Point-of-Care Multiplexed Immunosuppressant Monitoring

即时多重免疫抑制剂监测

• 批准号: 10759162
• 负责人: Anna Schibel
• 金额: $ 30万
• 依托单位: ELECTRONIC BIOSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-10 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10759162
• 关键词: Ambulatory Care Facilities; American; Antibodies; Autoimmune Diseases; Binding; Biological Sciences; Biosensing Techniques; Biosensor; Blood; Blood Circulation; Blood specimen; Bone Marrow; Charge; Chemicals; Chemistry; Clinic; Clinical; Collaborations; Complex; Consumption; Dangerousness; Darkness; Detection; Development; Disease remission; Dose; Drug Monitoring; Electrolytes; Electronics; Elements; Evaluation; Excision; Filtration; Fingers; Foundations; Glucose; Goals; Home; Hospitals; Hour; Immobilization; Immune system; Immunoassay; Immunosuppression; Immunosuppressive Agents; Individual; Infection; Ions; Kidney Transplantation; Label; Laboratories; Life; Ligands; Liquid Chromatography; Mass Spectrum Analysis; Measurement; Measures; Medical; Medicine; Metabolism; Methods; Microfluidics; Monitor; Organ; Organ Transplantation; Pancreas Transplantation; Pathology; Patient Care; Patient Monitoring; Patient-Focused Outcomes; Patients; Performance; Pharmaceutical Preparations; Pharmacogenetics; Phase; Physician Executives; Plasma; Process; Reader; Regimen; Research; Research Personnel; Risk; SDZ RAD; Sampling; Sensitivity and Specificity; Shapes; Side; Signal Transduction; Sirolimus; Small Business Innovation Research Grant; Solid; Speed; Surface; Systems Integration; Tacrolimus; Techniques; Technology; Testing; Therapeutic; Therapeutic immunosuppression; Time; Tissues; Toxic effect; Toxicology; Training; Transplant Recipients; Transplantation; Transportation; Tube; United States National Institutes of Health; Universities; Utah; Vial device; Whole Blood; aptamer; cost; cross reactivity; design; detection limit; dosage; improved; instrumentation; nanopore; organ transplant rejection; patient population; personalized care; point of care; prevent; professor; programs; prototype; research and development; response; sensor; sensor technology; side effect; signal processing; small molecule; solid state; tandem mass spectrometry; time interval; tool; transplant centers; voltage

Project Summary Approximately 24 million Americans require long-term immunosuppressive therapy/treatment, either due to an autoimmune disease or because they recently had a transplant, solid organ or bone marrow. The goal of immune suppression is to administer the minimum effective dose to prevent the immune system’s attack on the patient’s own tissue in the case of an autoimmune disease or prevent organ rejection in the case of a transplant, without leaving the patient dangerously vulnerable to infection. Research has shown there is a narrow window of therapeutic concentrations for immunosuppressive drugs in blood that is safely effective for a given patient and unfortunately, different patients can require dramatically different dosages to reach that optimal level. Complicating the matter further is the fact that drug levels must be measured at precise intervals after dosing to account for differences in the rates of metabolism from patient-to-patient. Unfortunately, the current technology for measuring these drug levels requires large blood draws that are only available in centralized lab facilities. So, in practice, immunosuppressive drug monitoring is logistically complicated and burdensome, in addition to being inconvenient and largely inaccessible for patients, who must: 1) arrange transportation to a blood draw clinic or transplant center, which may be hundreds of miles from home; 2) take a dose and wait around for hours for the drugs to enter their bloodstream; and/or 3) have several these blood draws. This process is unfeasible for routine drug monitoring. Electronic BioSciences, Inc. (EBS) proposes to develop a new method, based on the latest advances in nanopore technology, for the monitoring of immunosuppressive drugs. The advantage of the developed technology is that it will be as easy to obtain and use as a fingerstick glucose test. This will in turn enable readily available, routine immunosuppressive drug monitoring for these patients, at hospitals, transplant centers, outpatient clinics, or even at home. More frequent monitoring of immunosuppressive drug levels at specific time intervals will result in more accurate dosing, and consequently fewer life-threatening infections and/or episodes of organ rejection. Until a fast, easy, inexpensive test for immunosuppressive drug monitoring is developed, patients will be unnecessarily burdened and at risk, and doctors will continue to be in the dark when trying to correctly dose these drugs.

项目摘要 大约有2400万美国人需要长期的免疫抑制治疗/治疗 自身免疫性疾病或最近有移植，固体器官或骨髓。免疫的目标 抑制是管理最小有效剂量，以防止免疫系统对患者的攻击 在自身免疫性疾病的情况下，自己的组织或在没有移植的情况下防止器官排斥 使患者危险地容易感染。研究表明，有一个狭窄的窗口 血液中免疫抑制药物的治疗浓度对给定患者有效，并且 不幸的是，不同的患者可能需要急剧不同的剂量才能达到最佳水平。 进一步使此事复杂化的事实是，在给药后必须精确测量药物水平 解释了患者到患者的代谢率差异。不幸的是，当前的技术 为了测量这些药物水平，需要大量抽血，仅在集中式实验室设施中可用。所以， 实际上，除了是 对于患者而言，不方便的和很大程度上无法访问，必须：1）安排运输到抽血诊所或 移植中心，可能离家数百英里； 2）服用剂量，等待几个小时 吸毒进入血液；和/或3）有几种这些血液。这个过程对于常规是不可行的 药物监测。电子生物科学，Inc。（EBS）提出的，以最新的方式开发一种新方法 纳米孔技术的进步，用于监测免疫抑制药物。优势 开发的技术是，它将像指尖葡萄糖测试一样容易获得和使用。反过来将 可以随时为这些患者，在医院，移植中提供常规的常规免疫抑制药物监测 中心，门诊诊所，甚至在家。更频繁地监测免疫抑制药物水平 特定的时间间隔将导致更准确的给药，因此威胁生命的感染更少 和/或器官排斥的发作。直到进行免疫抑制药物监测的快速，简单，廉价的测试 已开发，患者将不必要烧毁并且处于危险之中，医生将继续处于黑暗状态 尝试正确剂量这些药物时。