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

基本信息

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
项目类别：
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&apos 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

项目摘要

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总体呈下降趋势，但自 2000 年以来，美国的增长率超过 25%。这一增长的主要原因之一是先兆子痫是一种妊娠并发症，其特征是血压升高、蛋白尿和在世界范围内，先兆子痫是涉及多个器官系统的内皮功能障碍的主要原因之一。胎儿和孕产妇发病率和死亡率，每年占孕产妇死亡人数的近 16% 此外，仅在美国，非洲裔美国女性就受先兆子痫的影响尤为严重。美国的发病率增加了 1.5 至 2 倍，死亡率增加了 4 倍。已归因于这种差异，但主要原因被认为是患者的评估错误对此的一种解释是缺乏敏感且具体的诊断测试来预测哪些患者。患有或将出现先兆子痫的患者需要在其期间加强监测。怀孕，甚至可能需要长期住院并持续监测母亲和胎儿；因此，迫切需要一种诊断测试来识别那些有风险的患者。最近，人们正在大力努力在疾病发作前检测先兆子痫，最近发现，先兆子痫患者中存在的生物标志物可以在先兆子痫诊断之前的妊娠中期进行检测，Affinergy 正在开发一种具有高灵敏度和特异性的方法。护理设备将捕获、分离并允许快速量化这种生物标志物并明确诊断先兆子痫。该技术将提高足细胞捕获的质量，并通过最大限度地缩短时间来显着节省成本并需要昂贵的设备，在这个第二阶段的应用中，我们将专注于开发最佳的肽- 用于分离足细胞的改良磁珠。