Phosphatidylethanol as an Alcohol Biomarker in Neonatal Blood Spots

DESCRIPTION (provided by applicant): It is now well recognized that frequent and/or binge drinking of alcohol by a pregnant woman puts her fetus at high risk for birth defects. Moreover, the prevalence of binge drinking in women of childbearing-age seems to be increasing. While there is presently no cure for fetal alcohol-induced neural damage, early diagnosis and appropriate care and treatment of these children can improve their long-term outlook. The current gold standard for identifying alcohol-exposed neonates is the detection of fatty acid ethyl esters (FAEE) in their meconium. There are limitations of this test, however, and these include the lack of a meconium sample in 8-20% of births and the relatively low sensitivity (lt70%) of the FAEE meconium t est. In addition, there are no good identifiers for a pregnant woman who has been drinking and self-reporting is not considered reliable. A cost-effective screening assay that would identify heavily alcohol-exposed neonates with high sensitivity (gt90%) co uld potentially result in the savings of hundreds of millions of dollars in costs associated with medical, behavioral, custodial, and judicial services for older children suffering from alcohol-induced birth defects. A relatively new specific alcohol bioma rker, phosphatidylethanol (PEth), has been shown to be present in red cells of heavy drinkers with a sensitivity approaching 100%. PEth is a pathologic membrane phospholipid formed by phospholipase D in the presence of alcohol. The goal of this Phase I pro ject is to determine the feasibility of detecting PEth in blood spots taken from neonates and comparing the incidence and level of PEth in the blood spot to the incidence and level of FAEE present in a matching meconium sample from 200 consecutive newborns . If the blood spot/PEth assay is equivalent or superior to the meconium/FAEE assay, we will have established the feasibility of developing a cost- effective, general population neonate alcohol exposure assay that could potentially be coupled to comprehens ive genetic screening assays currently in use. Design and validation of such a coupled alcohol exposure assay would be the primary goal of a Phase II study.