Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids

非侵入性、高特异性检测生物体液中的催产素

• 批准号: 9131542
• 负责人: Avni A Argun
• 金额: $ 22.5万
• 依托单位: GINER, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-18 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9131542
• 关键词: Aggressive behavior; Algorithms; Anesthesia procedures; Anesthesiology; Area; Attention deficit hyperactivity disorder; Automation; Back; Benchmarking; Binding; Biological; Biological Assay; Biosensor; Birth; Blood; Buffers; Child; Childbirth; Childhood; Clinical; Clinical Research; Cognitive; Collaborations; Collection; Complex; Data; Detection; Development; Discipline of obstetrics; Dose; Electrodes; Electronics; Ensure; Enzyme Immunoassay; Etiology; Evaluation; Feasibility Studies; Goals; Health Professional; Hormones; Hour; Human; Human Resources; Immunoassay; Label; Laboratories; Life; Link; Liquid substance; Long-Term Effects; Measurement; Measures; Medical; Methods; Miniaturization; Monitor; Morbidity - disease rate; Mothers; Muscle Contraction; Myometrial; Neonatal; Neuropeptides; Newborn Infant; Oxytocin; Performance; Perinatal; Peripheral; Phase; Plasma; Play; Pregnant Women; Preparation; Process; Protocols documentation; Reference Standards; Reporting; Research; Research Personnel; Risk; Role; Running; Saliva; Salivary; Sampling; Sensitivity and Specificity; Sex Behavior; Signal Transduction; Small Business Technology Transfer Research; Smooth Muscle; Social Behavior; Specificity; Surface; System; Testing; Time; Validation; Vasopressins; Vendor; Woman; Work; aptamer; autism spectrum disorder; base; childhood bipolar disorder; experience; improved; innovation; instrument; instrumentation; interest; magnetic beads; medical schools; neonate; nervous system disorder; non-invasive monitor; offspring; patient population; peptide hormone; point of care; programs; prohormone; public health relevance; research study; sensor; social; tool

 DESCRIPTION (provided by applicant): Non-Invasive Highly Specific Detection of Oxytocin in Biological Fluids Oxytocin, a neuropeptide hormone, plays an important role in a variety of complex social behaviors including affiliation, sexual behavior, and aggression. It is best known for its role to facilitate the birth process through induction of myometrial muscle contractions. However, recent studies have linked the exogenous administration of oxytocin during childbirth to various neurological disorders later in the offspring's life including autism spectrum disorder, bipolar disorder, childhood cognitive issues, and childhood ADHD. Administration of oxytocin during childbirth can therefore have consequences on the neurodevelopmental trajectory of children, necessitating its perinatal monitoring. There is an increased interest in accurate determination of oxytocin levels in the body; however, research in this area has unfortunately been limited by lack of noninvasive methods, especially considering the involvement of vulnerable patient populations. Therefore, it would be extremely valuable to provide researchers and medical professionals with a simple and practical point-of-care instrument that would accurately determine the peripheral levels of oxytocin in pregnant women and neonatals. Currently, oxytocin measurements are made using commercially available immunoassays; however, these methods are non-specific to extended forms of oxytocin prohormones and they also require skilled personnel and laborious sample preparation protocols in well-established laboratories that result in long turn-around- times (hours to days).The instrumentation is expensive as well and does not lend itself to desktop or portable needs. To the best of our knowledge, there is no currently available instrument that is capable of point-of-care detection of oxytocin. Giner, Inc. (Giner) proposes to develop an electrochemical assay and validate a point-of-care instrument for highly sensitive and near-real-time perinatal monitoring of oxytocin. During the Phase I work, Giner will develop the first of its kind assay by using aptamer-based targeting and direct electrochemical detection with a targeted oxytocin limit-of-detection (LOD) level of 10 pg/ml. The results will be evaluated for specificity in the presence of non-target peptide hormones such as vasopressin to achieve >100x selectivity. Finally, the sensor's performance will be evaluated in clinically collected human saliva samples and the results will be benchmarked to the immunoassay results. In Phase II, we will focus on miniaturization and automation aspects of the instrument (sensor with associated electronics) while improving the sensitivity and selectivity of the sensor that will aim to correlate the blood and saliva levels of oxytocin via a broader clinical research perinatal study.

 描述（由申请人提供）：生物体液中催产素的非侵入性高特异性检测催产素是一种神经肽激素，在多种复杂的社会行为中发挥着重要作用，包括归属、性行为和攻击性，它以其最广为人知的作用。然而，最近的研究表明，分娩过程中外源性施用催产素与后代生活中的各种神经系统疾病（包括自闭症谱系障碍）有关。紊乱， 因此，分娩期间使用催产素会对儿童的神经发育轨迹产生影响，因此需要进行围产期监测，但研究表明人们对准确测定体内催产素水平越来越感兴趣。不幸的是，由于缺乏非侵入性方法，该领域的研究受到限制，特别是考虑到弱势患者群体的参与，因此，为研究人员和医疗专业人员提供一种简单实用且能够准确地进行护理的仪器将非常有价值。确定孕妇和新生儿的外周催产素水平目前，催产素测量是使用市售的免疫测定法进行的；然而，这些方法对于扩展形式的催产素原激素没有特异性，并且还需要熟练的人员和繁琐的样品制备方案。 - 成熟的实验室导致周转时间较长（数小时至数天）。仪器也很昂贵，并且不适合台式或便携式需求。目前还没有能够进行即时检测的仪器 Giner, Inc. (Giner) 计划开发一种电化学测定方法并验证一种用于高灵敏度和近实时围产期监测的催产素仪器。此类检测采用基于适体的靶向和直接电化学检测，目标催产素检测限 (LOD) 水平为 10 pg/ml。结果将进行特异性评估。最后，将在临床收集的人类唾液样本中评估传感器的性能，并将结果与​​免疫测定结果进行基准比较。仪器的小型化和自动化（带有相关电子设备的传感器），同时提高传感器的灵敏度和选择性，旨在将血液和唾液水平关联起来 催产素通过更广泛的临床研究围产期研究。