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2400万美国人需要长期的免疫抑制疗法/治疗， 自身免疫性疾病或因为他们最近有移植，实体器官或骨髓。免疫的目标 抑制是给予最小有效剂量，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移植的情况下防止器官排斥反应， 使病人很容易受到感染研究表明，有一个狭窄的窗口， 血液中免疫抑制药物的治疗浓度，其对给定患者安全有效， 不幸的是，不同的患者可能需要显著不同的剂量来达到最佳水平。 使问题进一步复杂化的是，必须在给药后以精确的时间间隔测量药物水平， 解释了不同病人之间代谢率的差异。不幸的是，目前的技术 用于测量这些药物水平需要大量的血液抽取，这只能在集中的实验室设施中获得。所以， 在实践中，免疫抑制药物监测除了 不方便，患者必须：1）安排前往抽血诊所的交通工具， 移植中心，这可能是离家数百英里; 2）采取剂量，并等待数小时左右的 药物进入他们的血液;和/或3）有几个这样的抽血。这个过程对于常规来说是行不通的 药物监测Electronic BioSciences，Inc. (EBS)建议开发一种新的方法，基于最新的 纳米孔技术的进步，用于监测免疫抑制药物。的优势 新技术的一个优点是，它将像手指针刺葡萄糖测试一样容易获得和使用。这将反过来 使这些患者在医院，移植， 中心，门诊诊所，甚至在家里。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，从而减少危及生命的感染 和/或器官排斥的发作。直到有一种快速、简单、廉价的免疫抑制药物监测方法 如果这种技术发展起来，病人将承受不必要的负担和风险，医生将继续被蒙在鼓里。 在尝试正确给药的时候