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

描述（由申请人提供）：阴道炎/阴道病是女性就医的最常见疾病之一。约有1 000万次办公室就诊归因于阴道炎，每年的医疗保健费用超过5亿美元。超过90%的阴道炎可归因于三种类型的阴道炎：细菌性阴道病（BV）、念珠菌性阴道炎（CV）和滴虫性阴道炎（TV）。在过去，我们已经开发了一个床旁（POC）BV测试使用均相生物化学发光分析（HBA）为基础的技术。HBA技术可实现简单（一步测定）、灵敏和快速（<10分钟）的检测。使用简单且廉价的手持式探测器的测试。在本申请中，我们建议开发两种额外的阴道病POC测试，以便使用此样本测试覆盖大多数阴道病病例。在本提案中，我们将测试这些基于HBA的检测试剂盒的两种原型是否可以与BV检测试剂盒相同的方式在POC环境中分别用于CV和TV的灵敏度和特异性检测。该提案包含以下四个具体目标：1.用于CV和TV检测的两种底物的合成和纯化测定优化和检测试剂盒制剂3.分析性能评价4.拟议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记物是否适用于CV和TV的快速准确诊断。拟议研究的成功结果将使FDA批准的CV和TV诊断测试的开发成为可能，这将改善美国和国外，特别是资源贫乏地区的妇女保健。 公共卫生相关性：妇女经常因阴道炎/阴道病寻求医疗护理，每年约有1 000万人次就诊，医疗保健费用超过5亿美元。超过90%的阴道炎是由三种特定类型的阴道炎引起的，即，细菌性阴道病（BV）、念珠菌阴道炎（CV）和毛癣菌阴道炎（TV）。如果能够开发出易于使用和准确的检测方法来快速检测这3种疾病，将节省医疗费用，并改善妇女的健康，因为这些疾病可以很容易地治疗。到目前为止，我们已经开发了BV测试。在本申请中，我们建议使用相同的技术开发CV和TV测试。拟议研究的成功结果-评估一种新的检测技术和两种新的快速准确诊断滴虫病和滴虫病的标志物-将显着改善这两种常见类型阴道炎的诊断，每年影响数亿妇女，从而改善美国和全球妇女的医疗保健。

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.