URINE-BASED POINT-OF-CARE CHLAMYDIA/GONORRHOEA TEST
URINE-BASED POINT-OF-CARE CHLAMYDIA/GONORRHOEA TEST
批准号:
6405704
负责人:
JOHN Charles GERDES
金额:
$37.51万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-09-30 至 2003-09-29
中文摘要
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
英文摘要
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
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Point-of-care Diagnosis and Surveillance of Known and Emerging Influenza Viruses
-
批准号:8820237
-
项目类别:
-
资助金额:$108.37万
-
财政年份:2014
-
负责人:JOHN Charles GERDES
-
依托单位:
Point-of-care Diagnosis and Surveillance of Known and Emerging Influenza Viruses
-
批准号:8690899
-
项目类别:
-
资助金额:$118.66万
-
财政年份:2014
-
负责人:JOHN Charles GERDES
-
依托单位:
POC molecular method for detection of known and emerging respiratory viruses.
-
批准号:7743639
-
项目类别:
-
资助金额:$44.41万
-
财政年份:2009
-
负责人:JOHN Charles GERDES
-
依托单位:
Rapid point of care HIV PCR diagnostic device
-
批准号:7495581
-
项目类别:
-
资助金额:$9.94万
-
财政年份:2008
-
负责人:JOHN Charles GERDES
-
依托单位:
Microcytometer enrichment and detection of colon cancer*
-
批准号:7021339
-
项目类别:
-
资助金额:$10.0万
-
财政年份:2006
-
负责人:JOHN Charles GERDES
-
依托单位:
URINE-BASED POINT-OF-CARE CHLAMYDIA/GONORRHOEA TEST
-
批准号:6529951
-
项目类别:
-
资助金额:$35.29万
-
财政年份:1999
-
负责人:JOHN Charles GERDES
-
依托单位:
QUANTITATION AND ARCHIVING OF GENE EXPRESSION
-
批准号:6319186
-
项目类别:
-
资助金额:$7.12万
-
财政年份:1999
-
负责人:JOHN Charles GERDES
-
依托单位:
QUANTITATION AND ARCHIVING OF GENE EXPRESSION
-
批准号:2869468
-
项目类别:
-
资助金额:$12.88万
-
财政年份:1999
-
负责人:JOHN Charles GERDES
-
依托单位:
URINE BASED POINT OF CARE CHLAMYDIA / GC DIAGNOSTIC TEST
-
批准号:6015721
-
项目类别:
-
资助金额:$10.0万
-
财政年份:1999
-
负责人:JOHN Charles GERDES
-
依托单位:
海外基金