DIAGNOSTIC VIABILITY OF UMBILICAL CORD SPECIMENS

脐带标本的诊断可行性

• 批准号: 6737152
• 负责人: CHARLES A PLATE
• 金额: $ 10万
• 依托单位: U.S. DRUG TESTING LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-06-01 至 2004-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6737152
• 关键词: alcoholism /alcohol abuse; behavioral /social science research tag; biomarker; clinical research; diagnosis design /evaluation; diagnosis quality /standard; drug abuse; drug detection; embryo /fetus toxicology; enzyme linked immunosorbent assay; feces; human subject; immunologic assay /test; maternal behavior; newborn human (0-6 weeks); rapid diagnosis; sample collection; umbilical cord

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.

描述（由申请人提供）：该项目的目的是开发一种诊断测试，以评估脐带是否可以提供与胎便相同或更好的信息来识别胎儿药物暴露。母亲吸毒会给母亲和孩子带来许多医疗并发症。虽然有许多对被诊断患有子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由于采集了错误的样本或无法获得样本而被遗漏。在这个项目中，我们建议与胎便测试的“金标准”进行比较，以确定脐带的诊断可行性。脐带可用于所有新生儿的分析，无论是否存在子宫内窘迫或尿液和胎便收集错误。新生儿出生时诊断的能力将增加他们接受适当干预的机会；显着降低总体医疗费用，并且通过适当的干预可以大大提高新家庭的生活质量。 通常使用尿液和/或胎便样本在新生儿中检测滥用药物。尿液仅提供 2-3 天的药物暴露史，而胎便则由于子宫内窘迫而无法始终提供长达 20 周的药物暴露史。因此，为了准确诊断尽可能多的暴露新生儿，需要广泛使用的标本来提供良好的药物滥用历史测量结果。在第一阶段，建议对配对的胎便和脐带样本进行滥用药物分析，以确定脐带是否会提供与胎便相同的信息。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代替胎便和尿液收集，以测试所有可能接触药物的新生儿。该项目的进一步阶段将包括扩展药物测试组和脐带中酒精生物标记物的分析。该测试的商业化领域涉及初级保健提供者，他们将能够使用易于收集、历史准确且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，根据脐带分析评估胎儿药物和酒精暴露情况。