护理。 完成化学、器械设计、原型制作和制造，然后 临床验证研究将在II期进行。结束时 第11阶段，提取、扩增和检测化学过程在 原型将完成，其性能特点是利用尿液 标本 拟定商业应用： 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