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

 描述(申请人提供)：无创高特异性检测生物体液中的催产素催产素是一种神经肽激素，在各种复杂的社会行为中发挥着重要作用，包括从属关系、性行为和攻击。它最广为人知的作用是通过诱导子宫肌层肌肉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使用与后代晚年的各种神经疾病联系起来，包括自闭症谱系障碍， 双相情感障碍、儿童认知问题和儿童多动症。因此，在分娩期间使用催产素可能会对儿童的神经发育轨迹产生影响，因此有必要对其进行围产期监测。人们对准确测定体内催产素水平越来越感兴趣；然而，不幸的是，这一领域的研究由于缺乏非侵入性方法而受到限制，特别是考虑到脆弱患者的参与。因此，为研究人员和医学专业人员提供一种简单实用的治疗点仪器，准确地测定孕妇和新生儿的外周催产素水平，将是非常有价值的。目前，催产素的测量是使用商业上可用的免疫分析方法进行的；然而，这些方法是非特异性的，而且它们还需要熟练的人员和完善的实验室中繁琐的样品制备方案，这导致了长时间的周转时间(几小时到几天)。仪器也很昂贵，不适合台式或便携式的需要。就我们所知，目前还没有可用的仪器能够检测到 催产素。Giner，Inc.(Giner)建议开发一种电化学分析方法，并验证一种用于高灵敏度和近乎实时的围产期催产素监测的护理点仪器。在第一阶段的工作中，Giner将开发第一种基于适体的靶向和直接电化学检测方法，目标催产素的检测限(LOD)水平为10 pg/ml。将在存在非靶标多肽激素(如加压素)的情况下对结果进行特异性评估，以实现&gt；100倍的选择性。最后，传感器的性能将在临床收集的人类唾液样本中进行评估，并将结果与免疫分析结果进行基准比较。在第二阶段，我们将专注于仪器的小型化和自动化方面(传感器及其相关电子设备)，同时提高传感器的灵敏度和选择性，旨在将血液和唾液水平关联起来。 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.