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

基于尿液的护理点衣原体/淋病检测

• 批准号: 6529951
• 负责人: JOHN Charles GERDES
• 金额: $ 35.29万
• 依托单位: XTRANA, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2004-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6529951
• 关键词: Chlamydia trachomatis; Neisseria gonorrhoeae; bacterial DNA; biomedical equipment development; chlamydial disease; clinical chemistry; communicable disease diagnosis; diagnosis design /evaluation; gonorrhea; human subject; noninvasive diagnosis; urinalysis

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

描述（由申请人提供）：在第一阶段Xtrana/Biopool期间（以前 Molecular Innovations，Inc。）证明了基于尿液的可行性 可能在诊所进行的诊断测试检测 生殖器衣原体和淋病。该策略涉及发布 衣原体沙眼（CT）和淋病奈瑟氏菌（GC）核糖体RNA，捕获 进入Xtrana/Biopool的Xtrabind固相珠矩阵，然后直接 使用基于核酸序列的放大的等hunnal扩增 （NASBA）。 NASBA之后，添加了触发底漆，以便放大 wicking后立即将产品直接视为蓝线 通过侧向流膜。固相捕获的整合，直接 等温度放大，视觉横向流动检测启用设备 具有与核酸测试兼容的简单方案的平台 仅使用仪器加热块以降低成本的降低成本。 最终化学，设备设计，原型制造和制造，然后是 临床验证研究将在第二阶段进行。结束 第11阶段，提取，扩增和检测化学在该化学内运行 原型将完成，其性能是利用尿液的特征 标本。 拟议的商业应用： 无法使用