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

描述(申请人提供)：阴道炎/阴道病是女性求医最常见的病症之一。每年约有1000万人次的就诊归因于阴道炎，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)、念珠菌性阴道炎(CV)和滴虫性阴道炎(TV)。在过去，我们使用均相生物化学发光分析(HBA)技术开发了一种护理点(POC)BV测试。HBA技术实现了简单(一步)、灵敏和快速(&lt；10分钟)。使用简单且廉价的手持式检测器的测试。在这项应用中，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，我们将测试这些基于HBA的检测的两个原型是否可以使用与BV测试相同的方式，分别在POC环境中对CV和TV进行敏感和特异的检测。该建议包括以下四个具体目标：1.合成和纯化两种用于CV和TV检测的底物2.测试优化和测试试剂盒配方3.分析性能评估4.建议的测试的临床评估建议的研究将证明检测技术(HBA技术)和我们在这一新发展中采用的两种新标记物是否适合快速准确地诊断CV和TV。拟议研究的成功结果将有助于开发FDA批准的CV和TV诊断测试，这些测试将改善美国和国外的妇女保健，特别是在资源匮乏的地区。 与公共卫生相关：妇女经常因阴道炎/阴道病而寻求医疗护理，每年约有1000万人次就诊，医疗保健费用超过5亿美元。超过90%的阴道炎是由细菌性阴道病(BV)、念珠菌性阴道炎(CV)和滴虫性阴道炎(TV)三种特殊类型的阴道炎引起的。如果能开发出易于使用和准确的检测方法来快速检测这三种疾病，将节省医疗费用并改善妇女的健康，因为这些疾病很容易得到治疗。到目前为止，我们已经开发了BV测试。在此应用程序中，我们建议使用相同的技术开发CV和TV测试。拟议研究的成功成果--评估一种新的检测技术和两种快速准确诊断念珠菌病和滴虫病的新标记物--将显著改善这两种常见类型阴道炎的诊断，这两种疾病每年影响数亿女性，从而改善美国和全球女性的医疗保健。

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.