Rapid Point-of-Care Diagnostic Test for Chlamydia

衣原体快速护理诊断测试

• 批准号: 6834502
• 负责人: ZIHUA WANG
• 金额: $ 14.83万
• 依托单位: IQUUM, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-15 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6834502
• 关键词: Chlamydia trachomatis; alkyltransferase; biotechnology; chlamydial disease; clinical research; communicable disease diagnosis; computer assisted diagnosis; diagnosis design /evaluation; human subject; nucleic acid probes; nucleic acid quantitation /detection; nucleic acid sequence; nucleotidyltransferase; polymerase chain reaction; rapid diagnosis; urine

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.

描述（由申请人提供）：该项目的目标是开发一种快速、高灵敏度且易于使用的基于聚合酶链反应 (PCR) 的检测系统，可在医生办公室使用，利用 IQuum 的创新管内实验室 (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，美国每年新增衣原体病例超过 400 万例。据估计，美国每年因衣原体造成的损失超过 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迅速诊断衣原体，以协助医生开出适当的治疗方案。 在第一阶段，我们建议开发新型特异性 TaqMan 探针，可以将 CT 与其他细菌或变形菌区分开来，并在我们专有的管中实验室技术平台上开发用于 15 分钟内 CT 检测的快速实时 PCR。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，以方便样品制备。所提出的方法将使我们能够在 30 分钟内对尿液样本进行 CT 检测，无需离心或手动样本制备。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到一起，并使该检测可在现场护理环境中部署。我们还将计划对 CT 和淋病奈瑟菌 (NG)（第二常见的性传播疾病）进行多重检测。