Point-of-care device to identify patients at risk for preeclampsia

用于识别有先兆子痫风险的患者的护理点设备

• 批准号: 9789872
• 负责人: Shrikumar Ambujakshan Nair
• 金额: $ 73.62万
• 依托单位: AFFINERGY, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-24 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9789872
• 关键词: Accounting; Affect; African American; Alzheimer' s Disease; Antibodies; Binding; Biological Markers; Blood Pressure; Caring; Cell Count; Cells; Chronic; Clinical; Clinical Research; Collagen; Collection; Complication; Consumption; Cost Savings; Custom; Detection; Development; Devices; Diabetes Mellitus; Diagnosis; Diagnostic; Diagnostic tests; Equipment; Erythrocytes; Fetus; Fluorescence; Healthcare Systems; Hispanics; Hospitalization; Immunofluorescence Immunologic; Incidence; International; Kidney; Lead; Life; Magnetism; Maternal Mortality; Measures; Membrane; Methods; Monitor; Morbidity - disease rate; Mothers; Onset of illness; Organ; Patients; Peptides; Performance; Phase; Pre-Eclampsia; Pregnancy; Pregnancy Complications; Pregnant Women; Production; Proteinuria; Provider; Reader; Research; Risk; Risk Assessment; Second Pregnancy Trimester; Sedimentation process; Sensitivity and Specificity; Specimen; Stains; System; Technology; Testing; Time; United States; Urine; Urine Casts; Woman; body system; clinically significant; cost; diagnostic biomarker; endothelial dysfunction; fetal; improved; lead candidate; magnetic beads; maternal morbidity; mortality; novel; phase 1 study; podocyte; point of care; product development; prospective; prototype; scale up; stability testing; trend

Although international trends for maternal mortality have shown an overall decline, maternal mortality rates in the United States have increased by >25% since 2000. One of the leading causes for this increase is preeclampsia, a complication of pregnancy characterized by elevated blood pressure, proteinuria, and endothelial dysfunction involving multiple organ systems. Worldwide, preeclampsia is one of the leading causes of fetal and maternal morbidity and mortality, and annually accounts for nearly 16% of maternal deaths in the United States alone. Moreover, African American women are disproportionately affected by preeclampsia in the United States, with a 1.5- to 2-fold increase in incidence and a 4-fold increase in mortality rate. Several factors have been attributed to this disparity, but the leading cause is considered to be assessment errors by the patient’s provider. One explanation for this is the lack of a sensitive and specific diagnostic test to predict which patients have or will develop preeclampsia. Patients with preeclampsia require increased monitoring during their pregnancy and may even require extended hospitalization with continuous monitoring of the mother and fetus; thus, there is an urgent and unmet need for a diagnostic test that can identify those patients at risk for preeclampsia. Significant efforts are underway to detect preeclampsia prior to disease onset. Recently, it was demonstrated that biomarker present in preeclamptic patients can be detected in the second trimester, prior to preeclampsia diagnosis, with high sensitivity and specificity. Affinergy is developing a point-of-care device that will capture, isolate, and allow rapid quantification of this biomarker and unambiguous diagnosis of preeclampsia. Such a technology will improve the quality of podocyte capture and lead to significant cost savings by minimizing time and need for expensive equipment. In this Phase II application, we will focus on developing optimal peptide- modified magnetic beads for isolating podocytes.

尽管孕产妇死亡率的国际趋势显示总体下降，但#年的孕产妇死亡率 自2000年以来，美国的出口额增长了25%。造成这一增长的主要原因之一是 先兆子痫是妊娠的一种并发症，其特征是血压升高、蛋白尿和 涉及多个器官系统的内皮功能障碍。在世界范围内，先兆子痫是导致子痫的主要原因之一 胎儿和产妇的发病率和死亡率，每年占全国孕产妇死亡的近16% 单单是美国。此外，在美国，非裔美国妇女受到先兆子痫的影响不成比例。 在美国，发病率增加了1.5到2倍，死亡率增加了4倍。几个因素 都归因于这种差异，但主要原因被认为是患者的评估错误 提供商。对此的一种解释是，缺乏一种敏感和特异的诊断测试来预测哪些患者 患有或将要发展为先兆子痫。先兆子痫患者需要加强监测 怀孕，甚至可能需要延长住院时间，对母亲和胎儿进行持续监测； 因此，迫切需要一种诊断性测试，以识别那些有患病风险的患者，这种需求尚未得到满足 先兆子痫。目前正在作出重大努力，以便在发病前发现先兆子痫。最近，有研究表明，子痫前期患者体内存在的生物标记物可以在子痫前期诊断前的中期检测到，具有很高的敏感性和特异性。AffinEnergy正在开发一种护理点设备，该设备将捕获、隔离并允许快速量化这一生物标记物，并对先兆子痫进行明确诊断。这样的一个 技术将提高足细胞捕获的质量，并通过最大限度地减少时间来显著节省成本 以及对昂贵设备的需求。在这个第二阶段的应用中，我们将专注于开发最佳的多肽- 用于分离足细胞的改良磁珠。