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

 描述（由申请人提供）：生物流体中催产素的非侵入性高度特异性检测催产素是一种神经肽激素，在各种复杂的社会行为中起重要作用，包括亲密关系、性行为和攻击性。它最为人所知的作用是通过诱导子宫肌收缩来促进分娩过程。然而，最近的研究已经将分娩期间外源性催产素的施用与后代生命后期的各种神经系统疾病联系起来，包括自闭症谱系障碍， 躁郁症、儿童认知问题和儿童多动症。因此，分娩期间催产素的管理可能对儿童的神经发育轨迹产生影响，需要进行围产期监测。人们对准确测定体内催产素水平的兴趣越来越大;然而，不幸的是，这一领域的研究受到缺乏非侵入性方法的限制，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的即时检测仪器将是非常有价值的，该仪器将准确地确定孕妇和产妇中催产素的外周水平。目前，催产素测量是使用市售的免疫测定法进行的;然而，这些方法对催产素原激素的扩展形式是非特异性的，并且它们还需要熟练的人员和在完善的实验室中的费力的样品制备方案，这导致长的周转时间（数小时至数天）。据我们所知，目前还没有能够即时检测的仪器。 催产素Giner公司（Giner）建议开发一种电化学测定法，并验证一种用于高灵敏度和近实时围产期催产素监测的即时护理仪器。在第一阶段的工作中，Giner将通过使用基于适体的靶向和直接电化学检测来开发首个此类检测方法，目标催产素检测限（LOD）水平为10 pg/ml。将在非靶肽激素如加压素的存在下评价结果的特异性，以实现> 100 x的选择性。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测试。在第二阶段，我们将专注于仪器的小型化和自动化方面（传感器与相关电子设备），同时提高传感器的灵敏度和选择性，旨在将血液和唾液中的 催产素通过更广泛的临床研究围产期研究。

 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.