Development of Rapid Point-of-Care Tests for Women's Health

描述（由申请人提供）：阴道炎/阴道病是女性求医最常见的病症之一。大约有1000万的诊所就诊归因于阴道炎，每年的医疗费用超过5亿美元。超过90%的阴道炎可归因于三种类型的阴道炎：细菌性阴道炎（BV），念珠菌阴道炎（CV）和滴虫阴道炎（TV）。在过去，我们已经开发了一种使用均匀生物化学发光测定（HBA）技术的护理点（POC） BV测试。HBA技术可实现简单（一步测定）、敏感和快速（<10分钟）的测试，使用简单且廉价的手持检测器。在此申请中，我们建议开发两个额外的阴道病POC测试，以便它将覆盖使用此样本测试的大多数阴道病病例。在本提案中，我们将测试这两种基于hba的检测方法的原型是否可以与BV检测方法相同，分别用于POC环境下的CV和TV的敏感和特异性检测。该建议载有以下四个具体目标：CV和TV两种检测底物的合成与纯化测定方法优化及试剂盒配制分析性能评价拟开展的研究将证明检测技术（HBA技术）和我们在这项新开发中采用的两种新标志物是否适用于快速准确诊断CV和TV。拟议研究的成功结果将使FDA批准的CV和TV诊断测试得以发展，这将改善美国和国外，特别是资源贫乏地区的妇女保健。

DESCRIPTION (provided by applicant): Vaginitis/vaginosis is one of the most common conditions for women to seek medical care. Some 10 million office visits are attributed to vaginitis, which accounts for a health care cost of over $500 million each year. Over 90% of vaginitis can be attributed to three types of vaginitis: bacterial vaginosis (BV), Candida vaginitis (CV) and Trichomoniasis vaginitis (TV). In the past, we have developed a point-of-care (POC) BV test using a Homogeneous Biochemiluminescence Assay (HBA)-based technology. The HBA technology enables a simple (one-step assay), sensitive, and rapid (<10 min.) test that uses a simple and inexpensive hand-held detector. In this application, we propose to develop two additional vaginosis POC tests so it will cover testing majority of the vaginosis cases using this samples tests. In this proposal, we will test whether two prototypes of these HBA-based assays can be used the same way as the BV test for sensitive and specific detection of CV and TV, respective, in POC settings. The proposal contains the following four specific aims: 1. Synthesis and Purification of Two Substrates for CV and TV Detections 2. Assay Optimization and Test Kit Formulation 3. Evaluation of Analytical Performance 4. Clinical Assessment of the Proposed Tests The proposed studies will demonstrate whether the detection technology (the HBA technology) and the two novel markers we adapted in this new development are appropriate for rapid and accurate diagnosis of CV and TV. Successful outcomes from the proposed studies will enable the development of FDA approved CV and TV diagnostic tests that would improve women's health care in U.S. and abroad, particularly in resources poor regions. PUBLIC HEALTH RELEVANCE: Women often seek medical care due to vaginitis/vaginosis, which accounts about 10 million office visits with a health care cost of over $500 million each year. Over 90% of those vaginitis are caused by three specific types of vaginitis, i.e., bacterial vaginosis (BV), Candida vaginitis (CV) and Trichomoniasis vaginitis (TV). If easy-to- use and accurate tests can be developed to allow rapid detections of these 3 conditions, it would save medical care cost and improve women's health as these conditions can be readily treated. So far, we have already developed the BV test. In this application, we propose to develop CV and TV tests using the same technology. Successful outcomes from the proposed studies - evaluation of a novel detection technology and two novel markers for rapid and accurate diagnosis of Candidiasis and Trichomoniasis - will markedly improve the diagnosis of these two common types of vaginitis, which affect hundreds of millions of women each year, thereby improving the women's health care here in U.S. and globally.