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

小型企业创新研究(SBIR)第一阶段项目的更广泛影响是确定最准确地测量患者样本中蛋白质丰度的方法。所获得的答案将解决一种致命的新生儿肠道疾病-坏死性小肠结肠炎，这种疾病对非裔美国早产儿的影响不成比例，而且缺乏改善疾病的治疗。这项拟议的技术将作为医院、参考实验室和制药公司，特别是高敏感度新生儿重症监护病房的临床可部署诊断工具。拟议的项目将推动开发一种针对服务不足人群的诊断方法。此外，开发团队将包括未被充分代表的创新者。建议的项目将优化蛋白质丰度的参考标准和检测方法的选择。绝对量化是在实验、实验室和测试平台之间进行数据解释和验证的先决条件。目前的临床实践只利用了一种导致疾病的突变类型；它们很少针对具有广泛多态变异的目标蛋白质，这种变异与年龄和种族有关。这项建议的目标是开发临床上可靠的参考标准，以便能够在医院病理环境中使用新的候选生物标记物。研究目标包括：(1)确定两种常用方法在临床环境中量化生物分子的最佳参考标准组成，以及(2)了解这些参考标准在人类种群高度序列变异的背景下的使用限制。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.