Rapid Point-of-Care Diagnostic Test for Chlamydia

描述（由申请人提供）： 该项目的目标是开发一种快速、高灵敏度和易于使用的基于聚合酶链反应（PCR）的检测系统，可用于医生办公室，使用IQuum的创新试管实验室（LiatTM）技术检测沙眼衣原体（CT）感染。 衣原体是美国最常报告的性传播疾病，是女性输卵管不孕的主要原因，也是男性不孕的重要原因。据估计，美国每年有超过400万新的衣原体病例。在美国，衣原体每年的估计成本超过24亿美元。当患者仍在医生办公室时，需要进行即时核酸检测以及时诊断衣原体，以协助医生开出适当的治疗处方。 在第一阶段，我们计划开发新型特异性TaqMan探针，可以将CT与其他细菌或变形菌区分开来，并在我们专有的试管实验室技术平台上开发15分钟内快速实时PCR检测CT。此外，我们将开发从尿液和一次性用品中分离核酸的检测方法，以促进样品制备。建议的方法将使我们能够在不到30分钟的时间内从尿液样本中进行CT检测，而无需离心或手工样品制备。在第二阶段，我们计划使用Liat管技术将样品制备和检测集成为一体，并使该检测可在护理点环境中部署。此外，我们亦计划采用多重方法检测沙眼和淋病奈瑟菌，后者是第二大最常呈报的性传播疾病。

DESCRIPTION (provided by applicant): The goal of this project is to develop a rapid, highly sensitive, and easy-to-use polymerase chain reaction (PCR)-based detection system, which can be used in a physician's office, for detecting Chlamydia trachomatis (CT) infection using IQuum's innovative Lab-in-a-tube (LiatTM) technology. Chlamydia is the most frequently reported sexually transmitted disease in the United States, the leading cause of tubal infertility in women, and an important cause of infertility in men. It is estimated that each year there are over 4 million new Chlamydia cases in the United States. The estimated annual cost of Chlamydia in the United States exceeded $2.4 billion annually. A point-of-care nucleic acid test is needed to promptly diagnose of Chlamydia while the patient is still present in physician's office in order to assist physician to prescribe the appropriate treatment. In Phase I, we propose to develop novel specific TaqMan probes which can differentiate CT from other bacteria or proteobacteria, and develop a rapid real-time PCR for CT detection within 15 minutes on our proprietary lab-in-a-tube technology platform. In addition, we will develop assays for nucleic acid isolation from urine and disposables to facilitate the sample preparation. The proposed approach will allow us to perform CT detection from urine sample to result in less than 30 minutes without the need of centrifugation or hand-on sample preparation. In Phase II, we plan to integrate the sample preparation and detection into one using Liat tube technology and make this assay deployable in the point-of-care setting. We will also plan to multiplex the detections of CT and Neisseria gonorrhoeae (NG), the second most frequently reported sexually transmitted disease.