iKITT Innovative Keratitis Identity Type Test

项目摘要 由感染性微生物（细菌、真菌、阿米巴和病毒）或眼外伤引起的溃疡性角膜炎 或化学品暴露是一个重要的医学问题。每年，角膜炎占93万 医生办公室和门诊诊所以及58 000次急诊就诊，直接产生1.75亿美元 医疗保健支出和超过250，000小时的临床医生时间消耗。疾病表现 包括角膜溃疡、水肿和/或导致角膜变薄和穿孔的前房积脓， 眼内压和进展为眼内炎。因此，临床结果可能很严重， 包括部分或完全丧失视力，需要进行穿透性角膜移植术、角膜移植术、眼球摘除术 和内脏切除目前的临床实践包括眼科检查，以确认细菌，真菌或阿米巴 排除病毒性、化学性和外伤性角膜炎。不幸的是，这是极其困难的，如果没有 不可能，区分细菌，真菌或阿米巴角膜炎，简单地根据眼睛检查。 因此，收集角膜刮片样品并送至临床实验室进行基于培养的鉴定。 致病微生物同时，疾病进展的严重程度和视力损害的真实的风险 迫使临床医生凭经验开出广谱疗法的混合物，直到培养结果出来， 几天后才可以使用，此时对处方进行调整。该电流 视觉诊断和经验处方治疗的临床范例鼓励不必要地使用 治疗，延迟疾病的解决，增加治疗成本，最重要的是， 出现治疗抗性角膜炎致病菌株的风险。Lynntech公司联同 密西西比大学医学中心建议开发一种创新、快速、廉价和紧凑的 一种称为iKITT的测试，可有效诊断微生物性角膜炎，并提供病原体身份和类型 在护理点向临床医生提供信息。该信息将使临床医生能够释放电流 经验性治疗处方范例，并规定一个集中的单一疗法，有很高的可能性， 杀死致病微生物因此，iKITT有可能通过改变 目前的临床范例，以更好地诊断和治疗微生物角膜炎。在第一阶段SBIR工作中，我们的 具体目标是（1）组装iKITT并证明对四种常见角膜炎的选择性鉴别 （2）优化iKITT对临床相关范围内这些靶点的特异性和灵敏度， (3)通过非干预性临床研究初步证明iKITT的潜在临床效用。的 这些具体目标的成功实现应表明这一创新性新技术的充分可行性。 微生物角膜炎的诊断方法，并将使更全面的技术发展， 商业化推进了未来的后续第二阶段的努力。iKITT的最终商业可用性是 可能对患有微生物角膜炎的患者群体维持高度积极的临床影响。

PROJECT SUMMARY Ulcerative keratitis caused by infectious microbes (bacteria, fungi, amoebae and viruses) or due to eye trauma or chemical exposure is a medical problem of significant concern. Annually, keratitis accounts for 930,000 Doctor’s office and outpatient clinic and 58,000 emergency department visits, resulting in $175 million in direct healthcare expenditures and consumption of over 250,000 hours of clinician time. Disease manifestation includes corneal ulcer, edema and/or hypopyon leading to corneal thinning and perforation, elevated intraocular pressure and progression to endophthalmitis. Consequently, clinical outcomes could be severe, including partial or complete loss of vision, necessity for penetrating keratoplasty, corneal grafts, enucleation and evisceration. The current clinical practice involves an eye exam to confirm bacterial, fungal or amoebic keratitis and rule out viral, chemical and trauma induced keratitis. Unfortunately, it is extremely difficult, if not impossible, to distinguish between bacterial, fungal or amoebic keratitis, simply based on the eye exam. Therefore, a corneal scrape sample is collected and sent to the clinical lab for culture based identification of the causative microbe. Meanwhile, the severity of disease progression and the real risk of vision impairment force the clinician to empirically prescribe a cocktail of broad spectrum therapeutics until culture results become available several days later, at which time adjustments to the prescription are made. This current clinical paradigm of visually diagnosing and empirically prescribing therapy encourages the unnecessary use of therapeutics, delays disease resolution, increases the cost of treatment, and most importantly, increases the risk of emergence of therapeutic resistant keratitis causative strains. Lynntech, Inc. in collaboration with the University of Mississippi Medical Center proposes to develop an innovative, rapid, inexpensive and compact test, termed iKITT, to effectively diagnose microbial keratitis and provide causative identity and type information to the clinician at the point-of-care. This information will enable the clinician to shed the current empirical therapeutic prescription paradigm and prescribe a focused monotherapy that has a high likelihood of killing the causative microbe. Thus, iKITT has the potential to sustain major clinical impact by changing the current clinical paradigm to better diagnose and treat microbial keratitis. During this Phase I SBIR effort, our specific aims are to (1) assemble iKITT and demonstrate selective identification of four common keratitis causatives, (2) optimize specificity and sensitivity of iKITT to these targets in the clinically relevant range and (3) preliminarily demonstrate potential clinical utility of iKITT via a non-interventional clinical study. The successful completion of these specific aims should demonstrate ample feasibility of this innovative new microbial keratitis diagnosis approach, and will enable more comprehensive technology development and commercialization thrusts in a future follow-on Phase II effort. The eventual commercial availability of iKITT is likely to sustain high positive clinical impact for the patient populace suffering from microbial keratitis.