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

该项目的目标是开发一种基于核酸的双重检测方法，用于检测沙眼衣原体(CT)和淋病奈瑟菌(NG)，用于医疗保健。该项目将由一个财团实施，该财团由真实世界(欧洲)诊断有限公司和剑桥大学诊断开发单位组成。联合体各方带来的专业知识涵盖了实施该项目所需的所有活动：产品开发；扩大规模；在医疗保健环境中为监管提交进行验证和临床试验。CT/NG双重测试基于一个名为Samba(基于简化扩增的分析)的简单核酸化学平台。将使用简单且非侵入性的样本，例如自行收集的阴道拭子或由FirstBurst®收集的尿液，FirstBurst®是一种独一无二的首次无效尿液收集设备，可从尿流中收集含有84%细菌的前3毫升尿液。这种高度稳定的试剂装在单位剂量的试剂盒中，使用专利的侧向流动装置可以直观地读取结果。这种测试可以由受过最低限度培训的人员在护理地点轻松进行，并可以在患者仍在诊所时向临床医生提供结果，从而实现即时治疗和有效的接触者追踪。

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.