Simple and Inexpensive Diagnostic Tools for Yeast Infections

描述（由申请人提供）：酵母菌感染（念珠菌阴道炎）是世界范围内育龄妇女非常常见的疾病。CV的症状包括阴道分泌物、瘙痒和烧灼感;虽然不危及生命，但对患者来说肯定不是小事，可能会影响生活质量，每年给美国医疗保健系统带来10亿美元的负担。如果有一种便宜且易于使用的酵母菌感染诊断方法，那么消费者可以避免不必要的治疗（和成本），并且仍然有症状但没有念珠菌阴道炎的女性可以寻求医生进行更适当的治疗。门诊医生也将受益于快速检测酵母菌感染，这将减少不正确的诊断，并提供更准确的治疗方案。第一阶段项目的长期目标是开发一种快速简单的酵母感染消费者诊断方法。特别是基于高通量筛选，我们已经确定了7个酵母诊断的潜在靶标，将使用临床阴道拭子样本进行检测。一旦我们使用生物化学方法改进并选择了最佳诊断靶点，我们将把这种实验室检测转换为家庭妊娠样快速检测形式，然后用临床样本重新检测，以描述检测的灵敏度和特异性。本项目采用的方法包括：1）将酶靶点与亲和标签结合的蛋白质生物化学; 2）生殖道感染的临床微生物学和检测方法开发，以测试潜在的诊断靶点并将活性与疾病相关联，3）微流体和侧流专业知识，将工作台化学转化为基于膜的系统，以及4）在第二阶段的机械设计和工程中，将组件纳入独立的护理点快速（5分钟）诊断。公共卫生相关性：酵母菌感染是一种非常常见的疾病。对公共卫生的好处是酵母菌感染快速诊断产品的商业化，这将使妇女能够可靠地自我治疗或寻求医生，如果它不是酵母菌感染。

DESCRIPTION (provided by applicant): Yeast infections (Candida vaginitis) are a very common worldwide ailment in women of reproductive age. The symptoms of CV include vaginal discharge, itching, and burning; although not life threatening they are certainly not trivial to the patient and can impact the quality of life with a burden on the US healthcare system of $1 billion per year. If there was an inexpensive and easy to use diagnostic for yeast infections, then consumers could avoid the unnecessary therapy (and cost) and women who still have the symptoms but do not have Candida vaginitis could then seek a doctor for more appropriate therapy. Clinicians in an outpatient setting will also benefit from having a rapid test for yeast infections that will reduce improper diagnosis and provide more accurate treatment regiment. The long term goal and objective of this phase I project is to develop a rapid and simple consumer diagnostic for yeast infections. Specifically based on a high throughput screen, we have identified 7 potential targets for a yeast diagnostic that will be tested with clinical vaginal swab samples. Once we have refined and chosen the best diagnostic target using biochemical approaches we will convert this bench assay into a home pregnancy-like rapid test format and then retest it with clinical sample to delineate the sensitivity and specificity of the test. The methods employed in this project include 1)protein biochemistry for conjugating the enzyme target to affinity tags 2)clinical microbiology of genital tract infections and assay development to test the potential diagnostic targets and correlate the activities with disease, 3) micro-fluidics and lateral flow expertise to convert the bench chemistry into a membrane based system and 4) in phase II mechanical design and engineering to incorporate the components into a stand alone point of care rapid (5 minutes) diagnostic. PUBLIC HEALTH RELEVANCE: Yeast infections are a very common ailment. The benefit to the public health is the commercialization of a rapid diagnostic product for yeast infections that will allow women to reliably self-treat or seek a doctor if it is something other than a yeast infection.