SBIR Phase II: Absolute protein quantitation in in vitro diagnostics for gut inflammation

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响是推进临床方法，解决广泛的生理变化是年龄和种族依赖性。在过去的几十年里，人们广泛宣传的是缺乏早产儿疾病的医疗保健解决方案，早产儿的母亲在社会经济上存在严重的不平等。举例来说，坏死性小肠结肠炎（NEC）是早产儿常见且往往致命的胃肠道或肠道急症，对非裔美国婴儿的影响不成比例。这种疾病不仅使医生和护士困惑了200年，而且由于其高死亡率，这些新生儿紧急情况也使几乎所有早产儿护理提供者感到恐惧。 它在美国的医疗保健每年需要30亿美元，原因是反复的X光检查、手术、住院时间更长以及幸存者的长期并发症。NEC的早期和准确的诊断测试将是早产儿重症监护的颠覆性范式转变：它将使医疗干预更加有效，降低疾病进展的风险，每年减少数亿美元的医疗费用，并降低死亡率。拟议的项目将开发诊断测试所需的试剂，从而能够检测在肠道健康中发挥作用的婴儿蛋白质。 绝对定量是实验、实验室和测试平台之间数据解释和验证的先决条件。研究目标针对关键技术障碍：（1）确定在临床环境中定量宿主生物分子的最佳参比标准品，以及（2）了解这些参比标准品在人群高度变异背景下的使用限制。将用各种方法比较和分析天然和重组候选物。 预期的结果是参考标准，是年龄特定的诊断使用在最脆弱和最小的病人，是可接受的监管利益相关者。这个奖项反映了NSF的法定使命，并已被认为是值得支持的评估使用基金会的智力价值和更广泛的影响审查标准。

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is to advance clinical methods that address the extensive physiological variation that is age- and race-dependent. Well-publicized over the last few decades is the lack of healthcare solutions for diseases in preemie babies, who are born to mothers with significant socioeconomic inequalities. Case in point, necrotizing enterocolitis (NEC) is a common and often fatal gastrointestinal, or gut, emergency in premature infants that disproportionately affects African American babies. The disease has not only confounded doctors and nurses for 200 years, but also these neonatal emergencies are also frightening to almost all preemie care providers due to its high mortality rate. Its healthcare in the US requires $3 billion annually due to repeated x-ray testing, surgery, longer hospital stays, and long-term complications of its survivors. An early and accurate diagnostic test for NEC would be a disruptive paradigm shift in preemie intensive care: it would enable medical intervention to be more effective, reduce risk of disease progression, decrease medical care expenses by hundreds of millions annually, and lower mortality.The proposed project will develop requisite reagents for a diagnostic test that will enable detection of infant proteins that play a role in gut health. Absolute quantitation is a prerequisite for data interpretation and validation between experiments, laboratories, and testing platforms. Research objectives are directed toward critical technical hurdles: (1) determination of optimal reference standard to quantitate host biomolecules in clinical settings and (2) understanding the usage limitations of these reference standards in the background of high variation in the human population. Native and recombinant candidates will be compared and analyzed with various methods. Anticipated results are reference standards that are age-specific for diagnostic use in the most fragile and smallest patients and that are acceptable to regulatory stakeholders.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.