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Point of care nucleic acid-based duplex test for detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoae (NG

用于检测沙眼衣原体 (CT) 和淋病奈瑟菌 (NG) 的护理点核酸双联检测

基本信息

批准号：
100842
负责人：
金额：
$ 178.44万
依托单位：
DIAGNOSTICS FOR THE REAL WORLD (EUROPE) LIMITED
依托单位国家：
英国
项目类别：
Collaborative R&D
财政年份：
2010
资助国家：
英国
起止时间：
2010 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=100842
关键词：
Point care nucleic acid based

项目摘要

The project objective is to develop a nucleic acid-based duplex test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) for point-of-care use. The project will be carried out by a consortium, composed of Diagnostics for the Real World (Europe) Ltd. and the Diagnostics Development Unit, University of Cambridge. The expertise brought by the consortium parties covers all activities required to conduct the project: product development; scale up; validation and clinical trials in health care settings for regulatory submission.The CT/NG duplex test is based on a simple nucleic acid chemistry platform called SAMBA (“Simplified AMplification Based Assay). Simple to collect and non-invasive samples will be used, such as self-collected vaginal swabs or urine collected by FirstBurst®, a unique and patented first-void urine collection device, which collects the first 3 ml of urine containing 84% of bacteria from a urine stream. The highly stable reagents are provided in unit-dose cartridges and the results can be visually read using a patented lateral flow device. The test can be easily carried out by minimally trained personnel at point of care settings and can provide results to clinicians while the patients are still at the clinic, thus allowing immediate treatment and efficient contact tracing.

该项目的目标是开发一种基于核酸的双重检测，用于检测沙眼衣原体 (CT) 和淋病奈瑟氏菌 (NG)，供床旁使用。该项目将由 Diagnostics for the Real World (Europe) Ltd. 和剑桥大学诊断开发部门组成的财团执行。联合体各方带来的专业知识涵盖了开展该项目所需的所有活动：产品开发；扩大规模； CT/NG 双重检测基于名为 SAMBA（“简化扩增检测”）的简单核酸化学平台。将使用易于收集且非侵入性的样本，例如自行收集的阴道拭子或由 FirstBurst® 收集的尿液，FirstBurst® 是一种独特且获得专利的首次排尿尿液收集装置，可收集前 3 毫升尿液尿液中含有 84% 的来自尿流的细菌。高度稳定的试剂以单位剂量盒的形式提供，并且可以使用获得专利的侧流装置直观地读取结果。该测试可由经过最低限度培训的人员在护理机构轻松进行，并且可以在患者仍在诊所时向临床医生提供结果，从而允许立即治疗和有效的接触者追踪。