Point-of-care Testing (POCT) Tool Development for Critical Oxytocin Measurement

PROJECT SUMMARY/ABSTRACT Point-of-care Testing (POCT) Tool Development for Critical Oxytocin Measurement Oxytocin, a neuropeptide hormone, is best known for its role in the facilitation of childbirth through induction of myometrial smooth muscle contractions. Exogenous administration of oxytocin is critical in child birth for induction and augmentation of labor. Oxytocin is also administered to manage postpartum uterine atony and hemorrhage. Oxytocin levels also have great significance during the perinatal period as a potential biomarker for prediction of type of labor. Increased levels of circulating peripheral oxytocin levels are also linked to postpartum breast milk production, as well as decrease in frequency of migraine headaches over the course of pregnancy. 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 Testing (POCT) instrument that would accurately determine the peripheral levels of oxytocin. Currently, oxytocin measurements are made using commercially available immunoassays; however, these methods are not sufficiently specific and they also require skilled personnel and laborious sample preparation protocols 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 POC detection of oxytocin. Giner, Inc. will develop an electrochemical assay and validate a POC instrument for highly sensitive and near-real-time perinatal monitoring of oxytocin. Enabling measurement of oxytocin with a Limit of Detection (LOD) of 1 pg/mL, our novel electrochemical assay establishes fundamental development on such a POC device with high sensitivity and specificity. The Phase I program will improve and validate the current assay and build a pre-prototype that features a disposable cartridge coupled to a handheld reader. The entire assaying time will be less than 2 minutes. The Phase I program will build on successful preliminary results and Giner’s prior experience in biosensors to validate an electrochemical oxytocin monitor using both saliva, and blood samples. These samples will be collected and quantified by BioIVT and the results obtained from Giner’s assay will be benchmarked against the standard LC-MS/MS method.