DIAGNOSTIC VIABILITY OF UMBILICAL CORD SPECIMENS

描述(由申请人提供)：该项目的目的是开发一种诊断测试，以评估脐带是否能提供与胎粪相同或更好的信息，以识别胎儿药物暴露。母亲吸毒给母亲和孩子都造成了许多医疗并发症。虽然有许多对被诊断为宫内药物暴露的新生儿进行有效干预的成功案例，但许多受影响的新生儿因采集错误的样本或无法获得样本而被遗漏。在这个项目中，我们建议与胎粪检测的“金标准”相比较，来确定脐带的诊断可行性。脐带可用于所有分娩的分析，无论宫内窘迫或尿液和胎粪收集错误。新生儿出生时的诊断能力将增加他们接受适当干预的机会；大幅降低总体医疗成本，并通过适当的干预大大提高新家庭的生活质量。 通常使用尿液和/或胎粪样本在新生儿中检测到滥用药物。尿液只有2-3天的药物暴露史和胎粪，而由于宫内窘迫，提供长达20周的病史并不总是存在。因此，为了尽可能准确地诊断出尽可能多的暴露于此的新生儿，一个广泛可用的样本能够很好地衡量药物滥用的历史是必要的。在第一阶段，建议对成对的胎粪和脐带样本进行药物滥用分析，以确定脐带是否将提供与胎粪相同的信息。如果分析方法可行，产生的数据将能够确定脐带样本是否可以用来取代胎粪和尿液收集，用于对所有可能接触毒品的新生儿进行测试。该项目的进一步阶段将包括扩大药物测试小组和分析脐带上的酒精生物标记物。该测试的商业化领域涉及初级保健提供者，他们将能够使用一种易于收集、历史准确、广泛可用的样本类型来识别所有新生儿的药物和酒精暴露情况。总体目标是开发一种诊断测试，根据对脐带的分析来评估胎儿接触药物和酒精的情况。

DESCRIPTION (provided by applicant): The purpose of this project is to develop a diagnostic test to assess whether the umbilical cord can provide equivalent or superior information to meconium for the identification of fetal drug exposure. Maternal drug use causes numerous medical complications for both mother and child. While there are many success stories of effective intervention for newborns diagnosed with in utero drug exposure, many affected neonates are missed due to collection of the wrong specimen, or sample unavailability. In this project, we propose to determine the diagnostic viability of the umbilical cord, in comparison to the "gold standard" of meconium testing. The umbilical cord is available for analysis in all births, regardless of in utero distress or errors in urine and meconium collection. The ability to diagnose neonates at birth will increase their chances of receiving appropriate intervention; decrease overall healthcare costs dramatically and, with proper intervention greatly enhance the quality of life of a new family. Drugs of abuse are routinely detected in newborns using urine and/or meconium samples. Urine gives only a 2-3 day history of drug exposure, and meconium, while providing up to a 20-week history is not always present due to in utero distress. Therefore, in order to accurately diagnose as many exposed newborns as possible, a widely available specimen giving a good historical measurement of substance abuse is necessary. During Phase I, the analysis of paired meconium and umbilical cord samples for drugs of abuse is proposed in order to determine whether umbilical cord will provide the same information as meconium. If the analytical approach is feasible, the data produced will be able to determine whether the umbilical cord samples can be used to replace meconium and urine collections for the testing of all newborns potentially exposed to drugs. Further phases of the project will include extending the drug test panel and the analysis of alcohol bio-markers in the umbilical cord. Commercialization areas of the test involve primary care providers, who will be able to identify drug and alcohol exposure in all newborns using an easily collected, historically accurate, widely available sample type. The overall goal is to develop a diagnostic test to assess fetal drug and alcohol exposure based on the analysis of the umbilical cord.