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

这项小企业创新研究（SBIR）第一阶段项目的广泛影响是确定了测量患者样本中蛋白质丰度的最准确方法。获得的答案将解决致命的新生儿肠道疾病，坏死性小肠结肠炎，不成比例地影响非裔美国早产儿，缺乏疾病改善治疗。提议的技术将作为医院、参考实验室和制药公司的临床可部署诊断，特别是高锐新生儿重症监护病房。拟议的项目将促进为服务不足的人群开发一种诊断方法。此外，开发团队将包括代表性不足的创新者。本课题将优化蛋白质丰度参比标准品的选择和检测方法。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。目前的临床实践只利用一种引起疾病的突变；他们很少处理具有广泛多态性变异的靶蛋白，这是年龄和种族依赖的。本提案的目标是制定参考临床稳健的标准，使新的候选生物标志物在医院病理设置中使用。研究目标包括：(1)确定临床环境中两种常用的生物分子定量方法的最佳参比标准物组成；(2)了解这些参比标准物在人类高序列变异背景下的使用局限性。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is the determination of the most accurate method of measuring protein abundance in patient samples. The answers obtained will address a fatal neonatal gut disease, necrotizing enterocolitis, that disproportionately affects African-American preterm infants and lacks disease-modifying treatments. The proposed technology will serve as a clinically-deployable diagnostic for hospitals, reference labs, and drug companies, particularly high-acuity neonatal intensive care units. The proposed project will advance the development of a diagnostic for an underserved population. In addition, the development team will include underrepresented innovators. The proposed project will optimize the choice of reference standard and detection method for protein abundance. Absolute quantification is a prerequisite for data interpretation and validation between experiments, laboratories, and testing platforms. Current clinical practice exploits only a single type of mutation that gives rise to disease; rarely do they address a target protein with extensive polymorphic variation that is age- and race-dependent. The goal of this proposal is to develop reference clinically robust standards to enable use of a new candidate biomarker in hospital pathology settings. Research objectives include: (1) identification of optimal reference standard composition for two common methods to quantify biomolecules in clinical settings and (2) understanding usage limitations of these reference standards in the background of high sequence variation in the human population.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.